(90 days)
Indicated Use -- Patient interface accessory for Respironics CPAP and BiPAP® Systems
Targeted Population -- Adult
Environment of Use -- Hospital and Home
Intended Use -- Adult Obstructive Sleep Apnea (OSA)
Intended to be used with devices such as Respironics CPAP Systems and BiPAP Systems producing positive pressures ≥ 3.0 cm H2O at the mask.
Intended Environment - Hospital: Adult OSA
Intended Environment - Home: Adult OSA
The Spectrum Reusable Full Face Mask is an externally placed mask covering the nose and mouth (full face) of a patient. It is intended to provide a seal so that positive pressure from a positive pressure source is directed to the patient's nose and mouth. It connects to a patient circuit that contains an exhalation valve, tubing, and perhaps a humidifier and/or bacteria fitter. It incorporates an Entrainment Valve which permits entrainment of ambient air when positive pressure to the patient ceases. The entrainment valve opens and closes based upon positive pressure being delivered to the patient. In addition, the mask incorporates a quick-release mechanism allowing the patient to quickly and easily remove the mask if desired. It is held in place with an adjustable headgear system. It is intended to be cleaned with soap and water. The cleaning process requires limited disassembly.
The Spectrum Reusable Full Face Mask may be used with an optional thin, pliable flap which may be used to improve the comfort and sealing of the basic unit. This accessory is referred to as the Comfort Flap. It is available either with the mask or sold seperately as a replacement part.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Spectrum Reusable Full Face Mask:
The provided text describes a "Non-Confidential Summary of Safety and Effectiveness" for a medical device. This type of document is generally submitted to regulatory bodies (like the FDA for a 510(k) in the US) to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly lay out a table of "acceptance criteria" paired with "reported device performance" in a typical quantitative sense that you might find for a software or an imaging device. Instead, it uses a comparison table to predicate devices and then summarizes performance statements.
- Acceptance Criteria (Implicit from Comparison to Predicate and Performance Standards): The acceptance criteria are largely implied by demonstrating equivalence to predicate devices and meeting specific design requirements and functional characteristics. The "Yes" in the table indicates that the Spectrum Reusable Full Face Mask meets the criteria established by the predicate devices or specified design requirements.
| Acceptance Criteria (Derived/Implied) | Reported Device Performance |
|---|---|
| Intended Use: | |
| Patient interface accessory for Respironics CPAP and BiPAP® Systems | Yes (Meets intended use with these systems) |
| Targeted Population: Adult Obstructive Sleep Apnea (OSA) | Yes |
| Used with devices producing positive pressures ≥ 3.0 cm H2O at the mask | Yes |
| Intended Environment: Hospital (Adult OSA) | Yes |
| Intended Environment: Home (Adult OSA) | Yes |
| Design Characteristics: | |
| Offered in various sizes | Yes |
| Intended for single patient multi-use | Yes |
| Made to be cleaned with soap and water | Yes |
| Provided non-sterile | Yes |
| Incorporates an Entrainment Valve | Yes |
| Adapts to headgear | Yes |
| Performance Standards/Specifications: | |
| Entrainment valve activation pressure of 3.0 cm H2O minimum | Yes |
| Meets design requirements after cleaning (reusability) | Yes (Confirmed by qualification tests) |
| Initial performance characteristics are met | Yes (Confirmed by qualification tests) |
| Environmental performance (shipping, storage, usage) is met | Yes (Confirmed by qualification tests) |
| Performance after environmental simulations is met | Yes (Confirmed by qualification tests) |
| Performance at extreme user conditions is met | Yes (Confirmed by qualification tests) |
| Performance of repeated disassembly of the Entrainment Valve is maintained | Yes (Confirmed by qualification tests) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "samples of the intended device" were used for qualification tests but does not specify the sample size (e.g., how many masks were tested).
- Data Provenance: The study was conducted by the manufacturer, Respironics, Inc. The document does not explicitly state the country of origin of the data, but since Respironics Inc. is based in Murrysville, PA, USA, and this is a summary for regulatory submission, it is highly likely the testing was conducted in the USA or under US regulatory guidelines. The study is prospective in the sense that new testing was performed on the device to demonstrate its performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This type of device (face mask) typically does not involve "experts" in the sense of medical image interpretation (e.g., radiologists) for performance testing. The "ground truth" or acceptance criteria are based on engineering specifications and functional testing.
- The document does not mention any external experts or their qualifications for establishing ground truth. The evaluation is based on internal testing against established design requirements and predicate device characteristics.
4. Adjudication Method for the Test Set:
- Given the nature of the device and testing (functional and engineering-based), an "adjudication method" like 2+1 or 3+1 typically used for subjective assessments or discrepancy resolution in clinical trials or image interpretation is not applicable and not mentioned in this document. The results are likely objective measurements or pass/fail criteria based on engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done.
- This document describes safety and effectiveness for a physical medical device (a face mask), not an AI or software algorithm that assists human readers in interpreting cases. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant and not addressed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device is a physical face mask, not an algorithm. Therefore, a standalone performance study in the context of an algorithm is not relevant. The performance described is the standalone performance of the physical device.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance is based on:
- Engineering specifications and design requirements of the device itself.
- Comparison to the functional characteristics of legally marketed predicate devices.
- Objective physical and environmental testing (e.g., pressure measurements, durability under cleaning, environmental simulations).
8. Sample Size for the Training Set:
- Not applicable. This document describes a physical medical device, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no machine learning model or training set, this question is not relevant.
§ 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).