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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.

Device Description

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.

AI/ML Overview

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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