(335 days)
The iMask Child's Face Mask is intended to be worn by the patient/child (recommended ages 4-12) to provide protection for the respiratory tract. This is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.
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The provided text describes an FDA 510(k) clearance for a child's face mask. It does not contain information about acceptance criteria for a device that relies on performance metrics such as accuracy, sensitivity, or specificity. Therefore, I cannot generate the requested table and answer the study-related questions ([2] through [9]).
The document is a regulatory letter confirming that the "iMask Child's Face Mask" is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It does not include performance study data, details about a test set, expert involvement, or algorithm-specific information.
To elaborate, the product in question is a "Face Mask," which is a physical device (surgical apparel). The concept of acceptance criteria, test sets, ground truth, experts, and AI assistance, as outlined in your prompt, typically applies to diagnostic or AI-driven medical devices that output a result based on data processing (e.g., image analysis, signal processing). For a physical product like a mask, acceptance criteria would typically involve material safety, biocompatibility, filtration efficiency (for certain mask types), breathability, and fit, rather than algorithmic performance metrics.
§ 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.