Search Results

The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination gloves. The subject device's color is yellow. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

This document describes the regulatory approval for "Disposable, vinyl examination gloves, Yellow" and focuses on non-clinical testing for equivalence. Therefore, it does not contain the information requested for a study proving device performance against acceptance criteria in the context of an AI/medical imaging device.

The provided text pertains to a Class I medical device (disposable vinyl examination gloves) and its 510(k) submission for substantial equivalence to a predicate device. The information requested (acceptance criteria and study details for an AI-powered device or diagnostic tool) is not applicable to this submission.

However, I can extract the acceptance criteria and reported device performance from the "Summary of Non-clinical Testing" section (Table 2) in the document, which are related to the physical and biocompatibility properties of the gloves.

Here's a breakdown of the available information based on your request, with the understanding that it will not completely align with the format for AI/diagnostic studies:

1. Table of Acceptance Criteria and the Reported Device Performance

Ask a specific question about this device

The Viny/Nitrile Blend Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl/nitrile blend examination gloves. The subject device is blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

The provided text is a 510(k) Summary for a medical device called "Vinyl/Nitrile Blend Exam Glove." This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting studies validating an AI/ML driven medical device's performance against detailed acceptance criteria for diagnostic or prognostic tasks.

Therefore, many of the requested elements (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical glove submission. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility tests for manufacturing quality and safety, not for diagnostic performance evaluation of an AI model.

However, I can extract the relevant information from the provided document regarding its physical and biological performance acceptance criteria and results.

Here's the breakdown based on the provided text, focusing on the device itself (medical glove) and its physical/biocompatibility characteristics, not an AI system.

Acceptance Criteria and Device Performance for Vinyl/Nitrile Blend Exam Glove

This document describes the non-clinical testing performed to demonstrate that the Vinyl/Nitrile Blend Exam Glove meets established safety and performance standards for patient examination gloves. It is important to note that this is not an AI/ML device, and thus most AI/ML-specific study design criteria (e.g., ground truth, reader studies, AI performance metrics) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination gloves. The subject device's color is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for Vinyl Examination Gloves. This is a medical device focused on physical properties and biocompatibility, not an AI/imaging device. Therefore, many of the requested criteria regarding AI model evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance, and ground truth establishment methods) are not applicable to this document.

However, I can extract the relevant information regarding the device's performance against its acceptance criteria based on the provided non-clinical testing summary.

Here's the breakdown:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device