(161 days)
EnsoSleep is intended for use in the diagnostic evaluation by a physician to assess sleep quality and as an aid for physicians in the diagnosis of sleep disorders and respiratory related sleep disorders in pediatric as follows:
- · Pediatric patients 13 years and older with polysomnography (PSG) tests obtained in a Hospital or Sleep Clinic
- · Adult patients with PSGs obtained in a Hospital or Sleep Clinic
- · Adult patients with Home Sleep Tests
EnsoSleep is a software-only medical device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results, including the staging of arousals, leg movements, and sleep disordered breathing events including obstructive apneas (OSA), central sleep apneas (CSA), and hypopneas.
All automatically scored events and physiological signals which are retrieved, analyzed, displayed, and summarized are subject to verification by a qualified clinician. Central sleep apneas (CSA) should be manually reviewed and modified as appropriate by a clinician.
All events can be manually marked or edited within records during review.
Photoplethysmography (PPG) total sleep time is not intended for use when electroencephalograph (EEG) data is recorded. PPG total sleep time is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.
EnsoSleep is a software-only medical device that analyzes previously recorded physiological signals obtained during sleep. Users of EnsoSleep are consistent with the roles required to run a sleep clinic: sleep physicians, sleep technicians, clinic operations managers, and IT administrators. EnsoSleep can analyze at-home and in-lab sleep studies for both adult and pediatric patients who are at least 13 years old. Automated algorithms are applied to the raw signals in order to derive additional signals and interpret the raw and derived signal information. The software automates recognition of the following: respiratory events, sleep staging events, arousal events, movement events, cardiac events, derived signals, and calculated indices. EnsoSleep does not interpret the results, nor does it suggest a diagnosis. The device only marks events of interest for review by a physician who is responsible for diagnoses. The device does not analyze data that are different from those analyzed by human scorers.
The signals and automated analyses can be visually inspected and edited prior to the results being integrated into a sleep study report.
The software consists of 4 major components:
- The Application Platform runs on local clinic workstations and manages the detection, upload, and download of study records and scoring to and from the Storage Platform
- The Processing Platform accepts raw physiological signals as inputs in order to recognize events, derive signals, and calculate indices
- . The Storage Platform facilitates file and database storage in the EnsoSleep cloud through an API
- The Dashboard is a web-based user interface to support configuration, clinic management, and sleep study scoring
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text describes that "the acceptance criteria were selected based on PA, NA, OA, MAE, Deming Regression coefficient, Bland-Altman mean difference and limits of agreement performance criteria that validate performance substantially equivalent to, or greater than, but not lesser than by more than 10% or similarly defined criteria in any category of the predicate 510(k) reported device performance across all endpoints respectively."
For detailed performance metrics, the document presents tables for specific endpoints. Below is a structured representation focusing on the key performance indicators mentioned and a comparison to the predicate device where available.
