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ELAN® is a digital 12 channel electrocardiograph designed for acquisition and digitization of conventional diagnostic 12-lead simultaneous ECG waveforms and ECG data and real-time visualization of 1 to 6 leads on its built-in LCD monitor. ELAN® can also record and store in its internal memory up to 100 ECG tests. Each ECG test can be analyzed, printed on the internal thermal printer and/or sent to a PC via serial cable, LAN or modem. ELAN® can perform automatic measurements of ECG waveform and preliminary interpretation of ECG test; measurements and diagnostic statements are offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation.

ELAN® is a digital 12 channel electrocardiograph for the simultaneous acquisition of the 12 ECG leads, featuring 6-lead LCD screen, alphanumeric keyboard and high resolution thermal printer on 210 mm paper. ELAN ® can record and store in its internal memory up to 100 ECG tests. Each ECG test can include patient data, ECG measurements, automatic interpretation, physician report. Stored ECG tests can be reviewed, printed on the internal thermal printer and/or sent to a local or remote PC via serial cable, LAN network or external standard modem.

The provided text describes a 510(k) submission for the ELAN® Digital 12 Channel Electrocardiograph, aiming to establish substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, typically without requiring extensive new clinical studies. Therefore, the information provided focuses on technical specifications and functional comparisons rather than detailed performance studies with acceptance criteria in the same way one might find for a novel AI/ML device.

However, based on the document's content, we can infer acceptance criteria for "substantial equivalence" and report the device's characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are implied to be that the new device's specifications and performance are comparable to the predicate device. The following table directly compares the ELAN® device to its predicate, the M1770A Pagewriter 200i, for various technical specifications. The acceptance criterion for each specification is, therefore, that the ELAN® device's value is either the same as, or functionally equivalent or superior to, the predicate device.

Study Information

The provided text describes a 510(k) submission, not a detailed clinical study demonstrating the performance of a novel AI/ML device against specific acceptance criteria. A 510(k) aims to establish "substantial equivalence" to a predicate device. The study that "proves the device meets the acceptance criteria" in this context is the comparison against the predicate device based on technical specifications and functional performance.

The document states: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." and "After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Remco Italia S.p.A. that the ELAN® Digital 12 Channel Electrocardiograph is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

1. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not explicitly stated in terms of patient ECGs. The "test set" for this type of submission generally refers to the device itself undergoing various technical and functional evaluations (bench testing, electrical safety, EMC, user testing).
• Data Provenance: Not specified as retrospectively or prospectively collected patient data. The "user testing" mentioned might involve evaluation by clinical users, but details on the data (e.g., origin, number of cases) are not provided.

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

• Not applicable in the context of this 510(k) submission for an electrocardiograph. The "ground truth" for establishing substantial equivalence primarily relies on objective technical specifications and functional comparisons against the predicate device, rather than expert interpretation of a diagnostic output for a classification task. The device does perform "preliminary interpretation of ECG test" which is "offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation," indicating that physician review (expert input) is part of its intended use but not the primary method for establishing ground truth for the 510(k) comparison.

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

• Not applicable. This device is not being evaluated for a diagnostic accuracy task that would require expert adjudication of findings. Its performance is assessed against technical specifications and comparison with a predicate device.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device, while performing "automatic measurements of ECG waveform and preliminary interpretation," is explicitly stated as providing advisory statements that require physician review and validation. The submission does not claim to improve human reader performance but rather provides automated interpretation as an advisory tool.

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

• The device performs "automatic measurements of ECG waveform and preliminary interpretation of ECG test." This represents a form of standalone algorithmic performance. However, the regulatory submission does not detail the validation of this specific algorithmic performance against a ground truth, as it is presented as "advisory basis only" requiring physician validation. The "standalone" evaluation, in this context, is primarily against the performance characteristics of the predicate device's interpretation capabilities.

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

• For the purpose of substantial equivalence, the "ground truth" is typically the established technical and functional performance of the legally marketed predicate device. For the internal "preliminary interpretation," the document does not specify how the ground truth was established for the development of that algorithm, only that its outputs are advisory and subject to physician validation.

7. The sample size for the training set:

• Not applicable/Not provided. The document does not describe the development of a novel machine learning algorithm that would have a distinct training set. The "interpretation" functionality would have been developed based on existing ECG knowledge and algorithms, but details of a specific training set size are not part of this 510(k) submission.

8. How the ground truth for the training set was established:

• Not applicable/Not provided. As no specific training set for a novel AI/ML algorithm is described, the method for establishing its ground truth is not detailed in this document.

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The Click Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below:
a) Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
b) Evaluation of ECG documenting therapeutic interventions in individual patients or group of patients.
c) Evaluation of patient's ST segment alterations.
d) Patient follow up after M.I. or cardiac surgery.
e) Clinical and epidemiological studies
f) Pace maker evaluation
g) Time or Frequency domain heart rate variability analysis
h) Qt interval analysis

Click Holter is a personal three channels Ambulatory ECG recorder characterized by the following features:

• Up to 48 hours continuous ECG recording on three independent leads
• USB port for fast download of recorded data
• Possibility to store patient data in the recorder via USB port

The provided document is a 510(k) premarket notification for a medical device called "Click Holter," an ambulatory ECG recorder. It does not contain specific acceptance criteria, study data proving the device met those criteria, or details regarding sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on establishing substantial equivalence to a predicate device (DXP1000 Holter recorder) through a comparison of technical characteristics and compliance with recognized safety and performance standards.

Here's a breakdown of the information that is available related to your request, and where the document is lacking:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds. The "acceptance" is implied through the successful completion of standard compliance tests and demonstrating substantial equivalence to the predicate device.
• Reported Device Performance: The document lists the specifications and features of the Click Holter and compares them against the predicate device DXP1000. This comparison serves as the basis for claiming similar performance.

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

• Not specified. The document states that "Full safety tests according to IEC 601-1 / EN60601-1 Standard and performances tests according to IEC 601-2 47 / EN 601-2-47 and AAMI EC 38 1994 Standard have been performed on Click Holter." These are standard compliance tests, not clinical performance studies with specific patient test sets.

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

• Not applicable. This device is an ambulatory ECG recorder without analysis. There's no AI algorithm performing diagnosis or measurement that would require expert-established ground truth for a test set in the context of this 510(k). The regulatory submission focuses on the safety and technical performance of the recording device itself, not an interpretive algorithm.

4. Adjudication method for the test set:

• Not applicable for the same reasons as point 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:

• No. This device does not include AI for analysis, so an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

• No. This device is a data acquisition device, not an algorithm.

7. The type of ground truth used:

• Not applicable. The tests performed are engineering and electrical safety/performance tests (e.g., electrical safety, electromagnetic compatibility, accuracy of recording parameters as per standards like AAMI EC 38). The "ground truth" for these types of tests would be established by reference to calibrated test equipment and standard methodologies, not medical expert consensus or pathology.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable.

In summary: The provided document is a regulatory submission for a Class II medical device (ambulatory ECG recorder without analysis). The "acceptance criteria" and "study" described are in the context of demonstrating substantial equivalence to a predicate device and compliance with recognized industry standards for device safety and technical performance, rather than clinical performance or algorithmic accuracy as would be seen for devices with diagnostic algorithms. Therefore, many of the requested details related to "acceptance criteria" and "study" in your prompt (which often apply to AI/ML or diagnostic devices) are not present in this type of submission.

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