(630 days)
The surgical face masks are 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 the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The surqical face masks are pleated 3 plys sinqle use, disposable masks. Inner layers and outer layers are made of spun-bond polypropylene. Middle layer is made of melt blown polypropylene filter. Earloops are Knitted Elastic loops (not made with natural rubber latex). Tieon is made of spun-bond polypropylene. The nose piece is a malleable aluminum wire.
The provided document is a 510(k) Premarket Notification for a Surgical Face Mask. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI/ML powered device. As such, most of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not applicable to this type of regulatory submission.
However, I can extract the acceptance criteria and reported device performance based on the non-clinical tests conducted to support substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the surgical face masks are based on recognized standards and demonstrate the product's performance for bacterial filtration, particulate filtration, fluid resistance, flammability, and biocompatibility.
| Test Parameter | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ASTM F2101-07 (General Plastic Surgery/General Hospital) | Not explicitly stated in quantitative terms but implied to meet the standard. |
| Particulate Filtration Efficiency | ASTM F2299-03 (Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres) | Not explicitly stated in quantitative terms but implied to meet the standard. |
| Fluid Resistance | ASTM F1862-07 (Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)) | Not explicitly stated in quantitative terms but implied to meet the standard. |
| Flammability | 16 CFR Part 1610 (Standard for the Flammability of Clothing Textiles) - Class 1 | Class 1 |
| Biocompatibility | ISO 10993-1: 2009 (Evaluation and Testing Within a Risk Management Process) | Non-cytotoxic, Non-sensitizer, Non-irritant |
| Cytotoxicity | ISO 10993-5: 2009 (Tests For In Vitro Cytotoxicity) | Non-cytotoxic (as part of biocompatibility) |
| Irritation and Skin Sensitization | ISO 10993-10: 2010 (Tests For Irritation And Skin Sensitization) | Non-sensitizer, Non-irritant (as part of biocompatibility) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the document. For these types of standard tests, statistical sampling plans are typically used, but the specific numbers are not provided.
- Data Provenance: The tests were conducted to specific ASTM, MIL, CFR, and ISO standards, indicating laboratory testing conditions. The country of origin for the testing itself is not explicitly stated, but the manufacturer is BH Medical Products Co., Ltd. in Changzhou, Jiangsu, China. The document does not specify if the studies were retrospective or prospective; due to the nature of product performance testing, they would be considered prospective laboratory studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for surgical face mask performance testing. "Ground truth" in this context is defined by objective physical and biological measurements against established standards, not expert consensus interpretation.
4. Adjudication method for the test set:
- Not applicable. Performance is measured against objective standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This document describes a physical medical device (surgical face mask).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not a software/AI-based device. Performance tests are inherently "standalone" in the sense that they measure the device's physical and biological properties.
7. The type of ground truth used:
- The "ground truth" for the performance claims of the surgical face mask is based on objective measurements against established national and international standards (ASTM, MIL, CFR, ISO). These standards define specific methodologies and acceptance criteria for demonstrating performance (e.g., filtration efficiency, fluid resistance, flammability, cytotoxicity).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML 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.