(21 days)
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
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| For materials used in fabrication: | All materials used in the fabrication of this Convertors® shoe cover materials were evaluated through physical qualification tests. |
| For the Shoe Covers (demonstrated by specific tests): | "These shoe covers have met the requirements of the applicable standards and were found to be acceptable for the intended use." |
| Specific tests performed: Flammability, Hydrostatic head, Synthetic Blood Penetration, Ph X174 Penetration, Alcohol Repellency, Trapezoic Tear, Grab Tensile, Mullen Burst, Elmendorf Tear, Basis Weight, Thickness, Coefficient of Friction, Electrostatic Decay and Abrasion. | |
| Substantial Equivalence to Predicate Device (Kimberly-Clark X-Tra Traction Impervious Boot): | - The intended use is the same. |
- 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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.