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This device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids and particulate matter.

Surgical Gowns including various sizes and material.

The provided document describes the safety and effectiveness of the IMC Surgical Gown. Here's a breakdown of the requested information based on the text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical way for each test. Instead, it lists the tests performed and the standards they adhere to, implying that meeting these standards constitutes acceptable performance. The document states "All material used in the fabrication of the IMC Surgical Gowns were evaluated for:" followed by the table. This suggests the reported device performance is that it met these standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify the sample size used for the biological (cytotoxicity, irritation, sensitivity, systemic toxicity) and physical (flammability, hydrostatic pressure, impact penetration, lint, tensile strength) tests performed on the surgical gown material.

The data provenance is not explicitly mentioned. It's an FDA submission in the USA, so it's likely the testing was conducted to meet US regulatory requirements, but the origin of the raw data/testing facilities is not stated. The document does not indicate if the data is retrospective or prospective.

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

This is not applicable as the evaluation relies on standardized laboratory tests and not expert consensus on medical images or clinical outcomes. The "ground truth" for these tests are the established parameters and methodologies defined by the cited ISO, CFR, AATCC, IST, and ASTM standards.

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

This is not applicable. The methods for evaluating the material properties are defined by the referenced standards (e.g., ISO 10993, AATCC 127), which involve specific measurement techniques rather than expert adjudication.

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 is not applicable. The device is a surgical gown, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to its evaluation.

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

This is not applicable. The device is a physical product (surgical gown), not an algorithm or software. Its performance is evaluated through material testing.

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

The "ground truth" for the device's performance relies on objective measurements and procedures defined by established industry and regulatory standards. For example:

• Biological Endpoints: The "ground truth" for cytotoxicity, skin irritation, skin sensitization, and systemic toxicity is determined by the specific protocols and criteria outlined in various parts of ISO 10993.
• Physical Properties: The "ground truth" for flammability, hydrostatic pressure, impact penetration, lint, and tensile strength is based on the quantitative measurements and methodology described in standards like 16 CFR Part 1610, AATCC 127 & 42, IST 160.1, and ASTM D5034.

8. The sample size for the training set:

This is not applicable. The document describes the evaluation of a physical medical device (surgical gown) through laboratory testing, not a machine learning model. Therefore, there is no "training set."

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

This is not applicable as there is no training set.

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This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.

International Medsurg Connection Surgical Drape.

This document, K050538, is a 510(k) Premarket Notification for a Surgical Drape. It describes the device's intended use and claims substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is related to a physical medical device (surgical drape) and not an AI/software-as-a-medical-device (SaMD).

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance: This type of data is not applicable to a surgical drape's 510(k) submission, which focuses on material properties, sterility, and substantial equivalence.
2. Sample size used for the test set and the data provenance, etc.: Not applicable. Performance testing for drapes typically involves laboratory tests for barrier properties, fluid resistance, etc., not a "test set" in the context of AI/SaMD.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

This 510(k) submission confirms that the International Medsurg Connection Surgical Drape (specifically Angiography & Cardiovascular Drapes) is "substantially equivalent" to Surgical Drapes, Reference K030365 owned by DeRoyal Industries. The basis for this equivalence would be similarity in materials, design, intended use, and performance claims regarding barrier properties and safety, typically demonstrated through standardized physical and biological testing, not clinical studies with "ground truth" or "expert consensus" in the way an AI/SaMD would be evaluated.

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