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510(k) Data Aggregation
(97 days)
The Prodigy™ Thrombectomy System is intended for the removal and thrombi and thrombi from vessels of the peripheral arterial and venous systems.
Not for use in the coronaries, pulmonary vasculature, or the neurovasculature
The Prodigy™ Thrombectomy System is designed to remove thrombus from the vasculature using aspiration. The Prodigy™ Thrombectomy System is comprised of several components including:
- . Prodigy™ Catheter
- . Prodigy™ Twist
- . Prodigy™ Hotshot™ Controller
- TRUVIC Generator
- TRUVIC Canister
- . TRUVIC Tubeset
The single-lumen Prodigy™ Catheter targets aspiration from the TRUVIC Generator directly to the thrombus. The wire-based Prodigy™ Twist utilizes a soft, flexible polymeric tip to facilitate thrombus removal through the Prodigy™ Catheter as needed. The Prodigy™ Catheter is available in multiple diameters and both the Prodigy™ Catheter and Prodigy™ Twists are available in multiple effective lengths and are visible under fluoroscopy via radiopaque marker bands.
The Prodigy™ Hotshot™ Controller connects the Prodigy™ Catheter to the TRUVIC Generator and provides the user with the ability to control aspiration flow and visualize the extracted thrombus.
The provided text does not contain information about acceptance criteria and the study that proves a device meets those criteria in the context of a medical device cleared through a 510(k) submission.
The document is an FDA 510(k) clearance letter for the Prodigy™ Thrombectomy System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets them in the way one might expect for a de novo submission or a clinical trial for a novel device.
The "Non-Clinical testing / Performance Data" section (page 5) lists various tests performed, such as "Visual and Dimensional Verification," "Kink / Bend / Flex Verification," and "Simulated Use Performance Validation." It states, "The in vitro bench tests demonstrated that the Prodigy™ Thrombectomy System met all acceptance criteria and performed similarly to the predicate device." However, it does not explicitly state what those acceptance criteria were (e.g., a specific tensile strength value or a kink angle). It only broadly claims they were met.
Similarly, the "IN-VIVO GLP PRE-CLINICAL TESTING / PERFORMANCE DATA" section (page 6) mentions an animal study where "All acceptance criteria passed." Again, the specific acceptance criteria are not detailed.
Therefore, I cannot provide the requested table or answer most of the numbered questions because the specific acceptance criteria and detailed study results demonstrating their fulfillment are not present in this document.
To clarify, if the document had included a table like:
| Criterion | Acceptance Value | Reported Performance | Result |
|---|---|---|---|
| Tensile Strength Luer Lock | > 20 N | 25 N | Pass |
| Burst Pressure Catheter | > 500 psi | 550 psi | Pass |
...and then described the study (e.g., "A total of 10 samples were tested in a controlled lab environment according to ASTM FXXXX standard..."), I would be able to populate the requested information. However, this level of detail is absent.
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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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(481 days)
The Prodigy Choice 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, palm, upper-arm, calf or thigh. The Prodigy Choice Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Prodigy Choice 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 Choice 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 Prodigy Choice Test Strips are for use with the Prodigy Choice Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, palm, upper-arm, calf or thigh.
The Prodigy Choice Blood Glucose Monitoring System consists of a meter and 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 Choice Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The Prodigy Choice Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, 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 utilize the enzyme glucose oxidase, which is derived from recombinant protein derived from the fungus Aspergillus niger.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Prodigy Choice Blood Glucose Monitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in a quantitative table format. It refers to compliance with ISO and NCCLS standards but doesn't detail the specific performance thresholds required by those standards, nor does it present the device's performance against them directly within the summary.
Here's a table based on the information that is available:
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Compliance with ISO 15197 | Tested and complies |
| Compliance with NCCLS EP9-A | Tested and complies |
| Compliance with NCCLS SP5-A | Tested and complies |
| Compliance with ISO 14971 | Tested and complies |
| Label Comprehension | Tested with Human Factor Study and complies |
| Usability | Tested with Human Factor Study and complies |
Note: Since specific numerical acceptance criteria and direct performance metrics are not provided in the 510(k) summary, this table relies on the general statement that the device "was tested to the required standards" and "complies." Detailed performance data would typically be found in the actual test reports submitted to the FDA, which are not part of this summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size for the test set used in the performance testing. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.
