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The Stellar 150 is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb / 13kg 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 an uncuffed or deflated tracheostomy. 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. A microprocessor controlled blower generates the required airway pressure between 3-40 cm H2O. Comparing to previous ResMed devices, CPAP and Bi-level modes are implemented as in VPAP III ST-A / Kidsta mask system, which is indicated for patients above 40 lb (18 kg). With ongoing technological progress, the new device is further suitable to include a population above 30 lb (13 kg) for CPAP and Bilevel modes, which is comparable to Draeger Carina Home. The new device also includes a volume assured pressure support mode, indicated for patients above 66 lb (30 kg), which is substantially equivalent to Breas Vivo 40.

Here's a breakdown of the acceptance criteria and the study information for the Stellar 150 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of specific numerical acceptance criteria with corresponding performance data for the Stellar 150. Instead, it states that "All tests confirmed the predetermined acceptance criteria." The performance is described in terms of compliance with established standards and substantial equivalence to predicate devices.

• Complies with IEC 60601-1:1988 (and its amendments) and IEC 60601-1-2:2007.
• Complies with ISO 10651-6:2004.
• Complies with FDA guidance documents: "Draft Reviewer Guidance for Ventilators (July 1995)" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)". |
  | Risk Analysis Outcomes | - Design and Verification activities performed as a result of risk analysis.
• All tests confirmed predetermined acceptance criteria (implying risks were mitigated and performance met safety thresholds). |
  | Pressure Performance | - Performance testing comprises pressure performance.
• Microprocessor controlled blower generates required airway pressure between 3-40 cm H2O. |
  | Trigger and Cycling | - Performance testing comprises trigger and cycling. |
  | Volume Assured Pressure Support Ventilation | - Performance testing comprises volume assured pressure support ventilation. |
  | Substantial Equivalence | - Side-by-side testing demonstrated substantial equivalence to predicate devices (BREAS VIVO 40 SYSTEM, ResMed VPAP III ST-A/KIDSTA MASK SYSTEM, Draeger Carina Home) in terms of:
  • Same intended use
  • Same operating principle
  • Similar technologies
  • Same manufacturing process |
    | Indication Expansion (CPAP/Bi-level) | - New device further suitable for patients above 30 lb (13 kg) for CPAP and Bi-level modes, comparable to Draeger Carina Home. |
    | Indication (Volume Assured Pressure Support) | - New device includes a volume assured pressure support mode for patients above 66 lb (30 kg), substantially equivalent to Breas Vivo 40. |

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

The document does not specify a "test set" in the context of clinical data or a specific cohort of patients for testing. The performance data described refers to engineering verification and validation activities conducted on the device itself.

• Sample Size: Not applicable/not specified for a clinical test set. The testing refers to device units.
• Data Provenance: Not applicable/not specified in terms of patient data. The provenance is from internal design, verification, and validation activities.

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

This information is not provided in the document. The study described is not a clinical study involving expert ground truth for patient outcomes.

4. Adjudication Method for the Test Set

This information is not provided in the document, as it does not describe a clinical study requiring adjudication of patient cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No MRMC comparative effectiveness study is mentioned in the document. The study described focuses on technical performance and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a continuous ventilator, not explicitly an "algorithm" in the sense of an AI diagnostic tool. The performance described is inherent to the device's operation. Therefore, a standalone algorithm performance study is not directly applicable or described. The performance data reflects the device operating as intended without human intervention in its core functions (like pressure generation, trigger, and cycling).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Engineering Specifications and Design Requirements: The device was designed and tested against predetermined acceptance criteria derived from risk analysis and product design requirements.
• International Standards (ISO, IEC): Compliance with these standards serves as a benchmark for safety and performance.
• FDA Guidance Documents: Adherence to FDA guidelines is a form of regulatory "ground truth" for manufacturing and submission.
• Predicate Device Performance: Substantial equivalence claims are based on comparing the Stellar 150's performance and characteristics to those of legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The Stellar 150 is a hardware-based medical device with microprocessor control, not an AI/ML algorithm that requires a "training set" of data in the typical sense. Its control logic and parameters are developed through engineering design and testing, not statistical learning from a large dataset.

