Search Results

The New Device is intended for the same use as the Predicate Device. It is intended to be used for routine skin closure.
The indications statement for the New Device and the Predicate Device is the same. The devices are used for routine skin closure in a wide variety of surgical procedures.

The PROXIMATE® Disposable Skin Stapler is a sterile, single patient use instrument designed to deliver rectangular, stainless steel staples for routine wound closure.

This document is a 510(k) summary for a medical device (PROXIMATE® Disposable Skin Stapler) seeking clearance for market. It does not describe a study conducted to prove the device meets specific acceptance criteria in the context of an AI/algorithm-driven device.

The information provided describes a pre-clinical study to evaluate the cosmetic appearance and ease of extraction of staples, for a physical medical device (skin stapler). It is not a study assessing AI device performance with ground truth and expert reviews.

Therefore, most of the requested information regarding acceptance criteria, AI performance, ground truth, and expert involvement is not applicable to this specific document.

Here's an attempt to answer the questions based on the provided text, highlighting what is not applicable:

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

   Acceptance Criterion	Reported Device Performance
   Cosmetic appearance	Acceptable
   Perceived ease of extraction	Acceptable

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample size: Not specified.
   • Data provenance: Not specified, but described as a "pre-clinical study" which implies it was conducted under controlled conditions, likely prospective experimental data. Country of origin is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not specified. The study evaluates "cosmetic appearance and perceived ease of extraction," which would typically involve subjective assessment by trained personnel (e.g., clinicians, researchers), but the number and qualifications are not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable/Not specified. This refers to adjudication for expert ground truth, which isn't described for this subjective evaluation.

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 is not an AI device.

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

   • Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • The "ground truth" (or evaluation criteria) appears to be subjective assessment of "cosmetic appearance" and "perceived ease of extraction." This likely involved observations and subjective ratings by evaluators, but the specific form of "ground truth" (e.g., a standardized rating scale, expert consensus on "acceptable" cosmetic outcome) is not detailed.

8. The sample size for the training set

   • Not applicable. This is a pre-clinical study for a physical device, not an AI model requiring a training set.

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

   • Not applicable. This is not an AI model.

Ask a specific question about this device