Search Results
Found 1 results
510(k) Data Aggregation
(133 days)
The NomadAir PMU810 is intended to record physiological signals acquired from a patient for archival in a sleep study. Data may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of sleep-disordered breathing (SDB).
The NomadAir PMU810 is intended for use within a hospital, laboratory, clinic, nursing home, or patient's home.
The NomadAir PMU810 is intended for use on adults only under the direction of a physician or qualified sleep technician.
The NomadAir PMU810, or any accessory, does not include or trigger alarms, and is not intended to be used alone as, or a critical component of,
- an alarm or alarm system:
- an apnea monitor or apnea monitoring system; or
- a life monitor or life monitoring system.
The NomadAir PMU810 is a portable device that records physiological signals used for sleep studies. The device can be worn on the chest or the wrist and is attached to the patient using a RIP belt or a disposable strap comected directly to the patient also wears a pulse oximeter probe, a nasal cannula, and an optional sensor, such as a RIP belt, thermocouple, EMG electrode, or ECG electrode.
During the typical workflow of using the clinical user configures the device for a patient. The clinician will give the patient instructions on how to attach the device and send the unit and accessories home with the patient. Before going to bed, the patient will connect everything, then go to sleep. The Nomad Air records the signals from the sensors and saves the data to internal memory. The patient may perform up to 3 sleep studies before returning the device. Once the device, they can connect it to a PC using a USB cable and download the study for analysis.
Here's an analysis 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
| Study | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| AC Signal Accuracy | Accuracy of recorded signal is +/- the greater of 5 uV or 5%. | Pass |
| CMRR Test | Poly channel shows CMRR >= 90 dB. | Pass |
| Input Impedance | Input impedance >= 20 MOhm | Pass |
| Pressure Sensor Test | Accuracy of pressure sensor is +/- 1 cmH2O. | Pass |
| Body Position Test | Confirm all transition and hysteresis angles are within specifications | Pass |
| Sampling Rate Test | Base sampling rate is 250 Hz +/- 0.05% | Pass |
| Oximetry Test | Channel shows valid reading when sensor is correctly applied to subject. Channel shows zero when probe is disconnected or removed from subject. | Pass |
| Wireless Communication Test | Device transmits event driven status message and timed snapshot status messages successfully. | Pass |
| Data Transfer Speed Test | Files transfer in < 1 minute per 8 hours of recorded data. | Pass |
| Pressure Sensor Accuracy Test | Accuracy of pressure sensor is +/- 1 cmH2O when the temperature is at 5 °C and 40 °C (+/- 3 °C) | Pass |
| Bootloader Test | Device starts into bootloader when powered on by USB with user button held pressed. | Pass |
| Input Noise Test | RIP and Poly channels have <= 6 uVp-p of input noise (0.53 Hz to 60 Hz) | Pass |
| Battery Life Test | NomadAir records for a minimum of 24 hours after 72 hours of standby time | Pass |
| Operating Modes and Indicator Test | All LED indicators display correctly in all modes. | Pass |
| Cleaning Test | After performing cleaning cycles that represent typical device usage over the expected service life, device is not damaged and passes dielectric strength test. | Pass |
| Data File and Storage Test | Log events are saved with the data with the correct timestamp. | Pass |
| Power Interruption Recovery Test | Device recovers from power interruption by resuming state prior to interruption for all operating modes. | Pass |
| Power Interruption From Rough Handling | Device suffers no power interruption when handled roughly | Pass |
| RIP Driver Test | Peak to trough measurement is greater than 750 uV for 1" deflection of belt. Peak to trough noise is within -40 to 40 uV | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only refers to "Performance bench tests" and mentions that they "demonstrate that NomadAir PMU810 has met the functional requirements." It does not specify the sample size used for these tests. Furthermore, it does not provide any information regarding the provenance of data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not mention the use of experts to establish ground truth for the test set. The performance tests described are bench tests, which compare device output against predefined technical specifications rather than interpretations by human experts.
4. Adjudication Method for the Test Set
Since the ground truth for the "test set" (bench testing) is based on technical specifications and measurements, an adjudication method like 2+1 or 3+1 is not applicable and therefore not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
The provided text does not indicate that an MRMC comparative effectiveness study was done. The studies mentioned are bench tests of the device's technical performance. There is no mention of human readers, AI assistance, or an effect size of improvement with AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The studies described are standalone bench tests of the device's hardware and software components against technical specifications. The device itself (NomadAir PMU810) is a physiological signal recorder. Data collected by the device "may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of sleep-disordered breathing (SDB)." This suggests the device's output is intended to be interpreted by a human, rather than the device making a diagnosis itself. Therefore, while it undergoes standalone technical testing, it's not a standalone diagnostic algorithm in the sense of making a diagnosis without human input.
7. The Type of Ground Truth Used
The ground truth used for the performance tests is based on technical specifications and measurable physical quantities. For example:
- AC Signal Accuracy: +/- the greater of 5 uV or 5%
- CMRR Test: >= 90 dB
- Input Impedance: >= 20 MOhm
- Pressure Sensor Accuracy: +/- 1 cmH2O
- Sampling Rate: 250 Hz +/- 0.05%
- Battery Life: minimum of 24 hours
- RIP Driver Test: Peak to trough measurement > 750 uV for 1" deflection of belt
These are engineering and performance metrics, not clinical outcomes, expert consensus, or pathological findings.
8. The Sample Size for the Training Set
The provided text does not mention a training set because the device described, NomadAir PMU810, is a physiological signal amplifier and recorder. It does not appear to employ machine learning or AI algorithms that would require a distinct "training set" for model development. The performance testing focuses on its ability to accurately acquire and record physiological signals according to engineering specifications.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the method for establishing its ground truth is not applicable.
Ask a specific question about this device
Page 1 of 1