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510(k) Data Aggregation
(173 days)
The CURVE™ Positive Airway Pressure System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and also during an incipient apnea. The system includes a dedicated flow generator and a patient interface, and is intended for use in the home environment. This system is to be used by adult patients weighing more than 66 lbs (30 kg).
The CURVE™ Positive Airway System is comprised of five components: a Nasal Pillow, Headgear, Valve, Hose, and Flow Generator.
The CURVE™ System Airbox is a flow generator that provides airflow and pressure to the mask and delivers therapeutic pressure to the patient's airway during disordered breathing. The valve allows positive airway pressure to be generated during expiration but at the same time it (1) reduces the airflow required to provide positive airway pressure during inspiration and expiration, and (2) utilizes the patient's own breathing effort during both normal inspiration and expiration. During disordered breathing events, such as apnea or hypopnea, the valve opens to allow positive airway pressure to be provided to the patient directly from the flow generator. In addition, the valve is designed to channel excess airflow directly into the room, thereby minimizing spikes in pressure and preventing carbon dioxide rebreathing from the hose.
The CURVE™ System patient interface consists of a nasal pillow mask, headgear and a hose. The nasal pillow mask includes the valve and the mask is held in contact with the patient's nares via the headgear. The nasal pillow mask is available in three sizes (small. medium and large). The hose connects the flow generator to the valve in the mask to deliver air from the flow generator to the mask.
The CURVE™ System is designed to have pressurized air from the flow generator always available to provide airway support. During treatment, the flow generator is never "off" or paused. Pressurized air is always being delivered through the hose to the valve, and flows into the mask whenever there is a drop in pressure or flow rate.
The CURVE™ System flow generator can only be used with the CURVE™ System patient interface and vice versa. The size and configuration of the Curve System hose and flow generator connectors are designed to prevent connection to a standard Continuous Positive Airway Pressure (CPAP) hose, mask or flow generator.
Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The provided document outlines various criteria, primarily focusing on safety, biocompatibility, and performance, with a specific clinical non-inferiority endpoint.
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | External Communicating Components (Permanent Duration): Cytotoxicity, Sensitization, Intracutaneous reactivity, Extractables and leachables testing with risk assessment. Dry Gas Contacting Components: Total VOCs < 5,000 ppb, Particulate matter EPA PM2.5 < 12 ug/m³, Ozone concentration < 0.050ppm, Carbon monoxide concentration < 9 ppm, Carbon dioxide concentration < 10,000 ppm. | All tests passed. Results demonstrated biocompatibility. |
| Reprocessing | Post-validation, no visible soil, residual soil (carbohydrate and protein markers) reduced to levels below specified endpoints after 6 simulated use cycles, reflecting 90-day use period. | Validated following FDA guidance and AAMI standards. Test results showed no visible soil and residual soil reduced below specified endpoints after 6 simulated use cycles. |
| Safety (Electrical, EMC, Thermal) | Conformity to IEC 60601-1-2:2014, AAMI / ANSI ES60601-1:2005/(R) 2012 and A1:2012, IEC 60601-1-11 Edition 2.0 2015-01. | Device tested and conformed to electromagnetic compatibility, electrical, mechanical, and thermal safety standards. |
| Software | Adequacy of software documentation consistent with "Moderate" level of software concern, fulfilling design, implementation, and cybersecurity specifications. | Software documentation was deemed adequate. Validation and verification testing demonstrated that the device met its design, implementation, and cybersecurity specifications. |
| Bench Performance | Device Integrity: Hose crush resistance, adequate flow rate. Hose Torsion Force: Hose spins freely without disconnecting, measured peak torque. Hose/Valve Removal Force: Unintentional disconnection prevented, easy patient disconnection. Acoustics: Noise level ≤ 30dB at 10cmH2O setting (ISO 17510 and 3744). CO2 Rebreathing: Normal conditions: increase in CO2 from baseline ≤ 20%; Single fault: increase in CO2 from baseline ≤ 60% (ISO 17510). System Flow Rate: > 10 L/minute at various generator settings. Max Expiratory Pressure: Pressure drop into mask ≤ 2 cm H2O greater than generator pressure. Inhalation Pressure: Pressure drop into mask ≥ -1.0 cm H2O at 25 L/minute. Intra-Mask Static Pressure: Therapeutic pressure provided. Air Bolus Testing: No impact on specifications for generator/mask pressures, airflow, exhaust pressure, inspiratory resistance. Packaging Testing: No impact on specifications after simulated shipping challenges. Use Life Testing: Meets performance specs for up to 90 days after 712,800 breathing cycles and 100 cleaning cycles. Max Limited Pressure: Normal conditions: max pressure output ≤ 20 cm H2O; Simulated fault: max pressure output ≤ 30 cm H2O. Waveform Testing: Equivalent pressure/flow responses between clinical and final device configurations across simulated breathing conditions (normal, hypopnea, apnea). | All specified bench tests passed. Specific quantitative results provided for acoustics (≤30dB), CO2 rebreathing (normal: ≤20%, fault: ≤60%), system flow rate (>10 L/min), max expiratory pressure (≤2 cm H2O drop), inhalation pressure (≥ -1.0 cm H2O drop), max limited pressure (normal: ≤20 cm H2O, fault: ≤30 cm H2O). Use life testing validated 90-day use. Waveform testing demonstrated equivalence for 4 simulated patients at various settings and conditions. |
