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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.

• "Design and system verification testing in regards to mechanical and environmental testing according to IEC 60601-1-11:2010, electrical safety testing according to IEC 60601-1:2005, EMC testing according to IEC 60601-1-2:200, etc. was performed."
• "A regression analysis identified the features which were changed and which test cases needed to be repeated. End-to-end testing on the appropriate test cases has been performed."
• "The tests as well as the existing data from the K113640 submission, demonstrate that the Stellar 150 meets the predetermined acceptance criteria and is substantially equivalent to the predicate device (K113640)." |
  | Remote Alarm | Perform comparably to the Respironics Trilogy series Remote Alarm (K111610).
  Interoperate safely and effectively with the Stellar 150. | - "The Remote Alarm was compared to the Respironics Trilogy series Remote Alarm (K111610). The result of this comparison is that the Remote Alarm is substantially equivalent to the Trilogy Remote Alarm (K111610)."
• "The compatibility of Stellar 150 with the Remote Alarm was tested and confirmed."
• "In addition verification testing for the Remote Alarm was performed and demonstrated that it met the predetermined acceptance criteria." |

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.

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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 (K103167). For both devices as they are substantial equivalent, it is essential that a microprocessor controlled blower generates the required airway pressure. CPAP and Bi-level modes are implemented. With ongoing technological progress, the device is further suitable to include a population above 30 lbs (13 kg) for CPAP and Bilevel modes. The device also includes a volume assured pressure support mode (iVAPS), indicated for patients above 66 lbs (30 kg). The Stellar 150 in combination with the new developed ResMed Leak Valve supports the invasive use therapy. The ResMed Leak Valve incorporates a leak port as well as an integrated anti-asphyxia valve.

The provided document describes a 510(k) submission for the ResMed Stellar 150 ventilator, focusing on a change in the indication for use to include invasive therapy with a new ResMed Leak Valve. The submission asserts substantial equivalence to a previously cleared device (K103167).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• ISO 5356-1 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
• ASTM F 1246-91 Specification for Electrically Powered Home Care Ventilators, Part 1 - Positive-Pressure Ventilators and Ventilator Circuits |
  | System Verification (Stellar 150 + Leak Valve): | "System verification testing was performed as well as bench testing. The side-by-side testing demonstrated that there is no significant difference in delivering invasive therapy using the new ResMed Leak Valve (leak port with integrated anti-asphyxia valve) and therefore the Stellar 150 is Substantially Equivalent to the predicate device."
  "Performance and side-by-side testing demonstrated that there is no significant difference in [safety and effectiveness] between the ResMed Leak Valve and the new ResMed Leak Valve (leak port with integrated anti-asphyxia valve)." (likely a typo, intended to compare the new system to the predicate or non-invasive system) |

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

• Sample Size: Not explicitly stated. The document mentions "performance testing," "system verification testing," and "bench testing," but does not provide specific numbers of units tested, test runs, or patient data (as this appears to be a device performance and safety study, not a clinical trial with patient data).
• Data Provenance: Not explicitly stated. Given it's a submission for regulatory clearance of a medical device, the studies are typically conducted by the manufacturer (ResMed) in a controlled environment. The nature of the tests (bench and system verification) suggests laboratory-based testing rather than patient data from a specific country. This is retrospective in the sense that it relies on previously established performance for the core device and new testing for the new component.

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

• The document does not describe a ground truth established by human experts for a test set in the context of diagnostic accuracy. This submission is for a ventilator, and the performance criteria are based on engineering standards (ISO, ASTM) and functional comparisons, not expert interpretation of diagnostic output.

4. Adjudication Method for the Test Set

• Not applicable as there is no "test set" requiring expert adjudication in the context of diagnostic accuracy. The performance is assessed against engineering standards and functional equivalence.

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 is a regulatory submission for a continuous ventilator, not an AI-powered diagnostic tool. The concept of "human readers" and "AI assistance" is not relevant to this device.

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

• This is not an algorithm-only device. The device itself (ventilator) operates as a standalone unit in delivering therapy. The performance tests described (ISO, ASTM, bench testing) are standalone in the sense that they evaluate the device's functional attributes, not human interaction with an algorithm's output.

7. The Type of Ground Truth Used

• The "ground truth" for the performance evaluation of the new ResMed Leak Valve and the combined system is based on:
  • Engineering Standards: Compliance with ISO 5356-1 and ASTM F 1246-91.
  • Functional Equivalence: Demonstrated "no significant difference" in delivering invasive therapy when compared side-by-side to the predicate device/system.
  • Predetermined Acceptance Criteria: The core Stellar 150 device already met these from its prior clearance (K103167).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable, as there is no training set for this device.

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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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