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510(k) Data Aggregation
(229 days)
SOMNUM is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. SOMNUM is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay(retrieve), summarize and reports generation of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients.
For respiratory events - Sleep Disordered Breathing (Apneas)- obstructive, central, mixed apneas, and hypopneas must be manually scored by physician. The device does not output specific apnea or hypopnea events and therefore should not be used for management decisions.
SOMNUM is a standalone software application that analyze previously recorded physiological data obtained during level 1 sleep studies, referred to as polysomnography (PSG) records. The SOMNUM software can analyze any EDF files. Automated algorithms are applied to the raw signals in order to identify the occurrence of certain events. The software automates recognition of:
- · Sleep Stage Events : Wake, Stage N1, Stage N2, Stage N3, Stage REM
- Respiratory Events : Sleep Disordered Breathing (device output does not distinguish between Apneas and Hypopneas. Obstructive, central, mixed apneas, and hypopneas must be manually scored by physician)
- · Arousal Events
- · Leg Movement Events : Periodic Leg Movements during Sleep (PLMs)
The SOMNUM software can be used as a stand-alone application for use on Windows 10 operating system platform. All processing, scoring, and analysis of signal data occurs on local desktop PC.
The Honeynaps Co., Ltd. Somnum (v.1.1.2) device underwent a non-clinical performance test to establish substantial equivalence to predicate devices for the analysis of sleep and respiratory-related sleep disorders.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical thresholds for specific metrics before the results table. However, the "Discussion" sections following the results implicitly define acceptable performance based on comparisons to predicate devices and acceptable error ranges in clinical practice. The reported device performance is shown in the tables below.
Endpoint 1: Performance for Detecting Each Event Type (Sleep Stage, Arousal, SDB, PLMs)
| Event Type | Metric | SOMNUM Performance (CI) | Predicate Device (K162627) Reference Data | Predicate Device (K112102) Reference Data | Implied Acceptance Criteria (Based on discussion) |
|---|---|---|---|---|---|
| Sleep Stage (Overall OPA and Kappa with reference to K162627) | OPA | 87.5% (87.2, 87.8) | 91% (91,92) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). |
| Kappa | 82.1% (81.6, 82.5) | N/A | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). | |
| Wake | PPA | 89.9% (89.2, 90.6) | 86% (82,88) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). |
| NPA | 97.4% (97.3, 97.6) | 97% (95,98) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). | |
| N1 | PPA | 77.9% (77.0, 78.9) | 41% (33,48) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). |
| NPA | 94.6% (94.4, 94.9) | 94% (93,96) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). | |
| N2 | PPA | 91.1% (90.7, 91.5) | 77% (73,81) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). |
| NPA | 92.4% (92.0, 92.7) | 87% (85,90) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). | |
| N3 | PPA | 84.1% (82.6, 85.6) | 81% (74,88) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). |
| NPA | 99.1% (99.0, 99.2) | 93% (91,95) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). | |
| REM | PPA | 84.7% (83.8, 85.4) | 79% (72,84) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). |
| NPA | 98.9% (98.8, 99.0) | 99% (98,99) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). | |
| Arousal | OPA | 82.5% (82.2, 82.9) | 87% (85,88) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). |
| PPA | 82% (81.4, 82.6) | 66% (61,71) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). | |
| NPA | 82.8% (82.4, 83.2) | 90% (88,91) | N/A | The lower NPA (8% lower than predicate) is considered within "clinically acceptable error range of around 15%". | |
| SDB | OPA | 92.3% (92.1, 92.6) | 93.0% (from K112102 ref [1]) & 91% (90,92) (from K162627 ref [4]) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). |
