(205 days)
The DM-400 Holter ECG Cassette Recorder is a device designed for ECG recording of an ambulatory patient.
The Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder is a battery operated ambulatory ECG recording device. The DM-400 Holter Recorder is capable of recording three independent channels of ECG from an ambulatory patient. The patient is connected to the recorder by means of a 5 or 7 wire bonded lead set and silver/silver chloride self adhesive electrodes. The DM-400 Holter Recorder can perform either a 24 or 48 hour ECG recording. The recorder is equipped with self calibration and a patient event signal button.
Here's an analysis of the provided information regarding the Diagnostic Monitoring DM-400 Holter ECG Cassette Recorder, focusing on acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the performance testing of the DM-400 Holter ECG Cassette Recorder against its design specifications and to ensure it performs as intended with accuracy and repeatability. However, explicit, quantifiable acceptance criteria with pass/fail thresholds are not directly stated in the summary. Instead, the document frames the testing around verification of functionality and adherence to design specifications, and comparison to predicate devices.
Here's a table summarizing the areas tested and the reported performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality and adherence to design specifications | Met design specifications and performed as intended |
| Accuracy of ECG recording | Performed as intended with accuracy |
| Repeatability of ECG recording | Showed consistent results |
| Power supply and low battery features | Verified |
| Complete circuitry | Tested and verified |
| Unit calibration | Verified |
| ECG amplifier | Verified |
| Event signals | Tested |
| Baseline centering | Tested |
| Frequency response (0.05 to 100 Hz (-3dB)) | Tested (implicitly met, as it's a design spec shared with predicate devices) |
| Common mode rejection (60 dB minimum, 1 volt peak-to-peak 60 Hz) | Tested (implicitly met, as it's a design spec shared with predicate devices) |
| Motor Controller Circuit operation | Tested |
| Dynamic testing (electronic package with mechanical package) | Performed to assure correct function |
| 24-hour Calibration test | Performed |
| Visual inspection | Performed |
| Scanning verification | Performed |
| Performance within expected parameters of substantially equivalent devices | Confirmed that features and characteristics perform within expected parameters of predicate devices |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set. It mentions "units" in the plural ("units met the design specifications," "repeatability testing of the units").
- Data Provenance: The testing was performed by Diagnostic Monitoring, the manufacturer of the device. The data is prospective in the sense that it was generated specifically for the 510(k) submission to demonstrate the device's performance. The country of origin of the data is implicitly the USA, as the company is based in Irvine, CA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The testing described is primarily engineering and functional verification against design specifications, not clinical performance or diagnostic accuracy assessed by experts against a ground truth from patient data.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The testing performed was internal engineering and functional verification, not a clinical study requiring expert adjudication of results.
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
There was no MRMC comparative effectiveness study and no AI component mentioned in the document. The device is a Holter ECG cassette recorder, a hardware device for recording ECGs, not an AI-powered diagnostic tool. The comparison is made against existing predicate hardware devices to establish substantial equivalence in technical characteristics and intended use.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a hardware recorder, not an algorithm, and does not involve human-in-the-loop performance in the context of an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing described was primarily the device's own design specifications and the expected operational parameters of similar, legally marketed predicate devices. It involved functional checks and verification of engineering parameters such as frequency response and common mode rejection, rather than a clinical ground truth like pathology or expert consensus on clinical findings.
8. The Sample Size for the Training Set
This information is not applicable. The device is a hardware recorder, not an AI model, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As stated above, there is no AI model or training set involved.
§ 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).