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510(k) Data Aggregation
(380 days)
The SuperCheck Pro Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, forearm, upper arm, calf, thigh, or palm. It is intended to be used by a single person and should not be shared. The SuperCheck Pro Blood Glucose Monitoring System is for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.
The SuperCheck Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor for use with neonates.
Alternative site testing should be done only during steady-state conditions (when blood glucose is not changing rapidly).
SuperCheck Pro Blood Glucose Monitoring System is used for determining the approximate concentration of glucose in the blood. A complete kit (starter kit) of SuperCheck Pro Blood Glucose Monitoring System consists of:
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- SuperCheck Pro Blood Glucose Meter
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- SuperCheck Pro Blood Glucose Test Strips
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- OKmeter Control Solution (Level I, II)
Before use, The SuperCheck Pro Blood Glucose Test Strips should be inserted into the SuperCheck Pro Blood Glucose Meter first. Prick a fingertip with a sterile Lancet that installed in the Lancing device and apply the blood drop to the front edge of the Test Strip. Wait for 5 seconds and the Meter will display the test result.
OKmeter Control Solution containing a known amount of glucose that is used to confirm SuperCheck Pro Blood Glucose Meter and SuperCheck Pro Blood Glucose Test Strips are working properly together. Follow the same steps as above but replace the blood drop by OKmeter Control Solution.
OKmeter Control Solution and SuperCheck Pro Blood Glucose Test Strips could be separately bought.
The SuperCheck Pro Blood Glucose Monitoring System (Model OK-2MJB) measures the amounts of glucose in whole blood quantitative using fresh capillary whole blood from the fingertip and alternative sites including palm, forearm, upper arm, calf, and thigh. Amperometric technology is used for the detection of glucose from the strip with whole blood sample on the meter. Reagent consisting of glucose dehydrogenase with its cofactor flavin adenine dinucleotide (GDH-FAD) and mediator is deposited onto the reaction area of the test strip with carbon printed electrodes. The testing is based on the measurement of electrical current generated by the reaction of capillary whole blood glucose with the enzyme, GDH-FAD, on the test strip. The meter measures the strength of the current which is proportional to the amounts of glucose in the sample and displays the corresponding blood glucose concentration.
The provided text describes the SuperCheck Pro Blood Glucose Monitoring System and its substantial equivalence to a predicate device. It includes information on the device's indications for use, description, test principle, and a comparison with the predicate device. The document also summarizes non-clinical and clinical testing performed. However, it does not explicitly detail acceptance criteria with reported device performance in a numerical format, nor does it provide specific information regarding sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set details.
Based on the available text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document states that "all performance criteria were met" for both non-clinical and clinical studies. However, the specific numerical acceptance criteria for performance and the reported device performance values are not provided in the text. For example, for precision, linearity, or accuracy, the target ranges or thresholds and the actual measured performance are not listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "Clinical Testing Summary: A user evaluation confirmed the system accuracy, operation according to design, and ease of use..." but does not provide details on the sample size (number of participants) for this user evaluation or any other clinical study. The data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is a Blood Glucose Monitoring System, which does not involve human readers interpreting cases with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a blood glucose monitoring system intended for self-testing. Its performance is inherently standalone (algorithm/device only) in the context of generating a blood glucose measurement. The "Clinical Testing Summary" mentions "A user evaluation confirmed the system accuracy, operation according to design, and ease of use," implying human interaction for using the device, but the core measurement is a standalone function of the device. The text does not provide specific performance metrics for this standalone function, only that "all performance criteria were met."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a blood glucose monitoring system, the ground truth for accuracy would typically be established against a laboratory reference method (e.g., a laboratory analyzer that measures blood glucose). The document does not explicitly state the specific reference method used, but it is implied that the system's measurements were compared against accepted standards to confirm accuracy.
8. The sample size for the training set
This information is not applicable because this device is not an AI/ML device that requires a training set in the typical sense. It's a hardware-based electrochemical sensor system.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
Summary of available information related to acceptance criteria and study:
The submission confirms that non-clinical and clinical studies were conducted to test, verify, and validate the performance of the proposed device according to FDA Guidance issued on September 29, 2020: "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" and other relevant standards. The crucial statement is: "Results from these studies show that all performance criteria were met."
Non-Clinical Testing Summary: Design verification and validation testing included electrical/mechanical safety tests, functional performance tests (precision, linearity, interference, flex studies) as well as disinfection, cleaning, and robustness studies. Software validation was also performed.
Clinical Testing Summary: A user evaluation confirmed the system accuracy, operation according to design, and ease of use.
While the document states that all criteria were met and lists the types of tests performed, it lacks the specific quantitative details of the acceptance criteria and the measured performance results for each.
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(141 days)
The UniStrip1™ Generic Blood Glucose Test Strips are used with the OneTouch® Ultra®2, OneTouch®, UltraMini® and OneTouch®, UltraSmart® meters purchased before April 2016, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The strips are meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control.
They are for single patient use only and should not be shared.
They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearm. Testing is done outside the body (in vitro diagnostic use).
They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The UniStrip1™ Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch®, Ultra® meter). Alternative site testing should only be done during steady-state times (when glucose is not changing rapidly).
The UniStripl Generic Blood Glucose Test Strips are used with the OneTouch® Ultra, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters. The UniStrip1 Generic Blood Glucose Test Strips are intended for use outside the body (in vitro diagnostic use) by people with diabetes using the OneTouch® Ultra®, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® blood glucose monitoring systems as an aid to monitor the effectiveness of diabetes control. The UniStrip1 Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch* Ultra* meter). The UniStrip1 Generic Blood Glucose Test Strips can only be used with the OneTouch® Ultra®, OneTouch Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before April 2016. UniStripl Generic Blood Glucose Test Strips are only for use with calibration code 49.
