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A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Sensi-Derm® Latex Surgical Gloves meet all of the requirements of ASTM D 3577, Type 1. Sensi-Derm® Latex Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Sensi-Derm® Latex Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. Sensi-Derm® Latex Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.

This is a surgical glove, rather than an AI/ML device, so the requested information regarding AI/ML device performance criteria, training sets, expert adjudication, and MRMC studies is not applicable. The provided text describes the performance of "Sensi-Derm® Latex Surgical Gloves" against established ASTM (American Society for Testing and Materials) standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for testing against ASTM D 3577, D 5151, or for the biocompatibility tests (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). The data provenance is not explicitly stated in terms of country of origin, but the testing would have been conducted by or for Ansell Perry Inc., based in Massillon, Ohio, USA, to meet US regulatory requirements. The tests are descriptive of the product's inherent physical and biological properties.

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

Not applicable. This device is a surgical glove, and its performance is evaluated against established ASTM standards and biocompatibility protocols, not through expert-driven ground truth establishment in the same manner as an AI/ML diagnostic device. The "ground truth" here is the adherence to these predefined physical and biological standards.

4. Adjudication method for the test set:

Not applicable. The evaluation is based on objective measurements and observations against pre-defined ASTM standards and biocompatibility test outcomes. There is no expert adjudication process described for interpreting subjective results in the way one would see for image analysis or clinical diagnosis.

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 a physical medical device (surgical glove), not an AI/ML diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

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 glove), not an algorithm.

7. The type of ground truth used:

The "ground truth" for the device's performance is objective measurements and observations that demonstrate compliance with established ASTM (American Society for Testing and Materials) standards for dimensions, physical properties, and freedom from holes, as well as results from standard biocompatibility tests (Primary Skin Irritation in Rabbits and Guinea Pig Sensitization).

8. The sample size for the training set:

Not applicable. This is a physical medical device (surgical glove), not an AI/ML algorithm that requires a training set.

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

Not applicable. This is a physical medical device (surgical glove), not an AI/ML algorithm that requires a training set and associated ground truth establishment.

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