(39 days)
Universal XactTrace is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The 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, or other test environments.
Universal XactTrace is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.
The Universal XactTrace is a small battery powered reusable respiratory effort sensor. It incorporates electronics to measure and process a respiratory effort signal to provide an electrical signal suitable for connection to the inputs of a physiological recorder.
The Universal XactTrace is composed of a sensor belt and a belt cable. The sensor belt has two types: abdomen belt that is applied around the patient's abdomen and thorax belt that is applied around the patient's thorax. The sensor belts are intended to be worn over clothing. The belt cable is used to connect the belt sensor to a physiological recorder.
The Universal XactTrace is powered by a non replaceable battery that is built in the buckle of the sensor belt and switches on/off when the buckle is connected/unconnected.
The Universal XactTrace is based on Respiratory Inductive Plethysmograph (RIP) technique.
Here's a breakdown of the acceptance criteria and the study information for the Universal XactTrace Ventilatory Effort Recorder, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and compliance with regulatory standards, rather than defining specific numerical performance acceptance criteria (e.g., sensitivity, specificity) for a clinical outcome.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety Standards Compliance | Conforms to IEC60601-1:1988+A1:1991+A2:1995 (Medical Electrical Equipment, General Requirements for safety). |
| EMC Compatibility | Conforms to IEC60601-1-2:2001 (Electromagnetic Compatibility - requirements and tests). |
| Cable and Lead Compliance | Conforms to CDRH Guidance Document on the "Performance Standard for Lead Wires and Patient Cables" March 9, 1998. |
| Signal Detection Reliability/Usability | Signals detected with Universal XactTrace were compared to signals detected with predicate devices (Crystal Trace Piezo Respiratory Effort Sensor and Summit IP), demonstrating "reliability and usability of the abdominal and thoracic respiratory effort signals measured." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "the signals detected with the Universal XactTrace were compared to signals detected with the predicate devices." This implies a comparison study, but the number of subjects or recordings used for this comparison is not provided.
- Data Provenance: Not explicitly stated. The context suggests that the testing was performed internally ("internal testing and verification") and externally by SEMKO. It does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The study described is a comparison of instrument signals, not a clinical study requiring expert ground truth for disease diagnosis. The ground truth for signal comparison would be the signals produced by the predicate devices themselves.
4. Adjudication Method for the Test Set:
- Not applicable. As described, the study is a technical comparison of signals rather than a diagnostic performance study requiring adjudication of clinical outcomes by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document describes a comparison of device signals to those of predicate devices, not an assessment of human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, a standalone study was performed in the sense that the device's signal output was directly compared to the predicate devices. The "algorithm" in this context refers to the device's internal processing of respiratory effort signals. The performance discussed is about the output signal's characteristics, not an AI-driven diagnostic interpretation.
7. Type of Ground Truth Used:
- The ground truth used for performance assessment was the signals generated by the predicate devices (Crystal Trace Piezo Respiratory Effort Sensor and Summit IP). The study aimed to show that the Universal XactTrace produced comparable respiratory effort signals.
8. Sample Size for the Training Set:
- Not applicable. This device is a sensor and signal processor, not an AI/machine learning algorithm that requires a training set in the conventional sense for diagnostic classification. The embedded software implies some signal processing logic, but this is likely rule-based or engineered, not a trained model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8. The device's functionality is based on Respiratory Inductive Plethysmography (RIP) technique and standard signal processing, not on a machine learning model trained with a ground truth dataset.
§ 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).