(331 days)
The AT-102 is a 12-channel, ECG Device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the AT-102 can be used as a diagnostic aid for heart function and heart conditions. The AT-102 is designed for indoor use.
The device provide an optional interface to the SP-250 for pulmonary function data.
The CARDIOVIT AT-102 is a 12-channel ECG device. It has dimensions of 380x328x100mm and weighs 5.0 kg. It operates in temperatures from +10° to 40° C and storage temperatures from -10° to +50° C, with relative humidity between 25% and 95% (non condensing). It uses Standard / Cabrera leads and has a battery capacity of 2 hours of normal use. The frequency range of the digital recorder is 0 to 150Hz. It has an Alphanumerics, LCD Display control panel and a Myogram Filter programmable at 25Hz or 35Hz. Paper speed options are 5/10/25/50mm/s direct. It uses high resolution thermal printing with 40dots per mm / 1000 dots per inch time axes at 25mm/s. It uses Thermoreactive, Z-folded, 210mm chart paper and has 6 channels for recording tracks, positioned at optimal width on 80 mm / 3.2 inch with automatic baseline adjustment. It has 6 channel representation of 12 simultaneously acquired standard leads for automatic lead programs.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the SCHILLER CARDIOVIT AT-102 device:
1. Table of Acceptance Criteria and Reported Device Performance
The submission claims substantial equivalence to the predicate device CARDIOVIT AT-1C (K953396). The acceptance criteria implicitly refer to matching or exceeding the performance of this predicate device, especially for the ECG interpretation features.
| Feature / Acceptance Criteria Category | Reported Device Performance (CARDIOVIT AT-102) | Details from Submission Regarding Performance |
|---|---|---|
| ECG Measurement | Multi-lead atlas measurement results | Performance verified by Common Standards for Quantitative Electrocardiograph (CSE), multi lead atlas measurement results. (Implies adherence to CSE standards for accuracy) |
| ECG Interpretation | Detection of acute myocardial infarction | - Performance verified by enzyme evolvement (PREMIS study) |
- Performance verified by Cardiologists (Boehringer Ingelheim Study) |
| Safety Standards | Complies with relevant safety standards | EN 60601-1 (Safety), EN 60601-1-2 (EMC), IEC 601-1-4 (Software Quality) |
| Physical Dimensions | 380x328x100mm | Larger than predicate (290x210x69mm), but deemed not safety relevant. |
| Weight | 5.0 kg | Heavier than predicate (2.9 kg), but deemed not safety relevant. |
| Environmental Conditions | Same as predicate | Operating temp: +10° - 40° C; Storage temp: -10° - +50° C; Relative humidity: 25% - 95% (non-condensing) |
| Leads | Standard / Cabrera | Same as predicate. |
| Battery Capacity | 2 hrs of normal use | Same as predicate. |
| Frequency Range (digital recorder) | 0 to 150Hz | Same as predicate. |
| Control Panel | Alphanumerics, LCD Display | Different from predicate (Pad keys, LED indications), but deemed not safety relevant. |
| Myogram Filter | 25Hz or 35Hz programmable | Same as predicate. |
| Paper Speed | 5/10/25/50mm/s direct | More options than predicate (5/25/50mm/s direct), but deemed not safety relevant. |
| Printing Process | High resolution thermal | Same as predicate. |
| Printing Resolution | 40dots per mm / 1000 dots per inch (amplitude axes), 25mm/s (time axes) | Same as predicate. |
| Chart Paper | Thermoreactive, Z-folded, 210mm | Wider than predicate (90mm), but deemed not safety relevant. |
| Recording Tracks | 6 channels, positioned at optimal width on 80 mm / 3.2 inch automatic baseline adjustment | More channels than predicate (3 channels), but deemed not safety relevant. |
| Automatic Lead Programs | 6 channel representation of 12 simultaneously acquired standard leads | More channels than predicate (3 channels), but deemed not safety relevant. |
2. Sample Size Used for the Test Set and Data Provenance
- ECG Measurement (CSE Study): The submission mentions "Common Standards for Quantitative Electrocardiograph (CSE) study" for ECG measurement. It does not explicitly state the sample size or data provenance (country, retrospective/prospective) for this particular study within the provided text. CSE studies are typically large, international, and prospective/retrospective collections of ECGs.
- ECG Interpretation (PREMIS Study & Boehringer Ingelheim Study):
- PREMIS Study: Verified performance by "enzyme evolvement" for detection of acute myocardial infarction. No sample size, country of origin, or retrospective/prospective nature is provided in this document. The name "PREMIS" does not immediately point to a commonly known, publicly documented ECG study without further context.
- Boehringer Ingelheim Study: Verified performance by "Cardiologists." No sample size, country of origin, or retrospective/prospective nature is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- ECG Interpretation (Boehringer Ingelheim Study): Ground truth was established by "Cardiologists." The number of cardiologists and their specific qualifications (e.g., years of experience, board certification) are not specified in the provided document.
- ECG Interpretation (PREMIS Study): Ground truth was established by "enzyme evolvement." This implies a biochemical marker for myocardial damage, not expert opinion.
4. Adjudication Method for the Test Set
- For the "Cardiologists" verification in the Boehringer Ingelheim Study, the adjudication method (e.g., 2+1, 3+1, none) is not specified.
- For the PREMIS study using "enzyme evolvement," expert adjudication would not be the primary method for ground truth, but rather the enzyme levels themselves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A formal MRMC comparative effectiveness study, where human readers' performance with and without AI assistance is measured, is not explicitly mentioned or described in the provided text. The studies appear to validate the device's algorithmic performance against established ground truths, rather than its impact on human reader performance.
6. Standalone Performance Study
- Yes, standalone performance was done for the ECG measurement (CSE study) and ECG interpretation (PREMIS study and Boehringer Ingelheim Study). These studies describe the algorithm's performance in "detection of acute myocardial infarction" and "multi lead atlas measurement results" independent of human intervention in the interpretation process.
7. Type of Ground Truth Used
- ECG Measurement: Implicitly, the ground truth for the CSE study (Common Standards for Quantitative Electrocardiograph) would be highly accurate, meticulously measured ECG parameters, often meticulously reviewed or derived from diverse, well-defined populations.
- ECG Interpretation (PREMIS Study): "Enzyme evolvement" is the stated ground truth. This refers to the presence and changes in cardiac enzymes (e.g., troponin, CK-MB) in the blood, which are objective biochemical markers for myocardial necrosis (heart attack). This is a form of outcomes data/pathological evidence at a biochemical level.
- ECG Interpretation (Boehringer Ingelheim Study): "Cardiologists" are stated as the verifier, implying expert consensus/opinion as the ground truth.
8. Sample Size for the Training Set
- The document does not specify the sample size used for the training set for any of the algorithms (ECG measurement or interpretation).
9. How the Ground Truth for the Training Set Was Established
- The document does not specify how the ground truth for the training set was established. The mentioned studies (CSE, PREMIS, Boehringer Ingelheim) appear to relate to verification or validation, rather than the initial establishment of ground truth for a training dataset.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).