Search Results
Found 1 results
510(k) Data Aggregation
(229 days)
Honeynaps Co., Ltd
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.
Ask a specific question about this device
Page 1 of 1