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.

Device Description

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.

AI/ML Overview

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 < Tecnol FluidShield #47123-070 (Delta P = 4.2 at a face velocity of 20 ft/min and airflow of 62 lpm, compared to 5.0 for Tecnol). Also, 1818/1818FS < 1830/1830FS (Delta P = 2.4 vs 4.2).
Anti-Reflective Test	Anti-reflective coating reduces reflections on shield by > 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.

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.
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.
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.
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.
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.
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).
The sample size for the training set:
- Not applicable. This device does not use a "training set" in the context of machine learning.
How the ground truth for the training set was established:
- Not applicable. There is no training set for an AI algorithm.

Summary

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K965043

P. 1

510(k) Summary

MAR 1 0 1997

MANUFACTURER:

3M Health Care 3M Center St. Paul, MN 55144-1000

REGULATORY AFFAIRS CONTACT:

Karen C. Maass Regulatory Affairs Specialist 3M Medical Markets Group 3M Center, Bldg. 275-3E-08 St. Paul, MN 551441-1000

TELEPHONE: (612) 736-1031

DATE SUMMARY PREPARED:

October 9, 1996

DEVICE TRADE NAME: 3M 1830 Fluid Block Anti-Fog Tie-on Surgical Mask, 3M 1830FS Fluid Block Anti-Fog Tie-on Surgical Mask with Face Shield
COMMON OR USUAL NAME:

Surgical Mask

CLASSIFICATION: Surgical Apparel, Class II, 21 CFR 878.4040

3M 1818 Tie-on Surgical Mask and 3M 1818FS Tie-PREDICATE DEVICES: On Surgical Mask with Face Shield (K940707). Tecnol FluidShield(R) Surgical Masks (K913043).

DEVICE DESCRIPTION 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.
INTENDED USE: 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.

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SUBSTANTIAL EQUIVALENCE:

The 3M 1830/1830FS masks are the same product as the 3M Surgical Masks with Face Shield (K940707), with an additional "fluid block" layer to improve the masks fluid resistance. The following characteristics of the 3M 1830/1830FS mask indicate this device is substantially equivalent to the predicate devices listed above.

- Intended use
- Bacterial filtration efficiency
- Fluid resistance
- Anti-Fog coated face shield (1830FS only)
- Anti-fog strip incorporated in the mask design to reduce fogging of glasses
- Soft, non-irritating inner surface
- Flat, pleated, tie-on design
- Special fluid resistant layer
- Target population

TESTING SUMMARY:

Standard biocompatibility testing in animals and humans (including Cytotoxicity-Agar-Overlay, Primary Skin Irritation, Ocular Irritation, Human Draize Sensitization, and 21-Day Cumulative Irritation) on the product and/or its components indicate that the 1830/1830FS mask is non-irritating and hypoallergenic and safe for its intended use.

The following tests support the 1830/1830FS mask as acceptable for its intended use:

Mod. Greene & Vesley	>99% BFE
0.1 Micron Latex ParticleChallenge	>95% PFE
Fluid Resistance (Cup Test)	Resists a liquid volume> 65 ml for 120 hr.
Fluid Resistance (Nelson Test)	Resists liquid pressuresunder various conditions,i.e. 2cc synthetic blood at120 mm Hg (2.3 psi)/1.5inches/1 assault, and 2.3cc synthetic blood at 300mm Hg (5.8 psi)/18inches/5 assaults.

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K965043
p-3

TESTING SUMMARY (continued):

Differential Pressure (Delta P)

1818/1818FS < 1830/1830FS < Tecnol FluidShield #47123-070 at a face velocity of 20 ft/min. and airflow of 62 lpm. Delta P = 2.4, 4.2 and 5.0 respectively.

Anti-Reflective Test Anti-reflective coating reduces reflections on

shield by > 80%.

Regulation Number and Section

§ 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.