(279 days)
This product is indicated for infection control practices in the health care industry. When worn properly, The New Medical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
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This document is a 510(k) summary for "The New Medical Mask", comparing it to a predicate device, the TIDI Facemask (K092580). The study provided is a comparison of performance characteristics against a widely accepted standard (ASTM F 2100 - 07).
Here's an analysis of the provided information, focusing on acceptance criteria and the study that proves the device meets those criteria:
Description of Acceptance Criteria and the Study
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "The New Medical Mask" are defined by its ability to meet the requirements of ASTM F 2100 - 07, Standard Specification for Performance of Materials Used in Medical Face Mask. The reported performance of the device and its predicate (TIDI Facemask, K092580) are presented in the table below. The acceptance is based on achieving performance levels comparable to or exceeding those of the predicate device, thereby demonstrating substantial equivalence.
| Performance Characteristics | Acceptance Criteria (Predicate K092580 Performance) | The New Medical Mask Performance | Meets Criteria? |
|---|---|---|---|
| Bacterial Filtration Efficiency Performance (%) (ASTM F 2101) | >99.9% (High Barrier) | >99.9% (High Barrier) | Yes |
| Differential Pressure (Delta-P) (mm H2O/cm²) (MIL-M-36954C) | 3.4 mm H2O/cm² (Low Barrier) | 2.7 mm H2O/cm² (Low Barrier) | Yes (Better) |
| Sub-micron Particulate Filtration Efficiency at 0.1 micron Performance (%) (ASTM F 2299) | 99.6% (High Barrier) | 99.9% (High Barrier) | Yes (Better) |
| Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass results. (ASTM F 1862) | Pass at 80 mmHg | Pass at 160 mmHg | Yes (Better) |
| Flammability Class (16 CFR Part 1610) | Class 1 | Class 1 | Yes |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not specify the sample sizes used for each individual test (e.g., how many masks were tested for BFE, Delta-P, etc.). It only provides the performance results.
- Data Provenance: The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the provided text. However, since the device is being submitted for 510(k) clearance in the US, it implies the tests were conducted according to US-recognized standards (ASTM, MIL-M, CFR), likely by laboratories compliant with these standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to the "The New Medical Mask" submission. The ground truth for performance characteristics of a medical mask is established through standardized laboratory testing protocols (e.g., ASTM F 2101 for BFE, ASTM F 1862 for synthetic blood resistance), not through expert consensus or interpretation of medical images. The tests themselves provide objective numerical results.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies where human interpretation or clinical outcomes require consensus among experts. For objective lab tests of physical properties of a medical device like a mask, the test results are directly measured and do not require expert adjudication in this manner.
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
This information is not applicable. MRMC studies are typically performed for diagnostic devices (e.g., AI in radiology) where human readers interpret medical cases. "The New Medical Mask" is a physical barrier device, and its performance is evaluated through material property tests, not human interpretation of cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This question refers to the performance of artificial intelligence (AI) algorithms without human intervention. "The New Medical Mask" is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of "The New Medical Mask" is established through objective, standardized laboratory measurements against internationally recognized performance standards. Specifically:
- Bacterial Filtration Efficiency (BFE): Measured according to ASTM F 2101.
- Differential Pressure (Breathability): Measured according to MIL-M-36954C.
- Sub-micron Particulate Filtration Efficiency: Measured according to ASTM F 2299.
- Synthetic Blood Penetration Resistance: Measured according to ASTM F 1862.
- Flammability: Measured according to 16 CFR Part 1610.
These standards define the methodologies and acceptable limits for each characteristic.
8. The Sample Size for the Training Set
This information is not applicable. A "training set" is relevant for machine learning algorithms. This submission pertains to a physical medical device, and its development does not involve training data in the AI sense. The design and materials are chosen to meet the standards, and performance is verified through testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8. There is no training set or ground truth in the context of an AI algorithm 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.