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A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Sunmax Vietnam Co. Ltd Powder free Nitrile Examination Glove is a class I device having product code 80LZA. It is a disposable device that meets all requirements of ASTM D 631900a-05.

The provided document describes the Sunmax Vietnam Co. Ltd Powder Free Nitrile Patient Examination Gloves and its substantial equivalence to predicate devices, rather than a study proving performance against acceptance criteria in the typical sense of a clinical trial for a diagnostic or therapeutic device. However, it does provide performance data against established ASTM standards for examination gloves.

Here's an analysis based on the information provided, framed to address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the requirements of ASTM D 6319-00a-05 for powder-free nitrile examination gloves. The document also compares the new device to several predicate devices.

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

The document states that testing was conducted according to ASTM D 6319-00a-2005, which specifies sampling plans for physical properties and pinhole defects.

• Sample Size: For physical specifications and dimensions, the inspection level S-2, AQL 4.0 is mentioned. For pinholes, AQL 2.5 is stated. ASTM D 6319-00a-2005 (Standard Specification for Nitrile Examination Gloves for Medical Application) outlines specific sampling plans based on lot size for these AQLs. For instance, for an Inspection Level S-2 and an AQL of 4.0, a sample size is drawn from the lot. The exact number of gloves tested is not explicitly stated but is implicitly defined by the ASTM standard for the given AQLs and inspection levels.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied that testing was performed by the manufacturer or a third-party lab according to the ASTM standard.

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

This is not applicable in the context of this device. The "ground truth" here is objective physical and chemical testing against a recognized industry standard (ASTM D 6319-00a-2005). There are no human expert readings or interpretations required to establish ground truth for glove performance parameters like tensile strength, dimensions, or biocompatibility.

4. Adjudication Method for the Test Set

Not applicable. Testing involves objective measurements and pass/fail criteria based on ASTM standards, not expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study (MRMC) is typically used for diagnostic devices involving human interpretation of images or other data. For patient examination gloves, the evaluation focuses on physical properties, barrier integrity, and biocompatibility, not human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. "Standalone" performance generally refers to the performance of an AI algorithm. This device is a physical medical device (gloves), not an AI system. The testing described is intrinsic to the device itself.

7. The Type of Ground Truth Used

The ground truth used consists of:

• Established ASTM Standards: Specifically ASTM D 6319-00a-2005 requirements for physical properties (dimensions, tensile strength, ultimate elongation, barrier integrity).
• Biocompatibility Testing: According to recognized protocols for dermal sensitization and primary skin irritation.
• Permeation Testing: Per ASTM D 6978-05 (for resistance to permeation by chemotherapy drugs, if applicable, though the current device's predicate was tested for this, and the current device generally passes permeation testing).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a "training set." The manufacturing process for gloves is a continuous process, and quality control (QC) samples are taken periodically for testing. There isn't a "training set" in the machine learning sense.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for this type of device. Quality control and performance verification are established by adherence to manufacturing specifications and national/international standards.

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