(262 days)
The Prestige Ameritech Pediatric/Child Face Mask is intended to be worn by the patient/Child Facemask is a single use, disposable device, provided non-sterile. The Pediatric/Child Facemask is intended to be worn by the patient (ages 4-12) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions where transfer of microorganisms, body fluids, and particulates can occur.
The Prestige Ameritech Pediatric/Childs Face Mask is manufactured using ultrasonic bonding, composed of three layers of materials and pleated to form the mask. The inner layer is composed of nonwoven, the middle layer is meltblown polypropylene filter material, and the outer layer is cellulose. Decorative patterns are printed with colored inks. Masks are held in place on wearer with knitted polyester/spandex elastic earloop and contain a malleable aluminum nosepiece strip. The Pediatric/Child's Face Mask is appropriately sized to the smaller faces of children across a diverse population. The Pediatric/Child's Face Mask is a single use, disposable device, provided non-sterile with no shelf-life. Storage conditions will not affect device safety of effectiveness. All of the materials used in this device are typical materials commonly used in the construction of Surgical Masks and are being used in current legally marketed devices. This product is not made with natural rubber latex.
The provided text describes the acceptance criteria and performance of the Prestige Ameritech Pediatric/Child's Face Mask, comparing it to a predicate device. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Prestige Ameritech Pediatric/Child's Face Mask) |
|---|---|---|
| Particulate Filtration Efficiency at 0.1 microns, ASTM F2299 | 98.5% | 98% |
| Bacterial Filtration Efficiency (BFE), ASTM F2101 | 99.6% | 96.32% |
| Differential Pressure, Mil M36954C | 2.6 | 1.74 |
| Flammability Class, 16 CFR Part 1610 | Class I | Class I |
| Biocompatibility (MEM Elution, Repeated Patch Dermal Sensitization, ISO Primary Skin Irritation) | Tested under ISO 10993 Standard | Tested under ISO 10993 Standard |
| Anthropometry (adequate coverage for ages 4-12, 24-153 lbs, 3'3"-5'4") | Achieved by predicate | Achieved |
| Total Lead Content Analysis, CPSC-CH-E1002-08 | Met standard | Met acceptance criteria |
| Phthalate Analysis (DEHP, DBP, BBP, DINP, DIDP, DnOP, and DnHP), CPSC-CH-C1001-09.3 | Met standard | Met acceptance criteria |
| Migration of certain 19 elements, EN 71-3 | Met standard | Met acceptance criteria |
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 explicitly state the specific sample sizes for each test performed on the Prestige Ameritech Pediatric/Child's Face Mask. It mentions that the anthropometric study sample for determining fit was "representative of the current US population in both gender and racial distribution," implying a prospective study, but exact numbers are not given. The origin of the data is not specified beyond being generated for a U.S. FDA 510(k) submission.
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 document pertains to the performance testing of a physical medical device (a face mask) against established industry standards. There is no mention of "experts" in the context of establishing ground truth for a test set, as the evaluation relies on standardized laboratory testing methods rather than expert interpretation of data like in an AI/imaging study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The evaluation is based on objective laboratory test results against predefined standards, not on human interpretation requiring adjudication.
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
Not applicable. This is a review of a physical medical device (face mask) and does not involve AI or human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a review of a physical medical device (face mask) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on the results of standardized laboratory tests conducted according to recognized national and international standards (e.g., ASTM F2101, Mil M36954C, ISO 10993, CPSC, EN 71-3). These standards define the methodology and expected outcomes for measuring properties like filtration efficiency, breathability, flammability, and biocompatibility. For anthropometry, it's based on measurements against a "representative" population sample.
8. The sample size for the training set
Not applicable. There is no "training set" as this is a physical device evaluation, not an AI model.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" as this is a physical device evaluation, not an AI model.
§ 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.