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The Motex Anti-Fog Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

The Motex Anti-Fog Surgical Face Mask, type: Tie-on, Ear-loop, is flat pleated 3-ply device, which consists of four layers, i.e., Inner layer (Bicomponent thermal-bonded nonwoven, Polypropylene / Polyethylene, PP/PE), Filter layer (Polypropylene Melt-blown), Outer layer (Polypropylene Spunbond, blue/ green/ white/ pink color) and Anti-Fog films (EP coated Polyethylene). Each mask contains tie-on strips or elastic ear loops and of steel wire coated with Polyethylene resin to secure the mask fit over the user's mouth and nose. The dimensions of each mask are length 165±5 mm and width 95±2 mm.

The provided text describes the acceptance criteria and performance data for the Motex Anti-Fog Surgical Face Mask.

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

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Sterile Latex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and are intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Sterile Latex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and are intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

I am sorry to inform you that the provided text is a 510(k) clearance letter from the FDA for Sterile Latex Powder-Free Surgical Gloves.

This document does not contain information about a medical device that utilizes AI or algorithms, nor does it discuss acceptance criteria, study data, or ground truth establishment relevant to AI/ML device performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as the document does not contain this type of information. It is a regulatory document for a physical medical device (gloves).

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The Surgical Face Mask of different colors (Green, White, Blue and Pink) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material.

Modern Healthcare Corp. Surgical Face Mask, type: Tie-on and Ear-loop, are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded polypropylene) that sandwich a melt blown polypropylene filter material, also with elastic loops and / or strip. The nosepiece for all Modern Healthcare Corp. Surgical Face Mask is malleable aluminum wire. All the materials used in the construction of the Modern Healthcare Corp. Surgical Face Mask are being used in currently marked devices.

The provided text is a 510(k) summary for a surgical face mask. It indicates that no clinical tests were performed to establish acceptance criteria or to prove that the device meets those criteria. Instead, the device's substantial equivalence to a predicate device (K060776) was demonstrated through bench testing.

Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.

Here's a breakdown of what can be answered based on the provided text:

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

Not applicable. The document states "Discussion of Clinical Tests Performed: Not Applicable". Performance targets and results from clinical studies are not provided. The substantial equivalence is based on meeting the same technological characteristics as the predicate device, which implies compliance with relevant standards through bench testing, not clinical performance criteria.

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

Not applicable. No clinical test set or data provenance is mentioned. The submission relies on "bench testing" which is typically laboratory-based and doesn't involve human subjects for performance evaluation in the way a clinical study would.

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)

Not applicable. No clinical test set requiring expert ground truth establishment is mentioned.

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

Not applicable. No clinical test set requiring adjudication is mentioned.

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 is a surgical face mask, not an AI-assisted diagnostic device. No MRMC study or AI component is involved.

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

Not applicable. This is a surgical face mask, not an algorithm.

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

Not applicable. No clinical ground truth is mentioned. The evaluation is based on bench testing of the product's physical and filtration properties, comparing them to established standards and the predicate device.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable. No training set or ground truth for a training set is mentioned.

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