Search Results

A latex surgeon's gloves is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device, Latex Surgeon's Gloves Powdered and Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D3577-09. The rubber surgical gloves classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device includes Powdered and Powder Free Latex Surgeon's Gloves, and the come in different sizes ( 5½, 6, 6½, 7, 7½, 8, 8½, 9 ). All gloves share the same color, creamy white and all have beaded cuff and textured at the finger tips and palm. The proposed device is sterilized either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10th and place in a sterility maintenance package to ensure a shelf life of 3 years.

This appears to be a 510(k) summary for a medical device (latex surgeon's gloves), not a study specifically designed to assess an AI/ML device or its performance against acceptance criteria in the way typically expected for such technologies. Therefore, many of the requested elements (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or not detailed in this document.

However, I can extract the acceptance criteria and demonstrated performance for the physical and biological characteristics of the surgeon's gloves, as described in the "Product Comparison in Compliance with ASTM D 3577-09 Standard" and "Technological Characteristics Comparison" sections.

Here's the information formatted according to your request, with notes indicating where the requested AI-specific information is not present in this document:

1. Table of Acceptance Criteria and 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)

• Test Set Sample Size: The document does not specify exact sample sizes for each test conducted (e.g., how many gloves were tested for length, pinholes, tensile strength, etc.). It refers to meeting the standards like ASTM D3577-09, which would define the statistical sampling plans.
• Data Provenance: The submitting company is ST.MARY'S RUBBERS PVT. LTD. from Kottayam District, Kerala State, India. The tests were presumably conducted internally or by a contracted lab, but the specific location of data generation for these bench tests is not explicitly stated. The nature of these tests (physical and chemical properties) means there isn't "retrospective" or "prospective" data in the clinical sense. It's a characterization of manufactured product batches.

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 information is not applicable for this type of device and study. The "ground truth" for the physical and chemical properties of the gloves is established by objective measurements against international standards (ASTM, ISO), not by expert consensus or interpretation of medical images/data.

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

• This information is not applicable for this type of device and study. Adjudication methods are typically used in clinical or image-based studies where expert interpretation can vary. The tests here are objective measurements.

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 information is not applicable for this type of device and study. This is not an AI/ML device.

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

• This information is not applicable for this type of device and study. This is not an AI/ML device.

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

• The "ground truth" for these tests is defined by the quantitative specifications and methodologies outlined in the referenced international standards (ASTM D3577-09, ASTM D5151-2011, ASTM D6124-2011, ASTM D5712-10, ASTM D6499-12, ASTM F1929-2004, ISO 10993-10:2010, ISO 1137-2:2006, ISO 10993-7:2008, ISO 11135-1:2007). These standards provide the validated methods and acceptable limits for measuring physical, mechanical, and biological properties.

8. The sample size for the training set

• This information is not applicable for this type of device and study. This is not an AI/ML device, and there is no "training set" in the machine learning sense. The manufacturing process is controlled to meet the specifications, and testing is performed on manufactured lots.

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

• This information is not applicable for this type of device and study. See point 8.

Ask a specific question about this device