The provided text details various studies and their acceptance criteria for the UniStrip1™ Generic Blood Glucose Test Strips. This device is intended for self-testing of blood glucose with several OneTouch® Ultra® meters.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Study/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Altitude Study | Individual bias within ±10% at altitudes from 298 feet (91 meters) to 11,161 feet (3,402 meters). SD < 5.0 mg/dL for glucose < 100 mg/dL, and CV < 5.0% for glucose ≥ 100 mg/dL. | Individual bias fell within ±10% from 298 feet (91 meters) to 11,161 feet (3,402 meters). SD < 5.0 mg/dL and CV < 5.0% for specified glucose concentrations. Claimed usability up to 10,000 ft. |
| Hematocrit Study | (1) All SD and CV < 5 mg/dL and 5% respectively. (2) All individual bias of glucose measurement vs YSI mean < 15%. (3) Mean Bias% to YSI for each sample < 10%. (4) Difference % between mean glucose bias and mean bias of mid-level sample (Hct: 42%) < 10%. | (1) All SD and CV were less than 5 mg/dL and 5% respectively. (2) All individual bias of glucose measurement vs YSI mean was less than 15%. (3) Mean Bias% to YSI for each sample < 10%. (4) Difference % between mean glucose bias and mean bias of mid-level sample (Hct: 42%) < 10%. Results met criteria for HCT 30% to 55%. |
| Interference Study | All bias of test results within the tested range ≤ 10% compared with controlled pool measurements. Concentration limits of interfering substances higher than therapeutic or physiological levels. | All bias of test results within the range were ≤ 10% compared with controlled pool. No obvious interference observed at therapeutic or physiological levels for interfering substances at two blood glucose levels. |
| Linearity Study | Correlation coefficient > 0.95. 100% of individual glucose results bias within ±10 mg/dL for glucose < 100 mg/dL, and ±10% for glucose ≥ 100 mg/dL, compared with YSI 2300. | Correlation coefficients were 0.9994 (Lot I), 0.99925 (Lot II), and 0.99955 (Lot III), all > 0.95. 100% of individual glucose results bias fell within ±10 mg/dL (glucose < 100 mg/dL) and ±10% (glucose ≥ 100 mg/dL) compared with YSI 2300. Linearity established from 20 to 600 mg/dL. |
| Operation Condition | Individual bias within ±10 mg/dL for glucose < 100 mg/dL and within ±10% for glucose ≥ 100 mg/dL. SD < 5.0 mg/dL for glucose < 100 mg/dL, and CV < 5.0% for glucose ≥ 100 mg/dL. | Individual bias was within ±10 mg/dL (glucose < 100 mg/dL) and within ±10% (glucose ≥ 100 mg/dL). SD < 5.0 mg/dL (glucose < 100 mg/dL) and CV < 5.0% (glucose ≥ 100 mg/dL). Operated normally in conditions 42-111°F (6-44°C), 10-90% R.H. |
| Precision Study | Pooled and maximum SD < 5.0 mg/dL for glucose < 75 mg/dL. Pooled and maximum CV < 5.0% for glucose ≥ 75 mg/dL. Maximum individual bias < 10% compared with glucose analyzer YSI 2300. | Pooled and maximum SD were < 5.0 mg/dL for glucose < 75 mg/dL. Pooled and maximum CV were < 5.0% for glucose ≥ 75 mg/dL. Maximum bias for all levels was between -5.3% and 3.7%. Repeatability CVs were primarily between 1.8% and 3.5%. Intermediate Precision CVs between 3.6% and 3.9%. |
| Shelf-Life Study | All data meet acceptance criteria. | Unopened vials stable for 24 months. Opened vials stable for 90 days. |
| User Performance | (Lay users): Correlation values R' > 0.98. Populations of individual bias: ≥95% users within ±15 mg/dL for glucose < 75 mg/dL, and ≥95% users within ±15% for glucose ≥ 75 mg/dL, compared with YSI 2300. | R' values were 0.9827 (Lot I), 0.9816 (Lot II), 0.9876 (Lot III), all > 0.98. For glucose < 75 mg/dL: 100% within ±15 mg/dL for fingertip and forearm. For glucose ≥ 75 mg/dL: 100% within ±15% for fingertip and forearm. |
| Satisfactory Evaluation | More than 85% of volunteers agree that labels and user guide provide enough product information. More than 95% of volunteers' scores > 80 points. | More than 85% of volunteers agreed labels and user guide provided enough information. More than 95% of scores were > 80 points. |
| Sample Volume Study | Required at least 1.0 µL to obtain normal test results. | The sample volume of UniStrip1 Generic Blood Glucose Test Strips with OneTouch® Ultra® Meters was required at least 1.0 µL to obtain the normal testing results. Measured glucose results using sample volumes from 1.0 to 1.5 µL. |
| Error Message Verification | Error messages displayed correctly at given conditions. | Error messages of OneTouch® Ultra® Meters displayed correctly at given condition of procedures. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Altitude Study: Not explicitly stated, but implies sufficient samples to demonstrate individual bias and precision metrics over the specified altitude range.
- Hematocrit Study: Not explicitly stated, but samples with HCT from 30% to 55% were used.
- Interference Study: Not explicitly stated, but samples with various interfering substances at different glucose levels were used.
- Linearity Study: Not explicitly stated, but implies sufficient samples to establish linearity across 20 to 600 mg/dL for three strip lots.
- Operation Condition Study: Not explicitly stated, but implies sufficient samples for evaluation in normal and extreme environments.
- Precision Study:
- Repeatability: 100 tests per lot at each of 5 glucose levels (Total: 3 lots x 5 levels x 100 tests = 1500 tests).
- Intermediate Precision: Not explicitly stated, but likely multiple tests per lot at each of 3 glucose levels over several days for each of 3 lots.
- Shelf-Life Study: Not explicitly stated.
- User Performance (Lay users) Evaluation:
- Glucose < 75 mg/dL: 20 capillary blood samples for fingertip, 20 for forearm.
- Glucose ≥ 75 mg/dL: 80 capillary blood samples for fingertip, 80 for forearm.
- Linearity Analysis: Implies sufficient samples collected by lay users to generate linearity equations for 3 strip lots.
- Satisfactory Evaluation: "More than 85% of volunteers" and "more than 95% of volunteers" imply a volunteer sample size, but the exact number isn't specified.
- Sample Volume Study: Not explicitly stated, but involved measuring glucose with sample volumes from 1.0 to 1.5 µL.
- Error Message Verification Study: Not explicitly stated.
Data Provenance: The studies were conducted by OK Biotech Co., Ltd. in Taiwan. The description does not specify if the data was retrospective or prospective, but clinical performance studies using human samples imply prospective collection for tests like user performance. Other tests (e.g., altitude, hematocrit, linearity, precision) likely used controlled laboratory samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The document primarily refers to the YSI 2300 Glucose Analyzer as the reference method for establishing ground truth for glucose measurements. The YSI 2300 is a laboratory-grade analyzer, considered a gold standard for glucose measurement; therefore, specific human experts for ground truth adjudication are not typically used in this context.
4. Adjudication Method for the Test Set
- Adjudication in the traditional sense (e.g., 2+1 expert consensus) is not applicable here as the ground truth for glucose concentration is established by a reference laboratory instrument (YSI 2300). The device's performance is directly compared to the results from the YSI 2300.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
- No MRMC comparative effectiveness study was done. This device is a blood glucose test strip system, not an AI-assisted diagnostic imaging device or similar system where human reader performance would be a primary endpoint. The "User Performance" study evaluates lay users' ability to operate the device correctly and obtain accurate readings, which is a different type of assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is a standalone device in the sense that the test strip and meter system provide a direct glucose reading. There isn't an "algorithm only" component separate from the integrated device. The performance data presented (linearity, precision, interference, etc.) represent the standalone performance of the test strip system. The "User Performance" study specifically assesses human-in-the-loop performance by lay users but is focused on correct operation and result accuracy, not on assistance with an AI algorithm.
7. The Type of Ground Truth Used
- The primary ground truth used is reference measurement by a Glucose Analyzer, specifically the YSI 2300. This is considered a highly accurate laboratory method for quantitative glucose determination.
8. The Sample Size for the Training Set
- The document describes performance studies and evaluation against established methods (YSI 2300).
- No explicit training set or development set size is mentioned. This type of medical device (blood glucose test strips) typically undergoes analytical and clinical validation studies without a "training set" in the machine learning sense. The device's chemical and electrical components are designed and optimized, and then validated through these performance studies.
9. How the Ground Truth for the Training Set Was Established
- Since no explicit training set for a machine learning model is mentioned, the concept of establishing ground truth for a training set in that context does not apply directly. The "ground truth" for evaluating the performance of the device design and manufacturing process is consistently the YSI 2300 Glucose Analyzer, as mentioned above.
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(204 days)
The UniStrip1™ Generic Blood Glucose Test Strips are used with the OneTouch® Ultra@2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before April 2016, and OneTouch® Ultra® purchased before October 2012, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The strips are meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control.
They are for single patient use only and should not be shared.
They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearm. Testing is done outside the body (in vitro diagnostic use).
