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510(k) Data Aggregation
(13 days)
LIGHTSPEED 7.0 CT SCANNER SYSTEM
The LightSpeed 7.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
The LightSpeed 7.0 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 7.0 is evolutionary modification to LightSpeed 5.0 (K030420) and is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indications for Use.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance
The provided document is a 510(k) summary for the LightSpeed 7.0 CT Scanner System. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than establishing new performance acceptance criteria and conducting specific studies to prove those criteria.
Therefore, the document does not contain a table of acceptance criteria or reported device performance in the way a clinical performance study for an AI algorithm would.
Instead, the "performance" demonstrated is the equivalence to the predicate device (LightSpeed 5.0).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to LightSpeed 5.0 CT Scanner System | "LightSpeed 7.0 is an evolutionary modification to LightSpeed 5.0 (K030420) and is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indications for Use." |
| Same technological characteristics and operating principles | "It has the same technological characteristics and operating principles..." |
| Same indications for use | "...has identical indications for use." |
| Same basic design, construction, and materials | "...uses the same basic design, construction, and materials." |
| Compliance with relevant standards (UL, IEC, CFR J) | "Materials and construction are equivalent to the LightSpeed 5.0 CT Scanner System, which are compliant with UL 2601-1, IEC 60061-1 and associated collateral and particular standards, and 21CFR Subchapter J." |
| No new potential safety risks | "The LightSpeed 7.0 CT Scanner System, as an evolutionary modification to the currently [marketed] LightSpeed 5.0, does not result in any new potential safety risks..." |
| Performs as well as or better than devices currently on the market | "...and performs as well as or better than devices currently on the market." |
2. Sample size used for the test set and the data provenance
The document does not describe a test set or data provenance in the context of a clinical performance study. The evaluation for this 510(k) is based on a comparison of technical specifications and design features with the predicate device, not on new clinical data from a test set of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this 510(k) submission. No clinical test set requiring expert ground truth establishment is described.
4. Adjudication method for the test set
This information is not applicable to this 510(k) submission. No clinical test set is described.
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
This information is not applicable to this 510(k) submission. This is a CT scanner system, not an AI software intended to assist human readers, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable to this 510(k) submission. This is a CT scanner system, not an AI algorithm, and no standalone performance study is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable to this 510(k) submission. No clinical ground truth is established as part of this submission process. The "ground truth" here is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
This information is not applicable to this 510(k) submission. This device is a hardware system, not a machine learning model, and therefore does not have a training set in the AI sense.
9. How the ground truth for the training set was established
This information is not applicable to this 510(k) submission for the reasons stated above.
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