(162 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® Isolite® Earloop Face Masks Blue, Pink .
- Crosstex® Isofluid® Earloop Face Masks -- Blue, Pink, White, Green .
- Crosstex® Isofluid FogFree® Earloop Face Masks Blue, Peach .
- Crosstex® Isofluid FogFree® Face Masks with Splash Visor Blue, Peach ●
- Crosstex® Procedural Earloop Face Masks Blue, Pink, Yellow ●
- Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks Blue ●
- Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor -. Blue
The seven (7) Crosstex® Surgical Masks are constructed of either an inner/outer facing of medical grade tissue or 100% spunbonded polypropylene, a 100% facing of mediour grade tiesas of Tea, with white elastic loops and/or a fogfree strip. monown performs most (7) Crosstex® Surgical Masks is 27 gauge aluminum wire, some have an anti-fog strip, with the Crosstex® Ultra Fluid Resistant No Fog® having a vapor barrier. All of the materials used in the construction of the Crosstex® Surgical Masks are being used in currently marketed devices (see predicate information).
The provided text describes the submission for 510(k) premarket notification for Crosstex® Surgical Masks. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.
Here's an analysis of the provided information concerning acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document states: "It was our conclusion that Performance Testing met all relevant requirements of the aforementioned test standards." This indicates that the Crosstex® Surgical Masks met the acceptance criteria for each test. However, the specific quantitative acceptance criteria and the exact reported performance values are not provided in the document.
The "aforementioned test standards" refer to the non-clinical tests performed:
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| a. Fluid Resistance (Liquid (Water) Resistance Test/Impact Penetration Test) | (Not specified in document, but implied to be regulatory standards for fluid resistance in surgical masks) | Met all relevant requirements |
| b. Bacterial Filtration Efficiency (BFE) / Differential Pressure (ΔP) Tests | (Not specified in document, but implied to be regulatory standards for BFE and ΔP in surgical masks) | Met all relevant requirements |
| c. Flammability Testing | (Not specified in document, but implied to be regulatory standards for flammability in medical devices) | Met all relevant requirements |
| d. Latex Particle Challenge Test | (Not specified in document, but implied to be regulatory standards for particle filtration in surgical masks) | Met all relevant requirements |
| e. Biocompatibility Testing Per ISO 10993 | (Not specified in document, but implied to be the standards outlined in ISO 10993 for biocompatibility) | Met all relevant requirements |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the non-clinical tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. Given that these are non-clinical (bench) tests, the concept of "prospective" or "retrospective" data provenance for patient data doesn't directly apply. The data would have been generated in a laboratory setting.
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)
This information is not applicable and therefore not provided. The document describes non-clinical laboratory tests (e.g., fluid resistance, filtration efficiency, flammability, biocompatibility) of a physical device (surgical masks). These tests do not involve expert interpretation or establishment of ground truth in the way a diagnostic imaging study would. The 'ground truth' for these tests is based on the objective measurements against established test standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments. The non-clinical tests described are objective laboratory measurements, not subject to adjudication by experts.
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
There was no MRMC comparative effectiveness study done. The device is a surgical mask, and the evaluation involved non-clinical performance testing against established standards, not a comparison of human reader performance with or without AI assistance. This type of study is entirely irrelevant to the device under review.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A "standalone" performance evaluation in the context of AI refers to the algorithm's performance without human intervention. This concept is not applicable here as the device is a physical surgical mask, not an AI algorithm. The performance tests were conducted on the masks themselves, which is analogous to a "standalone" evaluation of the physical product's capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests described is the objective measurement against the specified test standards and methodologies. For example:
- Fluid Resistance: Ground truth would be the measurable resistance to fluid penetration as defined by the Liquid (Water) Resistance Test/Impact Penetration Test standard.
- Bacterial Filtration Efficiency (BFE): Ground truth would be the measurable percentage of bacteria filtered out, according to the BFE test standard.
- Flammability: Ground truth would be the measurable flammability characteristics as defined by the flammability test standard.
- Biocompatibility: Ground truth would be the biological response (or lack thereof) observed in accordance with ISO 10993 guidelines.
It is not expert consensus, pathology, or outcomes data, as these are clinical forms of ground truth.
8. The sample size for the training set
This information is not applicable and therefore not provided. The device is a physical medical product (surgical mask), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided, as there is no training set for a physical surgical mask.
§ 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.