They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control. Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The UniStrip1™ Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch® Ultra® meter). Alternative site testing should only be done during steady-state times (when glucose is not changing rapidly).
The UniStrip™ Control Solutions are for use with the UniStrip1™ Generic Blood Glucose Test Strips and OneTouch® Ultra® meters to check that the meters and test strip are working together properly and that the test is performing correctly.
UniStrip1 Generic Blood Glucose Test Strips are used with the OneTouch® Ultra, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters. The test strips are intended for use outside the body (in vitro diagnostic use) by people with diabetes using the OneTouch® Ultra®, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® blood glucose monitoring systems as an aid to monitor the effectiveness of diabetes control. UniStrip1 Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch* Ultra* meter). UniStrip1 Generic Blood Glucose Test Strips can only be used with the OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before April 2016, and OneTouch® Ultra® purchased before October 2012. UniStrip1 Generic Blood Glucose Test Strips are only for use with calibration code 49.
The document provided describes the UniStrip1 Generic Blood Glucose Test Strips and the studies conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several tests conducted according to ISO 15197:2013 and other CLSI/NCCLS standards. The acceptance criteria are generally qualitative (e.g., "met acceptance criteria," "within ±10 mg/dL," "less than 5.0 %"). For the User Performance Evaluation, a specific quantitative acceptance criterion is provided.
| Test / Performance Metric | Acceptance Criteria (as stated in document) | Reported Device Performance (as stated in document) |
|---|---|---|
| Sample Volume | Glucose measurements meet acceptance criteria. Required sample volume at least 1.0 µL to obtain normal testing results. | Glucose measurements of sample volume from 1.0 to 1.5 µL met acceptance criteria for normal testing results. |
| Operation Condition | Individual bias within ±10 mg/dL at glucose < 75 mg/dL and within ±10% at glucose ≥ 75 mg/dL. SD < 5.0 mg/dL at glucose < 75 mg/dL. CV < 5.0% at glucose ≥ 75 mg/dL. | Individual bias within ±10 mg/dL at glucose < 75 mg/dL. Individual bias within +10% at glucose ≥ 75 mg/dL. SD < 5.0 mg/dL at glucose < 75 mg/dL. CV < 5.0% at glucose ≥ 75 mg/dL. Operated normally in conditions 42-111 °F (6-44°C), 10-90% R.H. |
| Hematocrit Study | 1. All SD and CV < 5 mg/dL and 5%, respectively. 2. All individual bias vs. YSI mean < 15%. 3. Mean Bias% to YSI for each sample at each Hct level < 10%. 4. Difference % between mean glucose bias and mean bias of mid-level sample (Hct: 42%) < 10%. Test results met acceptance criteria. Hematocrit range from 30% to 55% available. | Met all four acceptance criteria. HCT ranges from 30% to 55% are available. |
| Altitude Study | Individual bias within ±10%. SD < 5.0 mg/dL at glucose < 75 mg/dL. CV < 5.0% at glucose ≥ 75 mg/dL. Test results met acceptance criteria. No significant effects from various altitudes. | Individual bias within ±10% at altitude from 298ft (91m) to 11,161ft (3,402m). SD < 5.0 mg/dL at glucose < 75 mg/dL. CV < 5.0% at glucose ≥ 75 mg/dL. Claims use up to 10,000 ft. |
| Linearity Study | R² > 0.95. 100% of individual glucose results within ±10 mg/dL at glucose < 75 mg/dL, and within ±10% at glucose > 75 mg/dL compared with Glucose Analyzer YSI 2300. Test results met acceptance criteria. Linearity available from 20 to 600 mg/dL. | Reported R² values for all meters and test sites are > 0.98 (ranging from 0.9829 to 0.9884), exceeding the >0.95 criterion. 100% of bias fell within ±10 mg/dL (<75 mg/dL) and ±10% (>75mg/dL) compared to YSI 2300. Linearity available from 20 to 600 mg/dL. |
| Precision Study | Pooled and maximum SD < 5.0 mg/dL at glucose < 75 mg/dL. Pooled and maximum CV < 5.0% at glucose ≥ 75 mg/dL. Maximum individual bias < 10% compared with glucose analyzer YSI 2300. Test results met acceptance criteria. | Within Run: SDs ranged from 1.2 to 8.2 mg/dL; CVs ranged from 1.5% to 3.5%. Between Run: SDs ranged from 0.8 to 8.0; CVs ranged from 2.1% to 3.1%. All stated to meet acceptance criteria for repeatability and intermediate precision. Maximum individual bias within 10% compared to YSI 2300. |
| Interference Study | All bias of test results for interfering substances within the range listed were < 10% compared with controlled pool measurements. No obvious interference observed at therapeutic or physiological levels. | All bias of test results within the listed range were < 10% compared with measurements of the controlled pool. No obvious interference observed in interfering substances at therapeutic nor physiological levels. |
| Shelf-Life Study | All data met acceptance criteria. Expected closed vial stability of 24 months, in-use vials 90 days for strips. Expected closed and in-use vial stability of 18 months and 90 days respectively for control solutions. | All data met the acceptance criteria. Closed vials of UniStrip1 Generic Blood Glucose Test Strips stable for 24 months, and 90 days for in-use vials. Closed and in-use vials of UniStrip Control Solutions stable for 18 months and 90 days respectively. |
| User Performance | Populations of individual bias ± 15 mg/dL at blood glucose concentration < 75 mg/dL and ± 15 % at blood glucose concentration ≥ 75 mg/dL compared with Glucose Analyzer YSI 2300 are more than 95 %. Test results met acceptance criteria, demonstrating proper operation by lay users. | The test results show that the populations of individual bias ± 15 mg/dL at blood glucose concentration < 75 mg/dL and ± 15 % at blood glucose concentration ≥ 75 mg/dL compared with Glucose Analyzer YSI 2300 are more than 95 %. |
| Satisfactory Evaluation | More than 85% of volunteers agree labels/user guide provide enough info. More than 95% of volunteers' scores > 80 points. | More than 85% of volunteers agree that the labels on the packing and the users' guide provided enough information. More than 95% of volunteers' scores were higher than 80 points. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Volume Study: Not explicitly stated, but "sample volume from 1.0 to 1.5 µL" was tested.
- Operation Condition Study: Not explicitly stated.
- Hematocrit Study: Not explicitly stated.
- Altitude Study: Not explicitly stated.
- Linearity Study: Not explicitly stated for each test point, but the method NCCLS/CLSI EP6-A:2014 suggests multiple readings across the range.
- Precision Study (Repeatability): For each of the 3 meters (OneTouch Ultra2, UltraMini, UltraSmart), 3 lots were tested, with 5 different glucose concentrations. For each concentration/lot/meter combination, n=50 measurements were taken. (e.g., 3 meters * 3 lots * 5 concentrations * 50 measurements = 2250 total measurements for repeatability study).
- Precision Study (Intermediate Precision): 3 lots were tested with 3 different glucose concentrations. Sample size not explicitly stated for each condition, but likely drawn from the broader precision study data.
- Interference Study: Not explicitly stated.
- Shelf-Life Study: Not explicitly stated.
- User Performance Evaluation: Not explicitly stated for the number of lay users.
- Satisfactory Evaluation: Not explicitly stated for the number of volunteers.
Data Provenance: The studies were conducted by OK BIOTECH CO., LTD. (Taiwan). The document does not specify the country of origin of the human blood samples used in the studies (e.g., for hematocrit, user performance). The studies are "pre-clinical data," implying they were conducted prospectively for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- No information is provided regarding the number of experts used or their qualifications for establishing ground truth for any of the studies.
