(272 days)
The intended use of the Chroma Holter Recorder RZ153C is to perform ambulatory ECG on the order of a physician, on those patients who may benefit from such a recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers. The data obtained at recording is not analyzed at the time of the recording.
The basic operation of the Chroma Holter Recorder RZ153C is to collect and store multiple channels of ECG data. The Holter scanner software reads this data and it can be printed out in tabular form or graphical form. This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. It can only display and store the data. The Holter for Windows software reads this data and provides ability to the user to review, edit and print the data collected.
The provided text describes a 510(k) premarket notification for the ScottCare Chroma Holter Recorder RZ153C, comparing it to a predicate device, the DXP1000 Holter Recorder. However, the document does not contain specific acceptance criteria, quantitative performance metrics, or detailed study methodology in the way that would typically be presented for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through feature comparison and qualitative outcome of testing.
Here's an analysis based on the information provided, addressing your specific questions to the best of my ability with the given text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or performance metrics for the Chroma Holter Recorder RZ153C's functionality. The evaluation is based on demonstrating "substantial equivalence" to the DXP1000 Holter Recorder via comparison of features and functional outcomes.
| Feature / Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Chroma RZ153C) |
|---|---|---|
| Number of ECG Channels | 2 or 3 (Predicate DXP1000) | 3 |
| Sample Rate & Resolution | 128-1024Hz / 8 or 10 bit (Predicate DXP1000) | 128-1024Hz / 8, 10 or 12 bit |
| Input Voltage Range | +/- 5mV (Predicate DXP1000) | +/- 5mV |
| Analog Bandwidth | 0.05 to 60 Hz (Predicate DXP1000) | 0.05 to 40 Hz |
| Pacemaker Detection & Reporting | Yes (Predicate DXP1000) | Yes |
| Open-Lead Detection & Reporting | Yes (Predicate DXP1000) | Yes |
| Recording Time | Up to 72 hours (Predicate DXP1000) | Unlimited, based on memory capacity (implies at least 72 hours if memory allows) |
| Memory Type | Removable flash memory (CF card) (Predicate DXP1000) | Removable flash memory (SD card) |
| Memory Capacity | Up to 2.0GB (Predicate DXP1000) | Up to 2.0GB |
| Data Transfer Method | Removable memory card (Predicate DXP1000) | Removable memory card or USB |
| Memory Card Data Format | Standard FAT format (Predicate DXP1000) | Standard FAT format |
| Display | Monochrome LCD (Predicate DXP1000) | 262k color OLED |
| Keypad | Protected membrane switch keys (Predicate DXP1000) | Protected membrane switch keys |
| Number of keys | 5 (Predicate DXP1000) | 5 |
| Battery (Type) | 1 – 1.5V AA (Predicate DXP1000) | 1 - 1.5V AAA |
| Battery Check Prior to Recording | Yes (Predicate DXP1000) | Yes |
| Internal Clock with Battery | Yes (Predicate DXP1000) | Yes |
| Clock Setting Functionality | Yes (Predicate DXP1000) | Yes |
| External Patient Cable | Yes (Predicate DXP1000) | Yes |
| Record identification procedure | Yes (Predicate DXP1000) | Yes |
| ECG channel preview | Yes (Predicate DXP1000) | Yes |
| Signal quality check prior recording | Yes (Predicate DXP1000) | Yes |
| Multi-language support | Yes (Predicate DXP1000) | Yes |
| Autostart when ready | Yes (Predicate DXP1000) | Yes |
| Overall Performance (Qualitative) | Produce results substantially similar to DXP1000 | "produced results very similar to the DXP1000 Holter recorder" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "The Chroma Holter recorder RZ153C was tested alongside the DXP1000 Holter recorder in a number of situations, including simulated normal ECG signals, simulated paced ECG signals, and on-person ECG signals in laboratory tests."
- Sample Size: Not specified. The phrase "a number of situations" implies multiple tests but no specific count of patients, simulated signals, or recording durations.
- Data Provenance: Not specified. It mentions "laboratory tests" and "on-person ECG signals," implying some form of prospective data collection during testing, but details on location or patient demographics are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a Holter recorder, which collects and stores ECG data; it does not perform diagnosis or interpretation itself (as stated: "This recorder is not capable of any diagnosis nor can it provide any interpretation of the data."). The "Holter for Windows software" is mentioned as reading and providing the ability to review, edit, and print the collected data. Therefore, the concept of "ground truth established by experts" for the device's output (raw ECG data) is not applicable here in the same way it would be for an AI/CADe diagnostic device. The ground truth for its performance would be the accurate capture and storage of ECG signals, which was compared against a predicate device. No details on expert involvement for ground truth establishment for the test set are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a device that records physiological signals, not an interpretive AI system requiring adjudication of diagnostic outputs. The evaluation focused on the similarity of recorded data between the new device and the predicate.
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 such study was conducted or reported. This device is a data acquisition tool, not an AI/CADe system designed to improve human reading performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone Holter recorder. Its performance was assessed in "laboratory tests" by comparing its recorded output with that of a predicate device against "simulated normal ECG signals, simulated paced ECG signals, and on-person ECG signals." The assessment was qualitative ("produced results very similar").
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly used for the recorder's function would be the known characteristics of the "simulated normal ECG signals" and "simulated paced ECG signals," and the actual cardiac activity of the individuals providing "on-person ECG signals." The assessment compared the device's recorded output against the known inputs or the output of a trusted predicate device, rather than against an expert-adjudicated diagnostic label.
8. The sample size for the training set
This device does not use an "AI algorithm" or machine learning in the sense that would require a dedicated training set. It is a hardware device for recording physiological signals. Therefore, the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI algorithm.
§ 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).