(17 days)
The "Indications for Use" of the modified DMS 300-2, 300-3 and 300–4 recorders are indicated for use in a clinical setting, by qualified medical professionals only, for recording multi-lead ECG data of patients during a minimum ambulatory time period of 24-hours. It is not a life supporting system, and is not connected to an AC power source. The "Intended Uses" of the modified 300-2, 300-3, and 300-4 Holter ECG Recorders are exactly the same as the predicate devices (DMS 300-7 and 300 ECG Recorder).Ambulatory multi-day electrocardiography is used for the below indications:
. Evaluation of patients with symptoms suggesting arrhythmias.
- . Evaluation of patients with pacemakers.
. Evaluation of patient heart rate changes and QRS interval changes.
. Evaluation of patient response to drug therapy treatment.
The modified DMS 300-2 Holter ECG Recorder is intended for use as a part of a Holter ECG analysis system for continuous and cardiac event monitoring, and is designed to be used with the DMS Premier Holter system. The DMS 300-2 provides three (3) leads of continuous ECG recording. With its memory built into its circuit board, the 300-2 can store up to thirty (30) days of Long-Term Ambulatory ECG, whether it be continuous ECG or patient symptomatic event ECG data. The 300-2 acquires, digitizes, and stores ECG data that can be later analyzed by the Premier Holter system. Short-term, two-minute ECG's can also be phone transmitted from the Holter recorder to a host PC for symptomatic ECG's. The Premier Holter system processes pre-recorded patient ECG data that has been stored in the DMS 300-2. The cardiac data provided by the 300-2 and the Premier Holter system is used by trained medical personnel to assist in the diagnosis of patients with various ECG rhvthm patterns.
The modified DMS 300-3 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 300-3 provides three (3) channels of continuous ECG recording. With its memory built into its circuit board, the 300-3 can store up to two (2) days of continuous Holter ECG data. The 300-3 acquires, digitizes, and stores data to be later analyzed by the Premier Holter system. The Premier Holter system processes pre-recorded patient ECG data that has been stored in the DMS 300-3. The cardiac data provided by the 300-3 and the Premier Holter system is used by trained medical personnel to assist in the diagnosis of patients with various ECG rhythm patterns.
The modified DMS 300-4 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 300-4 provides twelve (12) leads of continuous ECG recording. With its memory built into its circuit board, the 300-4 can store up to two (2) days of continuous Holter ECG data. The 300-4 acquires, digitizes, and stores data to be later analyzed by the Premier Holter system. The Premier Holter system processes nre-recorded patient ECG data that has been stored in the DMS 300-4. The cardiac data provided by the 300-4 and the Premier Holter system is used by trained medical personnel to assist in the diagnosis of patients with various ECG rhythm patterns.
The provided document is a 510(k) notification for bundling Holter ECG recorders. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and testing results against those criteria in the way a clinical trial would.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment are not explicitly present in this type of regulatory submission. The document relies on comparing specifications and stating that "the same input signals produce the same results in the processing of the ECG data with the same Holter playback device." This implies a functional equivalence test rather than a clinical performance study with predefined accuracy or clinical endpoint targets.
Here's an attempt to answer the questions based on the information available:
1. A table of acceptance criteria and the reported device performance
The document doesn't define explicit acceptance criteria in terms of numerical performance thresholds (e.g., sensitivity, specificity for arrhythmia detection) as a clinical study would. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices. The performance is reported by showing that the new devices have identical or improved specifications compared to the predicates and produce the "same results in the processing of the ECG data."
| Feature/Specification | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (DMS 300-2, 300-3, 300-4) |
|---|---|---|
| ECG Leads | Must be 3-Lead ECG (for 300-2, 300-3) or justified if different | 300-2: 3-Lead ECG |
| 300-3: 3-Lead ECG | ||
| 300-4: 12-Lead ECG (justified as a modification with no significant safety/effectiveness impact) | ||
| Resolution | 8-Bit | 8-Bit |
| Recording Duration | Equivalent to or greater than predicate (24-hours) | 300-2: 30-days |
| 300-3: 48-hours | ||
| 300-4: 48-hours | ||
| Bandwidth | 0.05 to 100 Hz | 0.05 to 100 Hz |
| Common Mode Rejection | > 60 dB | > 60 dB |
| Power Source | Functionally adequate (AA Alkaline or 9V) | AAA Alkaline (change justified by reduced size) |
| Average Current Drain | Functionally adequate (5 mA or 9 mA) | 3 mA (improvement) |
| Event ECG Button | Yes | Yes |
| Operating Temperature | 0 to 60 C (or 0 to 50 C for one predicate) | 0 to 60 C |
| 1-MV Input | 1-CM square wave | 1-CM square wave |
| Dimensions | Size reduction compared to predicate (4.94 x 2.75 x 0.94 in or 5.20 x 2.90 x 1.16 in) | 2.90 x 2.16 x 0.75 in. (smaller) |
| Weight | Weight reduction compared to predicate (4 oz or 8 oz w/o battery) | 2 oz. w/o battery (lighter) |
| Processing System | Premier Holter System | Premier Holter System |
| ECG Data Transfer | PC's hard disk | PC's hard disk |
| Functional Equivalence | Produce the same results in processing ECG data with the same Holter playback device as the predicate. | "Testing of the devices with the same input signals produce the same results in the processing of the ECG data with the same Holter playback device." |
| Intended Use/Indications | Same as predicate devices | Same as predicate devices |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in terms of patient data. The testing described is functional testing on the devices themselves using "the same input signals." Therefore, there is no mention of a sample size of patients or data provenance (country of origin, retrospective/prospective). This is a technical performance comparison between devices, not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this type of submission is the functional output of the predicate device when given standard input signals. Clinical ground truth (e.g., verified diagnoses by experts) is not discussed.
4. Adjudication method for the test set
Not applicable. There's no clinical test set requiring adjudication in the context of this submission. The comparison is against known technical specifications and functional output of 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
Not applicable. This submission is for Holter ECG recorders, which are hardware devices for data acquisition, not AI-powered analysis tools. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a hardware device, not an algorithm. The device itself is "standalone" in recording ECG data, but the data is then processed by a "Premier Holter system" which is mentioned as part of the overall system. The focus is on the recorder's ability to acquire and store data equivalently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the comparison is the known and established functional output and specifications of the legally marketed predicate device (DMS 300-7 Holter ECG Recorder K062007) when subjected to the "same input signals." It's a technical equivalency rather than a clinical ground truth.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is relevant for this hardware 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).