Search Results

Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are sterile or nonsterile single use devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization

Exact Medical Manufacturing Surgical Gown SMS w/PE Layer has the same design, material and performance characteristics of the predicate device.

The Exact Medical Manufacturing Surgical Gown SMS w/PE Layer met the acceptance criteria by demonstrating substantial equivalence to its predicate device (K023117) through a series of non-clinical performance tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

All results of the testing met acceptance criteria.

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

• Sample Size: Not explicitly stated. The document mentions "All results of the testing met acceptance criteria," implying that sufficient samples were tested for each criterion according to standard testing protocols for medical devices.
• Data Provenance: The data is generated from non-clinical performance testing conducted by Exact Medical Manufacturing, Inc. It is internal testing performed for regulatory submission.

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

• This is a non-clinical device (surgical gown) and does not involve human interpretation of data where expert consensus would be required to establish ground truth such as in diagnostic imaging. The "ground truth" is established by adherence to recognized national and international standards (e.g., ISO 10993, AAMI PB:70).

4. Adjudication method for the test set:

• Not applicable. As noted above, this involves objective, quantifiable laboratory tests against established standards, not interpretation or adjudication by experts.

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:

• Not applicable. This device is a surgical gown, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This device is a surgical gown, not an algorithm.

7. The type of ground truth used:

• The ground truth is based on accepted national and international standards and specifications for surgical gowns and medical device materials, including:
  • ISO 10993 for biocompatibility.
  • AAMI PB:70 for barrier properties (Level 3).
  • Other specific test methods for tensile strength, tear strength, flammability, linting, and sterility.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

• Not applicable, for the reason stated above.

Ask a specific question about this device