(14 days)
The LightSpeed 7.1 CT Scanner System is indicated for head and whole body Xray Computed Tomography applications.
The LightSpeed 7.1 CT Scanner System is composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. The LightSpeed 7.1 Scanner System is an evolutionary modification to LightSpeed 7.0 (K00372) It is developed from the hardware platform of LightSpeed 7.0 32/64 slice system by adding new application features that involve changes in software, firmware, recon and scan mode. The LightSpeed 7.1 Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60061-1 and associated collateral and particular standards, and 21CFR Subchapter J.
The provided text is a 510(k) summary for the GE Healthcare LightSpeed 7.1 CT Scanner System. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for a novel AI or diagnostic algorithm.
Therefore, the typical information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this type of submission.
Here's a breakdown of why this information is missing and what the document does address:
- Type of Device: The LightSpeed 7.1 CT Scanner System is a hardware Computed Tomography (CT) scanner with software modifications. It is not an AI algorithm or a diagnostic assay where performance metrics like sensitivity, specificity, or AUC would be paramount.
- Regulatory Pathway: The 510(k) pathway is for devices that are "substantially equivalent" to legally marketed predicate devices. The primary goal is to show that the new device has the same intended use, fundamental technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
- Focus of the Document: The document emphasizes:
- The LightSpeed 7.1 is an "evolutionary modification" of the LightSpeed 7.0 system (K040372).
- Changes involve "new application features that involve changes in software, firmware, recon and scan mode."
- It uses "the same materials and operating principle" as the predicate.
- It has "identical indications for use" (head and whole body X-ray Computed Tomography applications).
- It complies with the same electrical, radiation, and safety standards (e.g., UL 60601-1, IEC 60601-1, 21CFR1020.30, 1020.33).
- Risk management (hazard analysis) was performed, and controls are in place.
- "System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements" is mentioned, but specific performance criteria and the study results demonstrating adherence to them are not detailed in this public summary. These would typically be internal GE documentation used to support the substantial equivalence claim, rather than being part of the 510(k) summary itself.
In summary, none of the specific "acceptance criteria" or "study details" you requested for performance evaluation of a diagnostic or AI device are present in this 510(k) summary because it's a submission for an updated CT scanner, focusing on substantial equivalence to a predicate, not novel performance claims.
§ 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.