(14 days)
The HiSpeed X/i Smart Gantry Option CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
The HiSpeed X/i Smart Gantry Option CT Scanner System is composed of a gantry, shared patient table, console, computer, and associated accessories. The system is designed to be a head and whole body CT scanner utilizing a solid state detector, an intuitive Operator Console, and the same tube and similar features to the HiSpeed Family of CT Systems (K980169), but now the gantry is on a dolly that travels on rails to provide the capability of scanning by gantry travel instead of cradle travel. The stationary table/cradle to be used is a table that will be shared with a Linear Accelerator. The table/cradle will remain stationary while CT scanning is in progress.
The provided text is a 510(k) Summary for a medical device called the "HiSpeed X/i Smart Gantry Option CT Scanner System." This document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
It's important to note that a 510(k) summary for a CT scanner primarily focuses on demonstrating substantial equivalence in design, materials, and performance characteristics (like radiation output and image quality parameters) compared to a predicate device, and not on diagnostic acceptance criteria based on clinical outcomes or expert consensus for disease detection, which would be typical for an AI/CADe device.
Therefore, many of the requested items (like expert consensus, MRMC studies, standalone performance with metrics like sensitivity/specificity, and training set information) are not applicable to this type of device and, consequently, not found in the provided document. The acceptance criteria here would relate to engineering, safety, and performance specifications of the CT scanner hardware.
Based on the provided text, here is the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Substantial Equivalence | Device is substantially equivalent to currently marketed Computed Tomography X-ray Systems regarding type, design, material composition, energy source, and radiation characteristics. The device must perform "as well as or better than" devices currently on the market, and not introduce new safety risks. | The HiSpeed X/i Smart Gantry Option CT Scanner System is stated to be of comparable type and substantially equivalent to currently marketed Computed Tomography X-ray Systems. It has equivalent materials and construction to the HiSpeed Family of CT Systems (K980169). The system is designed with the same tube and similar features to the HiSpeed Family of CT Systems (K980169). Conclusion: The device "does not result in any new potential safety risks and performs as well as or better than devices currently on the market." GE "considers the HiSpeed X/i Smart Gantry Option CT Scanner System to be equivalent to other marketed devices with the same indications for use and meeting similar standards." |
| Regulatory Compliance | Compliance with relevant federal regulations and industry/international standards. Specifically mentioned: 21CFR1020.30, 1020.31, 1020.33 (X-ray requirements); UL 2601, IEC 60061-1, IEC 60601 (safety); 21CFR Subchapter J. | Materials and construction are stated to be equivalent to the HiSpeed Family of CT Systems (K980169) and "compliant with UL 2601, IEC 60061-1, and 21CFR Subchapter J." The device "will comply with the X-ray requirements of 21CFR1020.30, 1020.31, and 1020.33, as well as the safety requirements of UL2601, IEC 60601 and collateral standards." Control Measures: "System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements," and "Adherence to industry and international standards. (UL/CSA and IEC)." |
| Safety | Identification and control of potential electrical, mechanical, and radiation hazards. | Potential hazards are identified in a risk management summary and "controlled by System verification and validation... and Adherence to industry and international standards." The device "does not result in any new potential safety risks." |
| Intended Use | The device should be suitable for its stated indications for use. | Indicated for head and whole body X-ray Computed Tomography applications. The design description (gantry, table, solid-state detector, intuitive console, tube) supports this intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not mentioned. This document is for a CT scanner's hardware characteristics, not a diagnostic algorithm. There is no "test set" of patient data in the context of clinical performance metrics like sensitivity/specificity for disease detection. The performance testing would relate to engineering specifications and safety, which do not typically involve patient data sets in this way.
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)
- Not applicable / Not mentioned. Ground truth by experts is not established for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not mentioned. Adjudication is not relevant for this type of hardware device submission.
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
- Not applicable. This is a CT scanner, not an AI or CADe device. No MRMC study for improved human reader performance would be conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm to assess independently in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for a CT scanner would be its mechanical, electrical, and radiation output specifications meeting engineering standards and regulatory limits, as well as its ability to produce images according to technical specifications (e.g., spatial resolution, contrast resolution, dose). This is demonstrated through engineering verification and validation testing, not clinical ground truth in the diagnostic sense.
8. The sample size for the training set
- Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI algorithm.
§ 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.