(129 days)
To be used in conjunction with a CT scanner to acquire gated cardiac images. The product is an aid to the acquisition of CT cardiac scans.
The NeoCoil ECG CT Gating Device (ECGD) is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The ECGD product includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 3.), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.
The System is compatible with Toshiba Aquilion ONE and Aquilion PRIME CT scanners.
Here's a breakdown of the acceptance criteria and study information for the "ECG CT Gating Device," based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Test | Pass/Fail Criteria | Reported Device Performance |
|---|---|---|
| Technology Comparison (Heart rate range) | Predicate: 10 to 300 BPM (Adult) ±1% ±1 BPM | 30 to 200 BPM +/-2 BPM |
| Technology Comparison (Arrhythmias) | Identical to Predicate: |
- Normal Sinus Rhythm
- Sinus Arrhythmia (heart rate variability)
- Atrial Fibrillation (AFib)
- Paroxysmal Supraventricular Tachycardia (PSVT)
- Bradycardia
- Second-Degree Atrioventricular block | Identical |
| Technology Comparison (Trigger Output) | Identical to Predicate: 0V baseline, with +5V trigger, 100ms pulse width | Identical |
| Technology Comparison (Performance Index) | Provides trigger pulses to the scanner, corresponding with R wave peaks, with an accuracy (performance index) of ≥ 98%. | ≥ 98% |
| ECG CT Gating Device Compatibility Testing | Gating Device is Compatible with Toshiba Aquilon CT scanners. | Pass |
| ECG CT Gating Waveforms and Triggers | Device accurately produces waveforms and triggers through specified range and arrhythmias. | Pass |
| ECG CT Gating Device Interference Testing | Potentially interfering devices in the CT environment do not interfere with the ECG CT Gating Device. | Pass |
| ECG CT Gating Device Quality of Service | The ECG Gating Device provides a safe and effective wireless quality of service in the CT environment. | Pass |
| Clinical Performance (No adverse events) | No adverse events were reported during clinical performance testing. | No adverse events |
| Clinical Performance (Adequate performance for Indications for Use) | The ECG CT Gating Device demonstrated performance adequate to support the Indications for Use. | Demonstrated adequate performance |
Note on Performance Index: The device claims an accuracy of ≥ 98%, which is considered equivalent to the predicate, as the predicate did not make a specific claim for this metric. The document notes that in the rare case of a mistrigger, manual adjustment by the CT scanner operator can be done, similar to the predicate device.
2. Sample Size and Data Provenance for the Test Set
The document mentions "Clinical testing" and "clinical performance testing" but does not specify the sample size for these tests. It also does not explicitly state the country of origin for the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth for the Test Set
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted with human readers or AI assistance. The device is an ECG CT Gating Device, which is an accessory to a CT scanner, not an AI-powered diagnostic tool for interpretation.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance assessment was effectively conducted. The "Performance Index" of ≥ 98% for trigger pulse accuracy is a direct measure of the device's algorithmic performance in identifying R wave peaks and generating triggers. The "ECG CT Gating Waveforms and Triggers" test also assesses the device's standalone capability to accurately produce waveforms and triggers.
7. Type of Ground Truth Used
The type of ground truth used for performance assessment appears to be based on:
- Engineering/Technical Specifications: For criteria like heart rate range, trigger output, and accuracy of waveforms/triggers.
- Clinical Observation: For confirming the absence of adverse events and adequate performance for its intended use in generating cross-sectional cardiac images.
For the Performance Index, the ground truth would likely be established by comparing the device's generated trigger pulses against a "true" R-wave peak derived from a precise, independent ECG measurement or a known simulated ECG waveform.
8. Sample Size for the Training Set
The document does not provide information on a training set sample size. This device is not described as an AI/machine learning device that would typically have a distinct training set. Its functionality appears to be based on established physiological signal processing, rather than learned patterns.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, there is no information on how its ground truth might have been established.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.