(76 days)
The DR512 digital Holter recorder is intended for the recording and storage of long-term ECG data collected from ambulatory patients. The recorder is used under the order of a physician, who reviews the data after downloading and processing by a Holter playback system. The physician determines the presence of normal and abnormal ECG data during the events of the patient's daily activity.
The DR512 is a lightweight, compact, digital Holter recorder designed for ambulatory ECG applications. Three channels of ECG data are collected via a 5 or 7 lead wire set and silver-chloride electrodes. The recorder is battery powered to ensure electrical isolation of enclosure coated with an electromagnetic interference spray. The DR512 has internal calibration, and a patient activated event marker button. ECG data are collected for 24 hours.
Here's a breakdown of the acceptance criteria and the study information for the DATRIX DR512 Digital ECG Holter Recorder, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list "acceptance criteria" for the device, but rather describes a series of comprehensive tests performed to ensure the device met its "design specifications." Therefore, the "acceptance criteria" below are inferred from the tests conducted, and the "reported device performance" is a summary of the general findings.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Analog Hardware Verification: | |
| - ECG amplifier frequency response verification | Tested and shown to conform to design specifications. |
| - ECG amplifier amplification verification | Tested and shown to conform to design specifications. |
| - ECG amplifier common mode rejection ratio verification | Tested and shown to conform to design specifications. |
| - Voltage converter functionality | Tested and shown to conform to design specifications. |
| - Event button circuits functionality | Tested and shown to conform to design specifications. |
| - Battery polarity detection and handling | Tested and shown to conform to design specifications. |
| - Visual inspection of all parts | Visual inspection made. |
| Digital Hardware Verification: | |
| - RAM write-read functionality verification | RAM was functioning, data, address, and control lines were connected correctly, and the microcontroller was functioning. |
| Firmware Verification: | |
| - Flash disk control | Tested and shown to conform to design specifications. |
| - A/D conversion and sampling rate accuracy | Tested and shown to conform to design specifications. |
| - Compression-decompression algorithm functionality and accuracy | Tested with line segment data, calibration signals, and simulated ECG waveforms, conforming to design specifications. |
| Bench and Subject Testing: | Validated using both bench and subject testing. |
| Compatibility with Playback Systems: | Independently tested and shown to be compatible with commercially available playback systems. |
| Response to Improper Use: | Recorder responded appropriately to improper insertion of the flash card, improper termination of recording, improper insertion of the battery, and low battery. |
| Beep Functionality: | Beeps indicating proper functioning of the recorder were tested. |
| Environmental Performance: | Environmental tests (temperature, humidity, altitude, shock, EMC) were conducted to verify operating ranges. Results indicated accurate, consistent, and repeatable performance to design specifications. |
| Overall Performance (Summary from submission): | "Accurate and consistent device, with repeatable performance." "Performed to design specifications, and is suitable for ECG applications with ambulatory patients." |
| Year 2000 Compliance: | "Will continue to function properly regardless of the date." All time functions based on elapsed time from start of recording. Test devices had no date function or were tested to ensure no effect on quality or safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the number of subjects or the specific sample size used for the "subject testing" mentioned. It only refers generally to "subject testing."
- Data Provenance: The document does not specify the country of origin of the data. It mentions "subject testing," which is generally prospective, but no further details are provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the document. The study focuses on the technical performance and accuracy of the device itself rather than its diagnostic interpretation by humans.
4. Adjudication Method for the Test Set
- This information is not applicable/not provided. The study tested the recorder's technical performance and data recording capabilities, not direct diagnostic output requiring adjudication of human-interpreted results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The submission describes testing the technical specifications and functionality of the recorder, not evaluating the diagnostic performance of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- Yes, in effect, a standalone study was performed in terms of the device's technical functionality. The testing detailed (analog and digital hardware verification, firmware testing, compression algorithms, environmental tests) assessed the device's performance purely as a recording instrument, independent of human interpretation or a "human-in-the-loop" for its operation. The device's primary function is to record and store data, which is then processed by a separate "Holter playback system" and reviewed by a physician. The study confirmed the accuracy of this recording and storage.
7. The Type of Ground Truth Used
- The "ground truth" for the various tests was primarily based on:
- "Design specifications": The device's performance was measured against its intended technical specifications.
- Known input signals: For example, compression algorithms were tested with "line segment data, calibration signals, and simulated ECG waveforms," where the expected output would be known.
- Expected functional responses: For tests like event button circuits, battery polarity, RAM write-read, and environmental tests, the "ground truth" was whether the device performed as designed and expected under specific conditions.
- Compatibility with existing systems: For playback systems, the ground truth was successful data transfer and processing.
8. The Sample Size for the Training Set
- This information is not provided and is likely not applicable in the context of this device. The DR512 is a hardware recorder with firmware, not a machine learning or AI algorithm that requires a "training set" in the typical sense for diagnostic purposes. The firmware and algorithms (e.g., compression) would have been developed and tested against engineering specifications and simulated data during design, rather than "trained" on a dataset.
9. How the Ground Truth for the Training Set Was Established
- As a "training set" in the machine learning context is not applicable, the ground truth for any internal development or testing of firmware/algorithms was established based on engineering specifications, mathematical models, and known characteristics of ECG signals and data compression techniques.
§ 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).