(129 days)
The medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood fluids. This is a single-use, disposable device, provided non-sterile.
The medical surgical mask is designed and manufactured by Shenzhen Everwin Precision Technology Co, Ltd. It is non-sterile and for single use. It's a disposable device. The medical surgical mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elasticear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from steel wire.
The provided text describes a 510(k) premarket notification for a Medical Surgical Mask (K201991). This is a filing for a Class II medical device, specifically a surgical mask, and the data provided is for non-clinical performance testing rather than a study involving AI or human readers for diagnostic interpretation. Therefore, many of the requested points related to AI, human readers, ground truth establishment for AI training/testing, and MRMC studies are not applicable to this document.
However, I can extract information related to the acceptance criteria and the non-clinical performance tests conducted on the device.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria | Proposed Device Performance | Predicate Device Performance | Result |
|---|---|---|---|---|
| Biocompatibility | ||||
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Same |
| Sensitization | Non-sensitizing | Non-sensitizing | Non-sensitizing | Same |
| Skin Irritation | Non-irritating | Non-irritating | Non-irritating | Same |
| Performance Testing (ASTM F2100 Level 3) | ||||
| Flammability | Class I | Class I | Class I | Same |
| Bacterial Filtration Efficiency (BFE) | >=98% | >=98% | 98% | Same |
| Differential Pressure, mm H2O/cm2 | = 98% | >= 98% | Average 99.8% | Similar |
| Resistance to Penetration by Synthetic Blood (mmHg) | 29 out of 32 passes at 160mmHg | 29 out of 32 passes at 160mmHg | 29 out of 32 passes at 160mmHg | Same |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the non-clinical tests (e.g., how many masks were tested for BFE or flammability). It only provides the results for these tests. The data provenance is implied to be from the manufacturer's testing, based in China (Shenzhen Everwin Precision Technology Co., Ltd.). These are non-clinical lab tests, not human data, so "retrospective or prospective" doesn't strictly apply in the context of patient data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving human interpretation of medical images or patient data to establish ground truth. The "ground truth" for these tests is defined by the standardized testing methodologies (e.g., ASTM F2100 for mask performance, ISO 10993-1 for biocompatibility).
4. Adjudication method for the test set
Not applicable. This applies to cases where human experts might disagree on interpretation. For laboratory testing, the results are objectively measured according to established protocols.
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 pertains to a medical surgical mask and its physical performance and biocompatibility, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by the results of standardized laboratory testing (e.g., ASTM F2100 for performance, ISO 10993 for biocompatibility). These are objective measurements following validated protocols.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device that requires a training set.
In summary: The provided document details the non-clinical performance and biocompatibility testing of a medical surgical mask, demonstrating its substantial equivalence to a predicate device. It does not involve AI, human reader studies, or associated methodologies for AI device evaluation.
§ 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.