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Powder Free Yellow Synthetic Vinyl Patient Examination Gloves 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.

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves 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.
How the device functions: a4.1 PVC films form a barrier to body fluids and bloodborne Pathogens
Scientific concepts that form the basis for the device a4.2 The PVC 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.
Physical and performance characteristics such as design, materials and physical properties: a4.3 Poly (vinyl chloride) 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 D5250 and ASTM D5151 requirements.

The provided text describes the acceptance criteria and a study to demonstrate substantial equivalence for "Powder Free Yellow Synthetic Vinyl Patient Examination Gloves." This is a Class I medical device, and the evaluation is based on non-clinical performance testing against recognized standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• ASTM D5250-06 (Reapproved 2011)
• ASTM D 5151-06 (Reapproved 2011) | Meets ASTM D5151 (Reapproved 2011)
  Holes: Inspection Level I, AQL 2.5 | Substantially equivalent |
  | Residual Powder | ASTM D 6124-06 (Reapproved 2011) | Results generated values below 2mg of residual powder | Substantially equivalent |
  | Materials Used | PVC (Predicate device) | PVC | Substantially equivalent |
  | Dusting or Donning Powder | PU (Predicate device) | PU | Substantially equivalent |
  | Dusting or Donning Powder Name | PU (Predicate device) | Surface Coating Agent | Substantially equivalent |
  | Biocompatibility | SKIN IRRITATION, DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 | The test article was not an irritant and not a sensitizer.
  SKIN IRRITATION, DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 | Substantially equivalent |

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each individual test (e.g., length, width, thickness, pinholes, etc.). However, it indicates adherence to ASTM standards (D5250-06, D5151-06, D6124-06) and 21 CFR 800.20, which would dictate the appropriate sampling plans and statistical methods for these types of tests.

The data provenance is not explicitly stated in terms of country of origin of the data. However, the manufacturer is Made Plastic Co., Ltd. in Shijiazhuang, China, implying the testing was likely conducted in or overseen by this entity. The study is retrospective in the sense that it's a pre-market notification relying on collected test data to demonstrate substantial equivalence to an existing predicate device and established standards.

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

This type of information (number and qualifications of experts) is not applicable for this device and study. The "ground truth" for patient examination gloves is established by objective engineering and material science tests against recognized industry standards (ASTM) and regulatory requirements (21 CFR). There is no "expert consensus" or human interpretation involved in assessing, for example, the tensile strength or pinhole presence in gloves.

4. Adjudication method for the test set

Not Applicable. As explained above, the "ground truth" is determined by objective physical and chemical testing against pre-defined specifications in recognized standards. There isn't a subjective assessment that would require an adjudication method.

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 is not an AI-powered device. It is a physical medical device (patient examination gloves). MRMC studies are relevant for AI/radiology systems where human interpretation is a key component.

6. 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.

7. The type of ground truth used

The ground truth used for these tests is based on objective measurements against established engineering and performance standards. Specifically:

• ASTM D5250-06 (Reaffirmed 2011): Standard Specification for Vinyl Patient Examination Gloves.
• ASTM D5151-06 (Reaffirmed 2011): Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124-06 (Reaffirmed 2011): Standard Test Method for Residual Powder on Medical Gloves.
• ISO 10993-10: 2002/Amd. 1:2006(E): Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).
• 21 CFR 800.20: General requirements for examination of devices (relevant for freedom from pinholes).

8. The sample size for the training set

Not Applicable. This is a physical medical device, 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 there is no training set for a machine learning model, there is no ground truth for it. The "ground truth" for the device's performance is established by the specified ASTM and ISO standards for physical and biological properties.

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