(166 days)
Powder-Free Yellow 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 Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
The provided text is a 510(k) summary for the Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of a device's performance against specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, many of the requested elements for describing the acceptance criteria and study that proves an AI device meets acceptance criteria simply do not apply to this document, as it concerns a medical glove and not an AI/ML device.
However, I can extract the relevant information from the document that is analogous to "acceptance criteria" and "reported device performance" for this specific product, a patient examination glove.
Here's the closest interpretation of your request based on the provided text:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" for the Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves are defined by their conformance to specific ASTM standards and FDA regulations. The "reported device performance" is the statement that the device meets these standards.
| Feature / Performance Metric | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions - Length | Meets ASTM D5250-06 (Reapproved 2011) >230mm min. | Meets ASTM D5250-06 (Reapproved 2011) 230mm min for all sizes |
| Dimensions - Width | Meets ASTM D5250-06 (Reapproved 2011) (Specific ranges for S, M, L, XL) | Meets ASTM D5250-06 (Reapproved 2011) (Specific ranges for S, M, L, XL) |
| Dimensions - Thickness | Meets ASTM D5250-06 (Reapproved 2011) Finger 0.05mm min., Palm 0.08mm min. | Meets ASTM D5250-06 (Reapproved 2011) Finger 0.05mm min., Palm 0.08mm min. |
| Physical Properties | Meets ASTM D5250-06 (Reapproved 2011) Before aging/after aging Elongation ≥300% | Meets ASTM D5250-06 (Reapproved 2011) Before aging/after aging Elongation ≥300% |
| Physical Properties | Meets ASTM D5250-06 (Reapproved 2011) Before aging/after aging Tensile Strength ≥11MPa | Meets ASTM D5250-06 (Reapproved 2011) Before aging/after aging Tensile Strength ≥11MPa |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06 (Reapproved 2011), ASTM D 5151-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011) Holes Inspection Level I, AQL 2.5 |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) | ASTM D6124-06 (Reaffirmation 2011) Results generated values below 2mg of residual powder |
| Biocompatibility | Meets ISO 10993-10:2002/Amd.1:2006 (for Skin Irritation and Sensitization) | Under the conditions of the study, not an irritant and not a sensitizer. Meets ISO 10993-10 Third Edition 2010-08-01 |
The study proving the device meets these criteria is an internal non-clinical testing program conducted by the manufacturer, Tangshan Hongyun Plastic Products Co.,ltd, to ensure compliance with the referenced ASTM standards and ISO standard for biocompatibility.
Regarding the requested information for AI/ML devices (which are not applicable to this document):
- Sample size for the test set and data provenance: Not applicable. The "test set" here refers to samples of gloves tested according to ASTM standards. The document does not specify exact sample sizes for each test, but rather refers to conformance with standards which typically define sampling plans. The data provenance is internal testing by the manufacturer in China.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for a physical product like a glove is established by standardized measurement methods defined in ASTM standards, not by expert consensus in the way an AI algorithm's output might be.
- Adjudication method for the test set: Not applicable. Testing for physical properties follows specific protocols defined by the ASTM and ISO standards.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance, often with and without AI assistance, which is not relevant for a medical glove.
- Standalone (algorithm only) performance study: Not applicable. This device is not an algorithm.
- Type of ground truth used: For physical properties, the "ground truth" is the quantitative measurement obtained through standardized tests (e.g., length in mm, thickness in mm, tensile strength in MPa, AQL for pinholes, residual powder in mg/glove, biological response for biocompatibility).
- Sample size for the training set: Not applicable. This concept is for AI/ML models. For manufacturing, there are quality control processes, but not a "training set" in this context.
- How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory submission for a physical medical device (gloves), not an AI/ML device. Therefore, most of the questions relating to AI/ML study design are not addressed. The "acceptance criteria" are the established ASTM and ISO standards, and the "study" is the non-clinical testing performed by the manufacturer to demonstrate compliance with these standards.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.