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The PersonnaPlus Safety Scalpel System is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading, passing, and disposal.

The device is a combination scalpel blade and handle incorporating a sharps injury protection feature. There are two product options -(1) a totally disposable unit and (2) a metal handle with disposable blade and guard - our "reposable" product. The totally disposable unit uses a plastic handle while the reposable product has a stainless steel handle.

The provided document is a 510(k) summary for the PersonnaPlus Safety Scalpel System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer all the questions about specific acceptance criteria, a comprehensive study design with sample sizes, expert qualifications, adjudication methods, or MRMC studies.

Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a "successful simulated user study was conducted according to FDA guidance document Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA Document Issued on: December 31, 2002."

However, it does not provide a specific table of acceptance criteria or the quantitative results (e.g., number of accidental injuries, rate of successful guard deployment) from this simulated user study. The "reported device performance" is broadly stated as enhancing safety and being substantially equivalent.

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

The document mentions a "simulated user study," but does not specify the sample size (e.g., number of users, number of simulated procedures) used for this test.

• Sample Size for Test Set: Not specified.
• Data Provenance: The study was a "simulated user study," implying it was conducted in a controlled environment, likely in Australia (country of origin of OMI Manufacturing Pty Ltd) or the USA (where FDA guidance applies). It would be considered prospective as it's a study specifically conducted for regulatory submission.

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 a simulated user study on a safety scalpel, "ground truth" might refer to expert observation of proper use, safety feature deployment, or assessment of simulated injury events. However, no details are given.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the simulated user study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, this document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. MRMC studies are typically for evaluating diagnostic imaging or AI performance where multiple readers interpret cases. This device is a surgical scalpel with a safety feature, so an MRMC study is not directly applicable in its traditional sense. The study conducted was a "simulated user study" focusing on sharps injury prevention.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the PersonnaPlus Safety Scalpel System is a physical medical device (scalpel) with a mechanical safety feature, not an algorithm or AI. Its performance inherently involves human interaction (user handling).

7. The Type of Ground Truth Used

For the "simulated user study," the "ground truth" likely involved:

• Expert observation/assessment: Healthcare professionals or trained observers evaluating the proper use of the scalpel, the successful deployment of the safety feature, and the absence of simulated sharps injuries.
• Performance metrics related to sharps injury prevention: This would likely involve quantifiable outcomes like the number of successful activations of the safety mechanism, the rate of inadvertent exposures, or compliance with safe disposal protocols.

However, the document does not explicitly state the specific type of ground truth or how it was established beyond "a successful simulated user study."

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical device, not an AI or algorithm that requires a training set.

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

This question is not applicable for the same reason as above (not an AI/algorithm).

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