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Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided document is a 510(k) summary for the Nitrile Powder Free Patient Examination Gloves, Blue Color (K152712). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a novel device meets specific acceptance criteria through a clinical study involving AI or human readers.

Therefore, many of the requested fields are not applicable to the context of this document.

Here's the information that can be extracted from the provided text, formatted to address your request:

Acceptance Criteria and Device Performance

Study Details (Based on the Provided Document which is a 510(k) Summary)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not specify general "test set" sample sizes or data provenance in the context of clinical studies for performance evaluation of a device like an AI. Instead, it refers to compliance with ASTM standards and biocompatibility studies. The specific sample sizes for tests like pinhole detection, tensile strength, or biocompatibility are not detailed, but implied to be sufficient for standard compliance.
   • Data Provenance: Not explicitly stated for each test, but the submitter is Zhonghong Pulin Medical Products Co., Ltd. from Hebei, China. Biocompatibility studies specify rabbits and guinea pigs.

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 is a medical glove, not an AI diagnostic device requiring expert interpretation for ground truth. Ground truth for its performance properties is established through standardized physical, chemical, and biological testing as per ASTM and ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This concept is relevant for studies where human interpretation of medical data and subsequent consensus is needed to establish ground truth (e.g., in diagnostic AI), which is not the case for a patient examination glove.

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 a medical glove, not an AI system or software requiring comparison of human reader performance with and without AI assistance.

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

   • Not applicable. This is a physical medical device (glove), not an algorithm.

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

   • The "ground truth" for the device's performance is established by conformance to established industry standards (ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, 21 CFR 800.20) and biocompatibility testing results (ISO 10993-10). For example, "Freedom from pinholes" has a ground truth defined by the water leak test method described in 21 CFR 800.20. Biocompatibility has ground truth based on observed biological reactions in animal models.

8. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or AI models with training sets.

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

   • Not applicable. This device does not involve machine learning or AI models with training sets.

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