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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 examiner and the patient.

POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES. WITH WATER EXTRACTABLE PROTEIN LABELLING CLAIN 100 micron or lease of tatal with extracts

The provided document is a 510(k) premarket notification letter from the FDA to Alliance Rubber Products Sdn. Bhd. for "Polymer Coated Powder Free Latex Examination Gloves." This document does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment for an AI/ML powered device.

It is a clearance letter for a medical device (latex examination gloves) and primarily discusses:

• The FDA's determination of substantial equivalence for the gloves to legally marketed predicate devices.
• Regulatory classifications and general controls applicable to the device.
• Instructions for the company regarding marketing, labeling, and other regulations.
• The intended use of the gloves, which is "a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and the patient."

Therefore, I cannot provide the requested information based on this document.

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR.

The provided document is a 510(k) clearance letter from the FDA for Nitrile Examination Gloves. It does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, sample sizes, or expert qualifications for such studies.

The letter primarily:

• Confirms that the device is "substantially equivalent" to predicate devices.
• Outlines regulatory obligations for the manufacturer.
• Includes an "Indication For Use" statement for the gloves.

Therefore, I cannot provide the requested information based on the given text.

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE.

The provided document is a 510(k) clearance letter from the FDA for "Arsoft Nitrile Examination Gloves, Non-Sterile Powder-Free." This document does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it relates to an AI/ML-enabled medical device.

The letter is a regulatory approval for a physical medical device (gloves) based on substantial equivalence to a predicate device, not on performance criteria measured through a clinical or technical study in the context of AI/ML.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document.

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR.

The provided text is a 510(k) clearance letter from the FDA for Nitrile Examination Gloves. It does not contain any information about the acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

Therefore, I cannot fulfill your request for this specific input. The document is a regulatory approval for a physical medical product (gloves), not an AI-powered diagnostic or predictive tool.

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.

This document is a 510(k) clearance letter for Nitrile Examination Gloves. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it's a regulatory approval document for a medical device rather than a performance study report.

Therefore, I cannot answer your request based on the provided text.

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE. GREEN COLOR.

The provided document is a 510(k) clearance letter from the FDA for "Nitrile Examination Gloves, Powder-Free, Trade Name: Green Color" and includes its "Indication For Use." This document does not contain information regarding detailed acceptance criteria for device performance, specific study designs, sample sizes, expert qualifications, or ground truth establishment for a medical device's algorithm or imaging system.

The letter concerns the substantial equivalence of the gloves to previously marketed devices based on their intended use, and it mentions compliance with general controls provisions such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is strictly an FDA clearance letter for a medical device (nitrile examination gloves), not a study report or a technical performance specification.

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, Trade Name : Arsoft OR other client's trade name.

The provided document is an FDA 510(k) clearance letter for Nitrile Examination Gloves and does not contain information about acceptance criteria or a study proving device performance as typically expected for complex medical devices with performance claims (e.g., diagnostic AI tools).

The document is a regulatory approval notice, indicating that the device is substantially equivalent to a legally marketed predicate device. This type of clearance generally relies on demonstrating equivalence in terms of intended use, technological characteristics, and safety and effectiveness, rather than a detailed performance study against specific acceptance criteria.

Therefore, almost all of the requested information cannot be extracted from this document, as it is not a performance study report.

Here's what can be inferred or explicitly stated based on the document's nature:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document is an FDA clearance letter, not a performance study report. There are no acceptance criteria or reported device performance metrics in this context. The clearance is based on substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document does not describe a performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. This document does not describe a performance study with a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This document does not describe a performance study with a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an examination glove, not an AI or diagnostic device that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an examination glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a medical glove in the context of substantial equivalence primarily relates to its material properties, physical dimensions, leak resistance, and biocompatibility, which are typically assessed through standardized tests and comparisons to predicate devices, not expert consensus on diagnostic images or pathology.

8. The sample size for the training set: Not applicable. This document does not describe a performance study involving a training set for an algorithm.

9. How the ground truth for the training set was established: Not applicable. This document does not describe a performance study involving a training set for an algorithm.

In summary: The provided document is an FDA 510(k) clearance letter for medical gloves, indicating substantial equivalence to a predicate device. It does not contain the type of detailed performance study information with acceptance criteria, sample sizes, and expert adjudication that would be requested for an AI/diagnostic device.

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED.

This document is a 510(k) clearance letter from the FDA for medical gloves, not a study report. Therefore, it does not contain information on acceptance criteria or a study proving device performance as requested. The letter itself is part of the regulatory approval process which attests to the substantial equivalence of the device to a predicate device already on the market, but it doesn't detail the performance tests or data, nor does it discuss AI.

Therefore, I cannot provide the requested information based on the given input.

To fulfill your request, I would need a scientific study report or clinical trial results document that describes the device's performance, acceptance criteria, and the methodology of the study.

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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAM OR LESS)

This document is a 510(k) clearance letter from the FDA for examination gloves. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Therefore, I cannot provide the requested information based on the provided text.

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