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The surgical glove is a device made of synthetic latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile are made of synthetic rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

The provided text is a 510(k) summary for a medical device, specifically Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile. This type of document is for regulatory clearance of medical devices, demonstrating substantial equivalence to a predicate device, rather than a clinical study report proving diagnostic performance of an AI algorithm.

Therefore, many of the requested categories for AI algorithm studies (such as sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this document.

However, I can extract the acceptance criteria and the "study" (which in this context refers to the testing performed to demonstrate compliance with standards) that proves the device meets them.

Here's the information derived from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. Testing would typically involve a statistically relevant sample size as per the ASTM standards referenced.
• Data Provenance: The manufacturing company is WRP Asia Pacific Sdn Bhd, located in Sepang, Selangor Darul Ehsan, Malaysia. The testing would have been conducted by or for this company. The document does not specify if the data is retrospective or prospective, but testing for device compliance is generally prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. This is a physical device testing, not an AI diagnostic study that relies on expert interpretation for ground truth. Compliance is determined by adherence to established material and performance standards.

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

• Not Applicable. This refers to expert review in diagnostic AI studies. Device testing for surgical gloves follows specific methods outlined in the ASTM standards, which do not involve expert adjudication in this manner.

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 diagnostic system.

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

• Not Applicable. This is not an AI algorithm. The device's performance is standalone in the sense that its physical properties are measured directly against standards.

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

• The "ground truth" for this device is defined by the established specifications and test methods within the referenced ASTM standards (e.g., ASTM D 3577 - 01aE2 for dimensions, physical properties, and freedom from pinholes; ASTM D 6124 - 01 for powder residual; and FDA 21 CFR 800.20 for pinhole AQL). These standards provide objective, measurable criteria for device performance.

8. The sample size for the training set

• Not Applicable. This is not an AI model requiring a training set.

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

• Not Applicable. This is not an AI model.

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