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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR GINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN (YELLOW GOLD)

This document is a 510(k) clearance letter from the FDA for a medical device: "Opus-E Disposable Powder Free Vinyl Synthetic Exam Gloves With Vitamin Complex, Nopal and Lanolin (Yellow Gold)".

The letter states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls provisions. It does not contain information about:

1. Acceptance criteria and reported device performance: This document is a regulatory approval, not a performance study report.
2. Sample size and data provenance: No study data is presented.
3. Number and qualifications of experts for ground truth: No ground truth establishment is discussed for a study.
4. Adjudication method: Not applicable as no study is detailed.
5. MRMC comparative effectiveness study: No such study is mentioned.
6. Standalone performance study: No such study is mentioned.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

The document is a clearance letter, indicating regulatory approval based on substantial equivalence, not a detailed report of a performance study with acceptance criteria.

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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE VINYL SYNTHETIC EXAM GLOVE, POWDER FREE, PINK COLOR

This document is a 510(k) clearance letter from the FDA for disposable vinyl synthetic exam gloves. It does not contain information about acceptance criteria and a study proving device performance as requested. The letter is a regulatory approval, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR

The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Powdered Free Vinyl Synthetic Exam Gloves White Color." This document primarily addresses the substantial equivalence determination for a medical device and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications, as would typically be found in a study report or clinical trial documentation.

Therefore, I cannot provide the requested information based solely on the input provided. The document confirms the device's classification and allows its marketing but does not detail the technical performance or the studies behind it.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Powdered Vinyl Synthetic Exam Gloves, White Color." This document does not describe a study that proves the device meets specific acceptance criteria in the way that an AI/ML medical device submission would.

Instead, this letter is a determination of "substantial equivalence" to a legally marketed predicate device, meaning the gloves are considered safe and effective for their intended use because they are similar to existing devices already on the market.

Therefore, I cannot provide the requested information as the document does not contain details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for a training set or how ground truth for training was established.

The "Indications For Use" section (page {2}) simply states the intended purpose of the gloves: "A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER." This is not an acceptance criterion in the context of an AI/ML device study.

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