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

This question is not applicable for the reasons stated in point 8.

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The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments.

The Nasal-Aire II Pediatric is intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

The Nasal-Aire II Pediatric has been modified from the Nasal-Aire II to meet the requirements of the pediatric population and adults requiring smaller sizes to achieve the proper fit and comfort. The Nasal-Aire II Pediatric provides therapy through the nose only.

The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in hospital, clinic, or home environments.

For homecare applications, the Nasal-Aire II Pediatric may be reused multiple times by a single patient. For institutional applications (i.e. sleep lab, other clinical settings), the interface may be reused multiple times by multiple patients.

The Nasal-Aire II Pediatric interface has a soft nasal cannula to form a seal with the nasal openings. The nasal cannula has two nasal inserts and has integrated exhalation ports. The interface also has tubing, connectors to attach the tubing to the nasal cannula, and a swivel coupling that allows the interface to connect to the ventilation device. Headgear is attached to the device to secure the interface on the patient.

There are five nasal cannula sizes available, ranging from A (largest) to E (smallest).

The device is available by prescription only.

This document is a 510(k) summary for the Nasal-Aire II Pediatric device, which is an accessory to positive pressure ventilation devices. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, many of the requested items related to acceptance criteria and specific study details (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not present in the provided text for the Nasal-Aire II Pediatric device.

The document states that "functional testing relative to the intended use of the Nasal-Aire II Pediatric show that it is as safe and effective as the predicate devices." However, it does not detail what specific functional tests were performed, what the acceptance criteria for those tests were, or what the reported performance was.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot provide. The document does not specify quantitative acceptance criteria or report specific performance metrics for the Nasal-Aire II Pediatric. It broadly claims "functional testing" shows it is "as safe and effective as the predicate devices," but no details are given.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot provide. No information about a specific test set, its sample size, or data provenance is mentioned.

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)

• Cannot provide. No ground truth establishment for a test set is discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot provide. No information on adjudication methods is present.

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

• Cannot provide. This is a medical device (nasal cannula), not an AI/imaging device that would typically involve human readers or MRMC studies.

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

• Cannot provide. This device is a passive accessory and does not involve an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Cannot provide. No ground truth is discussed beyond the general assertion that functional testing supports safety and effectiveness.

8. The sample size for the training set

• Cannot provide. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Cannot provide. No training set or ground truth establishment for a training set is mentioned.

Summary of available information related to equivalence:

• Device Trade Name: Nasal-Aire II Pediatric
• Common/Usual Name: Accessory to Non-Continuous Ventilator
• Predicate Devices:
  • K060105: Kidsta Mask System (ResMed)
  • K022465: Nasal-Aire II (Innomed Technologies Inc. - likely the original version from which this pediatric version was modified)
  • K002001: Breeze Sleepgear with Nasal Pillows (Puritan Bennett Corp.)
  • K072993: Reusable Headrest® with Nasal Seal (AEIOMed, Inc.)
  • Unknown K number: Infant Nasal CPAP Set (Hudson RCI)
• Conclusion on Equivalence (from the submission): The Nasal-Aire II Pediatric device is substantially equivalent to the predicate devices in intended use, environment of use, patient population, and frequency of use. Its basic method of operation and design are also substantially equivalent to the predicates. Materials information and functional testing relative to the intended use of the Nasal-Aire II Pediatric show that it is as safe and effective as the predicate devices.
• Intended Use (as stated by FDA in the letter): The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments. Intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

This 510(k) summary focuses on demonstrating that the new pediatric version of the Nasal-Aire II maintains the same safety and effectiveness as already cleared predicate devices through design similarity and general functional testing, rather than presenting a performance study against specific, novel acceptance criteria.

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