(210 days)
The SE-2003/SE-2012 Holter System (including recorder and analysis software) is intended to record, analyze, display, edit and generate report of ambulatory ECG. The Holter System is intended to be used by trained personnel under the direction of doctors. The analysis results are offered to doctors on an advisory basis only. The Holter System is intended for adult, pediatric patients including infants weighing less than 10 kg.
It can be used for the following indications:
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- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
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- Evaluation of patients for ST segment changes.
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- Evaluation of drug response in patients taking anti-arrhythmic medications.
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- Evaluation of patients with pacemakers.
The Holter System, composed of a Holter recorder and Holter software, is designed to record and analyze continuous long-time (24-192 hours) ECG data. The Holter recorder contains lead wires and removable SD flash card to record ECG signals. The Holter software is installed in generally used PC to analyze recorded ECG data from Holter recorder. Typical recording time of Holter recorder powered by one AAA size battery with removable SD flash card is more than 24 hours up to 192 hours. Recorders are carried around by patients with a set of electrodes arranged by certain rules on them which are connected to recorders by lead wires. Patients are requested to come back to medical treatment site after recording time. The ECG data recorded in Holter recorders will be transferred into PCs and then analyzed, displayed and edited with the Holter software. An analysis report may be finally generated.
The provided text is a 510(k) Summary for the Edan Instruments, Inc. Holter System, models SE-2003 and SE-2012. It discusses the substantial equivalence to predicate devices and presents non-clinical performance data.
However, the document does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes for test and training sets for algorithmic performance, expert qualifications for ground truth, or adjudication methods that would typically be found in a study proving a device meets acceptance criteria for an AI/algorithm-driven device.
The "Performance Data" section details non-clinical testing related to safety (biocompatibility, electrical safety, EMC) and software verification/validation, but not the clinical performance of the Holter system's analytical capabilities in terms of accuracy for rhythm or other ECG interpretations.
Therefore, many of the requested items cannot be extracted from the provided text.
Based on the available information, here's what can be provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection) of the device's analytical software. It only states that "all the results show pass" for bench testing and compliance with safety and EMC standards.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility (ISO 10993-1) | All required tests passed. |
| Electrical Safety (IEC 60601-1:2005/A1: 2012) | Complies with the standard. |
| EMC (IEC 60601-1-2: 2007) | Complies with the standard. |
| Bench Testing (IEC 60601-2-47: 2012) | All results show pass. |
| Software Verification & Validation | Conducted and documented per FDA guidance; considered "moderate" level of concern. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document. The document states "Clinical data: Not applicable."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in the document.
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 provided in the document. The document states "Clinical data: Not applicable." This suggests no such clinical study was conducted or submitted for this 510(k).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not provide details on standalone algorithmic performance. It indicates that the "analysis results are offered to doctors on an advisory basis only," which implies a human-in-the-loop scenario, but does not quantify the algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not provided in the document.
8. The sample size for the training set
Not provided in the document.
9. How the ground truth for the training set was established
Not provided in the document.
Summary of what is present in the document versus what is requested for AI/algorithmic device evaluation:
The provided document focuses on demonstrating substantial equivalence primarily through comparisons of technical specifications and non-clinical safety testing (biocompatibility, electrical safety, EMC, and general software verification/validation) against predicate devices. It does not contain the detailed performance data for the analytical software's diagnostic capabilities that would be expected for a comprehensive evaluation of an AI-driven or algorithm-driven medical device, especially regarding its accuracy in ECG interpretation. The statement "Clinical data: Not applicable" confirms the absence of a clinical study assessing the device's diagnostic performance in patients.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).