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Powdered Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text describes a 510(k) summary for "Powdered Vinyl Patient Examination Gloves, Light Yellow Color." This is a medical device that falls under the category of general hospital devices, specifically patient examination gloves.

The text does not describe an AI/ML powered device, nor does it involve any studies related to human readers, AI assistance, or complex diagnostic tasks. The "acceptance criteria" and "study" described in the document are for basic physical, chemical, and biological properties of the gloves, not for an AI algorithm.

Therefore, I cannot extract the information required for the requested table and parameters related to an AI/ML device. The document pertains to a much simpler Class I medical device.

Here's a breakdown of why this document doesn't fit the request and what information can be extracted:

• No AI/ML Component: The device is a physical product (gloves), not a software or AI-driven system.
• No "Ground Truth" for AI: Concepts like expert consensus, pathology, or outcomes data as "ground truth" are irrelevant for examination gloves.
• No "Readers" or "Adjudication": There are no human readers or AI algorithms being evaluated in a diagnostic context.
• No "Sample Size for Test/Training Set" in AI Sense: The phrase "sample size" in this document refers to the quantity of gloves tested for physical properties (e.g., freedom from pinholes), not data points for an AI model.
• No "Effect Size of Human Readers Improve with AI": This is completely unrelated to the device described.

What can be extracted related to "acceptance criteria" from the provided text for this specific device:

The "acceptance criteria" are essentially the relevant ASTM standards and FDA regulations that the gloves must meet. The "device performance" is stated as "Meets" for all these criteria.

Table of Acceptance Criteria and Reported Device Performance (as per the document):

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Powdered vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

powdered vinyl patient examination gloves, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.

The provided text describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves (Light Yellow)." This is a medical device submission, specifically for patient examination gloves, which are low-risk devices. Therefore, the acceptance criteria and study design are different from what would be expected for a complex AI/ML diagnostic or prognostic device.

Here's the breakdown of the information based on your request, tailored to this type of device:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for pinholes, how many animals for biocompatibility). However, the tests are conducted according to established standards (ASTM, FDA regulations, ISO), which inherently define the sampling methods and acceptance levels.

• Provenance: This is a physical product (gloves), not data in the sense of patient records or images. The "data" provenance refers to the testing conducted on the manufactured gloves. There is no mention of country of origin for the data (testing results), but the manufacturer is based in China. The tests are non-clinical and would be considered prospective for the specific batch of gloves tested to support the submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable in the context of this device. "Ground truth" usually refers to diagnostic accuracy in complex medical imaging or clinical decision-making. For these gloves, "ground truth" is established by direct measurement against a defined engineering or biological standard. For example, a pinhole is objectively present or absent based on a waterleak test. Biocompatibility tests are performed by trained laboratory personnel following established protocols, not by "experts" establishing a subjective ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. The tests are objective measurements against defined criteria (e.g., glove dimensions, force at break, waterleak test for pinholes, standardized biological assays). There is no subjective interpretation requiring adjudication.

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

• No. MRMC studies are used for evaluating diagnostic performance of imaging devices or algorithms with human readers. This device is a medical glove, not a diagnostic tool requiring interpretation by human readers.

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

• Not applicable. This device is a physical product (glove), not an algorithm or AI system.

7. The Type of Ground Truth Used:

• The "ground truth" for the acceptance criteria is defined by industry standards (ASTM D 5250-06, ASTM D6124-01) and regulatory requirements (21 CFR 800.20, ISO10993-10). This includes:
  • Engineering specifications: For dimensions, physical properties (tensile strength, elongation), and powder amount.
  • Physical test results: For freedom from pinholes (waterleak test).
  • Biological assay results: For biocompatibility (primary skin irritation and dermal sensitization tests in animal models).

8. The Sample Size for the Training Set:

• Not applicable. This is a manufactured product, without a "training set" in the AI/ML sense. The manufacturing process uses quality control, and the design itself is based on general engineering principles for glove production, not machine learning.

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

• Not applicable, as there is no "training set" for this device. The design specifications and manufacturing process are established based on the requirements of the ASTM standards and FDA regulations, informed by decades of glove manufacturing and material science.

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