(474 days)
Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS is a NIOSH certified N95 respirator, and is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
Pasture F550S and Pasture F550CS respirators are disposable duck bill shaped N95 respirators with NIOSH certification number TC-84A-7504. They contain 5 layers composed of polypropylene, with a nose cushion, a synthetic elastic loop or strap, and a nosepiece which is the combination of zinc wires and embedded polyester inside of layers. F550CS is the same respirator as the F550S, but F550CS contains an adjustable buckle on the headband.
Pasture A520S and Pasture A520CS respirators are cup shaped N95 respirators with NIOSH certification number TC-84A-7454. They contain 4 layers composed of polypropylene with a synthetic elastic loop or a strap. A520CS is the same respirator as the A520S, but A520CS contains an adjustable buckle on the headband.
Pasture E520S and Pasture E520CS respirators are cup shaped N95 respirators with NIOSH certification number TC-84A-7453. They contain 4 layers composed of polypropylene with a nose cushion, synthetic elastic loop or strap, and an aluminum nosepiece. E520CS is the same respirator as E520S, but E520CS contains an adjustable buckle on the headband.
This document describes the premarket notification for several models of Pasture Surgical N95 Respirators (F550S, F550CS, A520S, A520CS, E520S, E520CS). The provided information is insufficient to answer all parts of the request as it pertains to medical device AI/ML performance studies. However, I can extract the relevant information from the document regarding the acceptance criteria and performance of these N95 respirators. The questions asked are typically for AI/ML devices, not for surgical respirators.
Here's an analysis based on the provided text, adapted to the context of a physical medical device (N95 respirator) and its regulatory submission.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for these N95 respirators are based on various performance standards and regulatory requirements for surgical masks and N95 respirators. The document primarily demonstrates substantial equivalence to a predicate device (WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095) through performance testing.
| Acceptance Criteria (Test Performed) | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Fluid Resistance | ASTM F1862 (for K070139, listed as 120mmHg; E520S is listed as 160mmHg in the main table) | Pasture F550S, F550CS, A520S, A520CS, E520S, and E520CS met the requirements of ASTM F1862. (F550S/F550CS/A520S/A520CS: Pass 120mmHg; E520S/E520CS: Pass 160mmHg) |
| Flammability | 16 CFR 1610 | Pasture F550S, F550CS, A520S, A520CS, E520S, and E520CS met the requirements of 16 CFR 1610 (Class 1). |
| Particulate Filtration Efficiency | NIOSH Certification (N95 standard) | F550S and F550CS: NIOSH Certification: TC-84A-7504 |
| A520S and A520CS: NIOSH Certification: TC-84A-7454 | ||
| E520S and E520CS: NIOSH Certification: TC-84A-7453 (These are N95 certified, meaning ≥95% filtration efficiency) | ||
| Bacterial Filtration Efficiency | NIOSH Certification (implied by N95 for healthcare) | F550S and F550CS: NIOSH Certification: TC-84A-7504 |
| A520S and A520CS: NIOSH Certification: TC-84A-7454 | ||
| E520S and E520CS: NIOSH Certification: TC-84A-7453 | ||
| Differential Pressure | NIOSH Certification (implied by N95 for breathability) | F550S and F550CS: NIOSH Certification: TC-84A-7504 |
| A520S and A520CS: NIOSH Certification: TC-84A-7454 | ||
| E520S and E520CS: NIOSH Certification: TC-84A-7453 | ||
| Cytotoxicity | (Conditions of the study, likely ISO 10993-5) | Pasture F550S, F550CS, A520S, A520CS, E520S, and E520CS were non-cytotoxic under the conditions of the study. |
| Irritation | (Conditions of the study, likely ISO 10993-10) | Pasture F550S, F550CS, A520S, A520CS, E520S, and E520CS were non-irritating under the conditions of the study. |
| Sensitization | (Conditions of the study, likely ISO 10993-10) | Pasture F550S, F550CS, A520S, A520CS, E520S, and E520CS were non-sensitizing under the conditions of the study. |
The following questions are not applicable to the provided document, as it concerns a physical medical device (N95 respirator) and not an AI/ML algorithm or software as a medical device (SaMD). The document does not describe a study involving readers, ground truth establishment by experts, or training/test sets in the context of an AI/ML device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a 510(k) premarket notification for physical N95 respirators, not an AI/ML device or its test set. Performance testing is typically conducted on a sample of manufactured devices according to established test methods for physical properties and biocompatibility. The specific sample sizes for each test (e.g., fluid resistance, flammability) are not detailed in this summary but would be specified in the full test reports referenced by the NIOSH certification and ASTM standards. The provenance of the data would be from the laboratories that performed these physical 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)
- Not Applicable. Ground truth in the context of expert consensus is relevant for diagnostic AI/ML algorithms. For N95 respirators, the "ground truth" is determined by physical and chemical test results against a defined standard (e.g., NIOSH standards, ASTM F1862). Expert qualifications would pertain to the technicians conducting these standardized tests, ensuring they follow protocols, not to clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML performance studies to resolve discrepancies in expert interpretations to establish a robust ground truth. For N95 respirators, performance is objectively measured by standardized tests, not by expert consensus on clinical findings.
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. MRMC studies are designed to assess the impact of AI assistance on human reader performance, typically in diagnostic imaging. This document does not pertain to an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This question relates to the performance of an AI algorithm in isolation. The product is a physical N95 respirator.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For physical devices like N95 respirators, the "ground truth" for performance is defined by adherence to established industry standards and regulatory requirements (e.g., NIOSH N95 certification, ASTM F1862 for fluid resistance, 16 CFR 1610 for flammability, ISO 10993 for biocompatibility). The tests objectively measure specific characteristics.
8. The sample size for the training set
- Not Applicable. Training sets are used for machine learning algorithms. This document describes a hardware device.
9. How the ground truth for the training set was established
- Not Applicable. As above, training sets are not relevant to this type of 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.