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 510(k) summary. For a blood glucose monitoring system, the "ground truth" would typically refer to a reference laboratory instrument's measurement of glucose in blood samples.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is typically relevant for interpretative devices (e.g., imaging AI). For a blood glucose meter, which provides a direct quantitative measurement, an MRMC study is generally not applicable or mentioned. The provided text does not indicate that such a study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a "Blood Glucose Monitoring System" which includes a meter and test strips. Its performance is inherently standalone in the sense that it provides a direct measurement without human interpretation of its output. The summary does describe "Performance Testing" to required standards, which implicitly refers to the standalone performance of the system.
7. The Type of Ground Truth Used
For a blood glucose monitoring system, the ground truth is typically established by laboratory reference methods for glucose measurement, which are considered highly accurate and precise. While not explicitly stated in the summary, this is the standard practice for validating such devices. The summary implicitly refers to this by mentioning compliance with standards like ISO 15197 and NCCLS EP9-A, which define acceptable accuracy against reference methods.
8. The Sample Size for the Training Set
For a blood glucose meter, there isn't typically a "training set" in the sense of a machine learning algorithm being trained on a dataset. The device uses an "electrochemical method-based meter and dry reagent biosensor" which operates on established chemical principles, not machine learning. Therefore, a training set is not applicable or mentioned.
9. How the Ground Truth for the Training Set Was Established
As explained above, a "training set" is not applicable for this type of device.
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(356 days)
The Prodigy® Diabetes Management Software is indicated for use as a data management tool for the acceptance, transfer, display, storage, processing (e.g., averaging). Reporting, and printing of patient blood glucose monitoring data.
The Prodigy® Diabetes Management Software is indicated for use with the Prodigy Blood Glucose Monitoring Systems only.
The Prodigy® Diabetes Management Software is a moderate level of concern software management system that allows the user an additional method of tracking their blood glucose level. The software allows for an accident member of their blood Glucose Monitor via a USB cable. The Prodigy® Diabetes Management Software is designed to operate on the patient's PC with Microsoft SQL Server 2005 or later operating system. Prodigy® Diabetes Care LLC website will provide a link to download the Microsoft SQL Server 2005 Server 2005.
Here's a breakdown of the acceptance criteria and study information for the Prodigy® Diabetes Management Software, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided document, primarily a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating quantitative or qualitative "acceptance criteria" and then directly reporting performance against them in the traditional sense of a clinical trial. Instead, the "acceptance criteria" are implied by the features and functionalities deemed necessary to be equivalent to the predicate device. The "reported device performance" is largely qualitative, indicating that these functionalities are present and work.
| Parameter (Implied Acceptance Criteria) | Prodigy Diabetes Management Software Performance (Reported as Present/Functional) |
|---|---|
| Download blood glucose meter readings via USB interface cable | Yes |
| Electronic Log Book | Yes |
| Create User Profile | Yes |
| Create reports | (Implied by existing report/trending functionality) |
| Create trending graphs | Yes |
| Option for printing reports | Yes |
| Set Target - target blood glucose range | Yes |
| Average reading for each meal over the past several | Yes |
| Patient can create personal and meter profiles | Yes (Stated in Substantial Equivalence summary) |
| Patient can import data from the Prodigy Blood Glucose Meter | Yes (Stated in Substantial Equivalence summary) |
| Patient can set blood glucose target ranges and personal schedule | Yes (Stated in Substantial Equivalence summary) |
| Patient has a Log book to view recorded data | Yes (Stated in Substantial Equivalence summary) |
| Patient can retrieve reports and trending graphs | Yes (Stated in Substantial Equivalence summary) |
| Patient can print Trend graphs and reports | Yes (Stated in Substantial Equivalence summary) |
| Ease of use | Verified (by clinical usability study) |
| Label comprehension | Verified (by clinical usability study) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "clinical usability study" or "Human Factor Study" but does not specify the sample size used for the test set.
