(219 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 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, provided non-sterile.
The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, YX011, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The model of proposed device, YX121, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polyethylene and iron.
The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
This document is a 510(k) summary for a "Surgical Face Mask" (Trade Name) from Hunan EEXI Technology & Service Co., Ltd. It's a regulatory submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Therefore, this document does not describe the acceptance criteria and the study that proves an AI/algorithm-based device meets acceptance criteria. It discusses the performance criteria for a physical medical device (a surgical face mask).
The request asks about aspects of an AI/algorithm study (e.g., sample size for training/test sets, expert adjudication, MRMC studies, ground truth establishment). These concepts are not applicable to the evaluation of a physical surgical face mask as described in this 510(k) submission.
However, I can extract the acceptance criteria and reported device performance for the Surgical Face Mask based on the provided text, and explain why other aspects of your question are not relevant here.
Acceptance Criteria and Reported Device Performance (for the Surgical Face Mask)
The acceptance criteria for this medical device are based on the ASTM F2100-19 standard for the "Performance of Materials Used in Medical Face Masks" and ISO 10993-1 for biocompatibility. The device is intended to meet Level 3 performance based on ASTM F2100.
Here's a table summarizing the performance standards (acceptance criteria) and the reported performance of the subject device (Surgical Face Mask, K202161) and comparison to its predicate device (K153496):
Table of Acceptance Criteria and Reported Device Performance
| Performance Test / Characteristic | Acceptance Criteria (Target for Subject Device) | Reported Device Performance (Subject Device K202161) | Predicate Device Performance (K153496) | Comments to Predicate |
|---|---|---|---|---|
| Material/Design | ||||
| Product Name | Surgical Face Mask | Surgical Face Mask | Disposable Surgical Face Mask | Similar |
| Product Code | FXX | FXX | FXX | Same |
| Regulation Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classification | Class II | Class II | Class II | Same |
| OTC use | Yes | Yes | Yes | Same |
| Intended Use | As described in section 6 | As described in section 6 | Similar to subject device | Same |
| Design Feature | Ear-loop, Tie-on | Ear-loop, Tie-on | Ear-loop, Tie-on | Same |
| Usage | Single use | Single use | Single use | Same |
| Color | Blue | Blue | Blue | Same |
| Size | (175±10) mm×(95±10)mm | (175±10) mm×(95±10)mm | (17.5±1) cm×(9.5±1)cm | Same (unit conversion) |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Material (Outer Layer) | Spun-bond polypropylene | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Material (Middle Layer) | Melt blown polypropylene filter | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Material (Inner Layer) | Spun-bond polypropylene | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose piece | Polyethylene and iron | Polyethylene and iron | Malleable aluminum wire | Similar |
| Ear-loops | Elastic fiber | Elastic fiber | Polyester | Similar |
| Tie-on | Spun-bond polypropylene | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Performance (ASTM F2100) | Level 3 Requirements | Meets Level 3 Classification | Meets Level 2 Classification | Subject device meets higher level |
| Fluid Resistance (ASTM F1862-13) | Meets Level 3 | Met Level 3 Requirements | Met Level 2 Requirements | Similar (higher performance) |
| Particulate Filtration Efficiency (ASTM F2299) | Meets Level 3 | Met Level 3 Requirements | Met Level 2 Requirements | Similar (higher performance) |
| Bacterial Filtration Efficiency (ASTM F2101) | Meets Level 3 | Met Level 3 Requirements | Met Level 2 Requirements | Similar (higher performance) |
| Differential Pressure (EN 14683:2019+AC:2019) | Meets Level 3 | Met Level 3 Requirements | Met Level 2 Requirements | Similar (higher performance) |
| Flammability (16CFR 1610) | Class 1 | Class 1 | Class 1 | Same |
| Biocompatibility (ISO 10993) | ||||
| Cytotoxicity | Non cytotoxic (ISO 10993-5) | Non cytotoxic | Non cytotoxic | Same |
| Irritation | Non irritating (ISO 10993-10) | Non irritating | Non irritating | Same |
| Sensitization | Non sensitizing (ISO 10993-10) | Non sensitizing | Non sensitizing | Same |
Response to AI/Algorithm-Specific Questions (Not Applicable to this document)
The following points are pertinent to AI/algorithm-based devices but are not discussed or applicable in this 510(k) submission for a physical surgical face mask. This document focuses on material properties, physical dimensions, and established performance standards for protective apparel.
- Sample sizes used for the test set and the data provenance: Not applicable. Tests are conducted on physical samples of the face mask, not a 'test set' of data in the AI sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance is measured objectively through standardized laboratory tests (e.g., measuring particulate filtration). Ground truth is established by the test method's result, not expert consensus.
- Adjudication method: Not applicable. No human interpretation or adjudication as in AI model evaluation.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI-assisted human reading, not for a physical mask.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. No algorithm is involved.
- The type of ground truth used: For physical masks, "ground truth" is typically defined by the results of the standardized physical and material tests (e.g., a certain percentage of particles were blocked, a certain fluid penetration resistance was achieved).
- The sample size for the training set: Not applicable. There is no 'training set' as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device (surgical face mask) and its evaluation against established performance standards for such products. It does not pertain to the development or validation of an AI/algorithm-based medical 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.