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The various surgical or patient drapes manufactured by DEKA Medical, Inc., consist of natural or synthetic materials intended to be used as a protective patient covering during surgical procedures. The primary purpose of the drapes is to isolate a site of surgical incision from microbial or other contamination.

DEKA Medical, Inc., will market Surgical Drapes composed of nonwoven fabric or polyethylene film and are of various configurations appropriate for Otological, Ophthalmic, Heart & Neurological, Peri/OB, Arthroscopic, and Specialty Procedures. These devices use nonwoven and film materials as a protective patient covering during surgical procedures. These barrier materials are essentially impervious to fluid transfer across them, thus function to isolate the operative site from the surrounding area. Drapes may feature tape adhesive to temporarily bind the drape to the periphery of the operative site. Fluid collection pouches are attached to the drape for collection of operative wound solid and liquid effluents. The DEKA Medical Surgical Drapes will be subjected to a sterilizing dose of gamma radiation sufficient to achieve a Sterility Assurance Level (SAL) of 10-6.

The provided text describes a 510(k) submission for a Patient Drape product, not an AI-powered device. Therefore, a direct comparison using typical AI/ML acceptance criteria and study methodologies (like those that assess algorithm performance, MRMC studies, or multi-reader, multi-case studies) is not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (Invotec International, Inc. Ear Drape K911039) for a medical device (surgical drape) that is not an AI-driven product. The study described is a nonclinical test data analysis, primarily evaluating the physical properties and biocompatibility of the materials used in the drapes.

However, I can extract the relevant information about the acceptance criteria and the "study" (nonclinical testing) as presented in the document for the Patient Drape:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials. The performance data is derived from material supplier data and specific laboratory tests on the drape materials and a "Composite Patient Drape." The exact number of material samples or drapes tested is not specified.
• Data Provenance: The data is "Physical properties data obtained from suppliers of DEKA Medical Surgical Drape nonwoven fabric, polyethylene films, and skin contacting adhesives." It also includes "Biocompatibility testing... of a gamma sterilized Composite Patient Drape." This is primarily retrospective (data from suppliers) and prospective (specific biocompatibility testing). The country of origin is not specified, but the submission is to the U.S. FDA, implying compliance with U.S. standards.

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

• This is not applicable as the "ground truth" for this medical device is based on objective physical and chemical properties testing against established standards (e.g., ISO for sterility and biocompatibility, 16 CFR for flammability), not expert interpretation of outputs.

4. Adjudication method for the test set

• Not applicable as the "test set" involves objective laboratory measurements against predefined specifications, not subjective reviewer performance.

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, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

• Not applicable. This is not an algorithm or AI device.

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

• The "ground truth" here is based on objective measurements and adherence to established industry standards and regulations for material properties and performance. Examples include:
  • Material specifications confirming impermeability, tensile strength, and puncture resistance (from suppliers).
  • Regulatory standards like 16 CFR Part 1610 for flammability.
  • International Standards like ISO 11137 for sterility assurance and ISO 10993-10 for biocompatibility.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The performance is based on the inherent properties of the manufactured materials and products.

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

• Not applicable, as there is no training set for this type of medical device.

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