(84 days)
Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.
The TIDI® Facemask are pleated multi-ply design which are supplied non sterile. The outer layers are made of 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of 100% SBPP. The nosepieces are made of aluminum, and can be supplied with an anti fog strip made of polyester urethane foam. All materials used in the construction of the mask are being used in currently marketed devices. The face mask covers the nose and mouth, and is secured to the face using ear loops.
This document describes the TIDI® Facemask and its non-clinical performance data to demonstrate substantial equivalence to predicate devices, as part of a 510(k) submission (K100800). The information provided is for a medical face mask, and thus the acceptance criteria and performance data are related to material performance rather than clinical diagnostic accuracy or reader studies.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The device performance is benchmarked against the requirements of ASTM F-2100-07, "Standard Specification for performance of Materials Used in Medical Face Masks." The document states that the TIDI® Facemask "meet the requirements" of this standard.
| Performance Metric | Acceptance Criteria (ASTM F-2100-07 requirement) | Reported Device Performance (TIDI® Facemask) |
|---|---|---|
| Resistance to Penetration by Synthetic Blood (ASTM 1862-07) | Meets ASTM F-2100-07 requirements | Meets requirements of ASTM F-2100-07 |
| Initial Efficiency of Materials to Penetration by Particulates Using Latex Spheres (ASTM F 2299-03) | Meets ASTM F-2100-07 requirements | Meets requirements of ASTM F-2100-07 |
| Bacterial Filtration Efficiency (BFE) (ASTM 2101-07) | Meets ASTM F-2100-07 requirements | Meets requirements of ASTM F-2100-07 |
| Flammability of Clothing Textiles (16 CFR Part 1610) | Meets 16 CFR Part 1610 requirements | Meets requirements of 16 CFR Part 1610 |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of masks tested for BFE, or number of synthetic blood penetration tests). The data provenance is non-clinical laboratory testing performed to established ASTM standards. The country of origin of the data is not specified beyond the fact that it's for a US FDA submission, suggesting the testing was likely conducted in a regulated environment in line with US standards. The data is retrospective in the sense that it was collected before the submission of the 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this document. The "ground truth" for the performance of a medical face mask is established by validated standardized testing methods (ASTM standards) rather than expert consensus on diagnostic images or clinical outcomes. The tests themselves are designed to objectively measure material properties.
4. Adjudication method for the test set
Not applicable. As described above, the evaluation relies on objective, standardized laboratory test results, not on subjective interpretations requiring adjudication.
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 document is for a medical face mask, which is a physical device, not an AI software or diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the TIDI® Facemask's compliance is the results obtained from standardized laboratory tests performed according to the specified ASTM standards. These standards define objective pass/fail criteria for material performance.
8. The sample size for the training set
Not applicable. This is not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical device.
§ 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.