(172 days)
The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 4-12) to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.
The Kimberly-Clark Pediatric/ Child Facemask is a three layer mask, constructed of nonwoven polyester blends and polypropylene materials. Bindings are nonwoven polyester and earloops are knitted polyester/lycra. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. The Pediatric/ Child Facemask is appropriately sized to the smaller faces of children across a diverse population. The Pediatric/ Child Facemask is a single use, disposable device, provided non-sterile.
This K113340 submission is for a Kimberly-Clark Pediatric/Child Facemask, which is a physical device, not an AI/ML powered device. Therefore, many of the requested elements for describing an AI/ML study (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size and ground truth establishment) are not applicable.
However, I can provide information based on the provided text regarding the acceptance criteria and study that proves the device meets the acceptance criteria for this specific medical device submission, focusing on the material characteristics and performance relevant to a face mask.
Here's the breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The device, a Kimberly-Clark Pediatric/Child Facemask, was tested against various standards. The summary states that "All results of testing met acceptance criteria." Specific numerical acceptance criteria are not detailed in the provided text, but the standards themselves imply the criteria.
| Acceptance Criteria (Implied by Standard) | Reported Device Performance (as stated in the summary) |
|---|---|
| Mil-M369454C (Military Specifications: Surgical Mask, disposable 1992) - Specific criteria not detailed in the provided text. | Met acceptance criteria |
| PSC CS-191-53 (Flammability Test Method (16 CFR 1610) for Flammability of Clothing Textiles) - Specific criteria not detailed. | Met acceptance criteria |
| ASTM F 2299 (Standard Test Method for Evaluating the Initial Efficiency of Materials Used in Medical Masks to Penetration of Particulates Using Latex Spheres) - Specific efficiency thresholds not detailed. | Met acceptance criteria |
| ASTM 2101-07 (Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials. Using a Biological Aerosol of Staphylococcus aureus) - Specific BFE thresholds not detailed. | Met acceptance criteria |
| ISO 10993 (Standards for evaluating the biocompatibility of a medical device) - Specific biocompatibility assessment results not detailed. | Met acceptance criteria |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the sample size (e.g., number of masks, number of material swatches) used for each of the tests.
- Data Provenance: Not explicitly stated, but the tests were performed by Kimberly-Clark as part of their 510(k) submission. This is prospective testing conducted specifically for this regulatory submission. There is no information about country of origin for the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device subject to performance testing against established engineering and medical standards, not diagnostic or interpretive tasks requiring expert ground truth for a test set in the same sense as an AI/ML medical device. The "ground truth" would be the objective results of the validated test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human interpretation of data for ground truth establishment, not to objective physical product testing.
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 not an AI/ML device, nor does it involve human readers/interpreters.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for this device's performance is established by the results of standardized physical, chemical, and biological tests (e.g., flammability, particulate filtration efficiency, bacterial filtration efficiency, biocompatibility) against the pre-defined criteria within the referenced standards (Mil-M369454C, PSC CS-191-53, ASTM F 2299, ASTM 2101-07, ISO 10993).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.