| PPA | 94.2% (93.8, 94.5) | 75.5% (from ref [4]) & 67% (58, 75) (from ref [1]) | N/A | Exceeds predicate performance. | |
| NPA | 91.3% (91.0, 91.6) | 98.1% (from ref [4]) & 93% (92, 94) (from ref [1]) | N/A | The lower NPA (1.7% lower than K162627, 6.8% lower than K112102) is considered acceptable when considering overall performance (PPA, OPA) and the 15% manual scorer agreement error range. | |
| PLMS | OPA | 94.1% (93.9, 94.4) | 95.7% (from ref [4]) & 89% (87,90) (from ref [1]) | N/A | Comparable to predicate and within clinically acceptable error (approx. 15%). |
| PPA | 92.9% (92.1, 93.6) | 78.4% (from ref [4]) & 71% (60,80) (from ref [1]) | N/A | Exceeds predicate performance. | |
| NPA | 94.3% (94.1, 94.5) | 97.6% (from ref [4]) & 90% (89,92) (from ref [1]) | N/A | The lower NPA is considered within "clinically acceptable range". |
Endpoint 2: Performance for Summary Variables (Absolute Max Difference/LOA)
| Variable | Type of Limit | SOMNUM Abs. MAX | Target (Reference) Abs. MAX | SOMNUM LOA Range | Reference LOA Range (if available) | Acceptance Criteria (Based on discussion) |
|---|---|---|---|---|---|---|
| TST | U | 20 | 120 (Ref [5]) | U: 7.8, L: -14.21 | U: 35, L: -70 | SOMNUM's LOA range is narrower than references or within target. Exceeds target. |
| SE | U | 5 | 13 (Ref [7]) | U: 1.69, L: -3.31 | U: 10, L: -12 | SOMNUM's LOA range is narrower than references or within target. Exceeds target. |
| SOL | U | 23 | 40 (Ref [7]) | U: 2.93, L: -4.21 | U: 15, L: -11 | SOMNUM's LOA range is narrower than references or within target. Exceeds target. Also, has smaller absolute error compared to target. |
| ROL | U | 120 | 170 (Ref [5]) | U: 62.01, L: -60.69 | U: 70, L: -90 | SOMNUM's LOA range is narrower than references or within target. Exceeds target. |
| Wake | U | 22 | 60 (Ref [7]) | U: 14.21, L: -7.80 | U: 70, L: -45 | SOMNUM's LOA range is narrower than references or within target. Exceeds target. |
| N1 | U | 45 | 80 (Ref [5]) | U: 25.30, L: -17.29 | U: 30, L: -30 | SOMNUM's LOA range is narrower than references or within target. Exceeds target. |
| N2 | U | 65 | 120 (Ref [5]) | U: 31.61, L: -29.10 | U: 10, L: -75 | SOMNUM's LOA range is narrower than references or within target. Exceeds target. |
| N1_N2 | U | 55 | 70 (Ref [5]) | U: 31.58, L: -19.17 | U: 30, L: -75 | SOMNUM's LOA range is narrower than references or within target. Exceeds target. |
| N3 | U | 40 | 140 (Ref [5]) | U: 18.83, L: -30.45 | U: 65, L: -5 | SOMNUM's LOA range is narrower than references or within target. Also, has smaller absolute error compared to target. |
| REM | U | 40 | 80 (Ref [5]) | U: 6.07, L: -31.95 | U: 18, L: -55 | SOMNUM's LOA range is narrower than references or within target. Exceeds target. |
| Arousal Index | U | 30 | - | U: 23.91, L: -15.21 | - | SOMNUM's LOA range is narrower than references or within target. Exceeds target. |
| PLMS Index | U | 43 | 7 (Ref [6]) | U: 12.24, L: -0.37 | U: 13, L: -15 | Shows almost same value as target. Differences considered within 15% clinical error range. |
| AHI Index | U | 18 | 7 (Ref [5]) | U: 8.79, L: -3.28 | U: 4, L: -2 | SOMNUM has smaller absolute error compared to target. |
Conclusion: The study concludes that SOMNUM passed all pass/fail criteria for both Endpoint 1 and Endpoint 2, demonstrating substantial equivalence.
2. Sample Size and Data Provenance
- Sample Size (Test Set): N=48 subjects
- Data Provenance: The data was recorded in a sleep laboratory. The country of origin is not explicitly stated. The study design is described as "cross-sectional experimental design," which implies it was specifically conducted for this evaluation. It is not explicitly stated if it's retrospective or prospective, but the phrasing "representative N=48 subjects of data recorded in the sleep laboratory" suggests it was existing data selected for the study.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three technologists.
- Qualifications of Experts: "Medical professionals certified on PSG recording and analysis". Specific years of experience are not provided.
