(65 days)
The AUTOSET SPIRIT self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The AUTOSET SPIRIT self-adjusting sleep apnea system has two treatment-modes (auto-titrating and fixed-pressure CPAP).
The optional integrated humidifier (HUMIDAIRE 2i) is indicated for the humidification and warming of air from the AUTOSET SPIRIT flow generator device. The AUTOSET SPIRIT self-adjusting sleep apnea System and HUMIDAIRE 2i are for home and hospital use.
The AutoSet Spirit (K013843) CPAP System is a microprocessor controlled blower-based system that self-adjusts the pressure from 4-20 cmH O as required to maintain an "air splint" for effective treatment of Obstructive Sleep Apnea (OSA) in adult patients. The system includes the flow generator, patient tubing, integrated humidifier and a mask (patient interface).
The provided text describes a 510(k) premarket notification for a medical device called the AutoSet® Spirit™ System. This submission is for an updated indication for use, not for a new device or significant performance claims requiring extensive new studies.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and comparative effectiveness studies is largely not applicable in the context of this specific submission.
Here's an explanation based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This 510(k) submission is for a modification to the "Indication for Use" statement, not for a change that would require new performance acceptance criteria or a new performance study. The device itself (AutoSet Spirit CPAP System) was previously cleared (K013843), and its performance would have been established at that time. The current submission explicitly states: "The only changes that were made relate to revised wording for the Indications for Use. Therefore, design Verification and Validation were not performed on the AutoSet Spirit System as there are no engineering changes required to the device."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No new test set data was generated for this specific submission because there were no engineering changes to the device or new performance claims.
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. As no new performance testing was conducted, there was no test set requiring ground truth establishment by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set, no adjudication method for this submission.
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
- Not Applicable. The AutoSet® Spirit™ System is a CPAP system, a therapeutic device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. The AutoSet® Spirit™ System is a self-adjusting CPAP device; it is not an algorithm that operates in a standalone diagnostic or analytical capacity. Its "self-adjusting" capability refers to the mechanical adjustment of pressure, not an AI algorithm analyzing data for diagnostic purposes.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. As no new performance studies were conducted, no new ground truth was established for this submission.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that would require a "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/machine learning device that would require a "training set" or its associated ground truth establishment.
In summary: The provided document is a 510(k) for a minor modification (rephrasing of the Indication for Use) of an already cleared device. This type of submission does not typically involve new clinical studies or performance data, hence most of the requested information is not relevant to this specific regulatory filing. The "study" here is essentially the internal review by the manufacturer to confirm that a wording change does not alter the fundamental safety or effectiveness of the device, and the FDA's review of this assessment for substantial equivalence.
§ 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).