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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:

• 1. SuperCheck Pro Blood Glucose Meter
• 2. SuperCheck Pro Blood Glucose Test Strips
• 3. 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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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

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

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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.

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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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.

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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

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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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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

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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:

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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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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