4. Adjudication Method
- Adjudication Method: 2/3 majority rule. This means at least two out of the three experts had to agree on the presence of an event within an epoch for it to be considered ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A MRMC comparative effectiveness study was not conducted to measure the improvement of human readers with AI assistance versus without AI assistance. The study focuses on the standalone performance of the AI.
6. Standalone Performance Study
- Yes, a standalone study was conducted. The performance test evaluated "SOMNUM device performance using a cross-sectional experimental design." The comparison was between SOMNUM's scoring and the ground truth established by expert consensus.
7. Type of Ground Truth Used
- Type of Ground Truth: Expert consensus (2/3 majority rule of three certified medical professionals).
8. Sample Size for the Training Set
- The document does not provide specific details regarding the sample size used for the training set. It only describes the performance test (test set).
9. How Ground Truth for Training Set was Established
- The document does not provide details on how the ground truth for the training set was established. It only describes the ground truth establishment for the test set.
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(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 |
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(192 days)
EnsoSleep is intended for use for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory related sleep disorders in adults only. 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 sleep, detection of arousals, leg movements, and sleep disordered breathing events including obstructive apneas. All automatically scored events are subject to verification by a qualified clinician. Central apneas, mixed apneas, and hypopneas must be manually marked within records.
EnsoSleep is a software application that analyzes previously recorded physiological signals obtained during sleep. The EnsoSleep software can analyze any EDF or EDF+ files.
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:
Sleep Stage Events
- Wake
- Stage N1
- Stage N2
- Stage N3
- Stage REM
Respiratory Events
- Sleep disordered breathing (apneas and hypopneas)
- Apneas detected with airflow signal are classified as obstructive apnea (OSA), and can be edited to be central or mixed appeas
- Sleep disordered breathing events not detected to be apneas are marked as hypopnea
- Central apneas, mixed apneas, and hypopneas must be manually marked within records
Arousal Events
- Arousals
Movement Events
- Periodic Leg Movements during Sleep (PLMS)
The EnsoSleep software can be used as a stand-alone application for use on Microsoft Windows 7 & 8 operating system platforms. All processing, scoring, and analysis of signal data occurs on the EnsoSleep cloud servers.
Here's a breakdown of the acceptance criteria and study details for the EnsoSleep device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria were established competitively based on the performance reported in the predicate device (Advanced Brain Monitoring, Inc. Sleep Profiler, K153412) and the reference device (Younes Sleep Technologies MICHELE Sleep Scoring System, K112102) 510(k) documentation. The study aimed to demonstrate that EnsoSleep's performance was statistically similar to or greater than these benchmarks.
Endpoint 1: Sleep Staging Performance
| Sleep Stage (overall-epochs) | EnsoSleep Performance (Bootstrapped Point Estimate & 95% CI) | Predicate Device (Sleep Profiler K153412) Performance (Point Estimate) |
|---|---|---|
| Wake | PA: 86% (82%, 88%), NA: 97% (95%, 98%), OA: 94% (92%, 95%) | PA: 73%, NA: 94%, OA: 89% |
| N1 | PA: 41% (33%, 48%), NA: 94% (93%, 96%), OA: 91% (90%, 93%) | PA: 25%, NA: 93%, OA: 89% |
| N2 | PA: 77% (73%, 81%), NA: 87% (85%, 90%), OA: 83% (80%, 85%) | PA: 77%, NA: 84%, OA: 81% |
| N3 | PA: 81% (74%, 88%), NA: 93% (91%, 95%), OA: 92% (90%, 94%) | PA: 76%, NA: 94%, OA: 91% |
| REM | PA: 79% (72%, 84%), NA: 99% (98%, 99%), OA: 96% (96%, 97%) | PA: 74%, NA: 97%, OA: 95% |
| Total (Overall Epochs) | PA: 78% (77%, 80%), NA: 95% (94%, 95%), OA: 91% (91%, 92%) | PA: 73%, NA: 93%, OA: 87% |
Conclusion on Endpoint 1: EnsoSleep showed no statistically significant differences or was significantly greater than the predicate device in all comparisons for sleep staging performance.
