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An 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 examiner.

The device is a glove with five fingers made from natural rubber that covers the hand on both sides up to the wrist, using a dip technology manufacturing process. The gloves are ambidextrous and therefore can be donned on either hand. The gloves are non sterile and for single use only, to be discarded after each examination is complete. The glove acts as a barrier between the examiner and the subject being examined in order to prevent contamination between the examiner and the subject.

This document describes the premarket notification (510(k)) for the "Preventive Care, Inc. Exam Perfect Powderfree Latex Examination Gloves Coated with Allogel®".

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Additional Acceptance Criteria and Reported Performance from Section 10 (Substantial Equivalence Comparison Table):

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

• Sample Size: The document mentions "Data of an actual representative shipment is detailed in Section 14 (original submission)" for various tests. However, the specific sample sizes (e.g., number of gloves tested for watertight, tensile strength, etc.) are not explicitly stated in the provided text.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It refers to "an actual representative shipment," implying that the data was collected from manufactured products.

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

• This device is an examination glove, and the "ground truth" for its performance is established through adherence to recognized international standards (ASTM, ISO) for physical and chemical properties. These standards define the test methodologies and acceptance criteria.
• Therefore, the "experts" involved are the organizations and committees that develop and validate these standards, and the personnel in testing laboratories who are qualified to perform these standard tests. The document does not specify the number or qualifications of individual experts who directly established the "ground truth" for this specific device's test set.

4. Adjudication method for the test set:

• For physical and chemical property testing (e.g., watertight, tensile strength), the "adjudication method" is the direct comparison of test results against the established quantitative acceptance criteria defined in the relevant ASTM and ISO standards. There is no mention of a human adjudication process (like 2+1 or 3+1) for these types of objective measurements.

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:

• This is a medical device (examination glove) and not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study to assess improvement with AI assistance is not applicable and was not conducted.

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

• Again, this is an examination glove, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not conducted.

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

• The ground truth for this device's performance is based on established objective technical specifications and test methods outlined in international standards (ASTM D3578, ASTM D5712, ASTM D6124, ASTM D412, ASTM D5151, ISO 10993).
• For biocompatibility, the ground truth is established by passing standard biocompatibility test criteria (e.g., for not being sensitizers or irritants), which are laboratory tests.

8. The sample size for the training set:

• This is a manufactured physical good. The concept of a "training set" in the context of machine learning or AI is not applicable here. There is no algorithm being trained. Manufacturing processes are optimized through quality control and adherence to specifications, not a training set.

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

• As explained in point 8, the concept of a "training set" is not relevant to this type of device. The "ground truth" for the device's performance is established through adherence to the objective criteria of the specified ASTM and ISO standards during manufacturing and quality control.

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An examination glove is a disposable device intended for medical and examination purposes that is worn on the examiner's hand to prevent contamination between the examiner and the patient or substance handled

Powderfree Nitrile Examination Gloves coated with Allogel®, in colors Blue, Magenta or Copper, is a disposable device worn on the hand of a healthcare or similar personnel, to prevent contamination between the wearer of the glove and the person or substance handled

The provided document describes the acceptance criteria and performance data for "Powderfree Nitrile Examination Gloves Coated with Allogel®".

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states "Data of an actual representative shipment is detailed in Section 14" for various physical property tests, but Section 14 is not provided in the input. Therefore, the specific sample size for the test set is not explicitly stated in the provided text.
• Data Provenance: The document does not specify the country of origin of the data. It indicates the data is from an "actual representative shipment," suggesting prospective data collection from manufacturing batches.

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

• This information is not applicable to this type of device (examination gloves). The performance is assessed against established ASTM standards and FDA watertightness requirements, not expert consensus on an interpretation.

4. Adjudication Method for the Test Set

• This information is not applicable. No adjudication method involving human interpretation is described as the tests are objective measurements against pre-defined standards.

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

• An MRMC comparative effectiveness study is not applicable to this device. This type of study is used for diagnostic AI systems, not for physical examination gloves.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This is not applicable. The device is a physical product (examination glove), not an algorithm or AI system. Its performance is assessed through laboratory testing, not algorithmic output.

7. The Type of Ground Truth Used

• The ground truth used for performance evaluation are established industry standards and regulatory requirements:
  • ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
  • FDA Water Leak Test (likely based on ASTM D5151)
  • ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension)
  • ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
  • Biocompatibility test criteria (not specified in detail but states "not being Sensitizers or Irritants").

8. The Sample Size for the Training Set

• This information is not applicable. There is no "training set" for physical product testing against objective standards. The gloves are manufactured and then samples are tested for conformance.

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

• This information is not applicable for the same reason as above. There is no training set mentioned or implied for this type of device.

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