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A powder-free surgeon's glove is a device made of synthetic latex that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. The radiation attenuating surgical glove is intended to be used during medical procedures where hands are necessarily exposed to radiation in order to offer some degree of protection to the hand from radiation. This includes surgical procedures that require the use of fluoroscopy or radiography.

The Powder-Free Radiation Attenuating Surgical Gloves are formulated using neoprene, synthetic latex. The gloves are supplied powder-free and sterile.

This document describes the acceptance criteria and performance of the Powder-Free Radiation Attenuating Surgical Glove by International Biomedical, Inc. It does not pertain to an AI/ML medical device, but rather a physical surgical glove. Therefore, most of the requested information regarding AI/ML studies is not applicable.

Here's the information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates "Summary of Test Results" but does not provide specific sample sizes for each test mentioned (e.g., how many gloves were tested for elongation and tensile strength, or how many subjects were involved in irritation/sensitization tests).

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. However, given that this is a 510(k) submission to the FDA, it is implied that the testing was conducted to meet US regulatory standards.

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

Not applicable. This is not an AI/ML device, and the evaluation involves physical and chemical property testing rather than expert-based ground truth establishment for diagnostic purposes.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML device; the tests are objective measurements of physical and chemical properties.

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 physical surgical glove, not an AI/ML system.

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

Not applicable. This device is a physical surgical glove, not an AI/ML system.

7. The type of ground truth used

The "ground truth" for this device is based on established industry standards and regulatory requirements for surgical gloves. These include:

• ASTM D 3577-01a: Standard Specification for Rubber Examination Gloves (likely referencing requirements for synthetic surgical gloves).
• ASTM D 6124-01: Standard Test Method for Residual Powder on Medical Gloves.
• Protocols for evaluating primary skin irritation and dermal sensitization.

8. The sample size for the training set

Not applicable. This device is a physical surgical glove, not an AI/ML system that requires a "training set."

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

Not applicable. This device is a physical surgical glove, not an AI/ML system.

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The "Infant Life Support Module - 20" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring is usually present. The system is to be operated by trained medical technical personnel. Intended use of the modified (K022876) and predicate device ( K854065) are identical.

The "Infant Life Support Module - 20" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring is usually present.

The provided text is an FDA 510(k) clearance letter for the "Infant Life Support Module-20," a neonatal transport incubator. While it mentions the device name, regulation information, and indications for use, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for any test set.
• Information regarding a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
• The type of ground truth used, training set sample size, or how ground truth for a training set was established.

This document is a regulatory approval letter, confirming the device's substantial equivalence to a predicate device, and thus permitting its marketing. It does not include the technical study details that would typically be found in a performance study report or a summary thereof.

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Ask a specific question about this device