(99 days)
The Disposable Surgical Face Mask is 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 a single use, disposable device(s), provided non-sterile.
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On (model: JB-DM04) or Ear Loops (model: JB-DM03) way for wearing, and they all has Nose Piece design for fitting the facemask around the nose.
The proposed device(s) 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 JB-DM04 of proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model JB-DM03 of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Nylon and spandex.
The nose chip contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PE and iron.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) Summary for a Disposable Surgical Face Mask, which is a medical device. The information requested pertains to the acceptance criteria and study proving a digital health or AI/ML-driven device's performance. This document does not describe such a device. Instead, it outlines the non-clinical performance testing for a physical medical device (a face mask).
Therefore, I cannot extract the information required by your prompt, such as sample sizes for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, standalone algorithm performance, or how ground truth was established for training, because these concepts are not applicable to the evaluation of a physical surgical face mask as presented in this document.
The document focuses on:
- Acceptance Criteria for the Face Mask: These are based on established standards for surgical masks, such as ASTM F2100 performance levels (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) and ISO 10993 for biocompatibility.
- Study Proving Device Meets Criteria: This involves non-clinical laboratory tests performed directly on the mask material or a sample of masks.
Here's an analysis of what is present in the document, framed against your request:
1. A table of acceptance criteria and the reported device performance:
| Test Methodology | Acceptance Criteria (level 2 & 3) | Proposed Device 1 (model: JB-DM04) Reported Performance | Proposed Device 2 (model: JB-DM03) Reported Performance | Result |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 160 mmHg for Level 3; 29 out of 32 pass at 120 mmHg for Level 2 | 32 out of 32 pass at 160 mmHg | 32 out of 32 pass at 120 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.9% | 99.9% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | >99.9% | >99.9% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) |
§ 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.