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510(k) Data Aggregation
(51 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Disposable Powdered Vinyl Examination Gloves
The provided document is a 510(k) premarket notification letter from the FDA for "Disposable Powdered Vinyl Examination Gloves". This type of document is for a medical device that demonstrates substantial equivalence to a legally marketed predicate device, rather than a novel AI/ML-driven diagnostic device.
Therefore, the specific information requested in the prompt about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable to this document. The FDA's determination for this device is based on demonstrating substantial equivalence to a predicate device, as outlined in the letter, rather than a clinical study with detailed performance metrics as would be required for an AI/ML diagnostic.
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(35 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Disposable Powder Free Vinyl Patient Examination Gloves
The provided document is a 510(k) premarket notification letter from the FDA for "Disposable Powder Free Vinyl Patient Examination Gloves." It is not a study report or clinical trial document for a diagnostic AI device. Therefore, it does not contain the information required to answer your request regarding acceptance criteria, study details, ground truth, or sample sizes related to an AI device.
The document discusses the substantial equivalence of the gloves to previously marketed predicate devices under the general controls provisions of the Federal Food, Drug, and Cosmetic Act.
To answer your questions, I would need a document that describes a study performed on a medical AI device.
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