(47 days)
The REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.
The REMstar Auto Continuous Positive Airway Pressure (CPAP) System is a microprocessorcontrolled, blower-based system that generates positive airway pressures from 4 to 20 cmH₂O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The previously cleared REMstar Auto has been modified to include a Split-Night with Auto-CPAP mode to simplify spilt night studies and to add a Non Responsive Apnea Hypopnea (NRAH) flag for clinical use. The basic functional and performance characteristics of the REMstar Auto CPAP System is unchanged from its device predicate (REMstar Auto CPAP System K012554).
The provided text describes a 510(k) summary for the Respironics REMstar Auto CPAP System (K031460). This submission focuses on modifications to an existing device and aims to demonstrate substantial equivalence to its predicates. The information required to fulfill the request, particularly regarding specific acceptance criteria, device performance, and details of a clinical study, is NOT present in the provided document.
The document states:
- "Design verification tests were performed on the REMstar Auto CPAP System in accordance with of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."
- "The basic functional and performance characteristics of the REMstar Auto CPAP System is unchanged from its device predicate (REMstar Auto CPAP System K012554)."
This indicates that internal design verification tests were conducted, but the specifics of what those acceptance criteria were and what the reported performance results were are not detailed. It also does not describe a clinical study in the format requested.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
Reasoning: The document states that "All tests were verified to meet the required acceptance criteria," but it does not list these criteria or the specific results. The focus of this 510(k) is on demonstrating substantial equivalence primarily through design modifications and compliance with standards, rather than presenting novel performance data from a clinical trial.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. (The document mentions "Design verification tests" but no specific clinical "test set" with patient data).
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a human-reviewed "ground truth" test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of a clinical "test set" requiring 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:
- MRMC Study Done: No. This document describes a CPAP device, not an AI-assisted diagnostic tool that would typically involve human readers.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not an AI algorithm. It's a medical device. The "standalone performance" refers to the device's functional and performance characteristics, which are stated to be "unchanged from its device predicate."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of typical AI device ground truth. For a CPAP device, performance is typically verified against engineering specifications, simulated physiological conditions, and potentially sleep lab data if new therapeutic efficacy claims were made (which they are not in this submission, as it's a modification to an already cleared device).
8. The sample size for the training set:
- Not applicable. This is not an AI/Machine Learning device that undergoes a "training set" process.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).