(290 days)
The Luna® CPAP and Auto CPAP System are intended to deliver pressure for the treatment of Obstructive Sleep Apnea. The optional integrated hunidifier is indicated for the humidification and warming of air from the flow generator. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.
The materials of water chamber of Luna® CPAF and Auto CPAP device were changed. The suppliers of Polycarbonate and silicone were changed. The basic functional and performance characteristics of the Luna® CPAP and Auto CPAF devices are unchanged from the predicate devices (K141770).
This document (K153387) is a 510(k) premarket notification for a medical device (Luna® CPAP and Auto CPAP System) to the U.S. Food and Drug Administration (FDA). It is not a study report that describes the acceptance criteria and performance of an AI/ML device in the way requested. Instead, it is a submission seeking clearance to market a modified version of an existing device (K141770) based on demonstrating "substantial equivalence" to the predicate device.
Therefore, the specific information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/ML device is not present in this document.
The document primarily focuses on:
- Device Modification: The only modification is a change in the materials used for the water chamber of the Luna® CPAP and Auto CPAP system. The suppliers of Polycarbonate and silicone were changed.
- Demonstration of Substantial Equivalence: The submission asserts that the modified device is substantially equivalent to the predicate device (K141770) because it has the "same intended use, same operating principle, same technology, and same manufacturing process."
- Non-Clinical Testing for Material Change: To address the material change, biological and mechanical tests were conducted on the new materials and the water chamber.
Here's how the information provided in the document relates to your request, highlighting what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the AI/ML context. This document is about a material change in a CPAP device, not an AI/ML diagnostic or prognostic tool.
- What is shown: The document refers to "appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1" and "Series mechanical tests were also conducted to demonstrate the mechanical performance of the water chamber, including: drop test, leak test, and humidity performance test." The specific acceptance criteria for these tests (e.g., maximum allowable leakage, specific drop test pass/fail conditions) are not detailed in this summary, nor are the quantitative results of these tests, beyond a statement that they "demonstrated substantial equivalence."
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 in the AI/ML context. This is not an AI/ML study.
- What is shown: The document does not specify sample sizes (e.g., number of water chambers tested for biocompatibility or mechanical performance). It also does not mention data provenance in the context of clinical studies, as this is a non-clinical material change submission.
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 in the AI/ML context. There is no "ground truth" establishment in the sense of expert review of images or clinical data for this type of submission. The "ground truth" here is the biological and mechanical safety/performance of the new materials, assessed through standardized lab tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable in the AI/ML context. No adjudication method is described as there's no diagnostic or interpretative task involved.
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. This is not an AI/ML device, and no MRMC study was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- What is shown: The "ground truth" for this submission are the results of standardized biocompatibility tests (ISO 10993 series, including Genotoxicity, Cytotoxicity, Implantation, Sensitization, and Irritation tests, plus Intracutaneous Reactivity, Ames test, In vitro Mammalian Cell Gene Mutation Test, Skin Sensitization Mammalian Test, In vitro Chromosome Aberration In Vitro Cytotoxicity Test and Muscle Implantation Test) and mechanical performance tests (drop test, leak test, and humidity performance test). The acceptance is that the new materials and components pass these established safety and performance standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device where a training set is relevant.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
In summary, this document is a regulatory submission for a minor device modification (material change) of a CPAP system and does not contain the information typically found in an AI/ML device study report.
§ 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).