(89 days)
The Tasman is indicated for the treatment of obstructive sleep apnea (OSA) in adult patients weighing more than 66 lb (>30 Kg). The Tasman mask system delivers airflow noninvasively to a user from the integrated Continuous Positive Airway (CPAP) device. The Tasman is intended for single-patient re-use in the home environment and while travelling.
The Tasman is a portable CPAP device where the blower, mask and tubing are integrated and mounted to the headgear. The blower generates the required CPAP pressure to maintain an "air splint" for effective treatment of OSA.
The ResMed Tasman device is a noncontinuous ventilator (IPPB) intended for the treatment of obstructive sleep apnea (OSA) in adult patients. The acceptance criteria and the study performed to demonstrate its performance are described below based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the acceptance criteria in a general sense, stating that "All tests confirmed the product met the predetermined acceptance criteria." However, specific numerical targets for each criterion are not provided in the summary. The performance is reported in terms of meeting these criteria rather than providing specific measurements.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Pressure stability | Met predetermined acceptance criteria |
| Jitter | Met predetermined acceptance criteria |
| Swings (pressure fluctuations) | Met predetermined acceptance criteria |
| ISO 17510-1 pressure performance | Met predetermined acceptance criteria |
| Functional dead space | Met predetermined acceptance criteria |
| Safety and effectiveness | New device has not altered the safety and effectiveness of CPAP treatment for adult OSA patients. |
| Compliance with FDA guidance | Complies with FDA Draft Reviewer Guidance for Ventilators (July 1995) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set of the verification activities. It generally refers to "Design and Verification activities" and "All tests."
The data provenance is not specified. It is likely internal testing conducted by ResMed, but the country of origin of the data or whether it was retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for a test set. The verification activities seem to be based on engineering and performance tests against predetermined criteria and predicate devices, rather than expert-adjudicated clinical outcomes.
4. Adjudication Method for the Test Set
No adjudication method is described, as the verification appears to be based on objective performance measurements rather than subjective assessments requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned. This device is a hardware device (CPAP machine) and not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a hardware CPAP machine, not an algorithm or AI system. Its performance is inherent to its mechanical and electronic function, which is assessed standalone.
7. The Type of Ground Truth Used
The ground truth for the device's performance is based on established engineering and medical device standards (e.g., ISO 17510-1) and comparison against predicate devices. This represents an objective, regulatory-defined "ground truth" for technical performance and safety, rather than clinical outcomes or pathology.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning. The device is a traditional medical device, not an AI/ML-based algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this type of device.
§ 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).