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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and evan miner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00 Ed

The provided document is a 510(k) summary for the "Powder free Vinyl Examination" glove, detailing its substantial equivalence to a predicate device. It does not contain information about a study with specific acceptance criteria and detailed device performance metrics in the way that would typically be described for a diagnostic AI device.

However, based on the information provided, I can extract what is considered the "acceptance criteria" for regulatory clearance (substantial equivalence) and the "study" that supports it, even if it's not a quantitative clinical study with metrics like sensitivity, specificity, or AUC.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing technological characteristics, intended use, and safety/effectiveness.

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

The document describes a regulatory submission for a medical device (examination glove) claiming substantial equivalence to a previously cleared predicate device. This is not a study in the sense of collecting new performance data on a "test set" from patients or a specific dataset. Instead, the "test" is the comparison of the device's characteristics and performance against established standards and the predicate device.

• Sample size for the test set: Not applicable in the context of clinical data. The assessment is based on the device's design, materials, manufacturing processes, and compliance with standards. If physical testing (e.g., for tensile strength, barrier integrity) was performed, the sample sizes for those specific tests are not detailed in this summary.
• Data provenance: Not applicable. The "data" here refers to the device's specifications and comparison to the predicate, as well as adherence to standards like ASTM D5250-00 Ed. This is not clinical data from patients or a specific country of origin.

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

Not applicable. This is not a study involving expert-established ground truth for a diagnostic outcome. The "ground truth" for a medical glove's safety and effectiveness is established through compliance with recognized standards and demonstration of equivalent performance to predicate devices which have already been deemed safe and effective.

4. Adjudication method for the test set

Not applicable. There is no "test set" in the context of human interpretation or diagnostic outcomes 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 medical glove, not an AI-powered diagnostic device. No MRMC study or AI assistance is relevant.

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

Not applicable. This is a medical glove, not an algorithm.

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

The "ground truth" for the device's safety and effectiveness relies on:

• Compliance with recognized standards: Specifically, ASTM Standard D5250-00 Ed for Vinyl Patient Examination Gloves.
• Demonstrated equivalence to a predicate device: The predicate device (Shanghai Foremost Vinyl Patient Examination Glove, Powder free, 510(k) #K971415), which was previously cleared by the FDA, serves as the benchmark for safety and effectiveness.

8. The sample size for the training set

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

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

Not applicable. There is no training set for this device.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirement of ASTM Standard D5250-00.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the requested format.

This document describes the acceptance criteria and studies conducted for the Shijiazhuang Eversharp Plastics Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves.

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • Physical and Dimensions Testing: The sample size is implicitly defined by "Inspection Level S-2, AQL 4.0" as per ASTM-D-5250-00, but a specific number is not provided.
  • Pinhole Test: The sample size is implicitly defined by "AQL 2.5, Inspection Level I" as per the FDA 1000 ml Water Fill Test, but a specific number is not provided.
  • Biocompatibility (Skin Irritation/Sensitization): Not specified.
  • Residual Powder Test: Not specified.
• Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests were conducted by the manufacturer, Shijiazhuang Eversharp Plastics Products Co., Ltd., based in Luquan, Hebei Province, P.R. China, implying the data originated from China. The nature of the tests (manufacturing quality control, laboratory testing) suggests they are prospective in nature, performed on the manufactured product.

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

Not applicable. The tests performed are objective, quantitative measurements (e.g., physical dimensions, water fill test, chemical analysis for powder, biological response in irritation tests) rather than subjective assessments requiring expert consensus for ground truth.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against established standards, not requiring multi-reader 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 device is a patient examination glove, not an AI-assisted diagnostic or imaging device.

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 performance validation is defined by:

• Established ASTM Standards: ASTM-D-5250-00 for physical characteristics and dimensions, and ASTM D6124-97 for residual powder.
• FDA Requirements: Specific FDA requirements for pinhole testing (1000 ml Water Fill Test).
• Biocompatibility Testing Protocols: Standard methods for primary skin irritation and sensitization testing.
  These are all objective, quantitative, and standardized criteria.

8. The sample size for the training set

Not applicable. This device 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 there is no training set, this question is not relevant.

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Ask a specific question about this device

Ask a specific question about this device

A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

A 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.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free (yellow) Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.

This is a 510(k) summary for a medical device that is a Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powder-Free (Yellow) Vinyl Patient Examination Glove. This submission is for a Class I medical device, which generally means it poses a lower risk to patients and users and often relies on established performance standards rather than extensive clinical studies for approval.

The document describes non-clinical tests performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria in the way one might describe for an AI/ML digital health product or more complex diagnostic device. For this type of glove device, acceptance criteria are tied to manufacturing standards and physical properties.

Here's the breakdown of the information requested, tailored to what's available for this specific medical device submission:

• ASTM Standard D5250-92 (for physical and dimensional properties)
• FDA 1000 ml. Water Fill Test (for pinhole integrity)
• Biocompatibility testing (Primary Skin Irritation and Skin Sensitization tests)
• USP Iodine Test (for powder-free claim verification). |
  | 8. Sample size for the training set | Not applicable. This is for a physical medical device, not an AI/ML system requiring a training set. |
  | 9. How the ground truth for the training set was established | Not applicable. This is for a physical medical device. |

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