(96 days)
The DS N95 Surgical Masks DTC3M-1/DTC3B, and flat surgical masks are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
The DS DTC3M-1 N95 surgical mask is constructed from a polypropylene spunbond used in the outer layer. The non-woven PP micro is the filter media and the Terylene is layered as the inner. The head strap is made of natural rubber(for double head straps) which is stapled to the mask. The inside nosepiece is a soft sponge foam.
The DS DTC3B N95 surgical mask is constructed from a polypropylene spunbond used in the outer cover, a polypropylene spunbond used in the inner cover. The non-woven PP micro fiber and polypropylene melt blown filter media is layered between the inner and out cover. The head straps are made of woven elastic strap(for single headband) which is circule to the mask. The inside nosepiece is a EVA micro-aperture foam.
The flat surgical masks (colors: blue, green, pink, white, yellow, orange) are flat pleated by 3-ply masks with outer layer and inner layers (spunbonded polypropylene) that sanwich a meltbown non-woven PP micro fibre filter material Ear-loops are made of spandex belt for free elastic loops. The nose piece for all DS Face Masks is malleable wire. Fog free masks have an anti-fog strip. Masks with splash visors have anti-fog treated plastic shield attached to masks,All of the material used in the construction of the DS Surgical Masks are being used in currently marketed devices (see predicate information).
All items are no - sterilized and only for single use.
The provided document is a 510(k) summary for surgical masks, not a study report for an AI device. Therefore, it does not contain information related to AI device performance, acceptance criteria, ground truth, or study methodologies typically associated with such devices.
The document discusses the substantial equivalence of DS N95 Surgical Masks and flat surgical masks to predicate devices based on non-clinical performance tests.
Here's a breakdown of the available information from the provided text, mapped to your requested categories where possible, and noting where information is not present due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| NIOSH Exhalation of Resistance Test, 84.180 | Implicitly, meet the requirements of NIOSH 84.180 (Specific criteria not provided in this document, but typically involve maximum exhalation resistance). | "performance testing meet all relevant requirements of the aforementioned test standard." (Specific values not provided) |
| NIOSH Inhalation of Resistance Test, 84.180 | Implicitly, meet the requirements of NIOSH 84.180 (Specific criteria not provided in this document, but typically involve maximum inhalation resistance). | "performance testing meet all relevant requirements of the aforementioned test standard." (Specific values not provided) |
| NIOSH Sodium Chloride (Nacl) - N95 84.181 | Implicitly, meet the requirements of NIOSH 84.181 for N95 filtration (Specific criteria not provided in this document, but typically >95% filtration efficiency). | "performance testing meet all relevant requirements of the aforementioned test standard." (Specific values not provided) |
| Flammability | Complied with 16 CFR 1610 Class I | "Complied with 16 CFR 1610 Class I" |
| Biocompatibility | Implicitly, meet the requirements per ISO 10993 (Specific criteria not provided, but typically involves cytotoxicity, irritation, and sensitization tests). | "performance testing meet all relevant requirements of the aforementioned test standard." (Specific details of tests or results not provided beyond compliance). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this document describes performance testing for surgical masks, not an AI device. The tests mentioned (NIOSH, Flammability, Biocompatibility) are standard tests for such products, and the sample sizes would be defined by the respective test standards. Data provenance is implied to be from a testing facility, likely in China where the manufacturer is located.
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)
This information is not applicable. The "ground truth" for surgical mask performance is established by objective measurements against recognized standards (e.g., NIOSH, ISO). It does not involve expert consensus in the way an AI diagnostic tool would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for subjective assessments or when discrepancies arise in expert interpretations, typically in diagnostic studies. Physical performance tests for masks do not involve such methods.
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
This information is not applicable. This document describes physical performance tests for surgical masks, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document describes physical performance tests for surgical masks, not an AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed is based on objective measurements and predefined physical/chemical standards outlined in each test method (e.g., NIOSH 84.180, 84.181, 16 CFR 1610, ISO 10993).
8. The sample size for the training set
This information is not applicable. This document describes performance tests for surgical masks, not an AI system that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. This document describes performance tests for surgical masks, not an AI system that requires a training set.
§ 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.