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The Dermoaroma Disposable Nitrile Examination Gloveare disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Dermoaroma Disposable Nitrile Examination Glove. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

The provided document is a 510(k) Premarket Notification summary for the Dermoaroma Disposable Nitrile Examination Glove. This device is a Class I, reserved product, and the information presented focuses on demonstrating substantial equivalence to a predicate device, rather than proving a novel device's safety and effectiveness through a comprehensive clinical study.

Therefore, the document does not contain the kind of detailed information about acceptance criteria for an AI/algorithm-based device and its validation study that your request is looking for. There is no AI or algorithm involved in this specific medical device (disposable examination gloves).

Here's why the document doesn't fit your request and what information it does provide:

1. AI/Algorithm Focus: The request explicitly asks about an "AI device" or an "algorithm-based performance study" and its acceptance criteria. The device in this document is a physical product (nitrile gloves), not an AI or algorithm.

2. Clinical Study vs. Substantial Equivalence: The document explicitly states: "No clinical study is included in this submission." Instead, it relies on non-clinical performance testing and comparison to a legally marketed predicate device to demonstrate substantial equivalence.

3. Type of Performance Data: The performance data presented refers to physical and chemical properties of the gloves (e.g., length, width, thickness, tensile strength, elongation, freedom from holes, powder content, biocompatibility). These are not the types of metrics (e.g., sensitivity, specificity, AUC) or study designs (MRMC, standalone algorithm performance) relevant to an AI/algorithm.

To address your specific questions based on the provided document (and explain why most cannot be answered):

1. A table of acceptance criteria and the reported device performance:

   • Context: This table relates to the physical and biological characteristics of the gloves, not AI performance metrics.
   • Table 5: Summary of Non-Clinical Performance Testing provides this information.
     • Acceptance Criteria Examples:
       • Skin Sensitization Test: Grades less than 1.
       • Skin Irritation Test: Primary irritation index 0-0.4 (Negligible).
       • In Vitro Cytotoxicity: Viability reduced to 70%).
       • Systemic Toxicity: Toxicosis response of testing group not greater than control.
       • Residual Powder: Powder residue limit of 2.0 mg.
       • Freedom from Holes: AQL 2.5, Criterion ≤7 gloves for water leakage (for 125 samples).
       • Dimensions (e.g., for Size S glove): width 80±10mm, Length ≥220 mm.
       • Physical Properties (Before Aging): Tensile strength ≥ 14MPa, Ultimate Elongation ≥ 500%.
       • Physical Properties (After Accelerated Aging): Tensile strength ≥ 14MPa, Ultimate Elongation ≥ 400%.
     • Reported Device Performance Examples:
       • Skin Sensitization Test: All grades are 0.
       • Skin Irritation Test: Primary irritation index is 0 (Negligible).
       • In Vitro Cytotoxicity: Viab.% of 100% test article extract is 20.8% (Indicates potential toxicity, but the submission argues this difference does not affect safety/efficacy when compared to predicate, likely due to the nature and contact of the device).
       • Systemic Toxicity: No toxicosis response in testing group.
       • Residual Powder: 0.13mg - 0.16 mg / glove.
       • Freedom from Holes: No glove water leakage found.
       • Dimensions (e.g., for Size S glove): width: 80-87 mm, Length 240-246 mm.
       • Physical Properties (Before Aging): Tensile strength 15.3-19.8 MPa, Ultimate Elongation 508.480% - 669.787%.
       • Physical Properties (After Accelerated Aging): Tensile strength 14.3-15.2MPa, Ultimate Elongation 435.176% - 542.968%.

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

   • Sample Sizes (for physical/biocompatibility tests):
     • For "Freedom from Holes" test (ASTM D5151), the sample size was 125 gloves.
     • Other tests (e.g., dimensions, physical properties, biocompatibility) would have specific sample sizes per the referenced ASTM/ISO standards, but these are not explicitly listed in the summary beyond "125 gloves"for the holes test. Often, these standards specify minimum sample sizes for material testing.
   • Data Provenance: The tests were conducted by the manufacturer, ChuZhou Harmony Gloves Medical Technology Co.,Ltd, based in AnHui Province, China. The document does not specify if these were retrospective or prospective studies in the general sense, but rather standard performance evaluations of manufacturing batches.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device does not involve expert-established ground truth like an AI diagnostic algorithm. Ground truth here is based on measurements against established engineering and biological standards (e.g., "0.13mg - 0.16 mg / glove" for powder content as measured by ASTM D6124).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there's no diagnostic component requiring human interpretation and consensus.

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 for a non-AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a non-AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance relies on established international standards and their specified methodologies for measuring physical, chemical, and biological properties (e.g., ASTM D6319 for dimensions and physical properties, ASTM D5151 for freedom from holes, ISO 10993 for biocompatibility).

8. The sample size for the training set: Not applicable. This device does not use an AI model that would require a training set.

9. How the ground truth for the training set was established: Not applicable. This device does not use an AI model or a training set.

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