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MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove 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.

Motex Powder-free Polyisoprene Surgical Sterile Gloves, Model # 6412 Nature, 6412_Blue; 6512_Nature, 6512_Blue are made of synthetic rubber. The sterile gloves are sterilized by the radiation method. 6412 Nature, 6412 Blue are of thin gloves. 6512 Nature, 6512 Blue are of thick gloves. They are processed by special treatment with no protein, and intended to be used in surgery to prevent the cross contamination between patients and users.

The provided text describes the acceptance criteria and the study results for the MOTEX Polyisoprene Powder-free Sterile Surgical Gloves. It is a 510(k) submission, demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria in the context of an AI/ML medical device. However, I can reframe the information to fit the requested table and provide a "study" description based on the non-clinical tests performed to show substantial equivalence.

Here's the breakdown of the information as requested, adapted for this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria (Non-Clinical Testing for Substantial Equivalence)

The documented "study" is a collection of non-clinical tests performed to demonstrate that the MOTEX Polyisoprene Powder-free Sterile Surgical Gloves are "as safe, as effective, and perform as well as or better than" the predicate device (Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves, K093300). This is a substantial equivalence claim under 510(k) regulations, not a typical clinical study with patient outcomes or a specific AI/ML performance evaluation.

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

• Sample Size for Test Set: The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for pinholes, how many for tensile strength). Compliance is reported against the ASTM and ISO standards, which themselves define minimum sample sizes for their respective tests. The provenance is from Shanghai Motex Healthcare Co., Ltd., China.
• Data Provenance: The tests were conducted by Shanghai Motex Healthcare Co., Ltd. in China, or by third-party labs on their behalf, to demonstrate compliance with international standards (ASTM and ISO). The data is retrospective in the sense that the tests were completed and evaluated prior to this 510(k) submission.

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

This section is Not Applicable to this type of device and submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic devices, particularly AI/ML applications. For surgical gloves, the "ground truth" is adherence to established engineering and material science standards (ASTM, ISO), which are verified through empirical laboratory testing.

4. Adjudication method for the test set

This is Not Applicable. Adjudication methods (like 2+1 reads) are used for resolving disagreements in expert interpretations, typically in diagnostic imaging. The "adjudication" here is the pass/fail result against objective criteria defined by the relevant 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

This is Not Applicable. This is a medical device for surgical procedures (gloves), not an AI/ML diagnostic or assistive tool. No human reader performance, AI assistance, or MRMC studies were conducted or are relevant.

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 (surgical gloves) and does not involve an algorithm or AI.

7. The type of ground truth used

The "ground truth" (or more accurately, the conformance criteria) for this device's performance is based on established international consensus standards (ASTM D3577-09, D5151-06, D6124-06, D5712-10, ISO10993, ISO11137) and laboratory test results demonstrating compliance with these standards.

• Expert Consensus: The standards themselves are developed through expert consensus, but not in the context of evaluating individual cases.
• Pathology/Outcomes Data: Not used as "ground truth" for the technical performance characteristics listed. Clinical data was stated as "Not applicable" for this particular submission.

8. The sample size for the training set

This is Not Applicable. There is no "training set" as this device is not an AI/ML algorithm.

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

This is Not Applicable. There is no "training set" or corresponding ground truth establishment process for this device.

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