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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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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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The Fluid Barrier Boot is intended to be used in the hospital environment to provide protection from all types of fluids in the Operating Room, Central Sterile and in the Emergency Room.

The Fluid Barrier Boot is manufactured from 6 gauge Poly Vinyl and is available in both knee-high or ankle high boots is small, medium or large sizes. The boots are secured with straps both at the ankle and over the call on the knee-high boot. The ankle-high boot secures only at the ankle.

Here's a breakdown of the acceptance criteria and the study details for the Fluid Barrier Knee-High Boots:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 35 samples were initially prepared, with 32 samples used for the passing/failing assessment.
• Data Provenance: Not explicitly stated, but the test (ASTM Method F1671-95) is a standardized laboratory test; it's retrospective in the sense that the test was conducted on manufactured samples.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This device is a physical barrier product, and its performance is assessed through a standardized laboratory test (ASTM Method F1671-95). Therefore, there is no "expert" involvement in establishing ground truth in the traditional sense of clinical interpretation. The ground truth is determined by the objective results of the viral penetration assay.

4. Adjudication Method for the Test Set

• No adjudication method (e.g., 2+1, 3+1) was used. The test results are objective and based on the presence or absence of ΦX174 on assay plates following the ASTM F1671-95 methodology.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This is not applicable for a physical barrier product being tested for viral penetration.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• This is not applicable as the device is a physical product, not an algorithm. The performance described is inherently "standalone" in the sense that it's the product's performance under specific test conditions, without human interpretation influencing the result.

7. Type of Ground Truth Used

• The ground truth used is based on objective laboratory test results from the "Viral Penetration Test" ASTM Method F1671-95, which measures the passage of a surrogate virus (ΦX174) through the material.

8. Sample Size for the Training Set

• This information is not applicable. The device is a manufactured physical product, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable, as there is no training set for this type of device.

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