| Clinical Efficacy (Non-Inferiority) | Co-Primary Efficacy Assessments: AHI and ODI. Non-Inferiority Margin: Difference < 5 units between FRESCA mask and commercial CPAP mask. | AHI: Difference of 0.6 (FRESCA mean 3.0, Commercial CPAP mean 2.4). p<0.001 for non-inferiority. ODI: Difference of 0.3 (FRESCA mean 1.4, Commercial CPAP mean 1.1). p<0.001 for non-inferiority. Both endpoints demonstrated non-inferiority. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set:
- Clinical Study: 36 patients completed both study nights with valid PSG results (out of 47 enrolled).
- Bench Testing: The text does not specify sample sizes for individual bench tests (e.g., number of hoses tested for crush force). It generally describes "testing" or "tests performed."
- Data Provenance (Clinical Study):
- Country of Origin: Not explicitly stated, but the study was conducted to support an FDA De Novo classification, implying it was likely conducted in the US or under US regulatory standards.
- Retrospective or Prospective: Prospective, controlled, randomized, cross-over clinical study.
3. Number of Experts and Qualifications for Ground Truth (Clinical Study)
- The clinical study relied on Polysomnography (PSG) readings to determine AHI and ODI.
- Qualifications of Experts: The document does not explicitly state the number or qualifications of experts (e.g., sleep technologists, physicians) who interpreted the PSG data to establish the ground truth for AHI and ODI. It refers to "valid PSG results" and assumes standard clinical interpretation for these metrics.
4. Adjudication Method for the Test Set (Clinical Study)
- The document does not explicitly mention an adjudication method (like 2+1 or 3+1 expert review) for the PSG data. It implies that the AHI and ODI were determined as standard clinical practice from the PSG results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not conducted in the traditional sense of comparing human reader performance with and without AI assistance.
- This study was a non-inferiority clinical trial comparing the performance of the device (FRESCA mask) itself against a commercial CPAP mask, with human patients as the "cases" and the outcome measured by standard PSG metrics (AHI, ODI), not human reader diagnostic accuracy. The "assistance" here is the physical mask, not an AI algorithm assisting a human reader in diagnosis.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, the core of the clinical study was essentially a standalone performance evaluation of the device (FRESCA mask) in treating OSA. There was no human-in-the-loop component being evaluated for diagnostic assistance. The device itself is the therapeutic agent, and its performance (measured by AHI/ODI reduction) was compared against another device.
7. Type of Ground Truth Used (Clinical Study)
- The ground truth for the clinical study was established using Polysomnography (PSG) results, specifically the Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI). These are standard physiological measurements used to diagnose and assess the severity of obstructive sleep apnea.
8. Sample Size for the Training Set
- The document describes a clinical study to demonstrate non-inferiority, which is a validation study, not a training set for an AI algorithm.
- Therefore, there is no specific "training set" sample size mentioned here in the context of an AI device. The device itself (CURVE™ Positive Airway Pressure System) is a physical medical device, not a software algorithm that requires a training dataset in the machine learning sense. The "waveform testing" might be considered a form of "training" or optimization data for the device's physical design and control algorithms, but the sample size for that is not explicitly quantified in terms of number of physiological waveforms other than "four simulated 'patients'."
9. How the Ground Truth for the Training Set Was Established
- As noted above, this is not an AI algorithm requiring a typical training set.
- For the device's internal operational parameters and algorithms (e.g., related to flow generation or valve response), the ground truth would have been established through engineering principles, physiological models, and extensive bench testing (as detailed in the "Performance Testing - Bench" section, particularly the "Waveform testing" which used "four simulated 'patients'" and various breathing conditions). The "ground truth" here is adherence to specified physical and physiological responses required for effective therapy.
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