(29 days)
The Performax Total Face Mask is intended to provide an interface for application of CPAP or BiPAP therapy to patients. The mask is for multi-patient reuse on adult patients in the home or hospital/institutional environment.
The Respironics Performax Total Face Mask has the exact same design as the previously cleared Performax Total Face Mask (K072592). The Performax Mask consists of a polycarbonate faceplate with silicon cushion seal for the face. An integrated entrainment valve is provided for exhalation. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The function of the entrainment valve is unchanged from K992969. The mask when used with the integrated entrainment valve has two integrated exhalation features, which includes the one port on the faceplate and an exhalation site on the elbow. A separate exhalation device is not required for the integrated entrainment valve design. The mask faceplate contains headgear hooks upon which the premium headgear is attached. The mask is available in two sizes - small and large.
The Respironics Performax Total Face Mask is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases.
This document is a 510(k) summary for the "Respironics Performax Total Face Mask," which is a ventilator, non-continuous (respirator) under product code BZD. The submission is a "Special 510(k) Attachment 4" because it is a modification to add autoclaving as an approved method of disinfection.
Here's an analysis of the provided text, broken down by your requested categories:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the submission focuses on demonstrating substantial equivalence to a predicate device (Respironics Performax Total Face Mask, K072592) after a modification: the addition of autoclaving as an approved method of disinfection.
The text does not provide specific, quantifiable acceptance criteria (e.g., "airflow resistance shall not exceed X Pa/cm3/s") or detailed performance data (e.g., "after X autoclave cycles, the mask maintained Y seal integrity"). Instead, it states a high-level conclusion.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Maintain Safety and Effectiveness after Autoclaving (Implied) | "Based on the testing performed, the additional cleaning and disinfection method has no effect on the safety or effectiveness of the device." "The Performax Total Face Mask has the exact same design as the previously cleared Performax Total Face Mask (K072592)." (implies original performance maintained) |
| Continue to provide an interface for CPAP/BiPAP therapy (Implied) | The intended use remains the same: "The Performax Total Face Mask is intended to provide an interface for application of CPAP or BiPAP therapy to patients." |
| Retain multi-patient reuse capability (Implied) | The intended use remains the same: "The mask is for multi-patient reuse on adult patients in the home or hospital/institutional environment." |
| Maintain operating principle (Explicit Statement) | "Same operating principle." |
| Maintain technology (Explicit Statement) | "Same technology." |
| Maintain manufacturing process (Explicit Statement) | "Same manufacturing process." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any testing. It also does not mention the data provenance (country of origin, retrospective or prospective). The statement "Based on the testing performed" implies that testing was conducted, but details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The type of submission (a 510(k) for a physical device modification) typically relies on engineering and sterility testing rather than expert-derived ground truth based on interpretation of data like medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are primarily relevant to studies involving human interpretation (e.g., diagnostic image reading), where disagreements need to be resolved. This document, describing a physical device modification and its substantial equivalence determination, does not involve such adjudication methods.
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
An MRMC study is not applicable to this type of device modification. This submission is for a physical medical device (a mask) and its disinfection method, not an AI-powered diagnostic or assistive tool. Therefore, there is no mention of an MRMC study or any effect size related to human readers' improvement with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This submission is for a physical medical device. There is no algorithm involved, and therefore no standalone performance study in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device modification, the "ground truth" would be established through a combination of:
- Engineering testing: To confirm the mask's physical integrity, seal effectiveness, pressure performance, and material properties after autoclaving.
- Sterility/biocompatibility testing: To demonstrate that the autoclaving process effectively disinfects the device and that the materials remain biocompatible.
- Previous clearance data (K072592): The original performax mask (K072592) served as the "ground truth" for the baseline design, safety, and effectiveness. The current submission's "ground truth" is that the modified device's performance after autoclaving remains equivalent to this established baseline.
The document does not explicitly state these ground truth types but they are implied by the nature of the device and the submission (e.g., "no effect on the safety or effectiveness").
8. The sample size for the training set
This information is not applicable as there is no AI/machine learning model being trained in this submission.
9. How the ground truth for the training set was established
This information is not applicable as there is no AI/machine learning model being trained in this submission.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).