(117 days)
ValuMax" Surgical Masks is 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 materials.
ValuMax" Surgical Masks are pleated 3-ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% meltblown polypropylene filter media. Ear-loops are made of soft latex free elastic loops. The nose piece for all ValuMax® Face Masks is malleable aluminum wire. Fog free masks have an anti-fog strip. Masks with splash visors have anti-fog treated plastic shield attached to masks. All of the material used in the construction of the ValuMax® Surgical Masks are being used in currently marketed devices (see predicate information).
The provided document describes the acceptance criteria and performance of ValuMax Surgical Masks. However, it does not include a study that proves the device meets the acceptance criteria in the way a typical AI healthcare device study would. Instead, it outlines non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
Here's the breakdown based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for each test. Instead, it concludes that "Performance Testing met all relevant requirements of the aforementioned test standards." The performance categories tested are:
| Acceptance Criteria Category | Reported Device Performance / Evaluation |
|---|---|
| Bacterial Filtration Efficiency (BFE) | Met all relevant requirements of test standards. |
| Pressure Differential (Delta P) | Met all relevant requirements of test standards. |
| Latex Particle Challenge (PFE) | Met all relevant requirements of test standards. |
| Flammability | Met all relevant requirements of test standards. |
| Biocompatibility (per ISO 10933) | Met all relevant requirements of test standards. |
| Fluid Resistant Synthetic Blood Penetration Resistant Test | Met all relevant requirements of test standards. |
Study Details (Based on the provided text)
Since this is for a physical medical device (surgical masks) and not an AI/software device, many of the requested categories (like sample size for test set, experts for ground truth, MRMC study, training set) are not applicable or not provided in the typical sense for an AI study. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable."
Here's what can be extracted:
- Sample size used for the test set and the data provenance: Not specified in the provided text, as the "tests" refer to non-clinical performance evaluations of the masks themselves, not a diagnostic algorithm. The provenance would be the manufacturing facility, Qing Dao Tong Hui Clothing Co., Ltd. in China, where the masks are produced and tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of tests (filtration efficiency, breathability, flammability, etc.) is established through standardized laboratory procedures and measurements, not expert consensus on medical images or diagnoses.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance tests are objective measurements based on established standards.
- 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 device is a physical surgical mask, not an AI diagnostic tool that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is based on the objective physical properties and performance characteristics of the mask as measured by standardized laboratory test methods (e.g., bacterial filtration rate, pressure differential, particle filtration, flammability).
- The sample size for the training set: Not applicable. There is no AI model or algorithm being trained for this device.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a 510(k) summary for a physical medical device (surgical masks). It establishes substantial equivalence to a predicate device based on non-clinical performance testing against established standards, rather than a clinical trial or AI model validation study. Therefore, many of the requested details specific to AI device studies are not present or not relevant.
§ 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.