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A sterile power-free latex surgeon's glove is a disposable device intended for medical purpose that is worn by operating room personnel to protect a surgical wound from contamination.

Sterile Powder-Free Latex Surgical Gloves

Analysis of Device Acceptance Criteria and Study:

The provided documents are a 510(k) clearance letter from the FDA for "Sterile Powder-Free Latex Surgical Gloves" and related forms. This type of FDA clearance relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical studies with specific acceptance criteria in the way a novel AI or diagnostic device would.

Therefore, many of the requested categories for a study that "proves the device meets the acceptance criteria" are not directly applicable to a 510(k) submission for a Class I medical device like surgical gloves. The "acceptance criteria" here are primarily regulatory and performance standards for gloves, not diagnostic metrics.

However, I can extract information relevant to the intent of your questions based on what is typically required for a 510(k) of this nature.

1. Table of Acceptance Criteria and Reported Device Performance:

For surgical gloves, the primary performance criteria revolve around safety, barrier integrity, and physical properties. These are typically assessed against recognized industry standards (e.g., ASTM, ISO). The 510(k) summary (which is not fully provided here but would be part of the submission) would detail the specific tests conducted and their compliance.

Note: The provided documents do not explicitly state these specific performance metrics or acceptance criteria. They only indicate that the device was found "substantially equivalent" to a predicate device, implying that it meets the performance standards required for such a device. This typically involves performance bench testing.

2. Sample Size Used for the Test Set and Data Provenance:

For surgical gloves, the "test set" would refer to the samples used for physical, chemical, and biological testing.

• Sample Size: Varies depending on the specific test and statistical sampling plan (e.g., AQL tables for pinholes, individual glove samples for tensile strength). These details are not in the provided documents.
• Data Provenance: The testing would typically be performed by the manufacturer (Pamitex Industries Sdn. Bhd.) or a certified testing laboratory, likely in Malaysia (country of origin of the manufacturer). The data would be prospective in the sense that new gloves from production batches are tested for compliance.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This concept is not directly applicable to the 510(k) clearance for surgical gloves. "Ground truth" in this context would be established by objective measurements against recognized standards, not expert consensus on diagnostic images or clinical outcomes. The "experts" would be the engineers and scientists performing the tests according to standardized protocols and interpreting the results against established specifications.

4. Adjudication Method for the Test Set:

Not applicable in the sense of clinical adjudication. Test results for gloves are typically objective measurements (e.g., tensile strength values, pinhole counts) compared against a pre-defined pass/fail criterion. There isn't typically an adjudication process among multiple "experts" for these types of bench tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not a diagnostic device where human readers interact with AI.

6. Standalone Performance (Algorithm Only):

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for surgical gloves is based on:

• Objective Measurement against Standards: Performance metrics (e.g., tensile strength, elongation, pinhole rates) are measured directly using standardized testing methods (e.g., ASTM D3577, ISO 11193) and compared to established thresholds.
• Biological Testing: Biocompatibility tests (e.g., ISO 10993 series) evaluate the device's interaction with the body.
• Sterility Testing: Validation of the sterilization process to achieve a specified Sterility Assurance Level (SAL).

8. Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a "training set."

9. How Ground Truth for the Training Set Was Established:

Not applicable.

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