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A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using polyisoprene, which is a synthetic rubber latex, and is brown in color. The glove is coated with hydrogel polymer coating.

The gloves are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.

This glove is suitable for use as a specialty surgical glove intended for orthopedic procedures or other procedures where a thicker barrier may be desired such as trauma and reconstructive surgery

The document describes the acceptance criteria and study for the Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating. This is a medical device, and the study focuses on its physical and biological performance against established standards rather than artificial intelligence or diagnostic capabilities. Therefore, some of the requested information regarding AI-specific elements (like human reader improvement with AI, ground truth for training sets, etc.) is not applicable.

Here's the information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the specific tests (e.g., number of gloves tested for freedom from holes, number of animals for biocompatibility). It refers to meeting standards like ASTM D3577 and ISO 10993-10, which would define appropriate sample sizes within their methodologies.

Data provenance is not specified as "country of origin" or "retrospective/prospective" in the context of device testing. The tests are conducted according to recognized international and national standards (ISO, ASTM, CFR).

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

This information is not applicable. The device is a surgical glove, and its performance is evaluated against established technical and biological standards, not through expert-labeled ground truth like in diagnostic AI studies.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation involves meeting predefined technical specifications and standards rather than human adjudication of results.

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

This information is not applicable. This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant.

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

This information is not applicable. This is not an algorithm or AI device. The tests described are for the physical and biological characteristics of a surgical glove.

7. The Type of Ground Truth Used

The "ground truth" used is defined by established regulatory standards and recognized consensus standards (e.g., ASTM D3577 for physical properties and freedom from holes, ISO 10993-10 for biocompatibility, and 21 CFR 800.20 for freedom from holes). For example, a glove either meets the specified AQL (Acceptable Quality Level) for freedom from holes or it does not. Similarly, it either causes irritation/sensitization or it does not, according to the test protocols.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI or machine learning device and therefore does not have a "training set."

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

This information is not applicable for the reason mentioned above.

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