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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 the patient and the examiner.

Lano-E Powder-Free Nitrile Examination Glove. Class I Powder-Free Nitrile examination glove 80LZA that meets a all of the requirements of ASTM Standard D 6319 - 00 Rev A. Powder Residue: Maximum 2mg/glove. Material: Nitrile. Cuff: Beaded. Processed with pharmaceutical quality lanolin as the emollient and conditioning agent. Also contains Vitamin E which complies with the current USP, Ph.Eur., DAB and BP monographs.

This looks like a 510(k) submission for examination gloves, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies or human reader improvement with AI) is not applicable to this document.

The document describes the device, its intended use, and its compliance with ASTM standards for physical properties. The "study" here is essentially the testing performed to ensure the gloves meet these established standards.

Here's the relevant information adapted to the context of this device:

Acceptance Criteria and Device Performance (for Lano-E Powder-Free Nitrile Examination Glove)

The Lano-E Powder-Free Nitrile Examination Glove meets the physical property requirements of ASTM D 6319-00 Rev A and the FDA 1000 ml water test both before and after aging.

1. Table of Acceptance Criteria and Reported Device Performance

Inspection Parameters (Acceptance by Inspection Level and AQL)

Physical Properties (Before Aging)

Physical Properties (After Aging)

Note: The document explicitly states: "The Lano-E Powder-Free Nitrile Examination Glove meets the physical property requirements of ASTM D 6319-00 Rev A and the FDA 1000 ml water test both before and after aging." This implies that the device performance met all listed acceptance criteria.

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

• Sample Size: The document does not specify a precise sample size for the testing of each individual criterion. However, the testing was conducted "in compliance with ASTM D6319-00 Rev A, EN 455-3 : 2000, EN 455-2 : 2000, EN 455-1 : 2000, ISO 2859-1:1999". These standards typically define the sampling plans (e.g., AQL tables) for quality control and testing.
• Data Provenance: The device manufacturer, N.S. Uni-Gloves Sdn. Bhd., is based in Malaysia. The testing data would have been generated internally by the manufacturer or by a contracted laboratory following the specified international standards. The data is retrospective in the sense that it was collected as part of the product development and quality assurance process prior to the 510(k) submission.

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

• Not Applicable: For this type of device (examination gloves), "ground truth" is established by adherence to measurable physical and chemical specifications outlined in established industry standards (like ASTM and EN standards). There are no "experts" in the sense of clinical reviewers establishing a subjective truth. The "truth" is objective measurement against a standard.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation). For examination gloves, the testing involves objective measurements (e.g., dimension, tensile strength, water tightness), which do not require human adjudication in the traditional sense. The pass/fail is determined by whether the measured value falls within the specified range or meets the AQL.

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 an examination glove, not an AI/ML diagnostic device. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

• Not Applicable: This is an examination glove. There is no algorithm or AI component involved.

7. The type of ground truth used

• Objective Standards and Measurements: The "ground truth" is defined by the objective, quantifiable specifications outlined in recognized international standards (ASTM D 6319-00 Rev A, EN 455 series, ISO 2859-1:1999) and the FDA 1000ml water tight test. This includes material properties, physical dimensions, and defect rates.

8. The sample size for the training set

• Not Applicable: There is no "training set" in the context of examination gloves. The manufacturing process is controlled to produce gloves that consistently meet the specifications. Continuous quality monitoring, potentially using statistical process control, ensures ongoing adherence.

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

• Not Applicable: As there is no training set, this question is not applicable. The design and manufacturing process for the gloves are based on achieving the objective criteria defined by the standards.

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