(184 days)
This device is intended for use in a sleep laboratory for the acqusition, display, storage, and analysis of polysomnography data obtained from a polygraph with IRIG compatible outputs. It's purpose is to assist a qualified sleep practitioner in the diagnosis of sleep disorders in patients 13 years of age and older. To use the analysis capabilities, there must be at least two EEG channels, two rapid eye movement channels (electroocculograms), a chin EMG (electromyogram) channel, a leg EMG channel, an airflow channel, two respiratory effort channels, and an oxygen desaturation channel. This device is to be used only under the direction of a physician or qualified sleep technician.
POLYSMITH is a polysomnography data acquisition, analysis, display, and storage system, which accepts polysomnography data and allows the operator to view the data on the computer monitor. The device also automatically analyzes the data to determine the sleep stage for each thirty-second epoch and to detect apneas and hypopneas. The hardware consists of a personal computer with an enclosed analog-todigital converter and a connector block for conveniently connecting the input data leads. The device is designed to input data from a polygraph that has IRIG-compatible outputs. To use all analysis capabilities, there should be at least two EEG channels, two rapid eye movement channels (electro-occulograms), a chin EMG (electromyogram), a leg EMG, an ECG, airflow, two respiratory effort channels and an oxygen saturation channel. The software, which is running under the NT operating system, will display all of the acquired data on the computer screen for reviewing and operator editing. The automated analysis feature, designed tor subjects 13 years of age and older, generates multiple reports, including a sleep stage summary, describing the sleep data.
The POLYSMITH study evaluated the device's performance by comparing it to a predicate device, the Oxford SAC system, and also to human scoring.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria (e.g., a specific percentage agreement or correlation coefficient that the device needed to achieve to be deemed acceptable). Instead, the assessment is framed around demonstrating "substantial equivalence" to a predicate device and comparison to human scoring. Therefore, the "reported device performance" is the finding of substantial equivalence based on these comparisons.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Oxford SAC system) for polysomnography data analysis | The device performance was compared with that of the predicate device, the Oxford SAC system, by analyzing six all-night sleep records. While no specific metrics are given, the FDA's 510(k) clearance indicates that this comparison supported a finding of substantial equivalence. |
| Agreement with human scoring for sleep staging, apnea, and hypopnea detection | The device performance was compared to human scoring using two all-night sleep recordings from patients with severe sleep apnea. Again, no specific metrics are given for "agreement" but the overall clearance implies acceptable performance relative to human scoring. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set for Predicate Device Comparison:
- Sample Size: Six all-night sleep records.
- Data Provenance: Recorded to optical disk at the Henry Ford Sleep Diagnostic Center (HFSDC) in Detroit, Michigan. The text states these were "all-night sleep records," implying retrospective data.
- Test Set for Human Scoring Comparison:
- Sample Size: Two all-night sleep recordings.
- Data Provenance: From the Henry Ford Sleep Diagnostic Center (HFSDC), of patients with severe sleep apnea. These were "all-night sleep recordings," implying retrospective data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the exact number of human experts who scored the two all-night sleep recordings used for comparison. It simply states "human scoring." It also does not provide specific qualifications (e.g., "radiologist with 10 years of experience"). However, for polysomnography data, it is generally understood that such scoring would be performed by qualified sleep technicians or physicians specializing in sleep medicine.
4. Adjudication Method for the Test Set
The document does not detail any specific adjudication method (e.g., 2+1, 3+1, none) for the human scoring used as ground truth. It refers to "human scoring" as a singular entity.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The comparison was against human scoring, but the framework for an MRMC study with multiple readers and analysis of improvement with AI assistance is not present in the provided text.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described represent standalone performance of the POLYSMITH device. The comparisons were made directly between the device's output and either a predicate device's output or human scoring, without human-in-the-loop interaction for the POLYSMITH during these evaluations. The device's function is to "automatically analyzes the data to determine the sleep stage for each thirty-second epoch and to detect apneas and hypopneas."
7. The Type of Ground Truth Used
- For the predicate device comparison: The predicate device's (Oxford SAC system) analysis results served as a form of reference or "ground truth" for demonstrating substantial equivalence.
- For the human scoring comparison: "Human scoring" served as the ground truth. This is a form of expert consensus/opinion, where human experts (presumably qualified sleep professionals) interpret the raw polysomnography data to determine sleep stages and detect events.
8. The Sample Size for the Training Set
The document does not provide any information about the sample size used for the training set. It focuses solely on the performance evaluation using test data.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for any potential training set was established.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).