- The ground truth reference method explicitly mentioned is the Glucose Analyzer YSI 2300. This is a laboratory reference instrument, not a human expert.
4. Adjudication Method for the Test Set
- No adjudication method (e.g., 2+1, 3+1, none) is mentioned or implied as the ground truth is established by a laboratory instrument (YSI 2300) rather than human interpretation that would typically require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. This device is a blood glucose test strip system, which provides a quantitative measurement, and does not involve human "readers" in the diagnostic interpretation sense that an AI-assisted imaging device would. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device (test strip + meter) is inherently a standalone system in terms of generating a glucose reading. The User Performance Evaluation evaluates the ability of lay users to operate the system correctly and obtain accurate results, which is a human-in-the-loop operational assessment, but the performance of the device itself in producing the glucose value is "standalone" from a diagnostic interpretation perspective. The closest comparison would be the linearity and precision studies that demonstrate the device's accuracy against a lab reference, which is essentially a standalone performance evaluation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for quantitative glucose measurements in several studies (Linearity, Precision, Hematocrit, User Performance) was established using a Glucose Analyzer YSI 2300. This is a laboratory reference instrument for measuring glucose concentration.
8. The Sample Size for the Training Set
- No information is provided about a specific "training set" or its size. This type of medical device (blood glucose test strip) does not typically involve machine learning or AI models that require distinct training sets in the same manner as image analysis algorithms. The device's performance is characterized through direct analytical and clinical studies.
9. How the Ground Truth for the Training Set Was Established
- As no training set is mentioned or implied for this type of device, this question is not applicable.
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(313 days)
Prodigy® Astro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The Prodig® Astro Blood Glucose Monitoring System is intended to be used in the home by a single person and should not be shared. The Prodigy® Astro Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Prodigy® Astro Blood Glucose Monitoring System should not be used for the diagnosis of, or screeming for diabetes, or for neonatal use. The alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). PRODIGY No Coding Test Strips are intended for use with the PRODIGY Astro blood glucose meters to measure concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh for self-testing at home.
Prodigy® Astro PRO Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The Prodigy® Astro PRO Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use by healthcare professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The Prodigy® Astro PRO Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes, or for neonatal use. The alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
PRODIGY PRO No Coding Test Strips are intended for use with the PRODIGY Astro PRO blood glucose meters to measure concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The system should only be used with single-use, auto-disabling lancing devices.
The Prodigy Astro Blood Glucose Monitoring System and the Prodigy Astro PRO Blood Glucose Monitoring System are identical devices (hereafter both are called the System), but the latter is claimed to be used not only in the home by a single person but also in professional healthcare settings.
The System consists of a meter and Prodigy No Coding Test Strips (or Prodigy PRO No Coding Test Strips). The System utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The System is marketed as a meter only with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The System is also marketed as a meter kit with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card, Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution.
The Prodigy No Coding Test Strips utilizes the active enzyme, Glucose Oxidase, derived from Aspergillus niger.
Here's a breakdown of the acceptance criteria and study information for the PRODIGY Astro Blood Glucose Monitoring System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document presents acceptance criteria within the study result descriptions. The table below consolidates this information.
| Test Category | Acceptance Criteria (from document) | Reported Device Performance |
|---|---|---|
| Robustness Evaluation | Individual bias of meter measurements < 10 mg/dL at glucose < 75 mg/dL; < ± 10 % at glucose ≥ 75 mg/dL (after cleaning/disinfection cycles). | Met: Individual bias < 10 mg/dL at glucose < 75 mg/dL and < ± 10 % at glucose ≥ 75 mg/dL. |
| Precision Evaluation | Pooled and maximum SD < 5.0 mg/dL at glucose < 100 mg/dL; pooled and maximum CV < 5.0 % at glucose ≥ 100 mg/dL. Maximum individual bias < 10 % compared with YSI 2300. | Met: Pooled and maximum SD < 5.0 mg/dL at glucose < 100 mg/dL; pooled and maximum CV < 5.0 % at glucose ≥ 100 mg/dL. Maximum individual bias < 10 % compared with YSI 2300. |
| Linearity Evaluation | Correlation coefficient > 0.95. 100 % of bias or bias (%) within ±10 % or 10%. | Met: Correlation coefficient > 0.95 (reported as 0.9998 to 0.9999 for R² and r). 100% of bias or bias (%) of individual glucose results fell within ±10 % or 10%. |
| System Accuracy Evaluation | > 95% of test results within ±15 mg/dL at glucose < 75 mg/dL; and within ±15 % at glucose ≥ 75 mg/dL. (ISO 15197:2013 standard is implied basis for these criteria, though not explicitly stated as such). | Met: For glucose < 75 mg/dL, 100% of measurements were within ±15 mg/dL for all sites and lots. For glucose ≥ 75 mg/dL, 100% of measurements were within ±20% for all sites and lots, and ≥ 95.3% (specifically 95.3% to 100%) were within ±15% for all sites and lots. |
| Hematocrit Evaluation | Individual difference < ±10% compared with individual YSI mean. Individual bias of BGM measurements < ±10 % compared to mean BGM at HCT 42%. All SD and CV within 5.0 mg/dL and 5.0%. | Met: All individual difference < ±10% from HCT 20% to 60%. All individual bias < ±10 % compared to mean BGM at HCT 42%. All SD and CV within 5.0 mg/dL and 5.0%. |
| Interference Study | Bias of mean test results ≤ 10% compared with YSI mean measurements. | Met: No obvious interference observed (bias ≤ 10%) at tested therapeutic or physiological levels for 26 substances. |
| Operation Condition Study | Individual bias < ± 10 % and CV/SD < 5.0 % and 5.0 mg/dL. | Met: Individual bias < ± 10 % and CV/SD < 5.0 % and 5.0 mg/dL. |
| Sample Volume Study | Test values for volumes between 0.7 and 1.5 µL fall within acceptable criteria. | Met: Data evaluation showed acceptable criteria for volumes between 0.7 and 1.5 µL. (Min. 0.7 µL required for accuracy). |
| Mechanical Resistance Study | Meters could withstand vibration and drop testing required by IEC 60068-2-64:1993 and IEC 61010-1:2010. | Met: All studies showed meters could stand the vibration and drop testing. |
| Shelf Life Study (Strips) | Data met acceptance criteria. | Met: Test results demonstrated stability for 25 months (unopened) and 96 days (opened). Claimed shelf-life is 24 months (unopened) and 90 days (opened). |
| Shelf Life Study (Meter) | All functions normal after 5 years and 4000 tests (at twice a day frequency). | Met: All functions normal after 5 years and 4000 tests. |
2. Sample Size Used for the Test Set and Data Provenance
-
System Accuracy Evaluation (Lay Persons):
- Sample Size: 100 lay persons. Blood samples were drawn from fingertip, palm, forearm, upper arm, calf, and thigh. 3 lots of test strips were used. For glucose concentrations < 75 mg/dL, there were 15 samples per site, per lot. For glucose concentrations ≥ 75 mg/dL, there were 85 samples per site, per lot.
- Data Provenance: Not explicitly stated, but given the manufacturer (OK BIOTECH CO., LTD. in Taiwan) and the regulatory submission to the FDA, the study was likely conducted in Taiwan or another country where the manufacturer operates, for submission to the US market. The study is prospective, as it involves active sampling and testing.
