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A powder-free sterile surgeon's glove is a disposable device made of Natural Rubber Latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Biogel Latex Sterile Powder-Free Surgeon's Glove with Low Dermatitis Potential and Protein Content Labeling Claim (50 micrograms or less)

I apologize, but the provided text only contains a 510(k) clearance letter from the FDA for a surgeon's glove. It does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked. This document is a regulatory approval notice, not a technical report detailing the device's validation.

Therefore, I cannot extract the requested information from the given input.

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A powder-free sterile surgeon's glove is a disposable device made of Non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Non-latex sterile powder-free surgeon's glove

I'm sorry, but this document does not contain the information requested. This document is a 510(k) clearance letter from the FDA for a non-latex sterile powder-free surgeon's glove. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not include details about:

• Acceptance criteria and reported device performance related to a study.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Any information regarding a multi-reader, multi-case study or standalone algorithm performance.
• Training set details for an algorithm.

This document is a regulatory approval, not a scientific study report.

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A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Poly-Isoprene non-latex sterile powder-free surgeon's glove with Non-pyrogenic statement

The provided document is a 510(k) clearance letter from the FDA for a Biogel Skinsense Poly-Isoprene Powder-free Surgeon's Glove With Non-pyrogenic statement. This type of medical device (a surgeon's glove) is classified as a Class I device and does not typically involve complex performance studies with acceptance criteria, expert adjudication, or AI components as would be found for, for example, diagnostic imaging software.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment is not applicable to this device and the provided document.

The FDA's review for this device primarily focuses on demonstrating substantial equivalence to a predicate device already on the market, meaning it has the same intended use and technological characteristics as a legally marketed device, or different technological characteristics that do not raise new questions of safety and effectiveness. The document itself is the clearance letter, not a detailed study report.

The "Indications for Use" section (document {2}) states the purpose of the device: "A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants." The "acceptance criteria" in this context would typically relate to manufacturing standards, sterility, physical properties (e.g., tensile strength, barrier integrity), and biocompatibility, rather than performance metrics of a diagnostic or therapeutic algorithm. These would be met through standard quality control and testing procedures for medical gloves, but not detailed in this 510(k) clearance letter.

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A powder-free sterile surgeon's glove is a disposable device made of de-proteinised latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Eclipse, Non-pyrogenic, latex, powder free, sterile surgeon's glove

The provided document is a 510(k) premarket notification letter for a surgeon's glove, which is a medical device. This type of document does not contain information about acceptance criteria and study data for an AI/ML-powered medical device. It pertains to traditional medical device clearance based on substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information from the provided text. The questions posed are related to the evaluation of AI/ML device performance, which requires a different kind of documentation (e.g., a clinical study report, detailed performance testing results).

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A powder-free sterile surgeon's glove is a disposable device made of Natural Rubber Latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

A powder-free sterile surgeon's glove is a disposable device made of Natural Rubber Latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

This document is a 510(k) clearance letter from the FDA for a medical device: "BIOGEL Latex Sterile Powder-Free Surgeon's Glove." It does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-enabled medical device.

This document is a regulatory approval for a physical medical device (gloves), confirming its substantial equivalence to a predicate device. The information requested (Table of acceptance criteria and device performance; sample sizes, data provenance, expert ground truth, MRMC studies, standalone performance, training set details, etc.) is specific to the evaluation of AI/ML software.

Therefore, I cannot provide the requested information based on the provided text.

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A powder-free sterile surgeon's glove is a disposable device made of latex that is worn on the hands, usually in surgical settings, to provide a barrier between the wearer and/or the patient and the surgical environment, and to prevent contamination between the patient and the wearer.

A powder-free sterile surgeon's glove is a disposable device made of latex that is worn on the hands, usually in surgical settings, to provide a barrier between the wearer and/or the patient and the surgical environment, and to prevent contamination between the patient and the wearer.

This document is a 510(k) premarket notification decision letter from the FDA for surgical gloves. It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The letter pertains to the "Eclipse Latex Powder Free Sterile Surgeon's Glove" and primarily confirms its substantial equivalence to previously marketed predicate devices under the 510(k) process. This is a regulatory pathway for medical devices that are similar to existing ones and does not typically involve detailed performance studies with acceptance criteria as would be expected for a novel AI/ML device.

Therefore, I cannot provide the requested information from the given text.

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A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Poly-Isoprene Non-Latex Sterile Powder-Free Surgeon's Glove, organized according to your requested points:

The provided text is a 510(k) clearance letter from the FDA for a surgeon's glove and its Indications for Use statement. It does not contain detailed information about acceptance criteria or specific study results showing the device meets those criteria.

A 510(k) clearance relies on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves comparing device characteristics (including performance) to the predicate device and showing that differences don't raise new questions of safety or effectiveness. While performance tests are conducted, the detailed acceptance criteria and study results are usually part of the 510(k) submission materials and not fully presented in the FDA's clearance letter itself.

Therefore, for almost all your requested points, the answer based solely on the provided text will be that the information is not available.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size used for the test set: Not specified in this document.
• Data provenance: Not specified in this document.

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 to this type of device and document. For a surgeon's glove, "ground truth" as typically understood in medical device studies (e.g., for AI algorithms or diagnostic tools) involving expert review wouldn't be relevant. Performance is generally assessed via standardized physical and chemical tests (e.g., tensile strength, puncture resistance, sterility, barrier integrity). The FDA reviewer (Chiu Lin, Ph.D., Director of Division of Anesthesiology, General Hospital, Infection Control and Dental Devices) assessed the submission.

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

• Not applicable to this type of device and document. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth from expert opinions in diagnostic or interpretive tasks, which is not relevant for a surgeon's glove performance evaluation.

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

• No, this is not applicable. MRMC studies and the concept of "human readers" improving with AI assistance are relevant for AI-powered diagnostic or assistive devices, not for a surgeon's glove.

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

• No, this is not applicable. This applies to AI algorithms, not a surgeon's glove.

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

• For a surgeon's glove, the "ground truth" for performance would be based on objective measurements from standardized tests (e.g., ASTM standards for glove performance such as tensile strength, elongation, puncture resistance, barrier integrity (water leak test), and sterility testing) compared against predetermined specifications. It is not established by expert consensus or pathology in the same way a diagnostic device would be.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm. If "training set" refers to manufacturing process validation or quality control, that information is not provided in this regulatory letter.

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

• Not applicable. This device is not an AI algorithm.

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