(83 days)
The product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms. In addition, the device is intended to reduce potential exposure of the wearer to blood and body fluids.
The 1830/1830FS is a flat, pleated, tie-on mask consisting of inner and outer cover webs with two different filter webs sandwiched in between. It covers the nose and mouth of the wearer, and is held in place by tie strings and a malleable plastic coated wire nose piece.
The provided text describes testing conducted for a surgical mask (3M 1830/1830FS) for 510(k) clearance, intending to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" and "device performance" in this context refer to the performance standards met by the new device during testing, rather than a clinical study of AI performance.
Here's the information extracted and formatted:
Acceptance Criteria and Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Bacterial Filtration Efficiency (BFE) (Mod. Greene & Vesley) | > 99% BFE |
| Particulate Filtration Efficiency (PFE) (0.1 Micron Latex Particle Challenge) | > 95% PFE |
| Fluid Resistance (Cup Test) | Resists a liquid volume > 65 ml for 120 hr. |
| Fluid Resistance (Nelson Test) | Resists liquid pressures under various conditions, i.e., 2cc synthetic blood at 120 mm Hg (2.3 psi)/1.5 inches/1 assault, and 2.3 cc synthetic blood at 300 mm Hg (5.8 psi)/18 inches/5 assaults. |
| Differential Pressure (Delta P) | 1830/1830FS 80%. |
| Biocompatibility (Cytotoxicity-Agar-Overlay, Primary Skin Irritation, Ocular Irritation, Human Draize Sensitization, and 21-Day Cumulative Irritation) | Non-irritating and hypoallergenic, safe for intended use. |
Study Details (as applicable to a medical device clearance, not AI)
Given that this document is for a 510(k) clearance of a surgical mask from 1997, it does not involve AI, diagnostic algorithms, or clinical studies of human readers using AI. Therefore, many of the requested points are not applicable.
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Sample size used for the test set and the data provenance:
- The document does not specify the sample sizes for the individual performance tests (e.g., number of masks tested for BFE, PFE, or fluid resistance).
- The data provenance is not explicitly stated beyond being part of a 3M product submission in the United States (K965043). The tests are standard industry tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical device performance study, not a study requiring expert consensus for ground truth on medical images or diagnoses.
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Adjudication method for the test set:
- Not applicable. This type of performance testing for a physical device does not typically involve expert adjudication in the same way clinical studies with human assessors do.
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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 submission is for a surgical mask, not an AI-powered diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No algorithm is involved. The performance tests are for the physical properties of the mask.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for these tests is defined by the standardized methodologies of the tests themselves (e.g., measuring filtration efficiency using specified particle challenges, or fluid resistance under controlled pressure).
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The sample size for the training set:
- Not applicable. This device does not use a "training set" in the context of machine learning.
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How the ground truth for the training set was established:
- Not applicable. There is no training set for an AI algorithm.
§ 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.