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Exact Medical Manufacturing Surgical Gown - Spunlace w/PE Layer are sterile single use devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

The Exact Medical Manufacturing Surgical Gown - Sounlace w/PE Laver are also sold as built nonsterile, single use items, to repackagerrelabeler establishments for further packaging and ethylene oxide sterilization.

Exact Medical Manufacturing Surgical Gown-SPL are single use, disposable surgical gowns using in the OR as a protective covering, for the operating room staff, from the transfer of microorganisms, body fluids and particulates. Exact Medical Manufacturing Surgical Gowns- Spunlace w/PE Layer are comprised of disposable nonwoven (Spunlace), 100% polyester cuffs, Velcro neck closure, reinforced areas fabric or polyethylene

This document describes the 510(k) submission for Exact Medical Manufacturing's Surgical Gowns – Spunlace w/PE Layer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI-based device. Therefore, many of the requested categories related to AI device evaluation (e.g., AI integration, multi-reader multi-case studies, training set details) are not applicable.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes "Non-clinical performance testing" that was conducted to demonstrate substantial equivalence to the predicate device (Medline (Proxima) Surgical Gowns 510(k)964142).

• Study Design: This was a series of in-vitro and laboratory tests designed to evaluate the physical properties, barrier performance, biocompatibility, and sterilization effectiveness of the new surgical gown. It's a non-clinical, comparative study against established standards and the characteristics of the predicate device.
• Conclusion: "All results of the testing met acceptance criteria." and the gowns are deemed "substantially equivalent in all specifications and performance compared to the predicate device... and do not present any differences that could raise concerns related safety and effectiveness."

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

• Sample Size: Not explicitly stated for each test. The wording "All results of the testing met acceptance criteria" suggests that a sufficient number of samples were tested for each performance characteristic to demonstrate compliance with the relevant standards.
• Data Provenance: Not specified. It's reasonable to assume the testing was conducted in a laboratory setting, likely in the US, given the submission to the FDA. The data would be prospective in nature for these performance tests (i.e., new tests performed on newly manufactured devices or materials).

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 Applicable. This is not an AI/diagnostic device that requires expert ground truth for image interpretation or similar tasks. The "ground truth" here is defined by established international and national performance standards (e.g., ISO 10993 for biocompatibility, AAMI 11135-1:2007 for sterilization, and likely ASTM or AAMI standards for physical properties and barrier performance).

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

• Not Applicable. As this is not an AI/diagnostic device, there is no expert adjudication process for results. Performance is assessed against quantitative and qualitative standards.

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-assisted diagnostic or interpretation device.

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

• Not Applicable. This is a physical medical device (surgical gown), not an algorithm or AI system.

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

• The "ground truth" for the performance tests consists of established industry, national, and international standards for medical device performance, material properties, biocompatibility, and sterilization. For example:
  • Physicochemical tests: Standards like ASTM for tensile/tear strength, AAMI for barrier properties.
  • Biocompatibility: ISO 10993 series.
  • Sterilization: AAMI 11135-1:2007.
  • The predicate device's performance also serves as a comparator for demonstrating substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is not an AI device that requires a training set.

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

• Not Applicable. This is not an AI device that requires a training set or its associated ground truth establishment.

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