-
Precision Evaluation:
- Sample Size: Not explicitly stated how many samples or runs were performed, but it reports "within-run and between-run tests" over the glucose range. Control Levels 1 and 2 were also used.
- Data Provenance: Not explicitly stated.
-
Linearity Evaluation:
- Sample Size: Data from "three lots of test strips" was used. The table shows aggregated results for "All" lots.
- Data Provenance: Not explicitly stated.
-
Hematocrit Evaluation:
- Sample Size: Not explicitly stated how many samples were used, but it evaluated HCT levels over a range of 20-60%.
- Data Provenance: Not explicitly stated.
-
Interference Study:
- Sample Size: 7 endogenous and 19 exogenous interfering substances were evaluated. Venous blood was spiked to three glucose concentration levels (50-100, 200-275, 400-500 mg/dL). Five meters and three lots of test strips were used.
- Data Provenance: Not explicitly stated.
-
Robustness, Operation Condition, Sample Volume, Virucide, Altitude, Mechanical Resistance, Shelf Life Studies: Specific sample sizes for biological samples are not provided in the summary. For mechanical tests, the "Mechanical Resistance Study" mentions "Ten Astro meters" for both vibration and drop tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Ground Truth Method: The ground truth for the device's performance (glucose concentration) was established using a YSI glucose analyzer (YSI 2300). The YSI 2300 is a widely accepted laboratory reference method for glucose measurement, not an expert consensus.
- Number and Qualifications of Experts: Not applicable, as the ground truth was a laboratory reference instrument rather than human experts.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" was determined by a reference laboratory instrument (YSI 2300), which is a definitive quantitative measurement without the need for human adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. This document details studies for an in vitro diagnostic device (blood glucose monitoring system), which typically evaluates analytical performance against a reference method rather than human reader performance.
- Effect Size: Not applicable.
6. Standalone Performance Study
- Standalone Study: Yes, a standalone performance study was done. The document focuses exclusively on the performance of the PRODIGY Astro Blood Glucose Monitoring System (algorithm/device only) against a reference method (YSI 2300) without human-in-the-loop interaction for interpretation of results. The various non-clinical tests (Precision, Linearity, System Accuracy, Hematocrit, Interference, etc.) are all standalone performance evaluations.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was a laboratory reference method, specifically the YSI 2300 glucose analyzer. This provides quantitative, highly accurate measurements of glucose concentration which are considered the "true" values against which the device's measurements are compared.
8. Sample Size for the Training Set
- Training Set Sample Size: The document does not specify a separate "training set" or its sample size. For an in vitro diagnostic device like a blood glucose meter, the development process involves internal calibraton and optimization during manufacturing, but the "training" in the context of AI/ML models (e.g., deep learning) is generally not applicable or explicitly mentioned in such submissions for this type of device. The studies described are primarily for validation of the device's analytical performance.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: As no explicit "training set" is mentioned in the context of AI/ML or model development, this question is not directly applicable. If "training set" refers to calibration data or internal development data, the document does not provide details on how the ground truth was established for such purposes. The validation studies explicitly state the use of the YSI 2300 for ground truth.
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(447 days)
The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The PRODIGY iConnect Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The PRODIGY iConnect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
PRODIGY No Coding Blood Glucose Test Strips are intended for use with the PRODIGY iConnect blood glucose meter to measure the concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm. upper arm, palm, calf or thigh for self-testing at home. They are for testing outside the body (in vitro diagnostic use only). Do not use them for diagnosis of, or screening for diabetes or for testing on neonates. PRODIGY No Coding Blood Glucose Test Strips are used as an aid to monitor the effectiveness of diabetes control.
The system is intended for use at home for single patient use. It should not be used for the diagnosis of diabetes or for the testing of newborns. It consists of three main components, i.e., iConnect blood glucose meter, PRODIGY No Coding Blood Glucose Test Strips and 2 levels of Prodigy control solutions (Level 1 & Level 2). The physical components of the meter are Housing, PCBA, LCD and Ear phone jack. The PRODIGY No Coding Blood Glucose Test Strips are not coded. The device has the function of alternative sites testing at Finger, Palm, Forearm, Upper arm, Calf and Thigh.
The system has the ability of physically connecting to mobile devices for the purpose of obtaining blood glucose determination via a mobile APP.
The PRODIGY iConnect Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Meter User Guide, Quick Reference Guide, Logbook, and Warranty Card. The PRODIGY iConnect Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Meter User Guide, Quick Reference Guide, Logbook, Warranty Card, Prodigy Lancing Device, Prodigy Lancets, PRODIGY No Coding Blood Glucose Test Strips, and PRODIGY Control Solution.
Here's a breakdown of the acceptance criteria and the study information for the PRODIGY iConnect Blood Glucose Monitoring System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Robustness | Individual bias of test results compared with YSI mean: < 10 mg/dL at glucose concentrations < 75 mg/dL; < ± 10% at glucose concentrations ≥ 75 mg/dL after 3,650 cleaning/disinfection cycles. | Individual bias of the test results compared with YSI mean were less than 10 mg/dL at glucose concentrations < 75 mg/dL and less than ± 10% at glucose concentrations ≥ 75 mg/dL. The test results met acceptance criteria. |
| Precision (Within-run & Between-run) | Pooled Standard Deviation < 5.0 mg/dL at glucose concentration < 100 mg/dL; Pooled Coefficient of Variation < 5.0% at glucose concentration ≥ 100 mg/dL, compared to YSI reference standards over ten days. | Pooled Standard Deviation less than 5.0 mg/dL at glucose concentration < 100 mg/dL, and pooled Coefficient of Variation less than 5.0% at glucose concentration ≥ 100 mg/dL for within runs and between runs compared to the YSI reference standards over the course of ten days. The test results met the acceptance criteria. |
| Linearity | Correlation coefficient > 0.95. 100% of individual glucose results bias within ±10% within the measuring range of 20 to 600 mg/dL. | Correlation coefficient is greater than 0.95 (Lot I: 0.9997, Lot II: 0.9998, Lot III: 0.9999). 100% of the bias of individual glucose results fallen within ±10%. The linearity of measurement is acceptable between 20 to 600 mg/dL. The test results met the acceptance criteria. |
| System Accuracy | For glucose concentrations < 75 mg/dL: ≥95% of results within ±15 mg/dL. For glucose concentrations ≥ 75 mg/dL: ≥95% of results within ±20%. | For glucose concentrations < 75 mg/dL: ≥96.9% of tests for which the differences fell within ±15 mg/dL (Finger: 100%, Palm: 100%, Forearm: 100%, Upper Arm: 100%, Calf: 100%, Thigh: 100%). For glucose concentrations ≥ 75 mg/dL: 100% within 20% (Finger: 100%, Palm: 100%, Forearm: 100%, Upper Arm: 100%, Calf: 100%, Thigh: 100%). The test results met the acceptance criteria. |
| Hematocrit Evaluation | Individual difference of blood glucose measurements compared with individual YSI mean fall within ±15% from HCT 20% to 60%. % bias difference on mean value of blood glucose measurements fall within 8% compared with mean of blood glucose measurements in HCT 40% from HCT 20% to 60%. | All of the individual difference of the blood glucose measurements compared with individual YSI mean fall within ±15% from HCT 20% to 60%. Also, % bias difference on mean value of the blood glucose measurements fall within 8% compared with the mean of blood glucose measurements in HCT 40% from HCT 20% to 60%. The test results met the acceptance criteria. |
