(44 days)
The following Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
- Crosstex® Surgical Earloop Mask White ●
- Crosstex® Surgical Earloop No Fog Mask White .
- Crosstex® Surgical Earloop No Fog Mask with Splash Visor White .
The Crosstex Surgical Masks are constructed of a cellulose inner facing, a 100% spunbonded polypropylene white outer facing, a 100% meltblown polypropylene filter media, with white non-latex elastic loops. The nose piece for the Crosstex Surgical Masks is aluminum wire while the no fog strip (if applicable) is made of melt blow polypropylene.
This document describes a 510(k) summary for Crosstex Surgical Masks, focusing on non-clinical performance tests rather than an AI-powered diagnostic device. Therefore, many of the requested categories related to AI studies, ground truth, and expert adjudication are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Fluid Resistance (Synthetic Blood Penetration Test) | Meet relevant requirements of test standards | Met all relevant requirements |
| Bacterial Filtration Efficiency (BFE) / Differential Pressure (△P) Tests | Meet relevant requirements of test standards | Met all relevant requirements |
| Flammability Testing | Meet relevant requirements of test standards | Met all relevant requirements |
| Latex Particle Challenge Test | Meet relevant requirements of test standards | Met all relevant requirements |
| Biocompatibility Testing (Per ISO 10993) | Meet relevant requirements of ISO 10993 | Met all relevant requirements |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as the study involves functional testing of a physical medical device (surgical masks), not an AI algorithm processing data. No "test set" in the context of data for an AI model is used. The testing would be performed on samples of the manufactured masks.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. "Ground truth" in the context of AI models refers to definitively labeled data. For performance testing of a physical device like a mask, the "ground truth" is established by adherence to standardized testing protocols and measurements, not expert consensus on data points. The laboratories conducting these tests are assumed to be accredited and their personnel qualified to perform the specific tests.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in AI studies where multiple human readers interpret data to establish a consensus ground truth. For device performance testing, the results are typically quantitative measurements comparing against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for comparing the diagnostic performance of human readers with and without AI assistance, which is outside the scope of this device (surgical masks).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable. The device is a surgical mask, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by objective measurements against recognized industry standards and test methods. For example, the Bacterial Filtration Efficiency (BFE) test produces a quantitative percentage that is compared to an accepted threshold. This is distinct from expert consensus, pathology, or outcomes data which are typically used for diagnostic devices.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. 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.