Search Results

The device is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb / 13 kg and above) with respiratory insufficiency or respiratory failure, with or without obstructive sleep apnea. The device is for non-invasive use, or invasive use (with the use of the ResMed Leak Valve). Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.

The Stellar 150 is a pressure controlled ventilator using a single limb vented circuit, product code MNT, and is substantially equivalent to the already marketed Stellar 150 device (K113640). The device contains a microprocessor controlled blower that generates the required airway pressure. CPAP and Bi-level modes are implemented and the device is suitable for patients weighing above 30 lbs (13 kg) for CPAP and Bi-level modes. The device also includes a volume assured pressure support mode (iVAPS), indicated for patients above 66 lbs (30 kg).

This submission updates the Stellar 150 to include a new Remote Alarm (optional) accessory. The Remote Alarm generates an audible and visual signal when an alarm is triggered on the ventilator. For the connection of this new Remote Alarm, the Stellar 150 requires an additional connector on the back of the device as well as electronics and software support for this additional port. This new Remote Alarm triggers this 510[k].

This is a 510(k) premarket notification for a minor modification (addition of a remote alarm accessory) to an existing medical device, the Stellar 150 ventilator. The submission primarily relies on demonstrating substantial equivalence to predicate devices rather than conducting extensive new clinical studies to establish novel performance metrics. As a result, many of the requested elements for a study proving device acceptance criteria in a typical AI/diagnostic device context are not directly applicable or explicitly detailed in this document.

However, I can extract and infer information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For the Stellar 150 ventilator itself, the acceptance criteria are implicitly that it performs as well as the prior cleared Stellar 150 (K113640) and meets applicable standards. For the new Remote Alarm accessory and its integration, the acceptance criteria are implicitly that it performs as well as the predicate Respironics Trilogy series Remote Alarm (K111610) and functions correctly with the Stellar 150. Specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are not presented as this is not a diagnostic device and the submission focuses on safety and performance equivalence.

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

The document does not specify a "sample size" in terms of patient data for a test set. This submission relies on engineering verification and validation testing (e.g., mechanical, electrical safety, EMC, software regression testing) rather than a clinical study with patient data. Therefore, the concept of data provenance (country of origin, retrospective/prospective) related to patient data is not applicable here.

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

Not applicable. Ground truth in the context of this submission would refer to the expected performance of the device under various engineering tests, which is established by engineering specifications, regulatory standards (like IEC 60601-1), and comparison to predicate device performance, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human adjudication process for interpreting test results. Device performance is determined by meeting pre-defined engineering and regulatory standards during verification and validation testing.

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-assisted diagnostic or imaging device, and no MRMC study was performed.

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

The Stellar 150 is a medical device, not an algorithm in the AI sense. Performance testing was done on the device (and its new accessory) as a standalone system to ensure it met its specifications and regulatory standards. The "standalone" performance here refers to the device itself operating as intended, independent of direct interaction during the test, but it's not "algorithm-only" performance as one might see in AI/ML submissions.

7. The Type of Ground Truth Used

The "ground truth" for this type of submission is established through:

• Engineering specifications and design requirements: Derived from the predicate device and relevant standards.
• Regulatory standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11.
• Performance of the predicate devices: The Stellar 150 (K113640) for the main device and the Respironics Trilogy series Remote Alarm (K111610) for the new accessory.
• Functional tests: Ensuring the device and accessory perform their intended functions (e.g., alarm triggers correctly, connectivity works).

There is no mention of pathology, expert consensus on clinical cases, or outcomes data as the primary ground truth for this technical verification and validation.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable, as no training set was used.

Ask a specific question about this device