(35 days)
The Click Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below:
a) Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
b) Evaluation of ECG documenting therapeutic interventions in individual patients or group of patients.
c) Evaluation of patient's ST segment alterations.
d) Patient follow up after M.I. or cardiac surgery.
e) Clinical and epidemiological studies
f) Pace maker evaluation
g) Time or Frequency domain heart rate variability analysis
h) Qt interval analysis
Click Holter is a personal three channels Ambulatory ECG recorder characterized by the following features:
- Up to 48 hours continuous ECG recording on three independent leads
- USB port for fast download of recorded data
- Possibility to store patient data in the recorder via USB port
The provided document is a 510(k) premarket notification for a medical device called "Click Holter," an ambulatory ECG recorder. It does not contain specific acceptance criteria, study data proving the device met those criteria, or details regarding sample sizes, expert ground truth establishment, or multi-reader multi-case studies.
The document primarily focuses on establishing substantial equivalence to a predicate device (DXP1000 Holter recorder) through a comparison of technical characteristics and compliance with recognized safety and performance standards.
Here's a breakdown of the information that is available related to your request, and where the document is lacking:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds. The "acceptance" is implied through the successful completion of standard compliance tests and demonstrating substantial equivalence to the predicate device.
- Reported Device Performance: The document lists the specifications and features of the Click Holter and compares them against the predicate device DXP1000. This comparison serves as the basis for claiming similar performance.
| Parameter | Click Holter (Reported Performance - Implicit Acceptance) |
|---|---|
| Storage capacity | Up to 48 hours |
| Memory type | Flash (non-volatile) |
| Memory portability | Non removable |
| On-board ECG analysis | No |
| Liquid Crystal Display (LCD) | No |
| Led indicators | Yes |
| Data Transfer method | USB port |
| Pacemaker detection & reporting | Yes |
| Battery | Two AA |
| Size | 11 x 8 x 1.5 cm |
| Weight | 149 gr |
| Continuous ECG recording | Up to 48 hours on three independent leads |
| Fast data download | Via USB port |
| Patient data storage | Via USB port |
2. Sample size used for the test set and the data provenance:
- Not specified. The document states that "Full safety tests according to IEC 601-1 / EN60601-1 Standard and performances tests according to IEC 601-2 47 / EN 601-2-47 and AAMI EC 38 1994 Standard have been performed on Click Holter." These are standard compliance tests, not clinical performance studies with specific patient test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is an ambulatory ECG recorder without analysis. There's no AI algorithm performing diagnosis or measurement that would require expert-established ground truth for a test set in the context of this 510(k). The regulatory submission focuses on the safety and technical performance of the recording device itself, not an interpretive algorithm.
4. Adjudication method for the test set:
- Not applicable for the same reasons as point 3.
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:
- No. This device does not include AI for analysis, so an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a data acquisition device, not an algorithm.
7. The type of ground truth used:
- Not applicable. The tests performed are engineering and electrical safety/performance tests (e.g., electrical safety, electromagnetic compatibility, accuracy of recording parameters as per standards like AAMI EC 38). The "ground truth" for these types of tests would be established by reference to calibrated test equipment and standard methodologies, not medical expert consensus or pathology.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is a regulatory submission for a Class II medical device (ambulatory ECG recorder without analysis). The "acceptance criteria" and "study" described are in the context of demonstrating substantial equivalence to a predicate device and compliance with recognized industry standards for device safety and technical performance, rather than clinical performance or algorithmic accuracy as would be seen for devices with diagnostic algorithms. Therefore, many of the requested details related to "acceptance criteria" and "study" in your prompt (which often apply to AI/ML or diagnostic devices) are not present in this type of submission.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).