(15 days)
The LightSpeed 6.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
The LightSpeed 6.0 CT Scanner System is composed of a gantry, patient table, console, and PDU, and includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. LightSpeed 6.0 is evolutionary modification to LightSpeed 5.0 (K030420) and is designed to be a head and whole body CT scanner incorporating the same basic operating principles.
This document describes a 510(k) summary for the GE Medical Systems LightSpeed 6.0 CT Scanner System. The submission focuses on demonstrating substantial equivalence to a predicate device (LightSpeed 5.0 CT Scanner System) rather than outlining specific performance metrics with acceptance criteria for a novel AI/CAD device.
Therefore, many of the requested elements for a study proving device meeting acceptance criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of regulatory submission. The focus here is on hardware and system modifications, safety, and compliance with existing standards.
However, I can extract information related to the device description and the general safety and effectiveness statement:
1. A table of acceptance criteria and the reported device performance
Since this is a CT scanner system and not a diagnostic AI/CAD device, the "acceptance criteria" are related to system specifications, safety features, and compliance with regulatory standards, rather than diagnostic accuracy metrics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Head and whole body X-ray Computed Tomography applications. | LightSpeed 6.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications, identical to the predicate device. |
| Technological Characteristics & Operating Principles: Comparable to predicate. | LightSpeed 6.0 has the "same technological characteristics and operating principles." It is an "evolutionary modification to LightSpeed 5.0." |
| Key Safety & Effectiveness Features: Comparable to predicate. | LightSpeed 6.0 is "comparable in key safety and effectiveness features." |
| Design, Construction, Materials: Same basic as predicate. | LightSpeed 6.0 uses the "same basic design, construction, and materials." Materials and construction are "equivalent to the LightSpeed 5.0 CT Scanner System." |
| Compliance with Standards: UL 2601-1, IEC 60601-1, 21CFR Subchapter J, 21CFR1020.30, 21CFR1020.33. | LightSpeed 6.0 is designed to comply with UL 2601-1, IEC 60061-1 (and associated collateral/particular standards), 21CFR Subchapter J. It "will be certified to comply with the X-ray requirements of 21CFR1020.30 and 1020.33, as well as the safety requirements of UL2601-1, and IEC 60601-1 and associated collateral and particular standards." Adherence to industry and international standards (UL/CSA and IEC) is part of risk control. |
| Safety Risks: No new potential safety risks compared to predicate. | The LightSpeed 6.0 CT Scanner System "does not result in any new potential safety risks." Potential electrical, mechanical, and radiation hazards are identified and controlled. |
| Performance: Performs as well as or better than devices currently on the market. | "Performs as well as or better than devices currently on the market." (General statement of equivalence). System verification and validation are used to "ensure performance to specifications, Federal Regulations, and user requirements." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this 510(k) submission. The document does not describe a clinical performance study with a test set of patient data as one would for an AI/CAD system. Instead, it focuses on engineering and regulatory compliance documentation.
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. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 2.
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
- No. This is a CT scanner system, not an AI/CAD device for radiological interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a CT scanner system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" in this context revolves around engineering specifications, safety standards, and performance characteristics validated through system testing and compliance checks, rather than diagnostic "ground truth" for disease detection.
8. The sample size for the training set
- Not applicable. This is a CT scanner system, not an AI/CAD device that requires a training set of patient data.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.