(212 days)
The Surgical Face Mask, Type: Tie-on, Ear-loop is indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism and body fluid.
Angeline Group Ltd. Surgical Face Mask, Type: Tie-on, Ear-loop are pleated 3-ply masks. The outer layers are made with 100% spun-bound polypropylene (SBPP). The filter media is composed of 10000 melt-blown polypropylene (MBPP). The inner layer is made of either 10000 medical grade tissue paper or 10000 SBPP. The ear loops are made of flat latex and fiberglass free elastic. The nosepieces are made of malleable aluminum wire. All of the materials used in the construction of the new masks are being used in currently marketed devices. The Surgical Face Mask, Type: Tie-on, Ear-loop is indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid, and particulate aerosol transfer.
This document is a 510(k) premarket notification for a Surgical Face Mask. The information provided describes the acceptance criteria and the study conducted to demonstrate substantial equivalence to a predicate device, rather than a clinical study evaluating the performance of a novel AI-powered medical device. Therefore, many of the requested categories are not applicable to this submission.
Here's an analysis based on the provided text, addressing the relevant points:
1. A table of acceptance criteria and the reported device performance
| Test/Characteristic | Acceptance Criteria (Predicate Device K051291) | Reported Device Performance (Angeline Group Ltd. Surgical Face Mask) |
|---|---|---|
| Bacterial Filtration Efficiency | 98% | 99% |
| Fluid Resistance | Passed at 80 mmHg (ASTM F1862-05) | Passed at 120 mmHg (EN 14683: 2005) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for individual tests. The document refers to "a series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests."
- Data Provenance: The tests were conducted internally or by a contracted lab to Angeline Group Ltd., whose address is in Taipei, Taiwan. The specific testing standards (EN 14683:2005, ASTM F1862-05, ISQ10993-5: 2009) are international. The data is prospective as it was generated for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This submission is for a physical medical device (surgical face mask) and relies on objective, standardized laboratory tests, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As per point 3, there's no expert adjudication involved for physical and mechanical tests.
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 is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance evaluation of the surgical mask is the established pass/fail criteria defined by recognized international standards for medical device testing (e.g., EN 14683 for masks, ASTM for fluid resistance, ISO for biocompatibility). These standards specify methodologies and acceptance thresholds.
8. The sample size for the training set
- Not Applicable. This is not an AI-powered device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As per point 8.
§ 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.