(367 days)
The Transoma Medical Sleuth Implantable ECG Monitoring System is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:
- patients with clinical syndromes or situations at increased risk of cardiac arrhythmias or .
- patients who experience transient symptoms that may suggest a cardiac arrhythmia.
The Transoma Medical Sleuth Implantable ECG Monitoring System is designed to measure and store the patient s electrocardiogram (ECG) during symptomatic and asymptomatic events. The Sleuth System consists of the Model 2010 Implantable Monitoring Device (IMD), the Model 4000 Activator, and the Model 5000 Base Station (Bluetooth Modem). The IMD is an anatomically-shaped Litanium structure which is implanted subcutancously, typically in the left pectoral region. The Activator is a hand-held device carried by the patient.
The IMD continuously measures the R-R interval and automatically stores ECG segments when this interval falls outside of pre-defined limits. Using the Activator, the patient can also request storage of ECG segments when symptoms are experienced. The IMD stores a limited quantity of events, which are · ansferred to the Activator via telemetry throughout the day. On a daily basis, the Activator transfers events through the Base Station to a service center for review and analysis.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:
Note: The provided text is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting formal acceptance criteria and a detailed study report for meeting those criteria. Therefore, explicit "acceptance criteria" and "reported device performance" in a quantitative table format are not directly stated or fully detailed as they would be in a comprehensive study report. However, I will infer what can be gleaned about performance and success based on the summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred from Study Goals) | Reported Device Performance (Summary of Findings) |
|---|---|
| Diagnostic viability of ECG signals | ECG waveform data was analyzable and categorizable by the cardiac monitoring center. "Diagnostic viability" was achieved, with 13 patients discovered to have arrhythmias, and Sleuth records aiding diagnosis. |
| Performance of the system (overall function) | Successfully captured events initiated manually. |
| Successfully detected and recorded asymptomatic events automatically. | |
| Successfully stored and transferred trending data. | |
| Safety Profile | Occurrence of two adverse events in >4,700 patient days was "within expectation" and not serious or definitively linked to the Sleuth system. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 28 patients.
- Data Provenance: Prospective clinical study conducted at 4 major medical centers in Panama.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document states, "The cardiac monitoring center has been able to analyze and categorize the ECG waveform data." and "Sleuth records were important in helping the physicians arrive at a firm diagnosis."
- Number of Experts: Not explicitly stated. It refers to a "cardiac monitoring center" and "physicians." It's likely involved multiple clinical staff, but a specific count is not given.
- Qualifications of Experts: Not explicitly stated, but inferred to be medical professionals at a "cardiac monitoring center" and "physicians" capable of diagnosing arrhythmias from ECG data.
4. Adjudication Method for the Test Set
Not explicitly stated. The document mentions a "cardiac monitoring center" analyzing and categorizing data and "physicians" using the records to arrive at a diagnosis. This suggests a clinical interpretation process, but no specific adjudication method (e.g., 2+1, 3+1) is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not described. The study focused on the performance of the Sleuth device itself, not on comparing human readers with and without AI assistance from the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an "Implantable ECG Monitoring System" that automatically detects and records events. While it automatically detects asymptomatic events, the "cardiac monitoring center" and "physicians" are involved in the "analysis and categorization" of data and "diagnosis." The clinical study focused on the system's performance in a real-world clinical setting with human involvement in the final diagnostic step. Therefore, it implicitly includes human-in-the-loop for diagnosis, even though the device performs automatic detection. A purely "standalone" algorithm-only performance evaluation, separate from human interpretation, is not explicitly detailed.
7. The Type of Ground Truth Used
The ground truth appears to be based on expert consensus/clinical diagnosis derived from the analyzed ECG waveforms. The statement "thirteen of the patients were discovered during monitoring to have arrhythmias, and the Sleuth records were important in helping the physicians arrive at a firm diagnosis" indicates that the physicians' final diagnoses, informed by the Sleuth data, served as the clinical ground truth for arrhythmia detection.
8. The Sample Size for the Training Set
The document does not provide information about a separate training set. The clinical study described with 28 patients appears to be a validation or performance study, not a training study for the algorithm. It's likely the device's algorithms were developed and potentially trained on other, unspecified data prior to this validation study.
9. How the Ground Truth for the Training Set Was Established
Since no information on a training set is provided, the method for establishing its ground truth is also not described in this document.
§ 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).