(132 days)
Curvus Sensor - Recorder: Curvus Regular Holter is intended to record single lead (channel) surface ECG data and accelerometer data from ambulatory patients (Holter) for a period of up to 72 hours (3 days). Recorded ECG data are intended to be analyzed by Curvus Analyzer. The Sensor and Recorder are intended for use outside of the hospital. Curvus software suite: Curvus Examiner is intended to program set up and closure of examination, while Curvus Analyzer analyzes the retrieved data from the examination. The system is intended to be used by trained operators under the direct supervision of a trained Health Care Practitioner in a hospital or a clinic environment.
The Curvus Regular Holter System is a wireless mobile system for collecting a 1-lead electrocardiogram from a patient and to present the results to medical personnel such as cardiologists with the purpose to assist them to diagnose arrhythmias (heart rhythm irregularities). The Curvus Regular Holter System consists of a set of functional units including software: - Curvus ECG Sensor to be applied to the patient's chest to measure ECG signal . - Curvus ECG Recorder a hand-held device to store monitored data . - Curvus ECG Examiner and Curvus ECG Analyzer software programs to be used by . medical staff for setup and closure of patient examination and for diagnostic evaluation.
Here's a breakdown of the acceptance criteria and study information for the Curvus Regular Holter System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices through a comparative table of specifications and features, rather than explicitly stating acceptance criteria and then demonstrating performance against them. Therefore, the table below will reframe the "acceptance criteria" as the comparable features and specifications of the predicate devices against which the Curvus Regular Holter System is being evaluated for substantial equivalence. The "Reported Device Performance" will be what is stated for the Curvus Regular Holter System.
| Acceptance Criteria (Predicate Device Specification/Feature) | Reported Device Performance (Curvus Regular Holter System) |
|---|---|
| Physiological parameters: ECG, Heart Rate, Activity (for Nuvant), Heart rate (for Vista Plus) | ECG, Heart Rate, Activity |
| Displays findings in Real Time: No (Vista Plus), Yes (Nuvant) | No |
| Number of channels: 1-3 (Vista Plus), 1 (Nuvant) | 1 |
| Number of electrodes (sensor): 3 (Vista Plus), 1 (Nuvant) | 1 (wireless), disposable sensor |
| Recording duration: Up to 264 h (Vista Plus), Not known (Nuvant) | 72 hours |
| Communication between sensor and recorder: Wires (Vista Plus), Bluetooth Technology (Nuvant) | Radiofrequency Technology |
| Sampling rate: 200 Hz (Vista Plus), Not known (Nuvant) | 250 Hz |
| Resolution: 10 (Vista Plus), Not known (Nuvant) | 12 |
| Dynamic range: +/- 6 mV (Vista Plus), Not known (Nuvant) | +/- 6 mV |
| Bit resolution: 12 uV (Vista Plus), Not known (Nuvant) | 12 uV |
| Memory type: CF card (Vista Plus), In sensor (Nuvant) | In recorder |
| Recording Full disclosure: Yes (Vista Plus), No (Nuvant) | Yes (All data can be retrieved via USB after examination) |
| Real time built in analysis: Yes, real time HR calculation (Vista Plus), In sensor for transmissions of irregular events (Nuvant) | Yes, HR analysis for real time viewed in Examiner (when connected via USB) |
| Patient trigger feature: Patient event key + voice recorder (Vista Plus), Activated by using a magnet over the sensor (Nuvant) | Patient Event Button on recorder |
| Pacer pulse detection and reporting: Yes (Vista Plus), No (Nuvant) | No |
| Replay and analysis system: Yes, Holter Soft Ultima (Vista Plus), Yes, telephonic transmission to Corventis server and analysis center (Nuvant) | Yes, viewed in Curvus Examiner and Analyzer |
| PC based: Yes (Vista Plus, Nuvant) | Yes |
| OS compatibility: Windows 98, NT, XP (Vista Plus), Not known (Nuvant) | Windows XP |
| Input data: CF card (Vista Plus), GSM transmitted data (Nuvant) | USB |
| Event list display: Yes (Vista Plus, Nuvant) | Yes |
| Arrhythmia detection: Yes (Vista Plus, Nuvant) | Yes |
| ECG strip edition and printing: Yes (Vista Plus, Nuvant) | Yes |
| QT-, HRV-, A-fib- analysis: Yes (Vista Plus), Not known (Nuvant) | No |
| ST analysis: Yes, multichannel (Vista Plus), No (Nuvant) | No |
| Archiving: Yes (Vista Plus, Nuvant) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary states: "The Curvus Regular Holter System has been verified and validated according to the required specifications." However, it does not provide specific details about the sample size used for a test set or the provenance of the data (e.g., country of origin, retrospective or prospective). The validation mentioned appears to be related to meeting internal specifications rather than a clinical performance study using a defined test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. There is no mention of a ground truth established by experts for a specific test set.
4. Adjudication Method for the Test Set
No adjudication method is described as there is no detailed report of a performance study involving a test set with expert ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC comparative effectiveness study is mentioned. The submission is for a Holter system that assists medical personnel in diagnosing arrhythmias, but it does not describe a study on the impact of its software on human reader performance. In 2010, the "AI" component would likely have referred to signal processing algorithms for arrhythmia detection, rather than advanced machine learning as understood today.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document mentions that the Curvus Analyzer "analyzes the retrieved data from the examination" and that the system has "Arrhythmia detection". It also states "Yes, HR analysis for real time viewed in Examiner (when connected via USB)". This indicates that the software performs its analysis independently of a human during the initial processing of the recorded data. However, this is not a formal "standalone performance study" with specific metrics (e.g., sensitivity, specificity) reported for its algorithmic performance against a ground truth. It is simply a functional description of the software's capabilities.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not explicitly state the type of ground truth used for any performance evaluation of the arrhythmia detection capabilities. Given that this is a 510(k) submission primarily for substantial equivalence based on technical specifications and functionality, a detailed clinical study with a rigorously established ground truth (e.g., expert consensus on ECGs) is not described in this summary.
8. The Sample Size for the Training Set
There is no mention of a training set sample size. This type of information is typically provided for devices utilizing machine learning or AI models, which were not explicitly the focus of 510(k) submissions in 2010 in the same way they are today. The device likely relies on established signal processing algorithms rather than trainable AI models.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as there is no mention of a training set or ground truth for such a set.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.