(367 days)
ALLURETM Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
ALLURE™ Surgical mask is valve less, consisting of 5 layers made up of breathable PP non-woven, hot air insulation cotton, two layers of melt blown fabrics, non-woven fabrics and plastic nose strips and Elastic cord. The device is designed and tested as per its device specific guidance; "Surgical Masks-Premarket Notification 510(k) Submissions".
The provided text describes the performance testing for the ALLURE™ Surgical Mask to demonstrate its substantial equivalence to a predicate device. This is not for an AI/ML powered device, therefore no AI-specific information like training data, expert consensus, or MRMC studies are present. The information pertains to the physical performance of the surgical mask based on established ASTM and ISO standards for medical face masks.
Here's an analysis of the provided information within the context of the requested questions, highlighting what is present and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
| Testing/Standards | Purpose of the Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F1862/F1862M-17 Resistance of Medical Face Mask to Penetration by Synthetic blood | To determine the splash resistance/Fluid Penetration- Resistance to blood | Allure Surgical mask should be resistant to Penetration by Synthetic blood | Pass. Allure face mask is resistant to Penetration by Synthetic blood |
| ASTM F2101-19 EN 14683: 2014 Bacterial Filtration Efficiency | To determine the filtration efficiency of Allure Surgical mask by comparing the bacterial control counts upstream of the Allure Surgical Mask to the bacterial counts downstream | Bacterial Filtration Efficiency should be >95.0% | Pass. Filtration Efficiency was found to be >95.0% |
| ASTM F2101-19 EN 14683: 2014 Determination of Breathability | To determine the Breathability test (Differential Pressure Pa.) | Level 1 95% | Pass. Allure face mask meets the requirement for Level 1 >95 |
| Biocompatibility | Testing/Standards | Result |
|---|---|---|
| Test for in vitro cytotoxicity: Elution method. | ISO 10993-5:2009(E) | Non-cytotoxic to Balb/c 3T3 cells. |
| Skin Sensitization Test in Guinea Pigs. (Guinea Pig Maximization Test) | ISO 10993-10:2010(E) | Non-sensitizer to Guinea Pigs. |
| Skin Irritation Test in New Zealand White Rabbits. | ISO 10993-10:2010(E) | Non-irritant to New Zealand White Rabbits. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "three non-consecutive lots" were used for performance testing. Specific numerical sample sizes for each test within these lots are not provided.
- Data Provenance: The document does not explicitly state the country of origin where the testing was performed, nor does it specify if the data was retrospective or prospective. It is implied that the testing was performed to meet international standards (ASTM, ISO, EN, CFR), suggesting generalized lab testing rather than clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This device is a physical product (surgical mask) and its performance is evaluated against material and barrier properties standards, not by expert interpretation of images or data. Therefore, there's no "ground truth" in the clinical sense established by human experts for a test set.
4. Adjudication Method for the Test Set:
- Not Applicable. As mentioned above, performance is measured against objective material standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. MRMC studies are relevant for evaluating diagnostic tools where human readers are involved. This is a physical product, not a diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is a physical surgical mask, not an algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is defined by the acceptance criteria specified in the referenced ASTM, ISO, and CFR standards for surgical masks. These standards define the physical and biological characteristics (e.g., filtration efficiency, fluid resistance, flammability, biocompatibility) that the mask must meet. The tests performed directly measure these properties.
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical product, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As no AI/ML model is involved, there is no training set or associated ground truth establishment.
§ 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.