(283 days)
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) 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 of the wearer to blood and body fluids. The Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) are single use, disposable device(s), provided non-sterile.
The subject device(s) are ASTM Level 1 (blue in color) Surgical and Procedure Mask(s). The Fluidshield* 1 Procedure Mask and the Fluidshield* 1 Surgical Mask are a three-layer mask, constructed of non-woven materials. The Surgical Masks (28802) are provided with ties while the Procedure Masks (25869) are provided with earloops. A malleable nosepiece is placed within the bindings to conform with the wearer's nose. The Fluidshield* 1 Procedure Mask and the Fluidshield* 1 Surgical Mask are single use, disposable devices, provided non-sterile.
The provided document is a 510(k) Premarket Notification for a medical device (surgical masks), not for an AI/software device. Therefore, the information requested regarding acceptance criteria, study design, ground truth establishment, and expert involvement for a software/AI device is not applicable and cannot be extracted from this document.
The document describes the non-clinical performance testing for surgical masks, which focuses on physical and biological properties rather than AI algorithm performance.
Here's an analysis of the provided information, specifically addressing the non-AI device context:
1. A table of acceptance criteria and the reported device performance:
| Test | Purpose | Acceptance Criteria | Reported Device Performance (28802 - Surgical Mask) | Reported Device Performance (25869 - Procedure Mask) |
|---|---|---|---|---|
| ASTM F2101 (Bacterial Filtration) | To demonstrate adequate bacterial filtration efficiency | Under study conditions, at least 95% efficiency | Pass | Pass |
| EN 14683:2019 +AC Annex C (Breathability) | To demonstrate acceptable breathability | Under study conditions, at most 5.0 mm H2O/cm² | Pass | Pass |
| ASTM F2299 (Particulate Filtration) | To demonstrate adequate particulate filtration efficiency | Under study conditions, at least 95% efficiency | Pass | Pass |
| ASTM F1862 (Resistance to Liquids) | To demonstrate adequate resistance to liquids | Under study conditions, passing at 80 mmHg conditions | Pass | Pass |
| 16 CFR 1610 (Flame Spread Resistance) | To evaluate flame spread resistance | Class 1 under tested conditions | Pass | Pass |
| ASTM F2100-19 (Mask Performance) | To evaluate mask performance | Level 1 under evaluated conditions | Pass | Pass |
| ISO 10993-5 (Cytotoxic Potential) | To evaluate the cytotoxic potential of the mask | Under study conditions, non-cytotoxic | Pass | Pass |
| ISO 10993-10 Sensitization | To evaluate the sensitization potential of the mask | Under study conditions, not a sensitizer | Pass | Pass |
| ISO 10993-10 Irritation | To evaluate the irritation potential of the mask | Under study conditions, not an irritant | Pass | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the exact sample sizes used for each of these non-clinical performance tests. These are standard laboratory tests typically performed on a statistically relevant number of samples to ensure representativeness. The provenance (country of origin, retrospective/prospective) is not detailed for these laboratory tests.
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 is not applicable to the performance testing of surgical masks. Ground truth, in the context of material and product performance, is established by adherence to standardized testing protocols (e.g., ASTM, ISO, EN) and validated laboratory methods, not by expert consensus or interpretations of complex data like medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. These are objective, quantitative laboratory tests with defined pass/fail criteria, not subjective assessments requiring expert adjudication.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-assisted device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for these tests is the objective measurement against established performance standards (e.g., specific filtration percentages, pressure differentials, flame spread classes), as defined by the international standards mentioned (ASTM, EN, ISO, CFR).
8. The sample size for the training set:
Not applicable. There is no training set for a non-AI medical device like a surgical mask.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for a non-AI 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.