(178 days)
The K Series CPAP System, is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.
The K Series CPAP systems are used on adult patients for treatment of obstructive sleep apnea (OSA). The K Series CPAP Systems has 3 commercially available models, Curasa CPAP (K120285), Floton CPAP (K120285), and Curasa CPAP SD (K123897). This 510(k) application adds the Curasa CPAP EUT model to the currently commercially available selection of models. as well as the AutoManager PC Software accessory. The K series CPAP system provides a stable continuous positive airway pressure (CPAP). The humidifier, which works with all the K Series CPAP Systems, provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. Each K Series CPAP system also includes the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier. The Curasa CPAP EUT has the same electronic design and similar software as the Curasa CPAP SD, except for the addition of EUT (expiratory unload trigger) feature. The EUT feature detects patient exhalation phase and reduces output pressure. EUT feature has 3 levels of pressure reduction. The CPAP EUT also works with a special accessory PC software tool, AutoManager™ AutoManager™ is used by the service provider to analyze the patient's CPAP compliant data and, if needed, update the CPAP pressure setting via the CPAP's SD card. The AutoManager™ software collects/updates CPAP device data via an SD card. The AutoManager™ PC software is an independent accessory to the CPAP device and runs on a stand-alone PC and not on the CPAP device itself.
This document describes the Curasa CPAP EUT with AutoManager PC Software accessory, a device intended for the treatment of Obstructive Sleep Apnea. The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for a novel device. As such, many of the requested elements (like sample size for test set, number of experts, adjudication methods, MRMC studies, specific ground truth types for training, effect size with AI) are not directly applicable or available in the provided text, as this is a 510(k) submission primarily focused on demonstrating equivalence through standard compliance and comparative design.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of specific acceptance criteria with quantitative thresholds for performance metrics. Instead, it lists compliance with various standards and successful completion of design verification tests, all reporting "Pass." The "acceptance criteria" here are implicitly linked to meeting the requirements of these standards and completing the specified tests without failure, thus demonstrating substantial equivalence rather than a novel performance claim.
| Design Verification Test | Results (Acceptance Criteria) |
|---|---|
| System and User Interface Testing | Pass |
| ESD / EMC / EMI | Pass |
| IFU Validation Testing (patients) | Pass |
| Provider IFU Validation Testing | Pass |
| Software Verification Testing | Pass |
| AutoManager Software Verification Testing | Pass |
| AutoManager Software IFU & User Interface testing | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "IFU Validation Testing (patients)", indicating that some patient data was used. However, the specific sample size for this test or any other test set is not provided.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study described focuses on technical compliance and equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
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: No MRMC comparative effectiveness study was done or mentioned. This submission does not involve AI for diagnostic purposes or human reader assistance.
- Effect Size of AI Improvement: Not applicable, as this device does not incorporate AI for diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The "Software Verification Testing" and "AutoManager Software Verification Testing" represent standalone testing of the software components. However, this is for functional verification of the CPAP device and its accessory software, not for an algorithm-only diagnostic or AI performance evaluation. The device itself is "algorithm only" in its automated pressure adjustment, but its primary function is therapeutic, not diagnostic.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the type of ground truth used for performance evaluation, as it primarily relies on established engineering and safety standards. For the "IFU Validation Testing (patients)", the ground truth would likely be related to patient comprehension and ability to use the device as intended, potentially assessed through observation or questionnaires, but this is not detailed. For software testing, the ground truth would be the expected functional behavior based on design specifications.
8. The sample size for the training set:
Not applicable, as this device does not involve machine learning or AI models with a distinct "training set" in the context of this submission. The development process would involve iterative testing and refinement, but this is not a traditional AI training set.
9. How the ground truth for the training set was established:
Not applicable, for the same reasons as 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).