(30 days)
The DMS 300-7 Holter ECG recorder is intended to acquire, record, and store up to 24-hours of three (3) channel ECG data for patients undergoing continuous ambulatory electrocardiography. The DMS 300-7 performs no cardiac analysis by itself and is intended to be used with the DMS Premier Holter system. In turn, the cardiac data and analysis provided by the Premier Holter system will be used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
The DMS 300-7 is indicated for use in a clinical setting, by qualified medical professionals only, for recording 3-channel ECG data of patients requiring ambulatory 24-hour monitoring. Holter ECG is appropriate for the indications below:
.Evaluation of adult patients with symptons suggesting arrhythmia
.Evaluation of adult patients with pacemakers
.Evaluation of patients with suspected abnormal heart rate changes
.Evaluation of patients with suspected abnormal QRS interval changes
.Evaluation of patient response to drug therapy treatment
The modified DMS 300-7 Holter ECG recorder is intended for use as a part of a Holter analysis system and is designed to be used with the DMS Premier Holter system. The DMS 300-7 provides three (3) channels of continuous ECG recorded over a 24-hour time period. The DMS 300-7 acquires, digitizes, and stores data to be later analyzed by the Premier Holter system. The Premier Holter system processes pre-recorded patient 3-channel ECG data that has been stored in the DMS 300-7. The cardiac data provided by the DMS 300-7 recorder and the Premier Holter system is used by trained medical personnel to assist in the diagnosis of patients with various ECG rhythm patterns.
The DMS 300-7 is a 3-channel ECG recorder that uses either a five (5) or seven (7) electrode ECG cable, as is the same with the predicate Model 300 ECG Recorder. The five (5) electrode ECG cable records a modified V1, V3, Lead II ECG recording. The seven (7) electrode ECG cable records three (3) bipolar leads, and can be used for an XYZ recording. A patient activated ECG Event button can be pressed by the patient to flag a symptomatic cardiac event ECG, as is the same with the predicate Model 300 ECG Recorder.
The DMS 300-7 uses a single AA alkaline battery as its power source, and stores acquired ECG data on a removable, non-volatile memory compact flash card. Stored ECG data is then downloaded to the hard disk drive of the Premier Holter system via a standard PCMCIA reader interface. The recorded data will remain in memory until it has been cleared by the clinician.
Here's a breakdown of the acceptance criteria and study information for the DMS 300-7 Holter ECG Recorder, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes the DMS 300-7 Holter ECG Recorder as substantially equivalent (SE) to its predicate devices, primarily the DMS 300 ECG Recorder (K923664) and the Datrix DR512 Holter Recorder (K982975). The basis for this equivalence is that "testing of the device with the same input signals produces the same results in the processing of the data with the same Holter playback device."
The acceptance criteria are implicitly defined by the specifications of the predicate devices. The study performed aims to demonstrate that the DMS 300-7 meets these established specifications.
Table of Acceptance Criteria and Reported Device Performance:
| Specification | Acceptance Criteria (Predicate Devices - 300 ECG Recorder / DR512) | DMS 300-7 Reported Performance | Meets Acceptance Criteria? |
|---|---|---|---|
| ECG Channels | 3-channel ECG | 3-channel ECG | Yes |
| Resolution | 8-Bit | 8-Bit | Yes |
| Recording Duration | 24-hours | 24-hours | Yes |
| Bandwidth | 0.05 to 100 Hz (300 ECG) / 0.05 to 50 Hz (DR512) | 0.05 to 100 Hz | Yes (at least for 300 ECG) |
| Common Mode Rej | > 60 db | > 60 db | Yes |
| Power Source | 9V (300 ECG) / 9V or AA alkaline (DR512) | AA alkaline | Yes (matches DR512 option) |
| Average Current Drain | 9 mA (300 ECG) / 5 mA (DR512) | 5 mA | Yes (matches DR512) |
| Event ECG Button | Yes | Yes | Yes |
| Operating Temp | 0 to 50 C (300 ECG) / 0 to 60 C (DR512) | 0 to 60 C | Yes (matches DR512) |
| 1-MV Input | 1-CM square wave | 1-CM square wave | Yes |
| Dimensions | 5.20x2.90x1.16 in. (300 ECG) / 4.94x2.75x0.94 in. (DR512) | 4.94x2.75x0.94 in. | Yes (matches DR512) |
| Weight (w/o battery) | 8 oz. (300 ECG) / 4 oz. (DR512) | 4 oz. | Yes (matches DR512) |
| Processing System | Premier Holter system | Premier Holter system | Yes |
| ECG Data Transfer | PC's hard disk | PC's hard disk | Yes |
Study Proving Acceptance Criteria:
The document states: "The Final Test results of the predicate 300 ECG Recorder (K923664) and the modified submission device DMS 300-7, show that testing of the device with the same input signals produces the same results in the processing of the data with the same Holter playback device."
This indicates a functional equivalence test was performed rather than a clinical study with patients to evaluate diagnostic accuracy. The study focused on technical performance and data fidelity.
Detailed Study Information:
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as "test set" in terms of patient data. The study involved "the same input signals" but does not quantify how many unique signals or recordings were used.
- Data Provenance: Not specified. It's an engineering or laboratory test using standardized input signals, not real-world patient data in this specific context.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts & Qualifications: Not applicable. The "ground truth" for this engineering test would be the known characteristics of the "same input signals" used to test both devices. This is a technical comparison, not a diagnostic accuracy study requiring expert human interpretation for ground truth.
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Adjudication method:
- Method: Not applicable. This was a direct comparison of output data from two devices given the same input, to verify identical processing. No subjective interpretation or adjudication by multiple individuals is mentioned.
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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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a Holter recorder, which acquires and stores data; it does not perform cardiac analysis itself. It is intended to be used with the DMS Premier Holter system for processing, which then provides data to trained medical personnel. The document focuses on the equivalence of the recorder's data acquisition and storage, not on the diagnostic performance of the overall system or human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: The document states, "The DMS 300-7 performs no cardiac analysis by itself and is intended to be used with the DMS Premier Holter system." Therefore, a standalone performance study of an algorithm within the recorder itself was not conducted, as the recorder does not contain such an algorithm. The study was a comparison of the recorder's output given specific inputs.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For the "testing of the device with the same input signals," the ground truth would be the known characteristics of these input signals themselves. This is a technical validation against a defined standard or reference waveform, not a clinical ground truth like pathology or expert consensus on patient data.
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The sample size for the training set:
- Training Set Size: Not applicable. This device is a data acquisition and storage device, not a machine learning or AI algorithm that requires a training set.
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How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable, as there is no training set for this device.
§ 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).