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Designed for testing glucose in whole blood by visually impaired persons with diabetes.

The Accu-Chek Voicemate is a portable blood glucose test system. The Accu-Chek Voicemate incorporates proven technologies, such as the Accu-Chek® Advantage® Monitor, Accu-Chek™ Comfort Curve™ Test Strips, and Accu-Chek™ Softclix® Lancet Device. The Accu-Chek Voicemate differs from the currently available devices in that it introduces a new function that will be especially helpful to the visually impaired insulin-using diabetics. We have worked in partnership with Eli Lilly & Company to develop a bar code reader that will reliably read bar codes printed on the insulin vials distributed by Eli Lilly. The bar code reader will help the visually impaired customers distinguish their insulin vials.

The provided text describes the Accu-Chek Voicemate, a self-monitoring blood glucose test system for visually impaired individuals with diabetes. However, the document is a 510(k) summary and approval letter, which primarily focuses on substantial equivalence to a predicate device and regulatory approval.

It does not contain detailed information about the acceptance criteria and the specific study proving the device meets those criteria, as typically found in clinical trial reports or performance evaluation summaries.

Therefore, I cannot provide a complete answer to all parts of your request based solely on the provided text.
I can, however, extrapolate some information based on the context of a medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the provided text. For a blood glucose meter, typical acceptance criteria would involve accuracy standards (e.g., ISO 15197 guidelines for blood glucose monitoring systems like accuracy within ±15% or ±0.83 mmol/L for a certain percentage of readings compared to a reference method).
• Reported Device Performance: Not explicitly provided in quantitative terms within this document. The document states "The Accu-Chek Voicemate incorporates proven technologies, such as the Accu-Chek® Advantage® Monitor, Accu-Chek™ Comfort Curve™ Test Strips," implying that the glucose measurement aspect relies on previously validated components. The key new feature, the insulin vial label reader, is described as capable of reading bar codes on specific insulin vial types.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified.
• Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective clinical data)

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

• Not specified. This information would typically be relevant for studies evaluating human interpretation, which is not the primary focus of this device's new feature (the barcode reader). For the glucose measurement, the "ground truth" would be established by a laboratory reference method.

4. Adjudication Method for the Test Set

• Not applicable/specified, as there's no mention of a clinical study requiring adjudication of expert interpretations for this specific submission's new features. For glucose measurement, the comparison is typically against a lab reference.

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

• No, an MRMC comparative effectiveness study is not mentioned. This type of study is more common for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated with or without AI assistance. The Accu-Chek Voicemate is a self-monitoring device, and its primary new feature is an automated barcode reader, not an AI assisting human interpretation of complex medical images.

6. Standalone (Algorithm Only) Performance

• The document implies standalone performance for the glucose measurement component (borrowed from Accu-Chek Advantage Monitor and Comfort Curve Test Strips) and the new insulin vial label reader. However, specific performance metrics (e.g., barcode reading accuracy, false positive/negative rates for the reader) are not provided in this 510(k) summary. The barcode reader itself is an algorithm-only function determining if a barcode is readable and corresponds to a defined insulin vial.

7. Type of Ground Truth Used

• For the core blood glucose measurement, the ground truth would typically be established by a laboratory reference method (e.g., YSI analyzer) for glucose concentration.
• For the new insulin vial label reader, the ground truth would be the actual identity of the insulin vial as confirmed by a human (e.g., visually inspecting the label for the correct insulin type).

8. Sample Size for the Training Set

• Not specified. This would be relevant for the development of any algorithms within the device (e.g., the barcode reader's recognition algorithm).

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

• Not specified. For a barcode reader, it would involve a dataset of various insulin vial barcodes (and possibly non-barcodes) with their known identities.

Summary of what's provided for acceptance criteria and study in the text:

The provided document is a 510(k) summary, which largely relies on demonstrating substantial equivalence to a predicate device (Accu-Chek II Freedom). The new device, Accu-Chek Voicemate, integrates existing, proven technologies for blood glucose measurement and adds a new function: an insulin vial label reader for visually impaired users.

While it mentions the "incorporation of proven technologies," specific performance data or a dedicated study demonstrating that the entire new device meets predefined acceptance criteria for its combined functionality (especially the new barcode reader) is not detailed in this summary. Regulatory submissions of this nature often reference internal testing or previous submissions for predicate components without fully re-reporting all raw data or detailed study designs in the public 510(k) summary.

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