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The JRP Wound Spreader is a non-invasive superficial wound retractor with integrated guard that is used for wound care and positioning of small superficial wounds in the skin of up to 1/4" in width, 1/4" in depth and 1/2" in length.

The JRP Wound Spreader is a manually operated handheld non-invasive superficial wound retractor with an integrated guard that can accommodate a needleless syringe for the purpose of facilitating the retraction, observing the wound and flushing of small superficial wounds in the skin if deemed necessary. The JRP Wound Spreader consists of an array of four small tensioning fingers, which can be positioned on the skin astride a small superficial wound or incision.

This document (K152538) describes the JRP Wound Spreader, a non-invasive superficial wound retractor. The information provided heavily emphasizes comparison to a predicate device and does not contain detailed acceptance criteria and performance data for a new AI/software-based medical device. Therefore, a direct response to all parts of your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided as it pertains to AI/software.

However, I can extract what is present in the document regarding performance and testing for this manual surgical instrument:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample size for test set: 40 people
• Data provenance: Not explicitly stated, but the study was conducted to demonstrate substantial equivalence for a device seeking FDA clearance in the USA. It is implied to be a prospective study designed for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is a physical device and the "ground truth" would be related to observed performance in the study participants. The study involved "performance and assembly tasks" where success was likely objectively determined based on the device's intended mechanical function.

4. Adjudication method for the test set:

• Not explicitly stated, but given the nature of the device (a mechanical wound spreader), adjudication for "performance and assembly tasks" would likely be based on direct observation of whether the device performed its intended function as described (e.g., successful retraction, secure connection).

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:

• Not applicable. This document is for a manual surgical instrument, not an AI or software-based device that would involve "human readers" or "AI assistance."

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

• Not applicable. This is a manual surgical instrument.

7. The type of ground truth used:

• The ground truth for the performance testing was based on the successful demonstration of the device's mechanical functions and safety in practical tasks performed by the 40 participants. This would be observational performance data rather than expert consensus, pathology, or outcomes data in the usual sense for diagnostic AI tools.

8. The sample size for the training set:

• Not applicable. This is a manual surgical instrument, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. No training set for an algorithm is involved.

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