(29 days)
The REMstar SE delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.
The REMstar SE is a microprocessor controlled blower based positive pressure system which is comprised of the therapy device, a heated humidifier and patient tubing (15mm, 22mm, or heated tubing).
The REMstar SE includes a CPAP mode only. While in CPAP mode, the device delivers a continuous positive airway pressure throughout the entire therapy session.
In addition to the CPAP therapy mode, the REMstar SE incorporates several optional features to aid with patient comfort. These features include ramp, adjustable pressure relief (FLEX technologies), and humidification. Humidification options include both a heated humidifier and heated tubing. The heated humidifier adjusts the level of humidification by varying the temperature of a heated plate used to heat up a chamber of water. Optional heated tubing can then be used to maintain that air at a desired temperature until it reaches the patient's mask.
The REMstar SE is intended for use with a patient circuit that connects the device to a patient interface device (mask). A typical patient circuit consists of patient tubing (15mm, or heated tubing) and an exhalation device (if one is not present in the mask). When a heated humidifier is attached to the therapy device, the patient circuit connects to the air outlet port of the heated humidifier.
The provided text describes modifications to an existing CPAP system (REMstar SE) and confirms its substantial equivalence to predicate devices. It does not present a study with detailed acceptance criteria and reported device performance in the format requested, nor does it provide information relevant to AI/ML device studies.
The document states that "Design verification tests were performed on the REMstar SE as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." However, it does not enumerate these criteria or provide specific performance metrics in a table. It also explicitly states, "Clinical tests were not required to demonstrate the safety and effectiveness of the REMstar SE. Product functionality has been adequately assessed by non-clinical tests." This indicates that the device's performance was evaluated through non-clinical or bench tests rather than studies involving human subjects or complex data analysis as typically seen with AI/ML devices.
Therefore, most of the requested information cannot be extracted from the given text.
Here is what can be inferred or explicitly stated from the document, with limitations highlighted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Flex performance | Verified to meet product specifications for each level of control. |
| Pressure stability | Verified across all environmental conditions including altitude, temperature, and humidity. |
| Humidifier performance | Verified to meet product specifications for humidity output. |
| Standards compliance | Designed to meet requirements of ISO 14971, ISO 10993-1, IEC 60601-1, IEC 62304, ISO 5356-1. |
| General safety & effectiveness | Modifications have no impact on safety and effectiveness; device is substantially equivalent to predicate devices. |
Limitations: The text does not provide quantitative acceptance criteria (e.g., "Pressure stability within X mmHg") or specific numerical performance results. It only states that specifications were met.
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 applicable/Not provided. The text mentions "design verification tests" and "non-clinical tests" but does not specify sample sizes for these tests, as they are likely bench tests on the device hardware and software, not data points in a clinical study.
- Data Provenance: Not applicable/Not provided. No clinical data or patient data is mentioned as being used for testing.
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 in AI/ML performance evaluation (e.g., expert consensus on medical images or diagnoses) is not described. The "ground truth" here would be the physical and functional specifications of the device, verified through engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to resolving discrepancies in expert labeling for clinical studies, which were not performed.
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. This is a non-AI/ML device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a non-AI/ML device. Its function is to deliver positive airway pressure, not to interpret data or perform diagnostic tasks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is its designed product specifications and compliance with relevant industry standards (e.g., ISO, IEC). These are engineering and performance specifications.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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).