Endpoint 1: Sleep Staging Event Detection (EnsoSleep K210034 vs. Predicate K162627)
| Metric | Acceptance Criteria (Conceptual) | EnsoSleep (K210034) Adult Sample (Reported) | EnsoSleep (K210034) Pediatric Sample (Reported) | Predicate (K162627) Adult Sample (Reported) |
|---|---|---|---|---|
| Positive Agreement (PA) | ≥ Predicate PA - 10% (Ideally ≥ Predicate PA) | Wake: 93.5% | Wake: 93.1% | Wake: 86% |
| N1: 37.0% | N1: 43.2% | N1: 41% | ||
| N2: 88.3% | N2: 92.6% | N2: 77% | ||
| N3: 80.0% | N3: 92.3% | N3: 81% | ||
| REM: 90.9% | REM: 80.9% | REM: 79% | ||
| Negative Agreement (NA) | ≥ Predicate NA - 10% (Ideally ≥ Predicate NA) | Wake: 97.2% | Wake: 99.2% | Wake: 97% |
| N1: 98.3% | N1: 98.8% | N1: 94% | ||
| N2: 89.3% | N2: 89.4% | N2: 87% | ||
| N3: 96.3% | N3: 97.5% | N3: 93% | ||
| REM: 99.3% | REM: 99.1% | REM: 99% | ||
| Overall Agreement (OA) | ≥ Predicate OA - 10% (Ideally ≥ Predicate OA) | Wake: 96.1% | Wake: 97.9% | Wake: 94% |
| N1: 95.0% | N1: 97.0% | N1: 91% | ||
| N2: 88.8% | N2: 90.9% | N2: 83% | ||
| N3: 95.0% | N3: 96.6% | N3: 92% | ||
| REM: 98.3% | REM: 97.0% | REM: 96% | ||
| Total (Overall) OA (Pooled) | ≥ Predicate Total OA - 10% (Ideally ≥ Predicate Total OA) | Adult: 86.6% | Pediatric: 89.7% | Adult: 78% |
| Conclusion on Acceptance Criteria (Endpoint 1) | All 3 EnsoSleep PA, NA, and OA point-estimates vs 2/3 Majority Scoring were observed to be greater than the predicate device PA, NA, and OA point-estimates in some events, with statistically significant results in terms of higher agreement for several stages (e.g., Adult REM, Pediatric Wake, N3, Total). None were observed 10% or lower than 2/3 Majority. |
Endpoint 2: Sleep Apnea Diagnostic Agreement (Per-Patient AHI)
| Metric | Acceptance Criteria (Conceptual) | EnsoSleep (K210034) Adult Sample (Reported) | EnsoSleep (K210034) Pediatric Sample (Reported) | Predicate (K162627) Adult Sample (Reported) |
|---|---|---|---|---|
| Positive Percent Agreement (PA) | ≥ Predicate PA - 10% (Ideally ≥ Predicate PA) | AHI ≥ 5: 94.4% | AHI ≥ 1: 94.4% | AHI ≥ 5: 91% |
| AHI ≥ 15: 94.0% | AHI ≥ 5: 90.5% | AHI ≥ 15: 95% | ||
| REM AHI ≥ 5: 86.7% | AHI ≥ 10: 78.6% | REM AHI ≥ 5: 83% | ||
| REM AHI ≥ 15: 81.5% | AHI ≥ 15: 85.7% | REM AHI ≥ 15: 79% | ||
| Negative Percent Agreement (NA) | ≥ Predicate NA - 10% (Ideally ≥ Predicate NA) | AHI ≥ 5: 89.7% | AHI ≥ 1: 77.8% | AHI ≥ 5: 76% |
| AHI ≥ 15: 96.3% | AHI ≥ 5: 100.0% | AHI ≥ 15: 98% | ||
| REM AHI ≥ 5: 83.0% | AHI ≥ 10: 94.9% | REM AHI ≥ 5: 89% | ||
| REM AHI ≥ 15: 93.3% | AHI ≥ 15: 100.0% | REM AHI ≥ 15: 96% | ||
| Overall Percent Agreement (OA) | ≥ Predicate OA - 10% (Ideally ≥ Predicate OA) | AHI ≥ 5: 93.0% | AHI ≥ 1: 89.4% | AHI ≥ 5: 85% |
| AHI ≥ 15: 95.0% | AHI ≥ 5: 95.7% | AHI ≥ 15: 97% | ||
| REM AHI ≥ 5: 85.0% | AHI ≥ 10: 91.5% | REM AHI ≥ 5: 86% | ||
| REM AHI ≥ 15: 90.0% | AHI ≥ 15: 97.9% | REM AHI ≥ 15: 92% | ||
| Conclusion on Acceptance Criteria (Endpoint 2) | EnsoSleep PA, NA, and OA point-estimates vs 2/3 Majority Scoring were observed to be greater than the predicate device for some OSA severity categories in both adult and pediatric samples. Only one instance (Pediatric AHI > 10 PA) was within 10% of the predicate. All met or exceeded objective performance goals. |
