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The Powder Free Vinyl Patient Examination Gloves (Green) is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Vinyl Patient Examination Gloves (Green) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011)--Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.

The provided text describes the submission for a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves (Green)". This document type does not include information about AI/ML device performance or large-scale comparative effectiveness studies involving human readers, as it pertains to a Class I medical device (patient examination gloves). The "acceptance criteria" and "study" described herein are related to the physical and chemical properties of the gloves, demonstrating their substantial equivalence to a predicate device.

Therefore, many of the requested fields regarding AI/ML device performance, human reader studies, and AI-specific ground truth establishment cannot be answered from the provided text.

Here's a breakdown of the available information regarding the glove's acceptance criteria and the study proving it meets these criteria:

Device Name: Powder Free Vinyl Patient Examination Gloves (Green)
Device Type: Patient Examination Glove (Class I Medical Device)
Regulation Number: 21 CFR 880.6250

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents a comparison between the subject device and a predicate device (Tangshan Hongyun Plastic Products Company Limited Powder-Free Yellow Vinyl Patient Examination Gloves, K141878) against various standards.

The acceptance criteria are generally "Meets" the specified ASTM standards and biocompatibility results (e.g., "not an irritant"). The reported device performance indicates that the subject device also meets these criteria, supporting substantial equivalence.

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

The document states that the physical and performance characteristics meet "all requirements of ASTM D5250-06 (Reapproved 2011)". This implies that standard testing methodologies as defined by these ASTM standards were followed. However, the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, tensile strength, etc.) are not explicitly provided in this summary.

• Data Provenance: The testing was conducted by Supermax Plastic Products Co., Ltd. in China (Hebei Province). The data is non-clinical testing performed to support substantial equivalence. It is inherently retrospective in the context of the 510(k) submission, as these tests would have been completed prior to submission.

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

Not applicable. This is a physical product testing scenario, not a study requiring expert clinical labeling or ground truth establishment in the context of AI/ML. The "ground truth" here is determined by objective measurements against established ASTM and ISO standards by qualified testing personnel.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study requiring adjudication of expert opinions. Device performance is measured against objective, standardized criteria.

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 document pertains to patient examination gloves, not an AI-assisted diagnostic device.

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

Not applicable. This document pertains to patient examination gloves, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on objective, standardized measurements against the specifications outlined in relevant industry standards, specifically:

• ASTM D 5250-06 (2011) - Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application
• ASTM D5151-06 (2011) - Standard Test Method For Detection Of Holes In Medical Gloves
• ASTM D6124-06 (2011) - Standard Test Method For Residual Powder On Medical Gloves
• ISO 10993-10 (third edition 2010-08-01) - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
• 21 CFR 800.20 - General requirements for device labeling

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set in that context. The "training" for manufacturing would be industrial process control, not data training.

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

Not applicable, as there is no AI/ML training set. The manufacturing processes would be subject to quality control and good manufacturing practices (GMP) to ensure the product meets specifications.

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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 Classince by I DA's Gelleral Hoopication Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

The provided text describes a 510(k) submission for Supermax Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves. It details the device, its intended use, comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence.

Here's an analysis based on your request, highlighting that this is for a medical device (glove), not an AI/software device, so many of your requested fields related to AI/software studies are "Not Applicable".

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • For the FDA 1000 ml Water Fill Test: Sampling based on AQL 2.5, Inspection Level I (specific number of gloves not provided, but determined by the AQL standard).
  • For general physical/dimensional testing: Inspection level S-2, AQL 4.0 (specific number of gloves not provided, but determined by the AQL standard).
  • For Primary Skin Irritation and Skin Sensitization: Not specified, but standard biological tests would use a certain number of subjects/samples.
  • For Residual Powder Test: Not specified, but based on ASTM D-6124-06.
• Data Provenance: Not explicitly stated, but the tests were conducted by the manufacturer (Supermax Plastic Products Co., Ltd. in China) and likely refer to internal testing data. It is a retrospective evaluation of manufactured batches.

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

• Not Applicable. This is a physical device (glove) evaluation, not an AI/software diagnostic tool. Ground truth is established by objective physical and chemical measurements (e.g., water leak, powder weight) and biological tests, not expert interpretation of outputs.

4. Adjudication method for the test set

• Not Applicable. As per point 3, ground truth is established by objective measurements and standardized tests, not by expert consensus requiring adjudication.

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 a physical device (glove); there are no "human readers" or "AI assistance" in this context.

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

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

7. The type of ground truth used

• The ground truth is established through adherence to recognized industry standards (ASTM D-5250-06e1, ASTM D-6124-06) and FDA-prescribed test methods (FDA 1000 ml Water Fill Test).
• It involves objective physical measurements, chemical analysis, and biological safety testing (primary skin irritation and sensitization).

8. The sample size for the training set

• Not Applicable. This is not an AI/ML model that requires a training set. The "training" in manufacturing would refer to process control and quality assurance over production runs, not data for an algorithm.

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

• Not Applicable. As per point 8, there is no training set in the context of an AI/ML model for this device.

Ask a specific question about this device

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.

The provided text describes a 510(k) summary for a medical device: Supermax Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Glove. This is a Class I device, and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than a novel AI system or diagnostic tool requiring complex clinical studies.

Therefore, many of the requested categories related to AI performance, multi-reader studies, and detailed ground truth establishment for complex medical imaging or diagnostics are not applicable to this type of device submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Pinhole Test: Inspection level I, AQL 2.5 (The exact sample size isn't explicitly stated but is determined by these AQL parameters).
   • Physical and Dimensions Testing: Inspection level S-2, AQL 4.0 (The exact sample size isn't explicitly stated but is determined by these AQL parameters).
   • Biocompatibility Tests: The text mentions "testing was conducted" but does not specify sample size or provenance (e.g., human subjects, animal studies, in-vitro).
   • Powder Test: The text mentions "at finished inspection" but does not specify a separate sample size for the test.
   • Data Provenance: Not explicitly stated, but typically for such product testing, it would be conducted at the manufacturing site or a certified testing laboratory.

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

   • Not applicable. The "ground truth" for glove performance involves objective physical and chemical measurements governed by established ASTM standards and FDA test methods, not expert interpretation of medical data.

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

   • Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). These tests involve objective pass/fail criteria based on measured values against standards.

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 tool. MRMC studies are not relevant here.

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

   • Not applicable. This device is a physical product, not an algorithm.

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

   • The "ground truth" is based on pre-defined, objective ASTM standards and FDA test methods for physical properties, dimensions, pinhole defects, biocompatibility, and residual powder. These are measurable values against a threshold.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable. No training set is involved.

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