(197 days)
The Nomad device is a digital amplifier capable of measuring bio-potential signals that may be incorporated into a Polysomnogram.
The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study, such as Limb Movement, Respiration Effort, and SpO2. The 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 Disorders.
This device is not to be used alone as an apnea monitor or as a critical component in an apnea monitoring system.
This device is intended for use on both adults and children on the order of physician.
This device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.
The device is not sterile.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
The device is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The bio-potentials are transferred to Polysmith polysomnography software running on a personal computer. Qualified practitioners use the information to score Polysomnograms and diagnose Sleep Disorders. The device is intended for use on both adults and children under the direction of a physician or qualified sleep technician.
The Neurotronics® Nomad device is a digital amplifier designed to measure, amplify, and record physiological signals for Polysomnography (PSG) or Sleep Studies. It aids qualified sleep clinicians in diagnosing Sleep Disorders by allowing analysis of data such as Limb Movement, Respiration Effort, and SpO2. This device is not intended as an apnea monitor or life support device.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes performance testing in general terms but does not present specific quantitative acceptance criteria values or detailed device performance metrics in a tabular format. Instead, it states that the device was verified and validated according to product specifications, and that test results confirmed the device is in accordance with its specifications.
| Acceptance Criteria Category | Acceptance Criteria (Specific Values) | Reported Device Performance (Specific Values) | Notes |
|---|---|---|---|
| General Performance | Device performs within expected specifications. | "The results of validation and verification confirmed that the device performed within expected specifications." | Broad statement; no specific quantifiable metrics provided. |
| Electromagnetic Compatibility (EMC) | Compliance with relevant EMC standards. | "Tests performed on the device include environmental and mechanical stress testing, electromagnetic immunity and emissions testing..." | Confirmed; no specific immunity levels or emission limits detailed. |
| Environmental & Mechanical Stress | Withstand specified environmental and mechanical conditions. | "...environmental and mechanical stress testing..." | Confirmed; no specific conditions or pass/fail criteria detailed. |
| Medical Device Safety | Compliance with relevant safety standards (e.g., IEC 60601-1). | "...medical device safety testing." | Confirmed; accessories comply with IEC 60601-1 Subclause 56.3(c). |
| Software Verification & Validation | Software functions according to operational requirements. | "Software on the device was verified and validated according to the functionality of the operations of the device." | Confirmed; no specific software test cases or pass rates provided. |
| Risk Evaluation | All identified risks are properly mitigated. | "The risk evaluation also confirmed all the risks have been properly mitigated." | Confirmed; no specific risk details or mitigation strategies provided. |
| Accessories Compliance | Accessories comply with 21 CFR Part 898 for electrode lead wires and patient cables. | "The accessories of the device comply with IEC 60601-1 Subclause 56.3(c) as determined by 21 CFR Part 898: Performance Standard for Electrode Lead Wires and Patient Cables." | Specific compliance stated for accessories. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for any clinical test set involving patient data. The performance and safety testing described pertains to device-level engineering and software verification/validation, not a clinical efficacy or performance study involving human subjects and diagnostic outcomes. There is no mention of data provenance (e.g., country of origin, retrospective or prospective) for a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical test set involving human subjects for diagnostic accuracy is described, there is no information provided regarding the number of experts used or their qualifications for establishing ground truth. The device is a physiological signal amplifier, and its performance evaluation focused on its ability to accurately measure, amplify, and record signals, rather than its diagnostic capabilities per se.
4. Adjudication Method for the Test Set:
Given the nature of the described performance and safety testing (device-level engineering), an adjudication method for a clinical test set involving diagnostic outcomes is not applicable and not mentioned in the provided text.
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 conducted or described. The document focuses on the device's technical performance and safety, and its substantial equivalence to a predicate device, rather than its impact on human reader performance.
6. If a Standalone (Algorithm Only) Performance Study Was Done:
The Nomad device is described as a "digital amplifier" that measures, amplifies, and records physiological signals. The data is then analyzed by "dedicated Polysomnography software" and "a qualified sleep clinician." The document does not describe a standalone algorithm (i.e., AI or automated interpretation) within the Nomad device that would require an "algorithm only" performance study. The device's role is to acquire data for human interpretation using separate software. So, no standalone algorithm performance study was described or performed as it's not applicable to this type of device.
7. Type of Ground Truth Used:
For the device's performance testing (environmental, mechanical, electromagnetic, safety, and software verification), the "ground truth" was established by engineering specifications, industry standards (e.g., IEC 60601-1, 21 CFR Part 898), and internal product requirements. There is no mention of expert consensus, pathology, or outcomes data as ground truth for such testing.
8. Sample Size for the Training Set:
Since the Nomad device is a physiological signal amplifier and not an AI/machine learning diagnostic algorithm in the context of the provided text, the concept of a "training set" in the context of AI models does not apply. The described testing refers to verification and validation of hardware and software functions. Therefore, no sample size for a training set is provided.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for an AI/machine learning model described, this question is not applicable. The ground truth for the device's technical specifications and compliance was based on established engineering principles, regulatory standards, and internal product definitions.
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).