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A powdered patient examintaion glove is a disposable device made of natural nubber latex of in for Indications for USE. A powdered patient camming and is intended to be worn on the hand or fingers (s) for synthell material that bears powder to facilities don't is neemals and other conteminants.

A powdered patient examintaion glove is a disposable device made of natural nubber latex of in for Indications for USE. A powdered patient camming and is intended to be worn on the hand or fingers (s) for synthell material that bears powder to facilities don't is neemals and other conteminants.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML medical device. The document is a 510(k) premarket notification letter from the FDA for "Shanghai Glovmax Enterprise Powdered Blue Nitrile Examination Glove," which is a personal protective equipment (PPE) device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, and expert details for a test set.
3. Adjudication method for a test set.
4. MRMC comparative effectiveness study details.
5. Standalone algorithm performance.
6. Type of ground truth used.
7. Sample size for the training set.
8. How ground truth for the training set was established.

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A powder-free patient examination glove is a disposable device that is worn on the examiners hand or finger to prevent contamination between patient and examiner,

Shanghai Glovmax Enterprise Powderfree Blue Nitrile Examination Gloves

The provided text is a 510(k) premarket notification letter from the FDA regarding "Shanghai Glovmax Enterprise Powderfree Blue Nitrile Examination Gloves." This document is a regulatory approval for a medical device (gloves) and does not contain any information about an AI/ML-driven medical device or any associated study that would include acceptance criteria, performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions posed are relevant to AI/ML device testing and evaluation, which is not what this document describes.

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A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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.

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Pre-powder Vinyl Patient Examination Glove, 80LYZ , powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Test Sets for Physical and Dimensions, Water Fill Test:
     • Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. The exact sample size n would depend on the batch size, as per ASTM sampling tables for Inspection Level S-2.
     • FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level S-4. The exact sample size n would depend on the batch size, as per FDA or ASTM sampling tables for Inspection Level S-4.
   • Test Sets for Primary Skin Irritation and Skin Sensitization: Not specified, but "samplings" were used.
   • Data Provenance: Not explicitly stated, but the company is based in Shanghai, China, suggesting the testing was performed on products manufactured there. It is a retrospective summary of tests performed to demonstrate compliance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these tests is based on objective measurements against established standards (ASTM D-5250-92, FDA water fill test criteria) and biological testing protocols for skin irritation/sensitization, not expert consensus on interpretations of images or findings.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The tests involve direct measurement against defined physical or biological criteria.

4. 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 a pre-powdered vinyl examination glove, not an AI-powered diagnostic device.

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

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Physical and Dimensions: Objective measurements compared against the specifications defined in ASTM D-5250-92.
   • Water Fill Test (Pinhole): Objective observation of water leakage, compared against the acceptance criteria (AQL 2.5).
   • Primary Skin Irritation and Skin Sensitization: Biological responses (e.g., skin reactions) observed in tested subjects (likely animals or human volunteers for patch tests), against predefined criteria for irritant or sensitizing reactions.

7. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

8. How the ground truth for the training set was established: Not applicable. This is not a machine learning or AI device.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

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.

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powder-free Vinyl Patient Examination Glove, 80LYZ , powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

The provided text is related to the 510(k) submission for SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Powder-free Vinyl Examination Gloves. This information primarily focuses on the device's substantial equivalence to a predicate device and its compliance with established standards for medical gloves. It does not include details about a study evaluating an AI/ML powered medical device, or any study that would typically report metrics like sensitivity, specificity, or reader performance.

Therefore, I cannot extract the requested information using the provided text. The document describes a traditional medical device (gloves) and its regulatory clearance process, not a software or AI-based device study.

If you have a document describing a study for an AI-powered medical device, please provide that text, and I will be happy to attempt to answer your questions.

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