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A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.

Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 3577, Type 2.

The provided text pertains to the 510(k) premarket notification for Ansell's Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use). It describes the device's characteristics and its conformance to established standards rather than a study proving the device meets acceptance criteria in the context of a typical AI/software medical device.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number/qualifications of experts, adjudication method, MRMC study, standalone performance) are not applicable to this type of device submission, as it's a conventional medical glove and not an AI-powered diagnostic or therapeutic device.

However, I can extract the relevant acceptance criteria and the "study" (which in this case refers to conformance testing against established standards) that proves the device meets these criteria.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size for Test Set: Not specified. For physical and biocompatibility testing of medical gloves, samples are typically drawn from manufacturing lots according to the respective ASTM standards, but specific numbers are not provided in this summary.
• Data Provenance: The nature of the studies (e.g., irritation, sensitization, cytotoxicity) suggests laboratory-based testing. The country of origin for the data is not specified, but the applicant (Ansell Healthcare Products LLC) is based in the USA. The studies are prospective in the sense that they are performed specifically to demonstrate compliance for this device.

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

• Not Applicable. For medical gloves, "ground truth" is established by conformance to objective, standardized testing methods (e.g., ASTM standards) rather than expert consensus on diagnostic images or clinical outcomes. The tests are conducted in laboratories by trained personnel following validated protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth from expert readings, which is not relevant to the physical and biocompatibility testing of gloves described here. Conformance is determined by meeting pre-defined thresholds in laboratory tests.

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 medical glove, not an AI-powered device.

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

• Not Applicable. This is a medical glove, not an AI-powered device.

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

• Objective Test Results against Standards: The "ground truth" is defined by the objective measurements and observations obtained from standardized laboratory tests (e.g., tensile strength, elongation, presence of holes, powder content, skin irritation responses) which are then compared against the acceptance criteria specified in the relevant ASTM standards.

8. The sample size for the training set

• Not Applicable. No training set is involved as this is not a machine learning or AI device.

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

• Not Applicable. No training set is involved.

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