Endpoint 3: Sleep Scoring Event Detection (EnsoSleep K210034 vs. Predicate K162627 and Reference K112102)
| Metric | Acceptance Criteria (Conceptual) | EnsoSleep (K210034) Adult Sample (Reported) | EnsoSleep (K210034) Pediatric Sample (Reported) | Predicate (K162627) Adult Sample (Reported) | Reference (K112102) Adult Sample (Reported) |
|---|---|---|---|---|---|
| Positive Agreement (PA) | ≥ Reference PA - 10% (Ideally ≥ Reference PA) | SDB: 75.4% | SDB: 72.7% | SDB: 67% | N/A (for SDB) |
| Hypopnea: 66.3% | Hypopnea: 68.8% | Hypopnea: 60.3% | Hypopnea: 60.3% | ||
| Obstructive Apnea: 74.1% | Obstructive Apnea: 45.5% | Obstructive Apnea: 53% | N/A (for Obstructive Apnea) | ||
| Central Apnea: 65.3% | Central Apnea: 68.9% | Central Apnea: 63.8% | Central Apnea: 63.8% | ||
| Arousal: 73.6% | Arousal: 78.6% | Arousal: 66% | N/A (for Arousal) | ||
| Leg Movement: 82.0% | Leg Movement: 66.0% | Leg Movement: 71% | N/A (for Leg Movement) | ||
| Negative Agreement (NA) | ≥ Reference NA - 10% (Ideally ≥ Reference NA) | SDB: 97.0% | SDB: 98.6% | SDB: 93% | N/A (for SDB) |
| Hypopnea: 97.1% | Hypopnea: 98.9% | Hypopnea: 97.6% | Hypopnea: 97.6% | ||
| Obstructive Apnea: 99.3% | Obstructive Apnea: 99.7% | Obstructive Apnea: 97% | N/A (for Obstructive Apnea) | ||
| Central Apnea: 99.5% | Central Apnea: 99.7% | Central Apnea: 99.6% | Central Apnea: 99.6% | ||
| Arousal: 95.6% | Arousal: 97.0% | Arousal: 90% | N/A (for Arousal) | ||
| Leg Movement: 92.4% | Leg Movement: 95.5% | Leg Movement: 90% | N/A (for Leg Movement) | ||
| Overall Agreement (OA) | ≥ Reference OA - 10% (Ideally ≥ Reference OA) | SDB: 94.9% | SDB: 97.6% | SDB: 91% | N/A (for SDB) |
| Hypopnea: 95.5% | Hypopnea: 98.0% | Hypopnea: N/R | Hypopnea: N/R | ||
| Obstructive Apnea: 98.8% | Obstructive Apnea: 99.5% | Obstructive Apnea: 96% | N/A (for Obstructive Apnea) | ||
| Central Apnea: 98.9% | Central Apnea: 99.5% | Central Apnea: N/R | Central Apnea: N/R | ||
| Arousal: 93.2% | Arousal: 95.5% | Arousal: 87% | N/A (for Arousal) | ||
| Leg Movement: 91.7% | Leg Movement: 94.5% | Leg Movement: 89% | N/A (for Leg Movement) | ||
| Conclusion on Acceptance Criteria (Endpoint 3) | EnsoSleep PA, NA, and OA point-estimates observed to be greater than or within 5% of the reference device performance for all event types, with statistically significant differences (greater performance) in a majority of cases. All met or exceeded objective performance goals. |
Endpoint 4: Total Sleep Time (TST) and Respiratory Rate (RR)
| Metric | Acceptance Criteria (Conceptual) | EnsoSleep PPG-TST (K210034) RR Sample (Reported) | EnsoSleep EEG-TST (K210034) RR Sample (Reported) | EnsoSleep EEG-TST (K210034) Adult Sample (Reported) | EnsoSleep EEG-TST (K210034) Pediatric Sample (Reported) |
|---|---|---|---|---|---|
| Deming Regression Slope ($β$1) | Near unity (0.90 |
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).