The data provenance is not specified (e.g., country of origin). It can be inferred that the study was prospective, as it was conducted "to verify ease of use and label comprehension" for the device being submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications, nor does it explicitly mention "ground truth" in the context of expert review for the usability study. The usability study would typically involve end-users, not necessarily experts for ground truth establishment.
4. Adjudication Method for the Test Set
The document does not provide any information regarding an adjudication method for the test set.
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. The performance data section only mentions a "clinical usability study" or "Human Factor Study" to verify ease of use and label comprehension. This type of study is not an MRMC comparative effectiveness study, and there is no mention of comparing human readers with and without AI assistance, nor any effect size.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is described as "software management system" and "data management tool" for blood glucose monitoring data. Its primary function is displaying, storing, processing, reporting, and printing data from a blood glucose meter. It is not an AI algorithm performing diagnostic tasks in a standalone manner where performance metrics like sensitivity/specificity for a diagnosis would be relevant. The "performance data" refers to a usability study, not a standalone algorithmic performance test. Therefore, a standalone algorithmic performance study in the typical sense for an AI diagnostic device was not conducted or is not applicable to this type of device.
7. The Type of Ground Truth Used
For the "clinical usability study," the "ground truth" would implicitly be the successful and intuitive completion of tasks by the study participants and their feedback on ease of use and comprehension, as measured against predefined usability criteria. It's not a "ground truth" derived from expert consensus, pathology, or outcomes data, as those are typically associated with diagnostic or image analysis devices.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is because the device is a data management software, not a machine learning or AI model that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for an AI/ML model, there is no information on how ground truth for a training set was established.
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(96 days)
The Prodigy™ 800V NPWT System is indicated for use in patients that would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from a patients airway or respiratory support system either during surgery or at the patients bedside.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Prodigy™ NPWT System, Model: Prodigy™ 800V). It confirms the device's substantial equivalence to a legally marketed predicate device.
Unfortunately, this document does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The letter focuses on regulatory approval based on equivalence, not on a detailed performance study report. Therefore, I cannot extract the requested information from this text.
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(121 days)
The Prodigy Voice 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.
The alternative site testing in this system can be used only during steady-state blood glucose conditions.
This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
Prodigy Voice Blood Glucose Monitoring System consists of a meter and 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.
This system contains speaker function which provides step by step instructions.
The provided text offers minimal details regarding the acceptance criteria and the study that proves the device meets those criteria. Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "The studies demonstrated that the performance of this system meets its intended use." However, it does not provide specific acceptance criteria (e.g., accuracy percentages, precision metrics, bias limits) nor detailed performance results to populate such a table.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: The studies were conducted "in the laboratory and in clinical settings by healthcare professionals and lay users." There is no mention of the country of origin or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not specified. The document only mentions "healthcare professionals" conducted studies.
4. Adjudication Method for the Test Set:
Not specified.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
Not mentioned or implied. The focus appears to be on the device's standalone performance rather than comparing human readers with and without AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance):
Yes, this was undoubtedly done. The "Performance Studies" section states, "The performance of Prodigy Voice Blood Glucose Monitoring System was studied in the laboratory and in clinical settings..." This implies the device was tested as a standalone system.
7. Type of Ground Truth Used:
While not explicitly stated, for a blood glucose monitoring system, the ground truth would typically be established by a reference method (e.g., a laboratory-grade blood glucose analyzer that is traceable to an international standard). The text mentions "quantitative measurement of glucose," which necessitates a highly accurate reference for comparison.
8. Sample Size for the Training Set:
Not specified.
9. How the Ground Truth for the Training Set Was Established:
Not specified.
