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The intended use of the Endodrape™ surgical and diagnostic procedure drape manufactured by Vortek Surgical is for patients receiving and/or medical professionals performing a non-sterile diagnostic procedure for colonoscopies to help protect the patient and staff from bodily secretions and to maintain a cleaner procedural site. The device is a single use disposable drape that is provided non-sterile. The device can, however, be EtO (ethylene oxide) sterilized by the end user prior to use.

The Endodrape™ surgical and diagnostic procedure drapes manufacture by Vortek Surgical, Inc. are non-sterile, single use, disposable barriers intended to be used by medical professionals as a protective patient covering; to protect clinical staff and equipment from patient secretions; and help maintain a cleaner procedural site. The drapes are blue in color and are a non-woven fabric that will be manufactured under private label to Vortek Surgical. The Endodrape™ fabric itself is a repellant treated, non-woven fabric manufactured under the trade name of Sontara by the contract manufacturer to Vortek Surgical, Inc. There are no reinforced areas of the drape. The drape is 0.13 inch thick and measures 43" x 49" and is without any areas of reinforcement. The fibers used in the drape are mechanically bonded together.

The provided document is a 510(k) summary for the Endodrape™ Surgical and Diagnostic Procedure Drape, a physical medical device (non-sterile surgical drape), not a software or AI-powered device. Therefore, many of the requested categories related to AI performance, such as multi-reader multi-case studies, standalone algorithm performance, training set details, and expert ground truth establishment for a test set, are not applicable.

However, I can extract information related to the acceptance criteria and the studies performed to demonstrate equivalence for this specific device.

1. Table of Acceptance Criteria and Reported Device Performance

The device is assessed for substantial equivalence to predicate devices based on various physical, mechanical, liquid barrier penetration, and biocompatibility characteristics. The acceptance criterion for each characteristic is generally "Same or similar" to the predicate devices.

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

The document does not explicitly state the sample size for each specific bench test performed on the Endodrape™. However, it indicates that "All physical and mechanical testing was performed in accordance with the applicable standards and regulations" set forth by ASTM, INDA, US CFR, AATCC, and ISO.

The data provenance is from non-clinical performance (bench testing) conducted by the contract manufacturer to Vortek Surgical, Inc. The location of the testing is not specified beyond being performed by the contract manufacturer. The data is prospective in the sense that these tests were specifically carried out for the submission.

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

Not applicable. This is a physical device being evaluated through bench testing against industry standards and comparison to predicate devices, not requiring expert ground truth for a test set in the conventional sense of clinical or diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. The "test set" here refers to the bench testing of the physical characteristics. Adjudication in the context of expert consensus is not relevant. The performance is objectively measured against established 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 device or an imaging device requiring human reader performance evaluation.

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

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance (bench testing) is based on:

• Established Industry Standards: Reference to ASTM, INDA, US CFR, AATCC, and ISO standards (e.g., for physical, mechanical, and liquid barrier properties).
• Predicate Device Characteristics: The comparison of the Endodrape™'s performance against the known characteristics of the predicate devices (HVO, Inc. surgical drapes and Medical Concepts Development's ColoShield Colonoscopy Drape Model E2000).
• Biocompatibility Testing: Results from specific biocompatibility tests (Cytotoxicity, Sensitization, Irritation) conducted in accordance with ISO 10993-1:2003.

8. The Sample Size for the Training Set

Not applicable. This is a physical device. There is no training set in the context of machine learning.

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

Not applicable. There is no training set for a physical device.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is the Non-Clinical Performance (Bench Testing).

• Study Design: Comprehensive bench testing covering Physical, Mechanical, Liquid Barrier Penetration, and Biocompatibility.
• Standards Followed: Testing was performed in accordance with applicable industry-recognized test methods and standards from ASTM, INDA, US CFR, AATCC, and ISO, and followed recommendations from the FDA Guidance Document for Surgical Gowns and Surgical Drapes, August 1993. Biocompatibility testing followed ISO 10993-1:2003.
• Comparison Basis: The results of these tests were compared to the characteristics of legally marketed predicate devices (HVO, Inc. surgical drapes and Medical Concepts Development's ColoShield Colonoscopy Drape Model E2000).
• Key Findings: The Endodrape™ surgical and diagnostic procedure drapes were found to have physical, mechanical, and liquid barrier properties that are "Same or similar" to the predicate devices. Furthermore, biocompatibility testing (cytotoxicity, skin irritation, and skin sensitivity) confirmed the device was non-cytotoxic, non-irritating, and non-skin sensitizing, even under worst-case EtO sterilized conditions.
• Conclusion of Study: The results of the non-clinical performance testing demonstrated that the Endodrape™ drapes are acceptable for their intended use and are substantially equivalent to the predicate devices, not raising any new questions regarding safety or effectiveness.

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