(331 days)
The SEER MC Ambulatory Digital Analysis Recorder is intended to provide ambulatory ECG signal and automated analysis of the recorded ECG data. Results of the automated analysis, when used in conjunction with an ECG review system, are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECC data. In addition, the SEER MC can record and analyze 12-lead ambulatory ECG data for definition of morphology shape and measurements, heart rate, rhythm, and ST segment trending. The SEER MC is intended for use on adult and pediatric (greater than 10Kg) patients in a clinical setting by qualified medical personnel.
The SEER MC in its 2 or 3 channel mode of operation detects the following: normal beats, ventricular beats, supraventricular beats, paced beats and artifact. This information with an ECG review system, documents the following: fastest and slowest heart rate, runs of ventricular beats, runs of supraventricular beats, pauses, ST segment changes, areas of atrial fibrillation, percentage of paced beats, prolonged QT, T-Wave Alternans, Heart Rate Turbulence, Heart Rate Variability and ECG strips associated with patient events and/or symptoms.
The SEER MC in its 12-lead mode of operation, in conjunction with a ECG Review system, documents the afforementioned information and also measures and trends the following 12 lead parameters: PR interval, QT interval, QRS diration, ST measurements at J point plus 40, 60 and 80 mseconds for all 12 leads and displays the Ventricular rate, and P, R and T axis for each 12-lead segment.
The SEER MC is not intended to be used as a substitute for a standard, diagnostic-quality 12-lead electrocardiograph.
SEER MC is a Holter Recorder designed to be used in conjunction with an ambulatory ECG system to assist in the diagnosis and assessment of patients. The SEER MC acquires, digitizes, stores and analyzes data for scanning and review by an ambulatory ECG review system. SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECG data. In addition, the SEER MC can record and analyze 12 lead ambulatory ECG data periodically or on demand. This analysis performs waveform measurements. These measurements are performed during recording for use in analysis and review within the ambulatory ECG review system.
The provided text is a 510(k) summary for the GE Medical Systems Information Technologies SEER MC Holter Recorder. It describes the device's intended use and claims substantial equivalence to predicate devices, but it does not contain acceptance criteria or a detailed study proving the device meets specific performance metrics beyond general safety and effectiveness.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The document states that the SEER MC "complies with the voluntary standards as detailed in Section 9 Test Summary: of this submission," but Section 9 is not included.
Here's an analysis of what can and cannot be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states, "The SEER MC complies with the voluntary standards as detailed in Section 9 Test Summary: of this submission." However, Section 9 (the Test Summary) is not provided in the input text. Thus, the specific acceptance criteria and detailed performance against those criteria are not available. The overall conclusion is that the device "is as safe, as effective, and performs as well as the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "Performance testing" and "Clinical use evaluation," but it does not specify any sample sizes, data provenance (e.g., country of origin), or whether the studies were retrospective or prospective.
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)
- Cannot be provided. The document does not describe the methodology for establishing ground truth for any testing performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. The document does not describe any adjudication methods.
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
- While the device includes an "automated analysis algorithm" and its results are "intended to assist the physician in the interpretation," the document does not describe an MRMC comparative effectiveness study directly comparing human readers with and without AI assistance, nor does it provide an effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device performs "automated analysis of the recorded data," and the analysis performs "waveform measurements." However, the text explicitly states the automated analysis is "intended to assist the physician" and "is not intended to serve as a substitute for the physician overread." While the algorithm performs analysis, the document does not detail a standalone performance study of the algorithm in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. The document does not specify how ground truth was established for any testing.
8. The sample size for the training set
- Cannot be provided. The document does not mention a training set or its sample size.
9. How the ground truth for the training set was established
- Cannot be provided. The document does not mention a training set or how its ground truth was established.
Summary of what is available regarding "study" information (limited):
The document mentions that the following quality assurance measures were applied to the development of the device:
- Requirements specification review
- Risk analysis
- Software and hardware testing
- Performance testing
- Safety testing
- Environmental testing
- Clinical use evaluation
- Final validation
The conclusion drawn from these measures is that "The results of these measurements demonstrated that the SEER MC is as safe, as effective, and performs as well as the predicate devices." This implies a comparative study or testing against predicate devices, but the details of such a study are not provided in the given text.
§ 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).