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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® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use), meet all of the requirements of ASTM D 3577, Type 2.
Derma Prene® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use) meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
Derma Prene® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
Derma Prene® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
Characteristics: Dimensions, Physical Properties, Freedom from holes, Powder-Free, Biocompatability Primary Skin Irritation in Rabbits, Guinea Pig Sensitization
Standard: Meets ASTM D 3577, Meets ASTM D 3577, Type 2, Meets ASTM D 3577, Meets ASTM D 5151, Meets described test in Attachment VI of K980929, Meets ASTM D 6124 Not more than 2 mg residue by mass., Passes, Passes

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets those criteria:

Device: Derma Prene® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use)

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not explicitly state the sample size used for the performance tests. It mentions "performance test data of the non clinical tests," but no specific number of units tested.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It implies the studies were conducted by Ansell Perry based on their submission.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Not applicable. The ground truth for this device (surgical gloves) is established through adherence to recognized international standards (ASTM) and specific performance tests, not through expert consensus on interpretation.

4. Adjudication Method for the Test Set

Not applicable. As the tests involve objective measurements against established standards (e.g., dimensional checks, physical property tests, hole detection), there is no need for an adjudication method by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is typically used for diagnostic devices where human readers interpret images or data. Surgical gloves are a medical device with objective performance criteria.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical product (surgical glove), not an algorithm or AI system. Its performance is measured directly through laboratory testing.

7. Type of Ground Truth Used

The ground truth used is primarily established international standards (ASTM) and objective laboratory test results (e.g., measurements for dimensions, tensile strength, elasticity, freedom from holes, powder residue, and biological response in animal models for biocompatibility).

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML product; therefore, there is no "training set."

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

Not applicable. As there is no AI/ML component, there's no training set or ground truth establishment in this context.

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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.

Derma Prene® Powder-Free Synthetic Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 2. Derma Prene® Powder-Free Synthetic Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Derma Prene® Powder-Free Synthetic Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. Derma Prene® Powder-Free Synthetic Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.

The provided text describes the acceptance criteria and performance of the Derma Prene® Powder-Free Synthetic Surgical Gloves. It does not describe a study involving AI, human readers, or clinical outcomes data in the way a typical medical device AI study would. The acceptance criteria and performance are based on established ASTM standards for surgical gloves and biocompatibility tests.

Here's an analysis based on the provided text, addressing the points where information is available:

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 each characteristic. The tests are described as "non clinical tests" and the data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature, though it's implied to be laboratory testing in support of the 510(k) submission.

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

This is not applicable as the measurements are against objective, quantitative standards (ASTM D 3577, D 5151, D 6124) and biocompatibility tests (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). There is no mention of human experts establishing a "ground truth" for the device's performance against these standards, as the standards themselves define the criteria.

4. Adjudication method for the test set

Not applicable. The performance is measured directly against predefined ASTM standards and test methods. There is no mention of adjudication for these types of objective physical or chemical 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 surgical glove device, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers or AI assistance was performed or described.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used

The "ground truth" for the device's performance against the acceptance criteria is defined by established industry standards (ASTM D 3577, D 5151, D 6124) and recognized biocompatibility testing methods. For example, "Meets ASTM D 3577" or "Passes" for biocompatibility tests are the ultimate ground truth for this device's regulatory submission.

8. The sample size for the training set

Not applicable. This is a manufactured product (surgical glove) and does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device