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QTEXX Pre - Powdered Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

QTEXX Pre - Powdered Nitrile Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 99 Standard Specification for Rubber Examination Gloves. They are blue or natural white in colour.

Here's an analysis of the provided text regarding the QTEXX Pre-Powdered Nitrile Examination Gloves, broken down into the requested categories. Please note that the document is a 510(k) summary for a medical glove, which is a low-risk device. As such, the types of studies and information typically found for higher-risk diagnostic or AI-driven devices are not present.

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

For medical gloves, "acceptance criteria" are typically the standards and specifications they must meet. In this case, the primary standard is ASTM D 3578-99.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This information is not explicitly provided in the summary. For non-clinical tests like those specified in ASTM D 3578-99, specific sampling plans are typically outlined within the standard itself.
• Data Provenance: The tests were performed by the manufacturer, LATEXX PARTNERS BERHAD, located in Kamunting, Perak, Malaysia. The testing is non-clinical/laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable for a medical glove submission. "Ground truth" in the context of medical gloves refers to objective physical and chemical testing against established standards (ASTM, FDA regulations) as well as animal model biocompatibility tests, not expert interpretation of diagnostic data.

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

This is not applicable for a medical glove submission. Adjudication methods are typically used in clinical studies or for subjective assessments (e.g., image interpretation), not for standardized physical property testing of manufactured goods.

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 not applicable for a medical glove submission. MRMC studies are used for diagnostic devices, particularly those involving human interpretation of data, often in conjunction with AI. This is a low-risk medical device (examination glove) where AI assistance or human reader performance improvement is not relevant.

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

This is not applicable. This device is a physical medical product, not an algorithm or AI system.

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

The "ground truth" for medical gloves is established by:

• Established Industry Standards: Primarily ASTM D 3578-99, which defines the physical and performance requirements (e.g., tensile strength, elongation, barrier properties, freedom from holes).
• Regulatory Requirements: 21 CFR 800.20, which deals with specific performance characteristics like freedom from holes.
• Biocompatibility Testing: Animal models (rabbit for primary skin irritation, guinea pig for delayed contact sensitization) provide objective data on biological response.
• Chemical Testing: USP iodine test for starch presence.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a manufactured medical glove. The product's design and manufacturing process are developed to meet the specified standards, not "trained" on data.

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

This is not applicable. As there is no training set, there is no ground truth for it.

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