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This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.

Surgical Drapes including various sizes and configurations of table covers, flat drape sheets, Lap drapes, cardiovascular drapes, head & neck drapes, general use drapes, cysto drapes, c-section drapes, orthopedic drapes and specialty drapes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the International Medsurg Connection Surgical Drape:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly lists the tests and the standards they adhere to, implying that meeting these standards constitutes the acceptance criteria. The phrase "All material used in the fabrication of the IMC Surgical Drapes were evaluated for" followed by the list of tests strongly suggests that the device met the requirements of these standards. However, specific quantitative performance data for each test (e.g., actual hydrostatic pressure achieved) is not provided in this summary.

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

The provided text does not include information on:

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

The tests listed are material property tests rather than clinical studies on patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to the type of testing described. The tests are laboratory-based material property assessments against established industry standards (ISO, AATCC, ASTM, CFR). Ground truth in this context is defined by the specifications and methodologies within these standards, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable. As discussed above, the tests are objective laboratory evaluations against material standards, not analyses requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not relevant for this type of device (surgical drapes). This device is a physical barrier, not an AI or diagnostic tool that would involve human readers interpreting data.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone study (in the context of an algorithm's performance) was not done. This device is a physical product, not a software algorithm. The tests performed are for material properties.

7. The Type of Ground Truth Used

The ground truth used for these tests is scientific and engineering standards and specifications. For instance:

• ISO 10993 (Biocompatibility): Standards define acceptable levels of cytotoxicity, irritation, and sensitization based on established biological safety principles.
• 16 CFR Part 1610 (Flammability): Federal regulations specify flammability performance requirements for textiles.
• AATCC (Textile Chemistry): Standards provide methodologies and criteria for properties like hydrostatic pressure and impact penetration.
• ASTM (Materials Testing): Standards outline methods for evaluating tensile strength.

The "ground truth" is adherence to these widely accepted and documented industrial standards.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device (surgical drapes), not a machine learning model, so there is no "training set."

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

This information is not applicable as there is no training set for this device.

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