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The POWDER FREE patient examination gloves is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

The subject device is a vinyl examination glove made of synthetic poly vinyl chloride compound. It is sterile, POWDER FREE. The device is ambidextrous. The device meets ASTM D 5250-06: Standard specification for poly vinyl chloride gloves for medical application. The device is for over-the counter single use.

The provided document is a 510(k) premarket notification for Sterile Vinyl Examination Gloves, Powder Free by Primus Gloves, Pvt. Limited (K170612). This document is a regulatory submission for a Class I medical device, which typically does not involve studies for AI performance or clinical efficacy comparison in the way a diagnostic imaging device would. Instead, the "acceptance criteria" and "study" refer to demonstrated conformance with established industrial standards for medical gloves and substantial equivalence to a predicate device.

Let's break down the information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by various ASTM and ISO standards for examination gloves. The reported device performance indicates that the "Sterile Vinyl examination gloves, POWDER FREE" meet these specified standards.

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

The document indicates sampling plans based on ISO 2859-1 for various tests (e.g., G1/AQL 2.5 for freedom from holes, S2/AQL 4.0 for dimensions and physical properties). For Powder Free residue, N=5 is stated.

• Sample Size:
  • For physical characteristics (Freedom from Holes, Dimensions, Physical Properties): Specific sample sizes are not explicitly given as absolute numbers, but the reference to ISO 2859-1 with specified Inspection Levels (G1, S2) and AQLs (2.5, 4.0) implies a statistical sampling methodology based on lot size.
  • For Powder Free residue: N=5 gloves.
  • For biocompatibility: The ISO 10993-10 standards would specify animal testing protocols (e.g., rabbits for irritation, guinea pigs for sensitization), but the exact number of animals or repeat tests is not provided in this summary.
• Data Provenance: Not explicitly stated for each test result, but the manufacturing company is PRIMUS GLOVES PRIVATE LIMITED located in Cochin, Kerala, India. It can be inferred that the testing data was generated locally or through contract labs testing products manufactured at this site. The studies are retrospective in the sense that they are tests performed on manufactured batches to confirm compliance with standards.

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

This type of device (examination gloves) does not typically involve human expert consensus for "ground truth" in the way an AI diagnostic algorithm would. The "ground truth" is defined by adherence to objective, measurable physical, chemical, and biological properties as specified in the referenced ASTM and ISO standards.

• Number of Experts: Not applicable in the context of expert consensus for AI ground truth. The "experts" in this scenario are the technical committees and bodies that establish the ASTM and ISO standards, and the qualified laboratory personnel who conduct the standardized tests.
• Qualifications of Experts: N/A for clinical expert consensus. The "experts" are the technicians and engineers performing standardized tests in accredited laboratories.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI diagnostic device requiring adjudication of interpretations. The tests are objective measurements against established thresholds.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, this is not an AI device or a diagnostic device that would typically undergo an MRMC study.

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

No, this is a physical medical device (examination gloves), not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on objective, measurable criteria defined by international and national standards and specifications (e.g., ASTM D 5250-06, ASTM D5151-06, ISO 10993-10, ISO 11737-02). These standards define acceptable ranges for physical dimensions, mechanical properties, chemical residue, and biological responses (biocompatibility).

8. The Sample Size for the Training Set

Not applicable. This is a manufactured product, not an AI model that requires a training set. The "training" for such a product would involve process validation and quality control measures during manufacturing, but not a dataset as understood in AI/ML.

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

Not applicable, as there is no "training set" in the context of an AI device. The manufacturing processes are validated to consistently produce gloves that meet the defined standards.

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