Summary of Available Information from the Provided Text:
| Feature | Details from the Text |
|---|---|
| Acceptance Criteria & Reported Performance | - Acceptance Criteria: NOT SPECIFIED. The document only states "The studies demonstrated that the performance of this system meets its intended use." - Reported Device Performance: NOT DETAILED. No specific metrics (e.g., accuracy, precision) or numerical results are provided. |
| Test Set Sample Size | NOT SPECIFIED. |
| Data Provenance (Test Set) | "in the laboratory and in clinical settings by healthcare professionals and lay users." - Country of Origin: Not specified. - Retrospective/Prospective: Not specified. |
| Number & Qualifications of Experts (Ground Truth - Test Set) | NOT SPECIFIED. Mentions "healthcare professionals" but no details on number, specialties, or experience. |
| Adjudication Method (Test Set) | NOT SPECIFIED. |
| MRMC Comparative Effectiveness Study | NO. Not mentioned or implied. |
| Standalone Performance | YES. Implied by "Performance Studies... in the laboratory and in clinical settings." |
| Type of Ground Truth Used | Reference Method (e.g., laboratory-grade glucose analyzer). While not explicitly named, the nature of glucose measurement requires a highly accurate and precise reference method for comparative ground truth. |
| Training Set Sample Size | NOT SPECIFIED. |
| How Ground Truth for Training Set Was Established | NOT SPECIFIED. |
Conclusion:
The provided 510(k) summary (a premarket notification for demonstrating substantial equivalence to a predicate device) is high-level. It confirms that performance studies were conducted and that the device met its intended use, which is sufficient for 510(k) clearance. However, it does not provide the detailed scientific and clinical evidence, including specific acceptance criteria, performance metrics, sample sizes, or ground truth methodologies that would typically be contained in the full submission to the FDA. The purpose of this summary is to briefly introduce the device and its regulatory status, not to serve as a comprehensive research paper.
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(81 days)
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(140 days)
The Prodigy Blood Glucose Test System is intended for use in the quantitative measurement of glucose in capillary whole blood from the fingertip and palm. 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 are not intended for use on neonates.
The Prodigy glucose test system consists of a meter and 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 also provides voice broadcast function when the meter is used to test.
The provided document (K060467) pertains to the 510(k) summary for the Prodigy Blood Glucose System. After careful review, the document does not contain the detailed acceptance criteria or the specific study results that would allow for a complete description of the device's performance against such criteria.
The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (TaiDoc Technology Corporation, K042005) rather than providing a detailed performance study against pre-defined acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor the detailed information regarding sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.
Here's what can be extracted and inferred from the text regarding safety and effectiveness:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states: "The results of clinical and non-clinical testing indicate that the new device is as safe and effective as the predicate." However, it does not detail what specific acceptance criteria were used or the quantitative performance results against them.
2. Sample sized 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 document.
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 document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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 information is not applicable/provided. The Prodigy Blood Glucose System is an in-vitro diagnostic device for measuring glucose, not an AI-assisted diagnostic tool requiring multi-reader studies with human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The Prodigy Blood Glucose System is an electrochemical method-based meter. Its performance is inherent to the device itself (strip and meter interaction). The concept of "standalone algorithm only" is not directly applicable in the same way it would be for image analysis AI. The "standalone" performance would be its accuracy in measuring glucose values, which is generally evaluated in clinical trials using reference methods. However, the details of such a trial are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For blood glucose measurement systems, the "ground truth" is typically established by comparing the device's readings against a laboratory reference method (e.g., a YSI analyzer) with high accuracy and precision. While the document mentions "clinical and non-clinical testing data," it does not explicitly state the type of ground truth method used.
8. The sample size for the training set:
This information is not provided in the document. (Note: For a traditional electrochemical blood glucose meter, the concept of a "training set" as understood in machine learning is not directly applicable. Calibration data and internal validation data would be collected during development and manufacturing, but specific "training set" size for an algorithm is not relevant here).
9. How the ground truth for the training set was established:
As above, this information is not provided and the concept of "training set ground truth" is not directly applicable in the context of this device type.
Summary of available device performance information (from the "Similarities" table):
| Item | New Device: Prodigy | Predicate K042005 |
|---|---|---|
| Enzyme | Glucose oxidase | Glucose oxidase |
| Test range | 20-600 mg/dL | 20-600 mg/dL |
| Sample volume | 0.7 uL | 1.8-2.5 uL |
| Test time | 7 sec. | 10 sec. |
This table highlights technical specifications and equivalence, but not detailed accuracy performance against clinical acceptance criteria.
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