(141 days)
The NeuViz 64 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
The NeuViz 64 Multi-slice CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.
Here's a breakdown of the acceptance criteria and study information for the Neusoft NeuViz 64 Multi-Slice CT Scanner System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria for image quality or clinical performance. Instead, it relies on a qualitative assessment and substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Images are of diagnostic quality and meet clinical requirements. | "the conclusion is that the images are of diagnostic quality and can meet the clinical requirements." |
| Substantial equivalence in safety and effectiveness to predicate device (SIEMENS Sensation 64 CT system K040665). | The sponsor states, "Based on the above considerations, it is Neusoft's opinion that NeuViz 64 system is substantially equivalent in safety and effectiveness to the predicate device: SIEMENS Sensation 64 CT system (K040665)." |
| Adherence to Good Manufacturing Practices (GMP) 21CFR 820 | "The safety and effectiveness of the NeuViz 64 system was assured by adherence to Good Manufacturing Practices(GMP) 21CFR 820" |
| Adherence to International Standards ISO 13485:2003 | "and to International Standards ISO 13485:2003." |
| Risk analysis according to ISO 14971 | "Risk analysis is performed according to ISO 14971 standard and internal risk management procedure." |
| Software safety according to accepted practices | "Software safety is assured by the company procedures that conform to accepted practices." |
| Electrical and Mechanical safety according to IEC 60601-1 | "Electrical and Mechanical safety is assured by adherence to IEC 60601-1 Standards" |
| Radiation safety according to 21 CFR, Subchapter J | "Radiation safety is assured by compliance with 21 CFR, Subchapter J Performance standards" |
| Dose check according to NEMA XR25 | "Dose check is assured by compliance with NEMA XR25 Dose check standard" |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 260 subjects
- Data Provenance: Obtained from 2 sites. The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Radiologist (singular, implying at least one, but the exact number is not specified).
- Qualifications: "Radiologist" - no further specific qualifications (e.g., years of experience, subspecialty) are mentioned.
4. Adjudication Method for the Test Set:
- The document states that a "Radiologist assessed the diagnostic quality of the images." It does not provide details on an adjudication method (e.g., 2+1, 3+1, none) if multiple radiologists were involved. Given the singular "Radiologist," it's possible a single reader assessed the images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study is not mentioned. The study described is a clinical image assessment, not a comparative study with and without AI assistance or a comparison among multiple readers using the device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- This device is a CT scanner, a hardware device that acquires and reconstructs images. It is not an AI algorithm intended for standalone diagnostic interpretation. Therefore, a "standalone algorithm only" study, as typically understood for AI, is not applicable or described. The study focuses on the diagnostic quality of the images produced by the scanner, which are then interpreted by a human radiologist.
7. Type of Ground Truth Used:
- Expert Consensus: The diagnostic quality of the images was assessed by a "Radiologist," which represents expert opinion. There is no mention of pathology, outcomes data, or other objective ground truth measures being used to validate the radiologist's assessment in this context.
8. Sample Size for the Training Set:
- The document describes a clinical evaluation of the scanner's output and its substantial equivalence to a predicate device. There is no mention of an "AI" or machine learning component that would require a separate training set. Therefore, this question is not applicable to the information provided.
9. How the Ground Truth for the Training Set Was Established:
- As there is no mention of a training set for an AI algorithm, this question is not applicable.
§ 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.