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510(k) Data Aggregation
(144 days)
PerforMax Pediatric EE Total Face Mask is intended to provide an interface for application of non-invasive positive airway pressure delivered to patients by a device such as a CPAP or bilevel system. The mask is for multi-patient use in the hospital / institutional environment only. The mask is to be used on patients 1 year or older (> 7 kg) for whom positive airway pressure therapy has been prescribed.
PerforMax Pediatric EE Total Face Mask is intended to provide an interface for application of non-invasive positive airway pressure delivered to patients by a device such as a CPAP or bi-level system. It provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose and mouth. It is held in place with an adjustable bonnet headgear. It may be cleaned by the professional in the hospital/institutional environment through a thermal high-level disinfection process or a chemical high-level disinfection process for multi-patient use.
The PerforMax Pediatric EE Total Face Mask consists of a faceplate with a bonded silicone seal for the face and an elbow with an integral entrainment valve. The mask features an interchangeable elbow hub which accepts an EE Leak 1 and EE Leak 2 elbow. The EE Leak 2 elbow includes built-in exhalation, an entrainment valve, a flexible tube, and a 22 mm connection. The EE Leak 1 elbow includes an entrainment valve and a 22 mm connection. The 22 mm elbow is used to conventional air delivery hose between the mask and the positive airway pressure source. The bonnet headgear is connected to the mask through slots in the upper part of the frame and clips that attach to the lower part of the frame. The mask is designed in such a way that it can be easily disassembled for disinfection or to replace several of the mask components, such as the headgear and elbow.
The provided document is a 510(k) summary for the PerforMax Pediatric EE Total Face Mask. It describes the device, its intended use, and compares its technological characteristics to predicate devices. It also outlines the non-clinical testing performed to demonstrate safety and efficacy.
However, this document does not contain information on "acceptance criteria" for a study in the context of device performance metrics (e.g., sensitivity, specificity, accuracy, etc.) nor does it describe a study that proves the device meets such criteria in the way typically associated with AI/software devices.
This submission is for a medical device (a face mask) and the "study" referred to is primarily bench testing to demonstrate performance and functionality under various conditions, particularly after cleaning and disinfection processes, and against established material safety standards.
Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and submission described in the input.
Here's an attempt to answer the questions based only on the provided text, flagging where information is not present or not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with specific numerical targets for performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly stated as meeting "performance specifications" and raising "no new issues of safety or effectiveness."
| Acceptance Criteria (Implicit from document) | Reported Device Performance |
|---|---|
| Meets performance specifications (e.g., inspiratory/expiratory resistance, mask leak, functionality pre and post disinfection) | "Results from this testing demonstrate that the PerforMax Pediatric EE Total Face Mask meets its performance specifications..." (Specific numerical results are not provided in this summary.) |
| Raises no new issues of safety or effectiveness | "...raises no new issues of safety or effectiveness..." (This is a conclusion drawn from the testing, not a direct measurement.) |
| Substantially equivalent to identified predicate devices | "...and is substantially equivalent to the identified device predicates." (This is the overarching conclusion of the 510(k) submission based on the comparisons and testing.) |
| Biocompatibility of patient-contacting materials | "All patient contacting or gas path materials used in the mask have been previously cleared by the FDA or evaluated in accordance with the guidance provided by ISO 10993-1." |
| High-level disinfection efficacy | Tested for high-level disinfection in accordance with AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), and FDA guidance. (The summary states it was tested, implying it met the criteria, but specific results are not detailed.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The testing described is "bench testing," meaning physical tests on the device itself, not on a human or animal population.
- Data provenance: Not applicable in the context of clinical data for this type of bench testing. The testing was performed pre and post institutional cleaning and disinfection treatments.
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)
Not applicable. Ground truth as typically understood for diagnostic algorithms (e.g., expert consensus on images) is not relevant for this physical device's bench testing. The "ground truth" would be the established engineering and safety standards/specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies, particularly for interpreting ambiguous findings or assessing reader agreement, which is not relevant for the bench testing of a medical mask.
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
No. An MRMC study is not mentioned and is not applicable to the evaluation of a non-AI medical mask. The document explicitly states: "Use of face masks with CPAP or bi-level therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the PerforMax Pediatric EE Total Face Mask, as was the case with the predicate devices."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an algorithm's performance. The device is a physical face mask, not an algorithm. Therefore, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device would be its ability to meet specified engineering performance metrics (e.g., mask leak, resistance) and material safety standards when subjected to various environmental and cleaning conditions. It is based on engineering specifications and established regulatory standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth established in that context.
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(125 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Unintentional leak | Completed and passed during extensive performance testing. |
| Pressure drop | Completed and passed during extensive performance testing. |
| CO2 rebreathing | Completed and passed during extensive performance testing. |
| Mask deadspace | Completed and passed during extensive performance testing. |
| Therapy device compatibility | Completed and passed during extensive performance testing. |
| Biocompatibility (new skin-contacting and air path-contacting materials) | Biocompatibility assessment completed in accordance with ISO 10993-1, including irritation, sensitization (ISO 10993-10), and cytotoxicity (ISO 10993-5) tests, and passed. |
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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