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Surgical Apparels, shoe and head covers, are worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

PrimeLine Medical Products Inc., priMED brand Head and Shoe Covers

I am sorry, but the provided text is a 510(k) clearance letter for "Primed Shoe Covers, Primed Head Covers" and an associated "Statement of Indications for Use". This document does not describe a study that involves acceptance criteria for device performance, nor does it contain information about AI-powered devices or diagnostic algorithms.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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The Shoe Cover is a device intended to be worn by hospital personnel from transfer of procedures to protect both the patient and the hospital personnel from transfer of materials.

Shoe Cover

This document is a 510(k) clearance letter from the FDA for a "Shoe Cover" device. As such, it is not a study report or clinical trial. Therefore, it does not contain information regarding detailed acceptance criteria, device performance metrics (such as sensitivity, specificity, AUC), sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as typically found in reports for devices utilizing AI or complex algorithms.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

The core of this FDA clearance is substantial equivalence to a predicate device, not a demonstration of specific performance metrics against pre-defined acceptance criteria through a quantitative study with the details requested. Such an extensive study as described in the prompt is generally not required for Class I devices cleared under the substantial equivalence pathway, especially not for a device like a shoe cover.

Given this context, I cannot provide the requested information from the provided document. The document describes a regulatory clearance process, not a performance study.

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Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.

Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.

The provided text is a 510(k) premarket notification letter from the FDA regarding a device called "Far-East Shoe Covers." It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market, but it does not detail any performance studies conducted by the manufacturer.

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The Convertors® Impervious Shoe Covers are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material

These shoe covers will be composed of a nonwoven fabric hot melt adhesively laminated to a synthetic polymer film. The nonwoven is a 1.5 osy blue spunbonded polypropylene. The film is a 1.25 mil embossed, polyethylene.

The provided text describes a medical device, the "Convertors® Impervious Shoe Covers," and its summary of safety and effectiveness. However, it does not contain information about software, AI, or algorithms, so many of the requested fields are not applicable.

Here's an attempt to answer the questions based on the provided text, indicating where information is not present or not relevant to AI/software:

Acceptance Criteria and Device Performance for Convertors® Impervious Shoe Covers

This document describes a traditional medical device (shoe covers) and not a software or AI-driven device. Therefore, many of the requested criteria related to AI/software performance studies (e.g., sample size for test set, number of experts for ground truth, MRMC studies, training set details) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

• The performance attributes are similar. |

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

• Sample Size for Test Set: Not explicitly stated for each test (e.g., number of shoe covers tested for flammability). The text mentions "All materials used" and "The tests performed on the Shoe Covers," implying a sufficient sample was tested to meet standards.
• Data Provenance: Not specified (e.g., country of origin). The testing was conducted internally by the manufacturer or a contracted lab to meet "applicable standards."
• Retrospective or Prospective: Not applicable, as this refers to physical testing of materials/devices.

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

• Not Applicable. This device is not AI/software-driven, so there is no concept of "ground truth" established by experts in the context of image interpretation or diagnostic accuracy. The "ground truth" for the physical tests would be the established scientific methods and industry standards for material properties.

4. Adjudication method for the test set

• Not Applicable. This is relevant for expert consensus in AI/software evaluations, not for physical product testing. The results of the physical tests would be objectively measured against predefined thresholds or standards.

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. No AI or human readers are involved with this device.

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

• Not Applicable. This device is not an algorithm.

7. The type of ground truth used

• For physical tests: The "ground truth" is implied to be objective measurements against established industry standards and specifications for material properties (e.g., flammability standards, penetration limits).
• For substantial equivalence: The "ground truth" is established by comparing the device's intended use and performance attributes to a predicate device (Kimberly-Clark X-Tra Traction Impervious Boot).

8. The sample size for the training set

• Not Applicable. This device does not involve machine learning or a training set.

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

• Not Applicable. This device does not involve machine learning or a training set.

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