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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.

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The 3B Luna CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated humidifier 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 Luna CPAP and Auto CPAP System is a microprocessor-controlled, blower-based system that generates positive airway pressure from 4 to 20 cm H20. The device is intended for use with a patient interface (mask). The device has been modified to include a color LCD, menu driven user interface, and a redesigned enclosure. The electrical circuit was redesigned to incorporate the color LCD. The basic functionality and performance characteristics of the Luna CPAP and Auto CPAP are unchanged from the predicate device RESmart CPAP and Auto CPAP (K132967).

This document is a 510(k) premarket notification for the 3B™ Luna CPAP and Auto-CPAP System, which includes an integrated heated humidifier. It compares the proposed device to a predicate device, the RESmart® CPAP and Auto-CPAP Systems (K132967). The main purpose of the notification is to demonstrate substantial equivalence to the predicate device, not necessarily to independently prove the device meets specific performance criteria beyond those of the predicate.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in the traditional sense of a new technology proving its efficacy against established benchmarks. Instead, it aims to demonstrate that the proposed device is substantially equivalent to a predicate device. Therefore, the "acceptance criteria" can be inferred as matching or performing similarly to the predicate device based on various technical specifications and non-clinical testing.

Device Performance Evidence Summary: The study essentially asserts that the proposed device performs equivalently to the predicate device. The performance data presented is a side-by-side comparison of specifications for both devices, highlighting that the proposed device shares the same intended use, operating principle, technology, materials, and manufacturing process as the predicate, or has comparable or slightly improved characteristics.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a premarket notification (510(k)) that relies heavily on bench testing and comparison to a predicate device, not clinical trials with human subjects.

• Test Set: No independent human subject test set is described. The "test set" consists of bench performance tests comparing the proposed device to the predicate.
• Sample Size: Not applicable in the context of human data. The sample size for non-clinical testing (e.g., number of devices tested for pressure accuracy) is not specified, but it's implied that sufficient units were tested to demonstrate performance.
• Data Provenance: The document does not provide information about the country of origin for any human data (as there isn't any mentioned). The testing itself is non-clinical, likely conducted by the manufacturer (BMC Medical CO., LTD, CHINA). The study is retrospective in the sense that it refers to the performance and testing of the predicate device (K132967) for many aspects, and current bench testing for the proposed device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission.

• Ground Truth: The "ground truth" for this submission is established through engineering and performance specifications and compliance with international standards (e.g., ISO, IEC), rather than expert consensus on medical outcomes or pathology.
• Experts: The document does not describe the involvement of medical experts to establish a "ground truth" for a test set. Engineering and regulatory specialists would be involved in designing and evaluating the bench tests.

4. Adjudication Method for the Test Set

This is not applicable. There is no "test set" in the sense of a set of cases requiring adjudication by multiple experts. The evaluation is based on objective measurements from bench testing against predefined engineering specifications.

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, an MRMC comparative effectiveness study was not done. This device is a CPAP/Auto-CPAP system for delivering positive pressure, not an AI-assisted diagnostic or interpretative tool that would involve human "readers" or AI assistance in a clinical setting.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is not an algorithm that functions in a standalone diagnostic capacity. It is a medical device for therapeutic delivery of positive pressure.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used for this submission is based on:

• Engineering Specifications and Performance Standards: Defined by international standards (ISO 17510-1:2007, IEC 60601 series) and the specifications of the predicate device.
• Performance Bench Testing: Objective measurements conducted in a laboratory setting to verify that the device meets its design specifications (e.g., pressure accuracy, sound level, humidification, electrical safety).
• Biocompatibility Testing: Conducted in the predicate device against ISO 10993 standards, and carried over due to identical materials.

8. The Sample Size for the Training Set

This is not applicable. The device is not based on machine learning or AI that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for this device.

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