| Interference Study | Bias of mean test results within the listed ranges ≤ 10% compared with the YSI mean measurements. The concentration limits of all interfering substances higher than therapeutic or physiological levels. | Bias of mean test results within the range listed above were ≤ 10% compared with the YSI mean measurements. No obvious interference was observed in the interfering substance at neither therapeutic nor physiological levels at three blood glucose levels. The test results met the acceptance criteria. |
| Operation Condition | Confirmed operation within temperature range of 4 - 40 °C and relative humidity range of 10~85%. | The study confirmed the operation conditions for the temperature range of 4 - 40 °C (39.2 - 104 °F), and the relative humidity range of 10~85%. |
| Sample Volume | Test values of volumes between 0.7 and 1.5 uL fall within acceptable criteria. Requires at least 0.7 uL of blood sample. | The test values of volumes between 0.7 and 1.5 uL were fall within acceptable criteria. It's required at least 0.7 uL of blood sample. The test results met the acceptance criteria. |
| Virucide Evaluation | Complete inactivation of Hepatitis B Virus at specified dilutions on case & lens coupons within 2 minutes contact time using PDI SUPER SANI-CLOTH germicidal disposable wipes. | PDI SUPER SANI-CLOTH germicidal disposable wipes (EPA Reg. No. 9480-4) within 2 minutes contact time can completely inactivate the Hepatitis B Virus at undiluted (HBsAg: 7857.9 IU/mL), 10X, 100X and 1000X virus dilution on the Case & Lens coupons. |
| Altitude Study | Individual results fall within ± 10% at altitude below 11,161 feet (3,402 meters). | The individual results fall within ± 10% at the altitude below 11,161 feet (3,402 meters). The results met the acceptance criteria. So it shows no significant effects on PRODIGY iConnect Blood Glucose Monitoring System at the altitudes below 11,161 feet (3,402 meters). |
| Mechanical Resistance | Meters can withstand vibration and drop testing required by ISO 15197:2013, IEC 60068-2-64:1993, and IEC 61010-1:2010. | All studies showed the meters could stand the vibration and drop testing required in ISO 15197:2013, IEC 60068-2-64:1993 and IEC 61010-1: 2010. |
| Shelf-Life Study | Unused test strips stable for 25 months; 96 days for opened vials. | The unused test strips were stable for 25 months and 96 days for opened vials. The shelf-life of PRODIGY Blood Glucose Test Strip is claimed as 24 months for unopened strips vials and 90 days for opened strips vials. All data met the acceptance criteria. |
| Software V&V | Device performs as intended based on Software Design Specifications, hazards mitigated. | All software documentation prepared and submitted, tested against specifications. Device Hazard Analysis completed and risk control implemented. Testing results support all software specifications met acceptance criteria of each module and interaction of processes. V&V with HTC and Apple platforms demonstrated safety and effectiveness. |
| Electrical Safety | Complies with IEC 60601-1: 2005, IEC 61010-1:2010, IEC 61010-2-101:2002, FCC 47 CFR Part 15 Subpart B/Oct. 2013 and CISPR 22/1997 (Class B Limit). | The device with Apple or HTC platform passed all the electrical safety testing according to national & international standards including IEC 60601-1: 2005, IEC 61010-1:2010, IEC 61010-2-101:2002, FCC 47 CFR Part 15 Subpart B/Oct. 2013 and CISPR 22/1997 (Class B Limit). |
| EMC | Complies with IEC 60601-1-2:2007, IEC 61326-1:2012, IEC 61326-2-6:2005, CISPR 11:2009 +A1:2010 Class B, IEC 61000-4-2:2008, IEC 61000-4-3:2010, IEC 61000-4-8:2009 for radiated emissions, electrostatic discharge, radio-frequency electromagnetic immunity, and power frequency magnetic field immunity. | The PRODIGY iConnect Blood Glucose Monitoring System with Apple or HTC platform has been tested and successfully met all of the relevant sections (Radiated Emissions, Electrostatic Discharge Immunity Test, Radiated Radio-Frequency Electromagnetic Immunity, and Power Frequency Magnetic Field Immunity Test to complies to all standards including IEC 60601-1-2:2007: Electromagnetic Compatibility, IEC 61326-1:2012, IEC 61326-2-6:2005, Emission: CISPR 11:2009 +A1:2010, Class B, Immunity: IEC 61000-4-2:2008, IEC 61000-4-3:2010, IEC 61000-4-8:2009. |
2. Sample Size Used for the Test Set and Data Provenance
- System Accuracy Evaluation (Lay Persons Study): 350 lay persons.
- Data Provenance: The document does not explicitly state the country of origin. It indicates "internal test results" and a study involving "lay persons," but no geographical specifics are provided. It does not mention whether it was retrospective or prospective. It is implied to be prospective for the lay persons study.
- Precision Evaluation: Tested over the blood glucose concentration range of 20-600 mg/dL and Control Levels 1 and 2 over the course of ten days. (Specific number of samples/runs not detailed, but standard deviations/CVs derived).
- Linearity Evaluation: Not specified exact number of samples, but used different lots of test strips (Lot I, Lot II, Lot III).
- Hematocrit Evaluation: Evaluated over an HCT range of 20-60%.
- Interference Study: "Ten meters and three lots of test strips were used for this study." Samples were venous blood spiked with various substances at three glucose levels (60, 120, 250 mg/dL).
- Robustness Evaluation: Ten iConnect meters for vibration and drop tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly mention the use of experts to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method as external expert review for ground truth was not explicitly stated. The ground truth was established by a reference method (YSI).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance.
This device is a blood glucose monitoring system, not an imaging device requiring human "readers" or AI assistance in interpretation in the context of MRMC studies common in radiology or pathology. Therefore, an MRMC comparative effectiveness study of human readers with/without AI assistance was not performed or applicable in the way described. The device is for direct quantitative measurement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
Yes, the studies performed (Precision, Linearity, System Accuracy, Hematocrit, Interference, etc.) evaluate the standalone performance of the PRODIGY iConnect Blood Glucose Monitoring System. The device directly measures glucose concentration without human interpretation of its output that would significantly alter the result. The software verification and validation also represent standalone algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for accuracy studies (System Accuracy, Precision, Linearity, Hematocrit, Interference) was established using a YSI reference standard (specifically, implies the YSI 2300 Glucose Analyzer, which is a common and highly accurate laboratory reference method for glucose measurement).
8. The sample size for the training set
The document does not specify a separate "training set" sample size. For medical devices, particularly for quantitative measurement systems, "training" in the machine learning sense is often not distinct in the same way as for AI image analysis. Instead, the devices are designed and then validated against established standards. The development and internal testing phases would involve data, but it's not typically compartmentalized as a "training set" in regulatory submissions for this type of device.
9. How the ground truth for the training set was established
As there's no explicitly defined "training set" in the context of machine learning, the establishment of ground truth for general device development and calibration would similarly rely on highly accurate laboratory reference methods like the YSI and adherence to standards (e.g., ISO 15197).
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(274 days)
Prodigy® AutoCode® Eject Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The Prodigy® AutoCode® Eject Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Prodigy® AutoCode® Eject Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Prodigy® AutoCode® Eject Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes, or for neonatal use. The alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
PRODIGY® No Coding Test Strips are intended for use with the PRODIGY® AutoCode® Eject blood glucose meter to measure the concentration of the blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh for self-testing at home. They are for testing outside the body (in vitro diagnostic use only) . Do not use them for diagnosis of, or screening for dabetes or for testing on neonates. PRODIGY® No Coding Test Strips are used as an aid to monitor the effectiveness of diabetes control.
