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510(k) Data Aggregation
(26 days)
A powdered surgeon's glove is a disposable device made of synthetic-co-polymer that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
A powdered surgeon's glove is a disposable device made of synthetic-co-polymer that bears powder to facilitate donning, and it 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) premarket notification letter from the FDA regarding a surgical glove, not a study or report on an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, experts, and sample sizes for an AI device cannot be extracted from the provided text.
The document states that the FDA has determined the ElastyLite® Synthetic Powdered Surgical Glove is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device's characteristics and intended use being similar enough to existing devices that it does not require a new premarket approval application (PMA).
To answer your prompt, I would need a different type of document, specifically a clinical study report, a performance evaluation report, or a 510(k) summary for an AI/ML-based medical device.
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(29 days)
A powder-free surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Elastyfree™ Synthetic Powder-Free Surgical Glove
This document is an FDA 510(k) clearance letter for the "Elastyfree™ Synthetic Powder-Free Surgical Glove." It does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria in the manner typically described for AI/ML or diagnostic devices.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or it has different technological characteristics but is as safe and effective as a legally marketed device.
Therefore, I cannot provide the requested information for an AI/ML or diagnostic device based on this document. The "Elastyfree™ Synthetic Powder-Free Surgical Glove" is a physical medical device (a surgical glove), and its clearance is based on demonstrating substantial equivalence, not on performance metrics against predefined acceptance criteria from a specific study as would be detailed for a diagnostic algorithm.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance: This type of data is not included in an FDA 510(k) clearance letter for a simple physical device like a glove.
- Sample size for the test set and data provenance: Not applicable here as there isn't a "test set" in the context of an algorithm or diagnostic device.
- Number of experts and their qualifications for ground truth: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study or human reader improvement: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The "Indications for Use Statement" on page 3 simply describes what the glove is and its intended purpose as a barrier. The clearance emphasizes that the device meets general controls provisions and is substantially equivalent to existing devices.
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(127 days)
A surgical glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Elastylon ® Powder-Free Surgical Glove
This document is a 510(k) clearance letter from the FDA for a surgical glove. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter confirms substantial equivalence of the "Elastylon Powder-Free Surgical Glove" to a legally marketed predicate device, enabling its market entry. Therefore, I cannot extract the requested information from this document.
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(292 days)
A surgeon's glove is a device made of natural or systemic rubber insended to be worn by operating room personnel to protect a surgical wound from contamination.
Elastyren Powder-Free Surgical Glove
This document is a 510(k) premarket notification decision letter from the FDA for the Elastyren Powder-Free Surgical Glove. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval letter, not a device performance study report.
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(173 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.
Elastyren Powder-Free Patient Examination Gloves
The provided text is a 510(k) clearance letter from the FDA for "Elastyren Powder-Free Patient Examination Gloves." It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone algorithm performance).
The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses. It refers to general controls provisions of the Act (e.g., annual registration, good manufacturing practice) but does not detail specific performance-based acceptance criteria or the studies used to demonstrate those specific criteria for the gloves themselves.
Therefore, I cannot extract the requested information from the provided document.
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