Endpoint 2: Sleep Apnea Diagnostic Agreement Performance
| Diagnostic Agreement (Per-Patient) | EnsoSleep Performance (Bootstrapped Point Estimate & 95% CI) | Predicate Device (Sleep Profiler K153412) Performance (Point Estimate) |
|---|---|---|
| AHI >= 5 (overall-mild) | PA: 91% (82%, 98%), NA: 76% (61%, 90%), OA: 85% (77%, 92%) | PA: 100%, NA: 85% |
| AHI >= 15 (overall-moderate) | PA: 95% (83%, 100%), NA: 98% (94%, 100%), OA: 97% (93%, 100%) | PA: 100%, NA: 97% |
| REM AHI >= 5 (REM-mild) | PA: 83% (72%, 94%), NA: 89% (79%, 97%), OA: 86% (79%, 93%) | PA: 84%, NA: 90% |
| REM AHI >= 15 (REM-moderate) | PA: 79% (56%, 94%), NA: 96% (90%, 100%), OA: 92% (85%, 97%) | PA: 73%, NA: 96% |
Conclusion on Endpoint 2: EnsoSleep showed no statistically significant differences in PA and NA compared to the predicate device, with one exception for overall-mild PA (a 2% difference in EnsoSleep's CI upper bound vs. predicate point estimate). EnsoSleep's point estimates for PA, NA, and OA exceeded, were equivalent to, or were within 10% of the predicate device's.
Endpoint 3: Event Detection Performance
| Event Type (Overall-Epochs) | EnsoSleep Performance (Bootstrapped Point Estimate & 95% CI) | Reference Device (MICHELE Sleep Scoring K112102) Performance (Point Estimate) |
|---|---|---|
| SDB | PA: 67% (58%, 75%), NA: 93% (92%, 94%), OA: 91% (90%, 92%) | PA: 75.5%, NA: 98.1%, OA: 93.0% |
| Apnea | PA: 56% (41%, 70%), NA: 96% (96%, 97%), OA: 95% (95%, 96%) | N/A (did not provide PA/NA) |
| Obstructive Apnea | PA: 53% (35%, 71%), NA: 97% (96%, 97%), OA: 96% (95%, 97%) | PA: 55.9%, NA: 99.3% |
| Arousal | PA: 66% (61%, 71%), NA: 90% (88%, 91%), OA: 87% (85%, 88%) | PA: 60.0%, NA: 94.1%, OA: 89.9% |
| Leg Movement | PA: 71% (60%, 80%), NA: 90% (89%, 92%), OA: 89% (87%, 90%) | PA: 78.4%, NA: 97.6%, OA: 95.7% |
Conclusion on Endpoint 3: EnsoSleep's point-estimates for PA and NA event detection performance exceeded, were equivalent to, or were within 10% of the reference device, with statistically significant differences observed in a minority of cases.
2. Sample Size for Test Set and Data Provenance
- Sample Size (Test Set): N=72 subjects (59719 epochs for epoch-based analyses, 72 for per-patient analyses).
- Data Provenance: Retrospective clinical PSG data. The data constituted an "archived collection of retrospective diagnostic clinical PSG data collected from an AASM Accredited" facility. The country of origin is not explicitly stated but implied to be the US given the FDA submission.
3. Number of Experts for Ground Truth and Qualifications
- Number of Experts: Three (3) independent registered sleep technologists (RPSGT).
- Qualifications: Registered sleep technologists (RPSGT) who met "all acquisition, scoring-bind, and rater controls." Specific years of experience are not mentioned.
4. Adjudication Method for Test Set
- Adjudication Method: 2/3 Majority Scoring was used to establish the designated comparative reference (ground truth).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done to evaluate human readers with and without AI assistance. The study described is a standalone performance evaluation of the AI algorithm against expert consensus.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone study was performed. The entire clinical performance testing described evaluates the EnsoSleep algorithm's performance (without human-in-the-loop) against a human expert consensus ground truth.
7. Type of Ground Truth Used
- Type of Ground Truth: Expert consensus (2/3 Majority Scoring by three independent RPSGTs).
8. Sample Size for Training Set
- The document does not specify the sample size for the training set. It only describes the validation/test set.
9. How Ground Truth for Training Set Was Established
- The document does not provide information on how the ground truth for the training set was established. It focuses solely on the clinical performance testing (validation/test set).
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