This system contains a speaking function, but is not intended for use by the visually impaired.
The Prodigy® AutoCode® Eject Blood Glucose Monitoring System consists of a meter and Prodigy No Coding Test Strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The Prodigy® AutoCode® Eject Blood Glucose Monitoring System is marketed as a meter only with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card.
The Prodigy® AutoCode® Eject Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card, Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution.
The Prodigy No Coding Test Strips utilizes the active enzyme is Glucose Oxidase, derived from Aspergillus niger. The Prodigy® AutoCode® Eject Blood Glucose Monitoring System has a speaking function.
The provided text describes the Prodigy® AutoCode Eject TM Blood Glucose Monitoring System and its substantial equivalence to a predicate device. However, it does not contain the detailed study information (sample sizes, expertise, ground truth establishment) typically associated with acceptance criteria for an AI/ML medical device submission.
The document is a 510(k) summary for an in vitro diagnostic (IVD) device, specifically a blood glucose monitoring system, which measures glucose using an electrochemical method. These devices are generally tested against analytical and clinical performance standards rather than requiring AI-specific study designs like MRMC studies.
Here's a breakdown of the available information, noting the absence of AI/ML-specific details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in the format of a table with specific thresholds for accuracy, precision, sensitivity, or specificity. Instead, it relies on demonstrating substantial equivalence to a predicate device (PRODIGY Preferred® Blood Glucose Monitoring System, K122338) that has already met regulatory requirements.
The "Synopsis of Test Methods and Results" section generally states that "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/FDA." This indicates that standard analytical and clinical performance studies for blood glucose meters were conducted, but the specific results or acceptance criteria are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The 510(k) summary only mentions that "Pre-clinical and clinical data are employed," but does not detail the sample size for any test sets or the provenance (country of origin, retrospective/prospective) of the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For blood glucose monitoring systems, ground truth is typically established by comparing the device's readings against a laboratory reference method (e.g., a YSI analyzer), not through expert consensus.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typical for interpreting subjective data (e.g., medical images) where human agreement is required to establish ground truth. For quantitative measurements like blood glucose, adjudication is not typically relevant at the point of establishing ground truth against a reference method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or at least not reported in this 510(k) summary. These studies are specific to AI/ML devices that assist human readers in tasks like image interpretation. The Prodigy® AutoCode Eject TM Blood Glucose Monitoring System is a standalone diagnostic device that provides a direct quantitative measurement of glucose, not an AI assistant for human interpretation. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The device itself is a standalone diagnostic device; its performance is inherently "algorithm only" in the sense that it measures glucose and provides a numerical output. However, it's not an AI/ML algorithm in the modern sense that often implies learning from data. It's an electrochemical system. The performance studies for such a device would inherently be standalone, evaluating the accuracy and precision of the meter and test strips.
7. The Type of Ground Truth Used
While not explicitly stated in this summary, for blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method, such as a YSI glucose analyzer, which is considered the gold standard for glucose measurement in clinical laboratories. This is a form of "objective measurement" or "pathology/reference method" rather than expert consensus or outcomes data.
8. The Sample Size for the Training Set
This information is not provided and is largely not applicable in the context of this device. The Prodigy® AutoCode Eject TM Blood Glucose Monitoring System is an electrochemical system, not an AI/ML device that requires a "training set" in the machine learning sense. Its underlying principle is a chemical reaction that generates an electrical current proportional to glucose, not a model trained on data.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated above (not an AI/ML device requiring a training set).
In summary, the provided document describes a traditional in-vitro diagnostic blood glucose meter. The request for information regarding AI/ML-specific study design elements (MRMC, training sets, number of experts, adjudication) is not directly addressed because the device is not an AI/ML medical device. The 510(k) process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device by showing similar indications for use, technological characteristics, and comparable safety and effectiveness through "pre-clinical and clinical data" (analytical and clinical performance studies, which are not detailed in this summary).
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(357 days)
The OKmeter Direct Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper-arm, calf, thigh, or palm. The OKmeter Direct Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The OKmeter Direct Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OKmeter Direct Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The OKmeter Direct Test Strips are for use with the OKmeter Direct Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper-arm, calf, thigh, or palm.
Based on an electrochemical biosensor technology and the principle of capillary action, Okmeter Direct Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and is displayed in 6 seconds.
Here's a breakdown of the acceptance criteria and study details for the OKmeter Direct Blood Glucose Monitoring System, as extracted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for glucose meters are typically defined by regulatory bodies like the FDA, often referring to standards like ISO 15197. While the document doesn't explicitly state "acceptance criteria" numbers as a separate table, it presents performance data in a way that implies these are the criteria against which the device is being tested for accuracy. The core criteria revolve around the percentage of results falling within specific deviation ranges from a reference method (YSI 2300).
The performance data is presented separately for two user groups: "Home Users" (lay users) and "Healthcare Professionals."
For Glucose Concentration < 75 mg/dL (4.2 mmol/L):
| Acceptance Criteria (Deviation from Reference) | Lay Users Performance (Range: Fingertip to Thigh) | Healthcare Professionals Performance (Range: Fingertip to Thigh) |
|---|---|---|
| Within ±5 mg/dL (±0.28 mmol/L) | 67% - 86% | 67% - 81% |
| Within ±10 mg/dL (±0.56 mmol/L) | 95% - 100% | 95% - 100% |
| Within ±15 mg/dL (±0.83 mmol/L) | 100% | 100% |
For Glucose Concentration ≥ 75 mg/dL (4.2 mmol/L):
| Acceptance Criteria (Deviation from Reference) | Lay Users Performance (Range: Fingertip to Thigh) | Healthcare Professionals Performance (Range: Fingertip to Thigh) |
|---|---|---|
| Within ±5% | 58% - 73% | 59% - 74% |
| Within ±10% | 84% - 100% | 85% - 100% |
| Within ±15% | 96% - 99% | 96% - 97% |
| Within ±20% | 100% | 100% |
Summary of Reported Performance (Across all alternative sites and user types, presenting the minimum reported compliance):
| Glucose Concentration Range | Accuracy (Within ±5 mg/dL or ±5%) | Accuracy (Within ±10 mg/dL or ±10%) | Accuracy (Within ±15 mg/dL or ±15%) | Accuracy (Within ±20% for ≥ 75 mg/dL) |
|---|---|---|---|---|
| < 75 mg/dL (4.2 mmol/L) | 67% (Forearm/Upper arm/Calf) | 95% (Palm/Forearm/Upper arm/Calf) | 100% | Not applicable |
| ≥ 75 mg/dL (4.2 mmol/L) | 58% (Calf) | 84% (Thigh) | 96% (Palm/Forearm/Upper arm/Calf/Thigh) | 100% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 135 patients
- Data Provenance: The document does not explicitly state the country of origin. The manufacturer is "OK Biotech Co., Ltd." based in "Hsin Chu City, Taiwan, ROC." It is reasonable to infer the study might have been conducted in Taiwan, but this is not definitively stated.
- Retrospective or Prospective: The document does not specify whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The ground truth was established by a YSI 2300 Analyzer. This is a laboratory reference instrument, not a human expert. Therefore, the concept of "number of experts" and their qualifications for establishing ground truth does not directly apply in the human sense.
