(387 days)
The Skypro, SP01 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 of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile.
Skypro, SP01 Mask, is a flat pleated procedure or surgical mask. It is 3 layers and composed of Polypropylene and Meltblown, with elastic earloops or Ties in either knitted polyester/lycra or non-woven polyester and A malleable nosepiece is placed within the bindings for comfort and individualized fir around the wearer's nose.
The provided text is a 510(k) summary for the Skypro, SP01 Mask, which is a surgical mask. It doesn't describe an AI/ML device, a comparative effectiveness study involving human readers, or the establishment of ground truth by medical experts. The acceptance criteria and performance data relate to the physical and functional characteristics of the mask itself, not an algorithm's performance.
Therefore, many of the requested categories are not applicable to the provided document. I will fill in the relevant information based on the document and explicitly state when a criterion is not applicable.
Here's the breakdown of the acceptance criteria and the study information for the Skypro, SP01 Mask:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Predicate Device K141875) | Reported Device Performance (Skypro, SP01 Mask) |
|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Pass @120mmHg | Pass @120mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | 99.4% | 99.28% |
| Bacterial Filtration Efficiency (ASTM F2101-07) | 99.76% | 99.66% |
| Differential Pressure (MIL-M-36954C) | 3.33 mm H2O/cm² | 3.72 mm H2O/cm² |
| Flammability Class (16 CFR Part 1610) | Class 1 | Class 1 |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (Sensitization) | Non-sensitization | Non-sensitization |
| Biocompatibility (Primary Skin Irritation) | Non-irritating | Non-irritating |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The document refers to "test data submitted," implying that samples were tested according to the respective ASTM and MIL standards.
- Data Provenance: Not specified in terms of country of origin of the data or if it was retrospective or prospective. It is assumed to be testing conducted specifically for this device 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 device is a physical medical supply (surgical mask), and its performance data are based on standardized laboratory tests, not expert interpretation of medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As per point 3, there is no expert adjudication involved in determining the performance of a surgical mask based on physical and filtration characteristics.
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 document pertains to a surgical mask, not an AI/ML device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This document pertains to a surgical mask, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Standardized Test Methods: The "ground truth" for the device performance is established by the results of standardized laboratory tests (e.g., ASTM F1862 for fluid resistance, ASTM F2299 for particulate filtration, ASTM F2101-07 for bacterial filtration, MIL-M-36954C for differential pressure, 16 CFR Part 1610 for flammability, and ISO 10993 for biocompatibility). These methods define the criteria for passing or failing each test.
8. The sample size for the training set:
- Not Applicable. This document pertains to a surgical mask, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As per point 8, there is no training set for this 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.