(56 days)
The following Prestige Ameritech Surgical Masks are single use disposable devices intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
Prestige Ameritech Earloop Surgical Mask-Blue, Pink, Green, White, Yellow, Peach Prestige Ameritech Earloop Surgical Mask with splash shield-Blue Green, White, Peach Prestige Ameritech Earloop Surgical Mask Tissue-Blue, Pink, White, Yellow Prestige Ameritech Tie on Surgical Mask-Blue, Pink, Green, White, Peach Prestige Ameritech Tie on Surgical Mask with splash shield-Blue, Green, White, Peach
The Prestige Ameritech Surgical Mask device is composed of three layers of material flat folded and pleated to form the Mask. The inner layer is composed of cellulose or spunbonded polypropylene, the middle layer is a meltblown polypropylene filter material and the outer layer is a medical grade tissue or spunbonded polypropylene. Masks with splash shields have anti-fog plastic shields attached to masks. Masks are held in place on wearer with tie strips or latex free elastic loops and contain a malleable aluminum nosepiece strip. All of the materials used in this device are typical materials commonly used in the construction of Surgical Face Masks and are being used in current legally marketed devices.
The provided 510(k) summary describes the Prestige Ameritech Face Mask, a surgical face mask. The acceptance criteria and device performance are based on bench testing of physical properties rather than clinical studies with human participants. Therefore, several of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information) are not applicable or cannot be extracted from this document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the results of the predicate devices, as the Prestige Ameritech device aims to demonstrate substantial equivalence by performing similarly or better.
| Performance Characteristics | Test Method | Predicate Device K022256 Results (Implied Acceptance) | Predicate Device K060776 Results (Implied Acceptance) | Prestige Ameritech Device Performance |
|---|---|---|---|---|
| Fluid Resistance | ASTM F1862 | No Visual Penetration (Implied: Fluid Resistant) | Fluid Resistant | Fluid Resistant |
| Particulate Filtration | ASTM F2299 | 2.0 microns (Implicit: Efficiency at 2.0 microns) | 96.8% at 0.1 microns | 98.5% at 0.1 Microns |
| Bacterial Filtration | ASTM F2101 | 97.9% | 99.9% | 99.6% |
| Differential Pressure | Mil M36954C | 1.8 | 2.34 | 2.6 |
| Flammability Class | 16CFR 1610 | 2 | 1 | 1 |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. These are bench tests, so sample sizes would refer to the number of mask samples tested for each characteristic.
- Data Provenance: The data is generated from laboratory bench testing (non-clinical tests) of the device and predicate devices. No information about the country of origin or whether it's retrospective or prospective is provided, but it's understood to be prospective testing for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for these performance characteristics is established through standardized laboratory test methods (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL M36954C, 16CFR 1610). Experts are involved in designing and executing these tests, but "ground truth" isn't established through expert consensus in the typical sense for medical imaging or diagnostic devices.
4. Adjudication method for the test set
Not applicable. This is not a study involving human interpretation or subjective assessments that would require 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 surgical mask, not an AI-powered diagnostic device, so MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a surgical mask, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is objective measurement against established industry standards and test methodologies. For example:
- Fluid Resistance: Visual observation of penetration after exposure to synthetic blood.
- Particulate Filtration Efficiency: Quantitative measurement of particle removal at a specific micron size.
- Bacterial Filtration Efficiency: Quantitative measurement of bacterial removal.
- Differential Pressure: Measurement of airflow resistance.
- Flammability: Classification based on burn rate.
8. The sample size for the training set
Not applicable. This is a physical device, and the submission does not describe a training set in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. No training set is described.
§ 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.