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The 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.

Nitrile Exam Glove, Pre-Powdered, Color White, Blue

The provided document is a 510(k) premarket notification letter from the FDA for Nitrile Exam Gloves. This type of document is for a Class I medical device (patient examination gloves) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a detailed study proving the device meets specific performance acceptance criteria through clinical trials or elaborate engineering studies typically associated with AI/ML or more complex medical devices.

The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not part of this type of regulatory submission for a simple Class I device like examination gloves. These details are much more relevant for software as a medical device (SaMD) or devices with complex algorithms, where performance metrics like sensitivity, specificity, AUC, and their associated studies are critical.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to address the prompt based only on the available information, noting where information is absent:

Acceptance Criteria and Device Performance for Nitrile Exam Glove

As this is a 510(k) submission for a Class I device (Nitrile Exam Glove), the "acceptance criteria" and "device performance" are primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical performance metrics. The core "acceptance criteria" for a 510(k) of this nature would revolve around meeting recognized standards and established physical properties for examination gloves, which are implicitly accepted by the FDA when a substantial equivalence determination is made. The document itself does not explicitly list a table of acceptance criteria or reported device performance in the way the prompt describes for more complex devices.

The "study that proves the device meets the acceptance criteria" for this type of device typically involves bench testing to demonstrate physical properties and biocompatibility, as well as an assessment against consensus standards. The 510(k) decision letter indicates that the FDA reviewed the submission, which would have included such data, but the letter itself does not contain the detailed study results.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided FDA letter. For examination gloves, this would typically involve samples from manufacturing lots tested for physical properties (e.g., ASTM D412, D6319 for physical properties, ASTM F1671 for viral penetration, ISO 10993 for biocompatibility)
• Data Provenance: Not specified in the letter. The manufacturer is "Jiangsu Sunshine Plastic Products, Company, Limited" based in "China, Taiwan 251," suggesting the manufacturing and potentially some testing data may originate from these regions. The document is retrospective from the perspective of the FDA review, as it's a letter confirming a decision on a submission that has already occurred.

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

• Number of Experts: Not applicable/not specified. For examination gloves, "ground truth" is typically established by objective physical and chemical testing against recognized standards, not by expert consensus on images or clinical assessments.
• Qualifications of Experts: Not applicable/not specified. Testing would be performed by qualified laboratory personnel following standard operating procedures.

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

• Adjudication Method: Not applicable/not specified. This method is used for resolving discrepancies in expert interpretations, common in image-based diagnostic studies. It is not relevant for the physical testing of examination gloves.

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

• MRMC Study: No. This type of study is completely irrelevant for an examination glove. These studies are used to assess the impact of AI/ML algorithms on human reader performance in diagnostic tasks.

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

• Standalone Performance: No. This is irrelevant as the device is not an algorithm or AI.

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

• Type of Ground Truth: For examination gloves, the "ground truth" refers to the established technical specifications and performance requirements derived from international and national standards (e.g., ASTM, ISO) for physical properties (e.g., tensile strength, elongation, leak resistance) and biocompatibility. Compliance is verified through laboratory testing as opposed to expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/not specified. This concept is relevant for AI/ML models, not for passive medical devices like gloves.

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

• Establishing Ground Truth for Training Set: Not applicable/not specified. This is relevant for AI/ML models, not for passive medical devices like gloves.

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