(442 days)
The XactTrace® Single Use Respiratory Effort Belt System is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.
The intended environments are hospitals, institutions, sleep centers, sleep clinics.
The XactTrace® Single Use Respiratory Effort Belt System is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.
The XactTrace Single Use Respiratory Effort Belt System subject device applies Respiratory Inductive Plethysmography (RIP) Sensor Belts to support respiratory effort signals used in the diagnosis of sleep disorders or sleep related respiratory disorders. The XactTrace Single Use Respiratory Effort Belt System subject device supports a measure of changes in inductance as a result of changes in abdominal, thorax circumference.
There are two variations of the XactTrace® Single Use Respiratory Effort Belt System:
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XactTrace® Single Use Cut-to-Fit Respiratory Effort Belt System, and
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XactTrace® Single Use Pre-Sized Respiratory Effort Belt System.
The XactTrace Single Use Cut-to-Fit Respiratory Effort Belt variation consists of a single use disposable Sensor Belt and Locks (belt connectors) with a cable that connects to a recording device. The system supports conversion of changes in inductance to a digital signal that provides both qualitative information of respiratory effort. The Sensor Belt of the XactTrace Single Use Cut-To-Fit Belt variation is cut by the medical professional to appropriate lengths to fit patient abdomen, thorax circumference.
The XactTrace Single Use Pre-Sized Respiratory Effort Belt variation consists of a single use disposable Sensor Belt and Snap Sensors (Sensor Belt connectors) with a cable that connects to a recording device. The XactTrace Single Use Pre-Sized Respiratory Effort Belt variation supports conversion of Sensor Belt changes in inductance to a signal that provides both qualitative and quantitative information of respiratory effort. XactTrace Single Use Pre-Sized Respiratory Effort belts are available in four sizes: Pediatric, Small, Medium and Large.
An optional Inductive Interface Cable (RIP Processor) is available to interface with PSG systems that accept the 1.5mm female touchproof connectors, and do not have internal RIP Sensor Belt technology.
Both variations of XactTrace Respiratory Effort Belts are interfaced with either an optional external Inductive Interface Cable or a RIP technology compatible Embla PSG system amplifier. Compatible Embla amplifiers are identified by keyhole connectors for Sensor Belt input.
Here's an analysis of the acceptance criteria and study detailed in the provided FDA 510(k) summary for the XactTrace Single Use Respiratory Effort Belt System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Requirement | Reported Device Performance (Result) |
|---|---|
| Dimensional requirements | Pass |
| Lock and Snap Sensor compatibility | Pass |
| Compatibility with Inductive Interface Cable and RIP technology compatible Embla PSG recording system input connections, key connector inputs | Pass |
| Resistance of XactTrace Single Use Cut-to-Fit Effort Belt, variation of XactTrace Single Use Respiratory Effort Belt System | Pass |
| Resistance of XactTrace Single Use Pre-Sized Effort Belt, variation of XactTrace Single Use Respiratory Effort Belt System | Pass |
| Cleaning of reusable Snap Sensor and Locks | Pass |
| Operational temperature and humidity range | Pass |
| Equivalence of breathing effort signal output (compared to primary predicate Universal XactTrace for both Embla amplifier and Inductive Interface Cable) | Pass |
| Equivalence of breathing effort signal output for same displacement of both XactTrace Single Use Sized Effort Belt, variations (Cut-to-Fit vs. Pre-Sized) | Pass |
| EMC compliance with Inductive Interface Cables | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of human subjects or clinical data. The performance testing described is primarily bench-level evaluations.
Therefore:
- Sample size: Not applicable in the traditional sense of a clinical test set. The tests involved components and systems.
- Data provenance: Not applicable in the context of country of origin or retrospective/prospective clinical data. The data originates from laboratory/bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The reported performance tests are engineering and bench performance evaluations, not clinical studies requiring expert interpretation of ground truth in patient data.
4. Adjudication Method for the Test Set
Not applicable, as this was not a clinical study involving human judgment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a respiratory effort belt system, not an AI or imaging device that would typically be evaluated with MRMC studies or involve human readers in that capacity.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The XactTrace system is a sensor that produces electrical signals for physiological recording equipment; it does not include an "algorithm" in the sense of an AI or automated diagnostic tool that would have standalone performance.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to established engineering specifications and the performance of the predicate device. For example:
- Dimensional requirements: Standard engineering measurements and specifications.
- Compatibility: Functional verification against established interface standards and predicate device behavior.
- Resistance: Direct electrical measurements against expected values.
- Equivalence of breathing effort signal output: Direct comparison of the electrical signal output from the new device and the predicate device under controlled conditions (e.g., same displacement).
- EMC compliance: Adherence to the IEC 60601-1-2, 4th edition standard.
Essentially, the ground truth is derived from engineering specifications, direct measurements, and comparative performance to the legally marketed predicate device under controlled bench conditions.
8. The Sample Size for the Training Set
Not applicable. The device is a hardware sensor system and does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 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).