(14 days)
The intended use of the Ventri 1.1 system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes. Ventri 1.1 is primarily intended for cardiac applications.
The Ventri 1.1 is a high-performance Single Photon Emission Computed Tomography system, mainly for nuclear cardiology imaging.
The GE Ventri 1.1 system is a Single Photon Emission Computed Tomography (SPECT) system primarily intended for cardiac imaging. The provided document is a 510(k) summary for the device, detailing modifications from a predicate device (Ventri K051855) and establishing substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a quantitative manner (e.g., target specificity or sensitivity values) nor does it provide detailed quantitative "reported device performance." Instead, it states that the system was tested to comply with safety and performance standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with safety industry standards (IEC60601 series) | System was tested and complies with IEC60601 series. |
| Compliance with performance industry standards (relevant parts in NEMA NU-1) | System was tested and complies with relevant parts in NEMA NU-1. |
| Substantial equivalence in performance to predicate devices (Ventri K051855) | "SW validation tests, Bench data and clinical images show that the Ventri 1.1 performance is substantially equivalent to the performance of the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical images" were used in the substantiation, but does not specify the sample size for this test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used, their qualifications, or how ground truth was established for the clinical images mentioned.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device described appears to be an imaging system, not an AI-driven diagnostic-aid software.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not describe a standalone algorithm performance study. The "SW validation tests" and "Bench data" are mentioned, but details on standalone performance metrics are not provided. Given this is an imaging system, not a purely algorithmic diagnostic tool, a "standalone" study in the sense of an AI algorithm might not be directly applicable without further context.
7. Type of Ground Truth Used
The document states that "clinical images" were used to demonstrate substantial equivalence, but it does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for the Training Set
The document does not specify a training set sample size. This device is an imaging system, and while it involves software ("SW validation tests"), it's not explicitly presented as an "AI algorithm" that undergoes a distinct training phase in the context of machine learning. Thus, the concept of a "training set" as typically understood for AI might not apply directly here.
9. How the Ground Truth for the Training Set Was Established
Since no training set is explicitly mentioned or detailed in the context of an AI algorithm, this information is not applicable and not provided.
Summary of Missing Information:
The provided 510(k) summary focuses on demonstrating the substantial equivalence of the Ventri 1.1 system to its predicate device based on compliance with industry safety and performance standards, and a general statement about "SW validation tests, Bench data and clinical images." However, it lacks detailed information regarding:
- Quantitative acceptance criteria for clinical performance.
- Specific quantitative performance metrics from clinical studies.
- Sample sizes, provenance, and ground truth methodologies for any clinical data used.
- Involvement of expert readers or adjudication processes.
- Any studies related to AI or algorithmic standalone performance, or human-AI collaboration.
This level of detail is typically not required for a 510(k) submission when the device is an updated version of a previously cleared predicate and primarily focuses on hardware/software modifications and compliance with established standards, rather than introducing novel diagnostic algorithms requiring extensive clinical validation against a defined ground truth.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.