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The test strips are to be used with the Accu-Chek Simplicity meter. The Accu-Chek Simplicity system is designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.

Device Description

Instrument Operating Principle -- photometric
Reagent Test Principle -- glucose deoxy reductase

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Accu-Chek Simplicity™ System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text primarily focuses on comparative data with a predicate device rather than explicitly stating acceptance criteria as a threshold your device must meet to pass. However, we can infer the acceptance criteria by looking at the performance of the predicate and the modified device's goal to show substantial equivalence.

Feature / Metric	Acceptance Criteria (Inferred from Predicate/Comparison)	Reported Device Performance (Modified Accu-Chek Simplicity)
Method Comparison: Capillary Blood	`N = 202`
`y = 1.02x + 2.6`
`r = 0.989`
`range = 51 to 490 mg/dL` (Predicate) - The modified device should demonstrate similar or improved correlation and agreement with the laboratory method.	`N = 297`
`y = 1.02x - 5.2`
`r = 0.977`
`range = 57 to 515 mg/dL` (Modified device shows comparable regression statistics and a wider testing range, implying acceptable performance given the predicate's performance.)
Method Comparison: Consumer Study	`N = 134`
`y = 1.082x - 2.9`
`r = 0.976`
`range = 58 to 357 mg/dL` (Predicate) - The modified device should demonstrate similar or improved correlation and agreement with the laboratory method in consumer use.	`N = 230`
`y = 1.05x - 7.0`
`r = 0.982`
`range = 57 to 515 mg/dL` (Modified device shows comparable regression statistics, particularly a slightly improved 'r' value and wider range, implying acceptable performance.)
Precision: Control Level 1	Predicate: Mean = 84.0 mg/dL, SD = 2.0 mg/dL. The modified device should demonstrate comparable precision.	Mean = 52 mg/dL, SD = 1.6 mg/dL (Note: The mean glucose level for Control Level 1 is different between the modified and predicate devices, so direct comparison of SD might be misleading without a CV for the predicate. However, a low SD indicates good precision.)
Precision: Control Level 2	Predicate: Mean = 196.4 mg/dL, CV = 2.5. The modified device should demonstrate comparable precision.	Mean = 167 mg/dL, SD = 4.7 mg/dL, CV = 2.8 (CV is comparable to the predicate at a different mean level, suggesting acceptable precision for the modified device).
Precision: Venous Blood Level 1	Predicate: Not explicitly stated with full data for comparison.	Mean = 53 mg/dL, SD = 1.7 mg/dL (Indicates good precision, though specific acceptance criteria against a predicate at this level are not delineated).
Precision: Venous Blood Level 2	Predicate: CV = 3.0. The modified device should demonstrate comparable precision.	Mean = 153 mg/dL, SD = 6.3 mg/dL, CV = 4.1 (CV of 4.1 for the modified device is slightly higher than the predicate's 3.0 at a different mean level, but potentially within acceptable limits given the context of substantial equivalence).
Precision: Venous Blood Level 3	Predicate: CV = 3.4. The modified device should demonstrate comparable precision.	Mean = 499 mg/dL, SD = 16.3 mg/dL, CV = 3.3 (CV is comparable to the predicate, suggesting acceptable precision).
Maximum Altitude	Predicate: Tested acceptably at elevations up to 9500 feet above sea level. The modified device target was to operate at higher altitude.	Tested acceptably at elevations up to 10,150 feet above sea level (Improved performance and meets the goal of acceptable performance at higher altitude).
Acceptable Sample Type	Fresh capillary and heparinized venous whole blood samples (Predicate). The modified device intentionally changed to limit this to capillary whole blood.	Fresh capillary whole blood only (This is a difference from the predicate, and a conscious decision to position the device for consumer testing, implying the performance for capillary blood is acceptable and venous blood claim was removed rather than failing).

2. Sample Sizes Used for the Test Set and Data Provenance

Capillary blood study: N = 297
Consumer study: N = 230
Precision studies (Control Levels 1 & 2): N = 20/Level
Precision studies (Venous Blood Levels 1-3): N = Not explicitly stated per level, but the table implies multiple measurements to calculate mean, SD, and CV.
Altitude study: Not explicitly stated, but mentioned as "The results of the 1999 study confirm the device performs acceptably at 10,150 feet."

Data Provenance: The document does not explicitly state the country of origin. It refers to "clinical investigation sites" for the altitude study. Given the submitter's address (Indianapolis, IN, USA) and the FDA submission, it's highly probable these studies were conducted in the USA. The studies are retrospective in the sense that they are presented as completed data for a submission, but the studies themselves would have been prospective data collection efforts.

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 for establishing the ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set results. The ground truth appears to be based on an established laboratory reference method.

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

An MRMC study was not done. This device is a blood glucose monitoring system, not an imaging diagnostic device that typically involves human "readers" or "interpreters" in the same way an AI-assisted diagnostic might. Therefore, the concept of "human readers improve with AI" does not apply to this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, implicitly. The performance characteristics reported (method comparison, precision data) represent the standalone performance of the Accu-Chek Simplicity™ System itself when used as intended. While it's used by humans (persons with diabetes or healthcare professionals), the performance data reflects the device's accuracy in measuring glucose values against a reference standard. There isn't an "AI" component or "human-in-the-loop" interaction in the typical sense for this device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for method comparison studies was recognized laboratory methods:

Hitachi glucose plasma (for the modified device's capillary and consumer studies)
Hitachi glucose hexokinase whole blood (for the predicate device's studies)

For precision studies, the ground truth would be the known concentration of the control materials or pooled blood samples, or the mean value derived from repeated measurements by a highly accurate reference method.

8. The Sample Size for the Training Set

The document does not mention a training set because this device is a chemical-photometric measurement system, not a machine learning or AI-based device that would require explicit training data for an algorithm. The "training" for such a device would be its engineering and calibration during manufacturing.

9. How the Ground Truth for the Training Set was Established

As there is no explicit training set for an algorithm in this context, the concept of establishing ground truth for a training set does not apply. The device's calibration and performance are established through rigorous manufacturing processes and quality control using known reference standards.

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