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510(k) Data Aggregation
(89 days)
Synthetic Vinyl Examination Glove, Powder Free 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.
Synthetic Vinyl Examination Gloves, Powder-Free
This document is a 510(k) clearance letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free". It does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML medical device.
The document is a regulatory approval for a medical device (gloves) based on substantial equivalence to a predicate device, not on performance studies against specific acceptance criteria like those used for AI/ML algorithms.
Therefore, I cannot provide the requested information. This document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets, nor data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Ground truth establishment for a training set.
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(85 days)
A Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent device in between patient and examiner.
Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green)
The provided text is a 510(k) premarket notification letter from the FDA regarding "Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green)". This document primarily deals with regulatory approval based on "substantial equivalence" to a legally marketed predicate device.
It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria.
Therefore, I cannot fulfill your request for the specific details outlined (table of acceptance criteria and performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training). The document is a regulatory approval letter, not a scientific study report.
Ask a specific question about this device
(38 days)
Synthetic Vinyl Examination Glove, Powder Free 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.
Synthetic Vinyl Examination Gloves, Powder-Free
I am sorry, but the provided text is a letter from the FDA regarding the 510(k) premarket notification for "Synthetic Vinyl Examination Gloves, Powder-Free." It primarily discusses the regulatory classification of the device and general compliance requirements.
This document does not contain any information about:
- Acceptance criteria for device performance
- A study proving the device meets acceptance criteria
- Sample sizes for test or training sets
- Data provenance
- Ground truth establishment or type
- Number or qualifications of experts
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance studies
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
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(82 days)
Synthetic Vinyl examination glove, Powder Free 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, Synthetic Vinyl Examination Gloves
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder-Free, Synthetic Vinyl Examination Gloves." This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/software as a medical device (SaMD).
Instead, it's a regulatory approval document for a Class I medical device (patient examination glove). The "acceptance criteria" discussed in this document refer to regulatory compliance and the demonstration of substantial equivalence to an already legally marketed predicate device, rather than performance metrics from a technical study for a diagnostic or therapeutic device.
Therefore, I cannot extract the requested information (1-9) as it pertains to AI/SaMD performance studies from this document.
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