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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.

POWDER-FREE LATEX EXAM GLOVES, WITH PROTEIN LABELING (50 ug/g or less)

This document is a 510(k) Pre-market Notification for Powder-Free Latex Exam Gloves. The information provided outlines the device's characteristics and its substantial equivalence to previously approved devices. However, it does not contain the type of detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML or complex diagnostics. Instead, it focuses on compliance with established standards for medical gloves.

Given this context, I will interpret "acceptance criteria" as the performance standards outlined for medical gloves and "study" as the testing reported in the 510(k) summary. Many of the requested fields (like sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, training set, etc.) are not applicable to this type of device and submission.

Here's the information extracted and interpreted based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details (as applicable to this device type)

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

   • Sample Size: Not specified in the provided document. The standards listed (e.g., ASTM D 5712-95, ISO 2859) define specific sampling plans and test methods, but the number of units tested is not reported here.
   • Data Provenance: The device is manufactured by HYCARE INTERNATIONAL CO., LTD. in Hat-Yai, Songkhla, Thailand. The testing would have been conducted by or for this manufacturer. The document doesn't specify if the data is retrospective or prospective, but typically for this type of product, it would be prospective testing of manufactured samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For medical gloves, "ground truth" as a concept for expert assessment (e.g., of images or diagnoses) is not relevant. Performance is determined by objective physical and chemical testing against established standards.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of complex data (e.g., medical images). For medical gloves, adherence to standards is determined by direct measurement and observation during testing, not by expert consensus or adjudication.

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 is a medical device (latex examination gloves), not an AI/ML diagnostic tool or an imaging system. MRMC studies are not relevant to its evaluation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used:

   • For this device, "ground truth" is defined by the objective specifications and quantifiable limits set by international and national standards (e.g., ASTM D 5712-95 for tensile strength, elongation, etc.; ASTM D 6124-97 for extractable protein levels; ISO 2859 for sampling procedures and acceptance quality limits). Biocompatibility is assessed based on in vitro and in vivo (animal, not human) tests with established criteria for response.

7. The sample size for the training set:

   • Not Applicable. This device does not involve machine learning; therefore, there is no "training set."

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set, this question is not relevant.

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