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The Precision A1c Home HbA1c Sample Collection Kit is intended to be a home-use or office-use device for the collection of a capillary blood sample on a blood sample collection card for in vitro diagnostic laboratory evaluation of the amount of HbA1c (glycosylated hemoglobin). This collection device will be used to monitor long-term blood glucose control in patients with diabetes mellitus.

The Precision Alc sample collection device will be marketed over-the-counter. This kit is not indicated for the diagnosis of diabetes mellitus.

The Precision A1c Home HbA1c Sample Collection Kit contains the materials necessary to collect a capillary blood sample from a finger-stick to a piece of filter paper and mail it to a clinical laboratory for the determination of percent hemoglobin A1c (also known as glycohemoglobin or glycosylated hemoglobin).

The Precision A1c sample collection kit contains a lancet, patient information sheet, instruction sheet, alcohol pad, gauze pad, bandage, pre-paid mailing envelope, and a blood sample collection card (inside a zip-locked foil pouch containing a desiccant).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance for Precision A1c™ Home HbA1c Sample Collection Kit (K983253)

The key performance criteria for the Precision A1c™ Home HbA1c Sample Collection Kit are based on the correlation and agreement of HbA1c results obtained from samples collected with the kit compared to whole blood samples. The study assessed the performance of the device when used by both trained operators and lay users.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values (e.g., "correlation coefficient must be > 0.95"). However, the language of the conclusion, stating "Results indicate excellent correlation... and equivalent results," strongly implies that the observed performance values were considered acceptable. Based on the data presented and the concluding remarks, the implied acceptance criteria would generally be a correlation coefficient close to 1.000, a slope close to 1.000, and a y-intercept close to 0.0, along with low bias and Sy.x values.

2. Sample Size for the Test Set and Data Provenance

• Sample Size:
  • Trained Operator vs. Whole Blood: N = 258
  • Lay User vs. Whole Blood: N = 259
  • Trained Operator vs. Lay User: N = 259
• Data Provenance:
  • The study involved clinical sites, and samples were collected from patients. However, the specific country of origin is not explicitly stated. The document refers to "LabOne" and "University of Missouri," suggesting the data is likely from the United States.
  • The study appears to be prospective in nature, as it describes the collection of samples specifically for the performance evaluation from patients, followed by parallel analysis.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

The establishment of ground truth in this study relies on established laboratory instruments and methods rather than individual expert interpretation of complex images or clinical cases.

• Number of Experts: Not applicable in the traditional sense of medical imaging or diagnostic interpretation by human experts.
• Qualifications of Experts: The "ground truth" reference measurements were performed by laboratory instruments (Roche Cobas Integra, HbA1c Cassette; Roche Cobas Mira, Unimate Reagent; Bio-Rad Diamat Glycosylated Hemoglobin Analyzer System) at clinical laboratories (LabOne and University of Missouri). These laboratories are assumed to be operating under standard clinical laboratory practices with qualified personnel.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by laboratory instrument readings, not by a consensus of human reviewers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study is focused on the performance of a sample collection device, not on diagnostic accuracy of human readers with or without AI assistance. The comparison is between different sample collection methods and operators, with a reference to a laboratory analyzer.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The study evaluates the performance of the Precision A1c Home HbA1c Sample Collection Kit by comparing the results obtained using the kit (both by trained operators and lay users) against whole blood samples analyzed on predicate laboratory equipment. This demonstrates the performance of the device (the collection kit) in isolation of further human interpretation (beyond the initial sample collection).

7. Type of Ground Truth Used

The ground truth used was laboratory reference measurements from venous whole blood samples analyzed on established and previously cleared predicate HbA1c testing systems (Roche Cobas Integra, HbA1c Cassette; Roche Cobas Mira, Unimate Reagent; Bio-Rad Diamat Glycosylated Hemoglobin Analyzer System). This represents an objective, quantitative measurement from a standard clinical method.

8. Sample Size for the Training Set

The document does not mention a training set. This is expected because the device is a sample collection kit and not a machine learning model that requires a training phase. The described study is a performance validation study.

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

Not applicable, as there was no training set for this device.

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