(88 days)
The Altor Safety 3-Ply Surgical Mask (Model:62222) is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 3-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.
The Altor Safety 3-Ply Surgical Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The mask outward facing layer is blue in color, using color master batch. The product model number of the subject device is : 62222. The ASTM Level of the subject device is ASTM Level 2. The subject device is manufactured with three layers: Outer Layer: Spunbond nonwoven polypropylene, Middle Layer: Melt Blown nonwoven polypropylene, Inner Layer: Spunbond nonwoven polypropylene. The subject device is provided non-sterile and is a single use, disposable device.
This document is a 510(k) premarket notification for a medical device (Altor Safety 3-Ply Surgical Mask). It is not a study proving a device meets acceptance criteria for an AI/ML-based medical device. Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device through physical and performance characteristics of a surgical mask, not a software algorithm.
Here's why the requested information cannot be extracted and why the prompt's assumptions do not apply to this document:
- Acceptance Criteria for AI/ML Device: The document does not describe acceptance criteria for an AI/ML device. It details performance criteria for a physical surgical mask (e.g., bacterial filtration efficiency, fluid resistance, breathability, flammability, biocompatibility).
- Study Proving Device Meets Acceptance Criteria: The "study" described is a series of bench tests and biocompatibility assessments on the surgical mask, comparing its performance to an existing predicate device based on established ASTM and ISO standards for surgical masks. It is not a study of an AI/ML algorithm's performance or its impact on human reader effectiveness.
- Sample Size for Test Set, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These concepts are relevant to the validation of AI/ML algorithms in medical imaging or diagnostics. They are entirely inapplicable to the regulatory submission for a physical surgical mask.
- Ground Truth: For a physical mask, "ground truth" refers to established physical properties and microbiological protection levels determined by standardized testing methods, not expert consensus on interpretations or pathology findings.
- Training Set: There is no "training set" for a physical device like a surgical mask. This concept applies to machine learning models.
In summary, the provided document is a 510(k) submission for a non-AI/ML medical device (a surgical mask). The specific questions in the prompt are designed for the evaluation of AI/ML-based medical devices, which are entirely different in nature and regulatory assessment.
§ 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.