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The "Intended Uses" of the modified 300-2W is exactly the same as the predicate device (model 300-2). The intended use is to acquire, record, and store one or more davs of multi-lead ECG data for patients undergoing continuous ambulatory electrocardiography. The 300-2 performs no cardiac analysis by itself and is intended to be used only with the DMS Premier II Holter system (K062088), as is the predicate 300-2 device.

The "Indications for Use" of the modified DMS 300-2W recorder is 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. Ambulatory 24-hour electrocardiography is used for the below indications:

• . Evaluation of patients with symptoms suggesting arrhythmias.
• Evaluation of patients with pacemakers. .
• Evaluation of patients heart rate changes.
• . Evaluation of patients QRS interval changes.
• · Evaluation of patients response to drug therapy treatment.

The "Indications for Use" for the modified 300-2W is exactly the same as the predicate 300-2 device.

The 300-2W is a Holter Recorder that records the ECG signal in the exact same manner as the predicate 300-2 device. The 300-2W transfers the Holter ECG from its memory in the exact same manner as the predicate 300-2. The 300-2W uses the same USB cable as is used by the predicate 300-2 to transfer the Holter file from the Holter Recorder to the Holter PC. The Holter PC program processes the 300-2W Holter ECG recording with the exact same software program as is used by the 300-2 predicate device. All of the Holter ECG screen displays and print pages are exactly the same when using either the 300-2W device or the 300-2 predicate device. The Holter report from which the physician makes a diagnosis is the exact same format when using either the 300-2W device or the 300-2 predicate device. The 300-2W uses the same firmware as the predicate 300-2 to record the Holter ECG data and to transfer the Holter recording to the Holter PC. The ECG signal in the 300-2W is the same ECG signal as the predicate 300-2. The Intended Uses of the 300-2W and the predicate 300-2 are the same. The Indications for Use of the 300-2W and the predicate 300-2 are the same. The Design Controls and Performance Standards for the 300-2W and the predicate 300-2 are from the same source processes. The manufacturing process has ISO 13485 certification.

The 300-2W and the predicate 300-2 are multi-day Holter recorders. Both the 300-2W and the predicate 300-2 use the same alkaline or lithium batteries that are off-the-shelf AA batteries. Both the 300-2W and the predicate 300-2 use off-the-shelf commercial memory chips. The 300-2W uses a larger capacity memory chip, and both recorders operate with the memory chip in the same manner. The larger commercial memory chips are now larger capacity and cost less money than 300-2 Holter ECG recorder of 2006. All Holter ECG recorders have auxiliary real-time ECG outputs. These auxiliary outputs have no effect on the safety, performance, Intended Use, or Indications for Use with either the 300-2W or the predicate 300-2. Both the 300-2W and the predicate 300-2 have two (2) auxiliary outputs. The traditional uses of these auxiliary outputs is to view the quality of the electrode application to the patient prior to leaving the doctor's office, or to see the operational ECG of the Holter recording. The 300-2W and the predicate 300-2 have the same USB auxiliary output. The 300-2W has a WiFi auxiliary output and the predicate 300-2 has a transtelephonic auxiliary output.

The provided text describes a Special 510(k) Notification for the DMS 300-2W Holter ECG Recorder, claiming substantial equivalence to its predicate device, the DMS 300-2. This type of submission focuses on minor modifications that do not affect the intended use, safety, or effectiveness of the device. Therefore, the document primarily details the lack of new performance studies because the modified device is considered to have identical performance to the predicate.

Given this, the acceptance criteria and study information typically found in a traditional 510(k) submission for a new device's performance are not present in this document. Instead, the "acceptance criteria" are effectively met by demonstrating that the modifications (larger memory and an additional auxiliary output) do not alter the fundamental characteristics or performance of the ECG recording and transfer process, which aligns with the predicate device that was previously cleared.

Here's a breakdown based on the information available, acknowledging the nature of a Special 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

The concept of specific "acceptance criteria" for performance in the traditional sense (e.g., accuracy, sensitivity, specificity for diagnostic claims) is not explicitly detailed for the 300-2W because its performance is asserted to be identical to the predicate 300-2. The acceptance criteria here are implicitly based on maintaining the same technical specifications and performance characteristics as the predicate.

The document states: "The 300-2W records the ECG signal in the exact same manner as the predicate 300-2 device," and "The ECG signal in the 300-2W is the same ECG signal as the predicate 300-2." "Both the 300-2W and the predicate 300-2 have successfully passed TUV Rheinland CE Test Reports for Holter Recorders." "The enclosed TUV CE Test Report 15030071 001 shows that the 300-2W Holter Recorder passed all the test specifications for EN 60601=1-2:2007."

2. Sample size used for the test set and the data provenance

No specific "test set" in terms of patient ECG data is described or used for this Special 510(k). The evaluation is based on engineering and performance testing against standards, confirming that the modified components do not alter the fundamental ECG signal acquisition or processing. The TUV CE Test Reports (Sections 12 and 13, and document 15030071 001) are mentioned for confirming compliance with electrical safety and EMC standards, which do not typically involve patient data test sets in this context. The provenance of such testing would be from accredited testing laboratories (e.g., TUV Rheinland).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As described above, there is no clinical "test set" requiring ground truth establishment by medical experts for this type of special 510(k). The submission relies on technical conformity to established standards and the assertion of identical performance to a previously cleared device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable for the same reasons as #3.

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. The device is a Holter ECG recorder, not an AI-assisted diagnostic tool. Its function is to record ECG data, not to perform analysis or integrate with AI for reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The 300-2W is a hardware device for recording ECGs, and its data is processed by the "Premier II Holter system" (K062088), a separate software component. The 300-2W itself does not perform analysis or have an "algorithm-only" performance to be evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical performance study involving diagnostic accuracy or clinical outcomes was conducted for this Special 510(k). The "ground truth" for the device's electrical and physical properties is its conformance to engineering standards (e.g., EN 60601=1-2:2007) as verified by testing.

8. The sample size for the training set

Not applicable. The device is a hardware recorder, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable for the same reasons as #8.

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