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The Polyisoprene Powder Free, Black Colour Surgical Gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination.

Polyisoprene Powder Free, Black Colour Surgical Gloves Model 1: 0.22 mm Model 2: 0.30 mm

Based on the provided FDA 510(k) clearance letter (K192933) for "Polyisoprene Powder Free, Black Colour Surgical Gloves," none of the requested information regarding acceptance criteria, study details, expert involvement, or ground truth establishment for a device that uses AI analysis is available.

This document is a clearance letter for a physical medical device (surgical gloves), not an AI/ML-enabled diagnostic or analytical device. The letter pertains to the substantial equivalence of the gloves to previously marketed predicate devices under the Federal Food, Drug, and Cosmetic Act.

Therefore, I cannot provide details on:

• A table of acceptance criteria and reported device performance (for AI)
• Sample size used for the test set and data provenance
• Number of experts and their qualifications
• Adjudication method
• MRMC comparative effectiveness study or effect size
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document only covers regulatory information for the surgical gloves, such as:

• Trade/Device Name: Polyisoprene Powder Free, Black Colour Surgical Gloves
• Regulation Number: 21 CFR 878.4460
• Regulation Name: Non-Powdered Surgeon's Glove
• Regulatory Class: Class I, reserved
• Product Code: KGO
• Indications for Use: "The Polyisoprene Powder Free, Black Colour Surgical Gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination."

In summary, the provided text does not contain any information related to the performance evaluation or validation of an AI-powered device.

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The PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination.

PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves Model 1: 0.22mm Model 2: 0.30mm

This document is a 510(k) clearance letter from the FDA for surgical gloves and an "Indications for Use" statement. It does not contain any information about acceptance criteria or a study proving that a device meets those criteria.

The prompt asks for details related to acceptance criteria, device performance, study design (sample size, data provenance, ground truth establishment, MRMC studies, standalone studies), and expert qualifications, which are typical for studies supporting the effectiveness or substantial equivalence of diagnostic or AI-powered devices.

Since the provided text is for surgical gloves, which are general hospital devices and not diagnostic or AI-powered, these detailed study requirements are not applicable to the documentation provided. The 510(k) process for surgical gloves focuses on demonstrating substantial equivalence to a predicate device, primarily through material properties, manufacturing standards, and performance characteristics like barrier integrity, rather than complex clinical studies involving ground truth and expert consensus for interpretation.

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The X-Ray protection gloves PROGUARD are sterile examination gloves, radio-opaque, to be worn by hospital personnel, specifically surgeons, to protect their hands from radiation during operation of x-ray equipment. These gloves are destined to specific examination purposes. They are not intended to be used instead of a Radiographic Protective Gloves, normally used in radiography for those studies which need the physician's hands or forearms to be inserted intop the primary x-ray beam, but not the sterility or the degree of manual dexterity allowed by the PROGUARD.

Moreover these gloves are not to be used in or next to the primary x-ray beam or conducted primary x-ray beam. The main purpose of these gloves is to reduce the amount of dispersed radiation exposure to the hands from the primary x-ray beam during examinations or procedures under fluoroscopy performance.

This product contains natural rubber latex. The gloves are a product of Malaysia. The manufacturer of these latex-lead gloves complies with all the current specifications listed under The American ociety for testing and Materials (ASTM) Specification D 3578 -91 and FDA Water Leak Test.

The quality assurance testing for the finished product includes testing for physical properties such as tensile strength and elongation: dimensions such as length, width and thickness; visual tests such as colour and material uniformity. In addition, sampling and testing for leaks conforms to the FDA Water Leak Test for patient examination gloves.

The provided text describes safety and effectiveness information for X-Ray protection gloves, but it does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets such criteria.

The document is a 510(k) summary for a physical medical device (X-Ray protection gloves) from 1998. It details the physical properties of the gloves, their intended use, and a caution statement. It also includes an FDA clearance letter for the device, confirming its substantial equivalence to previously marketed devices.

Therefore, I cannot extract the requested information using the provided input. The questions you've asked are specific to the evaluation of AI/SaMD performance, which is not covered in this document.

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