4. Adjudication Method for the Test Set
- Since the ground truth was established by an objective laboratory instrument (YSI 2300 Analyzer), no human adjudication method (like 2+1, 3+1) was required. The device's readings were directly compared to the YSI 2300 readings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- The document describes a study comparing the device's performance to a reference standard (YSI 2300) when used by both lay users and healthcare professionals. While different user groups ("readers") are involved, this is not a traditional MRMC comparative effectiveness study designed to measure the improvement of human readers with AI vs. without AI assistance. It's a performance study of the device itself under different user scenarios.
- Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable in this context.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was done. The entire study presented quantifies the accuracy of the OKmeter Direct Blood Glucose Monitoring System (the algorithm/device) against a reference standard (YSI 2300 Analyzer). The metrics (e.g., % within ±5 mg/dL or ±5%) are direct measurements of the device's accuracy.
7. Type of Ground Truth Used
- The ground truth used was established by a laboratory reference method: the YSI 2300 Analyzer. This is a highly accurate instrument used for glucose measurement in clinical settings.
8. Sample Size for the Training Set
- The document does not provide information regarding a training set sample size. The data presented is for the evaluation of the final device rather than its development.
9. How the Ground Truth for the Training Set Was Established
- Since information on a training set is not provided, how its ground truth was established is not available in this document.
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(335 days)
The Okmeter Match Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in this system can be used only during steady-state blood glucose conditions. The meter has some audible features but it is not for use by the visually impaired.
The Okmeter Test Surins are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Okmeter Test Strips must be used with the Okmeter Match Blood Glucose Monitoring System. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.
The Okmeter 2 levels (Normal and High) Control Solution are for use with the Okmeter Match Blood Glucose Monitoring System and Okmeter Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Based on an electrochemical biosensor technology and the principle of capillary action, Okmeter Match Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 6 seconds. The device including two test strips there are identical in structure design and test performance, the only difference in colors (White for strip A and Green for strip B).
The provided text lacks specific details about acceptance criteria and the results of a study proving the device meets those criteria. However, I can extract the available information and highlight what is missing based on your request.
Here's a breakdown of the available information and what's not present:
Acceptance Criteria and Device Performance:
The document mentions "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/FDA." This implies that the device was tested against FDA guidance, which would contain specific acceptance criteria for accuracy, precision, and other relevant performance metrics for blood glucose monitoring systems. However, the exact acceptance criteria and the reported numerical performance of the Okmeter Match Blood Glucose Monitoring System are not provided in the given text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy (e.g., within +/- X% of Y reference) | Not provided in the text | Not provided in the text |
| Precision (e.g., standard deviation) | Not provided in the text | Not provided in the text |
| Measuring Time | 6 seconds (implied as a feature, not a criterion) | 6 seconds |
| Sample Volume | Small amount of blood (implied) | Small amount of blood |
| Detecting Range | Not provided in the text | Not provided in the text |
| HCT Range | Not provided in the text | Not provided in the text |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not provided in the text. The document states "Pre-clinical and clinical data are employed," but it does not specify the number of subjects or samples used in these studies.
- Data Provenance: The manufacturer is OK Biotech Co., Ltd., located in Taiwan, ROC. The studies were likely conducted in Taiwan, but this is not explicitly stated for the clinical data. The document does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
- Not provided in the text. For a blood glucose monitoring system, the "ground truth" is typically established by laboratory reference methods, not by expert consensus on image interpretation. Therefore, this question may not be directly applicable in the same way it would be for an AI-powered diagnostic imaging device. If expert validation of a reference method was involved, the details are missing.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided in the text. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in subjective assessments (e.g., expert interpretation of medical images). For a quantitative device like a blood glucose meter, the "ground truth" is typically a quantitative measurement from a highly accurate lab instrument, not subject to individual interpretation or adjudication among experts in this manner.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- Not applicable/Not provided in the text. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The Okmeter Match Blood Glucose Monitoring System is a standalone device for direct quantitative measurement, not an AI-assisted diagnostic tool that helps human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, by definition. The Okmeter Match Blood Glucose Monitoring System is a standalone device. Its performance, as implied by the "Pre-clinical and clinical data," would represent its standalone accuracy and precision. The reported "6 seconds" for result display is a standalone performance metric.
7. The Type of Ground Truth Used:
- Implied to be laboratory reference methods for glucose measurement. While not explicitly stated, for a blood glucose monitoring system, the ground truth is universally established by a highly accurate, often laboratory-based, glucose analyzer. The document mentions "Pre-clinical and clinical data," which would have involved comparing the device's readings to such a reference method. The text does not mention pathology, outcomes data, or expert consensus in this context.
8. The Sample Size for the Training Set:
- Not applicable/Not provided in the text explicitly as a "training set." Blood glucose meters based on electrochemical biosensor technology generally do not involve AI/machine learning training sets in the same way an image recognition algorithm would. While there is likely internal verification and calibration during development, the document doesn't describe a distinct "training set" with established ground truth as would be relevant for an AI model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not provided in the text. See the explanation for point 8.
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(130 days)
The OK Meter Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for both lay uses by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus. Not for use on neonates.
The OK Meter Blood Glucose Monitoring System based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. The OK Meter Blood Glucose Monitoring System only needs a 0.7 ul small amount of blood. Capillary action both side near the end of the test strip that draws the blood into the action chamber and the blood glucose result is precisely and displayed in 6 seconds.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:
The provided documents describe the "OK Meter Blood Glucose Monitoring System" and its 510(k) submission. However, the document is notably lacking detailed information regarding specific acceptance criteria and the results of a study designed to explicitly prove the device meets those criteria. The information provided focuses on general claims of substantial equivalence to a predicate device and a brief description of the device's technology.
Here's a breakdown of what can and cannot be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding reported device performance metrics (e.g., accuracy percentages, precision data, agreement rates, etc.). It generally states that "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA." However, the actual data or the acceptance thresholds are absent.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the given text. For blood glucose meters, the "ground truth" would typically refer to results from a laboratory reference method, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically used when human interpretation is involved in establishing ground truth for subjective outcomes (e.g., radiology reads). For a blood glucose meter, the reference method provides a direct, objective measurement.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool that would involve human "readers" or an "effect size" of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device operates as a standalone system. The text states: "The OK Meter Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use)." This directly implies standalone performance by the device itself to produce a quantitative measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "type of ground truth used," but for blood glucose monitoring systems, the ground truth is universally established by laboratory reference methods (e.g., a YSI analyzer), known for their high accuracy and precision, against which the device's measurements are compared.
8. The sample size for the training set
This information is not provided in the given text. For a device based on an electrochemical biosensor, the "training set" might refer to data used for calibrating the sensor and developing the algorithm that converts electrochemical signals into glucose concentrations.
9. How the ground truth for the training set was established
This information is not provided in the given text. Similar to the test set, the ground truth for any calibration or development data would typically be established using highly accurate laboratory reference methods.
Summary of what is available and what is missing:
The document serves as a 510(k) summary, which is typically a high-level overview. While it states that pre-clinical and clinical data were submitted, it does not disclose the detailed results of those studies, the specific acceptance criteria for performance, sample sizes, or the methodology for establishing ground truth beyond the general mention of following FDA guidance for IVD test systems. The primary claim of "substantial equivalence" is made based on shared working principles and technologies with the predicate device, implying that if the predicate device met performance standards, then the OK Meter, by being substantially equivalent, would also be expected to meet similar standards.
To obtain the detailed information requested, one would need to review the full 510(k) submission (K063026) which would contain the detailed study reports and data.
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