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A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D5250-06e1.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Hongze Plastic Technology Co., Ltd. Powder Free Vinyl Patient Examination Gloves:

Acceptance Criteria and Device Performance

Study Information

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

   • Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (No specific number of gloves given for the test set, but AQL and inspection level define the sampling plan.)
   • FDA 1000 ml Water Fill Test (Pinhole): AQL 2.5, inspection level 1. (No specific number of gloves given for the test set, but AQL and inspection level define the sampling plan.)
   • Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but typically involves a certain number of human subjects or animal models according to the test standards.
   • Residual Powder Test: Not explicitly stated.
   • Data Provenance: Not specified, but generally refers to in-house laboratory testing by the manufacturer or a contracted lab. The document implies the tests were conducted by or for Hongze Plastic Technology Co., Ltd.

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

   • Not applicable. These are objective physical and chemical tests, not diagnostic or subjective evaluations requiring expert consensus for ground truth.

3. Adjudication method for the test set:

   • Not applicable. The tests are based on objective pass/fail criteria from ASTM standards and FDA requirements.

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 patient examination glove, not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This is not an algorithmic device.

6. The type of ground truth used:

   • Objective measurements/standards: The ground truth for these tests is established by the specified ASTM standards (D5250-06e1, D-6124-06) and FDA requirements (1000 ml Water Fill Test). These standards define acceptable ranges for physical properties, maximum defect rates (AQL), and chemical residue levels. Biocompatibility (irritation/sensitization) also has established clinical/toxicological parameters for "no reaction."

7. The sample size for the training set:

   • Not applicable. There is no machine learning or AI component that would require a training set. The "training" here refers to the manufacturing process adhering to quality control standards.

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

   • Not applicable, as no training set for AI is involved. The manufacturing process is geared towards meeting established product specifications and quality standards defined by ASTM and regulatory bodies.

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A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

This document is a 510(k) summary for a "Powder Free Vinyl Patient Examination Glove," which is a Class I medical device. The document primarily focuses on establishing substantial equivalence to a predicate device and demonstrating compliance with relevant ASTM standards and FDA requirements. It does not present a study proving the device meets acceptance criteria in the typical sense of a clinical or AI-based diagnostic device study.

Instead, the "acceptance criteria" here refer to the performance standards and tests required for this type of medical glove to be marketed. The "study" refers to the non-clinical tests performed to demonstrate compliance with these standards.

Here's the breakdown of the information requested, tailored to the context of this device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• ASTM D5250-06e1 (Physical and Dimensions Testing): Inspection level S-2, AQL 4.0. (Specific sample size not explicitly stated, but these AQL values dictate the sampling plan).
• FDA 1000 ml. Water Fill Test: Inspection level I, AQL 2.5. (Specific sample size not explicitly stated, but these AQL values dictate the sampling plan).
• Biocompatibility Tests (Skin Irritation and Sensitization): Sample size for testing on subjects is not specified.
• Residual Powder Test (ASTM D6124-06): Sample size not specified.
• Data Provenance: The document does not specify the country of origin for the testing or if it was retrospective or prospective. Given it's a 510(k) submission, the testing would be conducted prospectively to demonstrate compliance before market entry.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable. This is a physical product (medical glove) and not a diagnostic device that requires expert interpretation for a "ground truth." The "ground truth" for these tests comes from objective measurements against established ASTM standards and FDA requirements.

4. Adjudication Method for the Test Set

• Not Applicable. As explained above, this is about objective measurements against standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance

• Not Applicable. This is a medical glove, not an AI-assisted diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• Not Applicable. This is a medical glove, not an algorithm/AI.

7. The Type of Ground Truth Used

• The "ground truth" for this device is based on objective measurements and adherence to established industry standards (ASTM D5250-06e1, ASTM D6124-06) and regulatory requirements (FDA 1000 ml. Water Fill Test, biocompatibility criteria).

8. The Sample Size for the Training Set

• Not Applicable. This is a physical product, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As above, there is no "training set" for this type of device.

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