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Found 3 results
510(k) Data Aggregation
(163 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Powder Free Latex Examination Glove, Polymer Coated
The provided text is a 510(k) clearance letter from the FDA for a Powder Free Latex Examination Glove, Polymer Coated. This document does not contain information about acceptance criteria or a study proving that an AI/ML-enabled device meets those criteria.
The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is specific to the evaluation of AI/ML performance in a medical device context. This document, however, pertains to a physical medical device (examination gloves) and its substantial equivalence to a predicate device based on its intended use and general controls.
Therefore, I cannot provide the requested information based on the input text.
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(110 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Latex Examination Glove with Protein Labeling Claim of 50 ug/dm2 or less
I apologize, but the provided text is a 510(k) premarket notification letter from the FDA regarding a "Powder Free Latex Examination Glove with Protein Labeling Claim of 50 ug/dm2 or less." It primarily discusses the regulatory approval of the glove and its classification.
This document does not contain any information about:
- Acceptance criteria or device performance data for an AI/ML medical device.
- Study details such as sample sizes, data provenance, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is absent from the provided text.
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(109 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
POWDER FREE BLUE NITRILE EXAMINATION GLOVE
This document is a 510(k) clearance letter from the FDA for a 'Powder Free Blue Nitrile Examination Glove'. It primarily deals with the regulatory approval of a medical device (a glove), determining its substantial equivalence to previously marketed devices.
The request asks for information related to acceptance criteria and a study proving a device meets those criteria, specifically within the context of an AI/algorithm-based medical device study.
This document does not contain the information requested.
Specifically:
- It is not about an AI/algorithm-based medical device.
- It does not describe acceptance criteria for an algorithm's performance (e.g., sensitivity, specificity, AUC). Instead, it's about the regulatory acceptance of a physical medical device (gloves).
- It does not describe a study involving test sets, training sets, ground truth establishment by experts, or MRMC studies. The documentation for mechanical properties, biocompatibility, or other performance characteristics of the glove would be in the 510(k) submission itself, not in the clearance letter.
Therefore, I cannot extract the requested information from this document.
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