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This Sugeon's Glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

NUZONE X2T, powderfree surgical glove meets the requirements for surgical gloves described by the American Standard for Testing and Material ASTM D 3577 - 01a²

The provided text describes a 510(k) submission for the NUZONE X2T Surgical Glove Powderfree. This is a medical device and the submission focuses on demonstrating substantial equivalence to a predicate device and adherence to established performance standards for surgical gloves.

Here's an analysis of the acceptance criteria and the study information as presented in the document:

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

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: The document does not explicitly state the sample sizes used for the specific tests (e.g., how many gloves were tested for physical properties, or how many subjects for skin irritation/sensitization). The "Brief description of non-clinical tests" section states, "Test conducted per ASTM D 3577 - 01ae2, ASTM D512 indicates that the product meet the requirements." This implies compliance with the sampling methods outlined in those ASTM standards, but the specific numbers are not provided.
• Data Provenance: The Submitter is "Terang Nusa Sdn Bhd" located in Kelantan, Malaysia. While the country of origin for the data is not explicitly stated, it is reasonable to infer that the tests were conducted or overseen by the Malaysian company or its affiliates. The document does not specify whether the data was retrospective or prospective, but given the nature of device testing for regulatory submission, it would typically be prospective testing conducted specifically for this submission.

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 type of information is generally not applicable to the testing of surgical gloves for physical properties and biocompatibility. The "ground truth" for these tests is defined by the objective measurement criteria within the ASTM standards (e.g., tensile strength, elongation, barrier integrity) and the absence of a biological reaction in biocompatibility studies. There are no "experts" establishing a subjective "ground truth" in the way one would for diagnostic imaging.

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

Not applicable. Adjudication methods are typically used in clinical studies or studies involving subjective assessments, where multiple readers might interpret data and a consensus or tie-breaking mechanism is needed. For standardized physical and biocompatibility testing, the results are typically objective measurements.

5. If a multireader multicase (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. MRMC studies are relevant for assessment of diagnostic accuracy, particularly with AI medical devices. This submission concerns a physical medical device (surgical gloves) and does not involve AI or human "readers" interpreting cases.

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

Not applicable. This device is not an algorithm or an AI product.

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

The "ground truth" for the tests performed is derived from:

• Objective Measurement Standards: The specifications and performance requirements outlined in ASTM D 3577 - 01a for surgical gloves. These define the acceptable ranges for physical properties like dimensions, physical integrity (e.g., absence of pinholes), and strength.
• Biological Endpoints: For biocompatibility tests (ASTM F 719-81 and ASTM F 720-81 (86)), the ground truth is the biological response, specifically the absence of primary skin irritation and dermal sensitization.

8. The sample size for the training set

Not applicable. The NUZONE X2T surgical glove is not an AI/Machine Learning device, so there is no "training set" in the context of algorithm development. The manufacturing process of the gloves could be considered "trained" through quality control and iterative process improvements, but this is not typically quantified as a "training set" in a regulatory submission context.

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

Not applicable, for the same reasons as point 8.

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