(32 days)
The ClearMask Transparent Surgical Face Mask is intended for use in healthcare settings, such as in operating rooms, or in other medical procedures such as dental, isolation and veterinary procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device allows for full view of the face and facial expressions, particularly the nose and mouth areas.
The device is indicated for over-the-counter use. The device is disposable and is indicated for single use. The device is not provided sterile.
Not Found
This document is an FDA clearance letter for the ClearMask Transparent Surgical Face Mask (K200576). It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA did not require the manufacturer to conduct new clinical trials to demonstrate safety and effectiveness for this type of device. Substantial equivalence is often established by showing that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
Therefore, I cannot provide the requested information because the provided text does not describe:
- Acceptance criteria and reported device performance: This information would typically be found in a performance study report, which is not part of this clearance letter.
- Sample size for test set and data provenance: No test set is described.
- Number of experts used to establish ground truth and qualifications: Ground truth establishment is not discussed.
- Adjudication method: Not applicable as no test set or ground truth establishment is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
- Standalone performance study: No such study is mentioned.
- Type of ground truth used: Not applicable as no ground truth is established.
- Sample size for the training set: Not applicable as a training set for an AI/algorithm is not discussed.
- How ground truth for the training set was established: Not applicable.
The document is a regulatory approval notice, not a scientific study report.
§ 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.