(178 days)
The S9 Greenhills is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep annea (OSA), central and/or mixed apneas, or periodic breathing.
It is intended for home and hospital use.
The hunidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.
The S9 Greenhills is similar to the predicate device(s), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is identical to the S9 VPAP Adapt (K113801) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmH2O. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
The S9 Greenhills is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV mode) or (ASVAuto mode) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average minute ventilation. It then adjusts the degree of pressure support to servo-control the patilation to at least equal the target ventilation. The same is true for ASVAuto mode except the EPAP is adjusted to address any obstructive apneas detected.
Therapy modes contained in the S9 Greenhills are CPAP, ASV, and ASVAuto and unchanged from the S9 VPAP Adapt (K102586). They are:
- . CPAP mode - the device delivers a continuous positive airway pressure throughout the entire therapy session;
- ASV mode the device automatically adjusts pressure support in response to the . patient's recent average minute ventilation; and
- ASVAuto mode the device automatically adjusts pressure support in response to . the patient's recent average minute ventilation and EPAP level for OSA events.
The functional characteristics of the S9 Greenhills system includes all the clinician and user friendly features of the predicate device which have been verified during usability studies in accordance with IEC 62366 Medical devices - Application of usability engineering to medical devices.
The provided 510(k) summary for the ResMed S9 Greenhills device describes its acceptance criteria and the study conducted to demonstrate its performance. However, it's important to note that this submission focuses on demonstrating substantial equivalence to a predicate device, not on proving overall clinical effectiveness from scratch. Therefore, the "study" is primarily comparative bench testing, and some of the requested information (like human reader performance with/without AI assistance, or expert consensus for ground truth on a large test set) is not applicable or not provided in this type of submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide a direct table of specific numerical acceptance criteria with corresponding performance metrics like a typical clinical trial report. Instead, it states that "All tests (predicate bench testing) confirmed the product met the predetermined acceptance criteria." and "Side-by-Side bench testing was performed to verify that the S9 Greenhills met the predetermined pass/fail requirements of the S9 Greenhills System Specification when compared to the predicate devices."
The key performance characteristics compared, which inherently define the acceptance criteria for substantial equivalence, are:
| Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (S9 Greenhills) |
|---|---|---|
| Indication for Use | Treatment of patients > 66 lb (30 kg) with OSA, central/mixed apneas, or periodic breathing. Intended for home and hospital use. | Same as predicate. |
| Location of Use | Hospital/Home | Same as predicate. |
| Pressure Range & Modes | CPAP: 4-20 cm H2OASV: 3-25 cm H2OASVAuto: 3-25 cm H2O | Same as predicate. |
| RAMP Settings | User selected "Off" to 45 minutes in 5-minute increments. Max ramp time at clinician's discretion. | Same as predicate. |
| System Components | Flow generator, integrated humidifier (H5i), mask, air tubing, heated tubing. | Flow generator, humidifier, mask, air tubing, heated tubing. (Note: Humidifier is now integrated and contributes to overall weight/dimensions). |
| Power Supply | 100-240V, 50-60Hz | Same as predicate. |
| Flow Generator Weight | 1.7 lb (for flow generator unit only) | 2.5 lb (includes humidifier internal to the Flow Generator, so combined weight). Accepted as equivalent due to inclusion of humidifier. |
| Dimensions H x W x D | Flow generator unit: 3.4 x 5.5 x 6.0 inches | Flow generator unit: 4.5 x 9.6 x 6.0 inches. Accepted as equivalent and accounts for inclusion of the humidifier with larger width. |
| Supplemental Oxygen | Labeled for use with supplemental oxygen. | Same as predicate. |
| Therapy Mode Performance | Consistent with maintaining CPAP treatment pressure (CPAP mode), adjusting PS (ASV mode), adjusting PS and EPAP (ASVAuto mode) based on patient condition. (Traced to S9 Greenhills System Specification and predicate device's performance). Specific quantitative acceptance criteria are not detailed in this section. | "S9 Greenhills met the predetermined pass/fail requirements of the S9 Greenhills System Specification when compared to the predicate devices." Implies performance consistent with the predicate across therapy modes. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document refers to "Side-by-Side bench testing" using "a breathing machine simulates patient breathing patterns." No specific number of simulated patient breathing patterns or cases are quantified.
- Data Provenance: The testing is described as "bench testing" and is therefore synthetic data generated by a breathing machine, not human patient data. There is no country of origin of data or retrospective/prospective designation in the clinical sense, as it is a bench study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The "ground truth" for this bench testing is the expected performance of a well-functioning CPAP/ASV device, primarily benchmarked against the predicate device's known performance characteristics. The tests verify engineering specifications, not clinical diagnoses that would require expert consensus.
4. Adjudication Method for the Test Set
Not applicable. This was a bench test against predetermined engineering specifications and comparison to predicate device performance. No human adjudication of clinical outcomes or images was 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 a ventilation device, not a diagnostic imaging device using AI to assist human readers. Therefore, an MRMC study comparing AI-assisted vs. non-AI-assisted human reader performance is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone medical device that delivers therapy based on internal algorithms and sensor inputs. The "bench testing" described evaluates the performance of these algorithms and the device's hardware independently. While not explicitly framed as an "algorithm only" study in the AI context, the bench tests verify the device's automated functioning.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this study is primarily:
- Engineering Specifications: Predetermined pass/fail criteria from the "S9 Greenhills System Specification."
- Predicate Device Performance: The known and established performance of the S9 VPAP Adapt (K113801) is used as the benchmark for comparison, establishing "substantial equivalence." The "breathing machine simulates patient breathing patterns" to test the device's response against expected physiological responses.
8. The Sample Size for the Training Set
Not applicable. This medical device primarily uses control algorithms based on established physiological principles and engineered specifications, not machine learning algorithms that require a distinct "training set" of data in the AI sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device. The device's operating principles and algorithms are based on established medical science for respiratory support.
§ 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).