Search Results

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.

Powdered Blue Nitrile Examination Gloves

The provided text is a 510(k) clearance letter from the FDA for "Powdered Blue Nitrile Examination Gloves." This document does not contain any information about the acceptance criteria or study results for a device that relies on algorithms or AI.

The letter pertains to a physical medical device (examination gloves) and focuses on its substantial equivalence to a predicate device, as required for 510(k) clearance. Therefore, it does not include the type of information requested about artificial intelligence performance metrics, training sets, expert ground truth, or MRMC studies.

To answer your request, I would need a document that describes the evaluation of an AI-powered medical device.

Ask a specific question about this device

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.

Powdered Latex Examination Gloves Without Protein Content Labelling Claim

This document is correspondence from the FDA regarding a 510(k) premarket notification for Powdered Latex Examination Gloves. It is not a study report or clinical trial. Therefore, none of the requested information regarding acceptance criteria, device performance, study details, or ground truth can be extracted from this document.

The document only states that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It does not contain any data on device performance or studies conducted to establish its effectiveness or safety beyond demonstrating substantial equivalence.

Ask a specific question about this device

Ask a specific question about this device

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.

Latex Examination Gloves Polymer Coated (Powder-Free)

This looks like a 510(k) clearance letter for latex examination gloves, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML specific performance metrics is not applicable to this document.

The document states that the device is "substantially equivalent" to predicate devices, which is the standard for 510(k) clearance for many medical devices, particularly those that are well-established.

Therefore, I cannot provide the information requested in the format of the table or answer the specific questions related to AI/ML device studies.

Ask a specific question about this device

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.

LATEX Powder Free Patient Examination Gloves with A PROTEIN LABELING CLAIM 2 50 MICROGRAMS OF TOTAL EXTRACTABLE PROTETH

The provided text is a letter from the FDA regarding the clearance of a medical device, specifically "Latex Examination Gloves Powder-Free with Trade Name: Protein Labeling Claim (50 Micrograms or Less Total Extractable Protein)".

This document is a regulatory approval letter and does not contain the information requested regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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. It lists the product code and the indications for use.

To answer your questions, one would need to refer to the actual 510(k) submission (K991777) or related testing documentation, which is not present in the provided text.

Ask a specific question about this device

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.

Nitrile Powder Free Patient Examination Gloves, Now-Stern e Device Name

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets those criteria.

The document is a letter from the FDA to Seltom Pacific SDN. BHD. regarding the clearance of Nitrile Examination Gloves Powder Free (white) under K991776. It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, it does not contain any details about:

• Specific acceptance criteria for the gloves (e.g., tensile strength, barrier integrity, tear resistance).
• A study conducted to prove the device meets any such criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth was established.

The letter primarily focuses on the regulatory aspects of 510(k) clearance and general controls. The "Indications for Use" section simply describes the purpose of the medical glove.

Ask a specific question about this device

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.

Nitrile Powder Free Patient Examination Gloves (BLUE), Non-sterile

The provided text is a 510(k) clearance letter from the FDA for Nitrile Examination Gloves Powder Free (Blue). This document does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML medical device.

The information requested in the prompt is typically found in clinical study reports or performance evaluation documents for AI/ML medical devices, not in a 510(k) clearance letter for a physical medical glove. A 510(k) for a physical device like gloves primarily focuses on demonstrating substantial equivalence to a predicate device, often through physical and chemical testing rather than clinical performance studies with human readers or AI algorithms.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device