(260 days)
For adult use. The Gereonics Ultra-Piezo Limb Movement Sensor (LMS) is used to detect periodic limb movements for recording or monitoring on a physiological amplifier. The LMS is intended for use in sleep disorders studies.
The Pro-Tech predicate device and the Gereonics Ultra-Piezo Limb Movement Sensor (LMS) utilize a piezo disc (sometimes referred to as a piezo element, diaphragm or bender). There is no external voltage supply -- the sensor directly converts motion to voltage. The piezo disc and output resistor convert minute taps to voltage. A lengthy lead wire extends from this assembly and terminates with two electrode style safety connectors. The LMS is applied to the patients limb using 3M Coban LF Latex Free Self-Adherent Wrap. The sensor is reusable and the self-adherent wrap is disposable. The predicate device is applied using a reusable Velcro strap with a pouch that holds the LMS.
The provided document describes the Gereonics Ultra-Piezo Limb Movement Sensor (LMS) and its comparison to a predicate device (Pro-Tech PLM SENSOR). The study conducted is primarily a comparative performance and temperature test to demonstrate substantial equivalence, rather than establishing specific acceptance criteria for a new clinical performance claim.
Here's a breakdown of the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative sense with specific thresholds that the device had to meet. Instead, the study aimed to show similarity to the predicate device.
| Feature/Test | Acceptance Criteria (Implicit - Similarity to Predicate) | Reported Device Performance (Gereonics LMS) |
|---|---|---|
| Comparative Performance Test: | Similar sensitivity and identical output pulse waveform to predicate device. | Peak to Peak Voltage Output: 600 millivolts (Predicate: 300 millivolts). Within normal variability of other test devices. |
| Output Pulse Waveform: Identical to predicate device on the test system, except for amplitude. | ||
| Identical signal waveform and sensitivity when attached to ankle and tapped on floor. | Signal Waveform and Sensitivity (Ankle Test): Identical to predicate device. | |
| Comparative Temperature Test: | Similar performance across temperature range of 8°C to 43°C. Similar temperature coefficient. | Temperature Coefficient: -6% per °C in the 20-30°C range (Predicate: -5% per °C). Performed similarly to predicate. |
| Electrical Design: | Essentially identical to predicate device. | Essentially identical to predicate device, with modification of output resistor value (50K vs 75K in predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the "test set" in terms of number of devices or number of human subjects. The comparative tests refer to "the Pro-Tech test unit" and "the Gereonics LMS." This implies a very small sample, likely one unit of each for the bench tests.
- Data Provenance: The study was conducted by Gereonics, Inc., the manufacturer of the device. The data is retrospective in the sense that it's a comparison to an existing predicate device. No country of origin for diverse patient data is relevant as human subjects data is not presented.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This study did not involve human expert review to establish ground truth for clinical cases. It was a bench-testing comparison of device performance.
4. Adjudication Method for the Test Set
Not applicable. There was no need for adjudication as the study focused on objective measurements from bench testing, not subjective interpretations of clinical data by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study's purpose was to demonstrate substantial equivalence through technical comparison, not to evaluate human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance assessment akin to an algorithm-only evaluation was implicitly done through the bench tests. The "Comparative Performance Test" and "Comparative Temperature Test" assessed the Gereonics LMS's direct output (voltage, waveform, temperature coefficient) and compared it to the predicate without human intervention in the signal interpretation.
7. Type of Ground Truth Used
The ground truth for this study was the performance of the predicate device (Pro-Tech PLM SENSOR) as measured through controlled bench tests and a simple "tapping on the floor" test. The goal was to show that the Gereonics LMS performed "similarly" or "identically" under these conditions.
8. Sample Size for the Training Set
Not applicable. This device is a passive, non-software-driven sensor. There is no "training set" in the context of machine learning or AI algorithms. Its function is based on piezoelectric principles, not learned from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this device, no ground truth needed to be established in this context.
§ 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).