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The PerforMax Total Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. For multi-use in the hospital/institutional environment or single patient reuse in the home. The mask is to be used on patients 7 years or older (>40 lbs/18.2 kg) for whom CPAP or bi-level therapy has been prescribed.

The PerforMax Total Face Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. The small size mask is intended for use on patients 7 years or older (>40 lbs/20kg) and the large size mask is intended for use on patients (>66 lbs/30 kg) for whom CPAP or bilevel therapy has been prescribed.

The PerforMax Total Face Mask consists of a polycarbonate faceplate and a silicone cushion seal for the face. The PerforMax Total Face Mask can utilize a bronchoscopy elbow. This elbow will allow physicians to perform bronchoscopy procedures on a patient while the patient is receiving non-invasive ventilation. A pressure-pick off port is located on the elbow. A separate exhalation device is required when using the Respironics PerforMax Total Face Mask with bronchoscopy elbow because exhalation is not built into the mask. 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 therapy device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing and a method of venting exhaled gases.

This document describes a 510(k) submission for the Respironics PerforMax Total Face Mask. The submission focuses on a modification to an existing device, specifically the introduction of a bronchoscopy elbow, and asserts substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes used for each specific test (unintentional leak, pressure drop, CO2 rebreathing, mask deadspace, therapy device compatibility, biocompatibility). The testing described appears to be retrospective in the sense that it evaluates a modification to an existing device against established performance benchmarks for that device. The provenance of the data is internal testing conducted by Respironics, Inc. There is no indication of external data sources or specific countries of origin beyond the company's location.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The testing described focuses on engineering and biocompatibility benchmarks, not on clinical interpretation or expert consensus regarding performance.

4. Adjudication method for the test set:

This information is not applicable as the evaluation is based on objective performance metrics and compliance with engineering standards, rather than subjective expert adjudication.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical mask for CPAP/bi-level therapy, not an AI-assisted diagnostic tool or imaging system. Therefore, the concept of human readers improving with AI assistance is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

A standalone algorithm performance study was not done. This device is a physical medical mask, not an algorithm.

7. The type of ground truth used:

The ground truth used for this product is based on engineering performance specifications and biocompatibility standards. Specifically:

• For performance tests (leak, pressure drop, CO2 rebreathing, deadspace, compatibility), the ground truth is established by the pre-defined performance specifications for the device, consistent with the predicate device tests.
• For biocompatibility, the ground truth is established by international standards such as ISO 10993-1, ISO 10993-10, and ISO 10993-5.

8. The sample size for the training set:

There is no training set in the context of this device, as it is a physical medical device and not a machine learning model.

9. How the ground truth for the training set was established:

This question is not applicable as there is no training set for this device.

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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.

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.

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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 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 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. Similar to the device predicate, Total Face Mask, 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.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device (Respironics Performax Total Face Mask), and it primarily focuses on establishing substantial equivalence to a predicate device. It describes:

• Device identification and contact information.
• Substantial equivalence: Comparing the new mask to an older one (K992969) and listing design modifications.
• Intended use: Who the mask is for and what it does.
• Device description: Components and general characteristics.
• FDA correspondence: The FDA's letter of clearance.

The text does not contain any of the specific details requested in your prompt regarding acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement. These types of details would typically be found in a separate study report or a more detailed section of a 510(k) submission that is not included in this excerpt.

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