(179 days)
The Disposable Surgical 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, provided non-sterile and sterile.
The proposed device, Disposable Surgical Mask is a three-layer, flat-folded mask with ear strap and nose clip. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The color of the surgical mask is blue. The disposable surgical mask is available in three different specifications: 17.59.5cm, 14.59.5cm and 14.5*8cm. The device is single use and provided non-sterile and sterile.
The provided document is a 510(k) Pre-market Notification for a Disposable Surgical Mask, primarily focusing on proving substantial equivalence to a predicate device based on non-clinical performance standards. It explicitly states, "No clinical study is included in this submission." Therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets acceptance criteria using clinical or AI-driven performance metrics.
The document outlines acceptance criteria for non-clinical tests (e.g., fluid resistance, particulate efficiency, bacterial filtration, differential pressure, flammability, biocompatibility) to demonstrate the proposed device performs as well as or better than the predicate surgical mask. However, these are physical and biological performance metrics for the mask itself, not measures of a complex device's performance in a clinical setting or where AI is involved.
Here's a breakdown of why I cannot fulfill your request based on the provided text, and what information is available related to performance:
Information NOT available in the provided document:
- A table of acceptance criteria and the reported device performance related to a clinical or AI-driven study: The document presents a comparison table (page 5) of the proposed and predicate device's specifications and physical performance parameters, not clinical performance against acceptance criteria for a device involving AI or complex decision-making.
- For example, it states "Fluid Resistance: Pass at 160 mmHg" as a characteristic, which is a physical test result, not a clinical outcome or AI performance metric.
- Sample size used for the test set and data provenance: Not applicable as no clinical or AI test set is mentioned.
- Number of experts used to establish ground truth and qualifications: Not applicable as no ground truth for a clinical or AI study is established.
- Adjudication method for the test set: Not applicable.
- If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: "No clinical study is included in this submission." (page 7)
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable, as no AI/machine learning component is described.
- How the ground truth for the training set was established: Not applicable.
Information related to "acceptance criteria" and "performance" that IS in the document, but for physical/biological mask properties:
The document lists performance measures for the physical characteristics of the surgical mask:
1. A table of acceptance criteria and the reported device performance (for physical/biological properties):
| ITEM | Proposed Device Performance (Reported as "Pass at...") | Predicate Device Performance (Reported as "Passed at...") | Comparison |
|---|---|---|---|
| Fluid Resistance | Pass at 160 mmHg | Pass at 160 mmHg | Same |
| Particulate efficiency | Pass at >98.01% | Passed at 99.7% | Similar |
| Bacterial filtration | Pass at >98.12% | Passed at >99% | Similar |
| Differential Pressure | Pass at |
§ 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.