(13 days)
The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
The LightSpeed 4.0 CT Scanner System is composed of a gantry, patient table, console, computer, and associated accessories.
Materials: Materials and construction are equivalent to the LightSpeed 3.0 CT Scanner System (K002978) are compliant with UL 2601-1, IEC 60061-1, and 21CFR Subchapter J.
Design: The system is designed to be a head and whole body CT scanner utilizing a new solid state detector, an intuitive Operator Console, and the same tube and similar features to the LightSpeed 3.0 CT Scanner System (K002978), but now capable of imaging 16 slices per rotation. The system will use a new multi-slice detector having thinner detector elements.
The provided text describes a 510(k) summary for the LightSpeed 4.0 CT Scanner System. However, it does not include specific acceptance criteria or a detailed study proving the device meets particular performance metrics.
Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices. This means that the manufacturer is asserting their new device is as safe and effective as a predicate device, rather than providing new performance data against specific, novel acceptance criteria.
Therefore, many of the requested items in your prompt cannot be answered directly from the provided text.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "criteria" are implied to be "as good as or better than" currently marketed devices and compliance with relevant standards.
- Reported Device Performance: No specific performance metrics (e.g., spatial resolution, contrast-to-noise ratio, dose efficiency) are provided in the summary. The "performance" is generally described as being "as well as or better than devices currently on the market."
| Criterion (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness comparable to predicate devices | "Performs as well as or better than devices currently on the market." |
| Compliance with X-ray requirements (21CFR1020.30 & .33) | "It will comply with the X-ray requirements..." |
| Compliance with safety standards (UL2601-1, IEC 60601-1) | "It will comply with... safety requirements..." |
2. Sample size used for the test set and data provenance:
- Not Applicable. The document does not describe a clinical study with a test set of human subjects or data. It relies on a comparison to predicate devices and adherence to engineering/safety standards.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not Applicable. No ground truth establishment is described, as there's no clinical test set for performance comparison.
4. Adjudication method for the test set:
- Not Applicable. No test set or adjudication process 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:
- No. This document is for a CT scanner system, not an AI or CAD (Computer-Aided Detection/Diagnosis) device. Therefore, an MRMC study with AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a hardware device (CT scanner), not a standalone algorithm.
7. The type of ground truth used:
- Not Applicable. No clinical ground truth is described. The basis for safety and effectiveness is substantial equivalence to a predicate device and compliance with standards.
8. The sample size for the training set:
- Not Applicable. This is a hardware device; there is no mention of a "training set" in the context of an algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. As there's no training set, there's no ground truth establishment for one.
Summary of the "Study" (or rather, the basis for clearance):
The "study" or basis for clearance is not a traditional clinical trial with acceptance criteria for device performance. Instead, it is a demonstration of substantial equivalence through:
- Design comparison: Stating the LightSpeed 4.0 CT Scanner System is "of comparable type and substantially equivalent" to currently marketed systems, sharing features like an intuitive Operator Console and the same tube as its predecessor (LightSpeed 3.0 CT Scanner System K002978).
- Material comparison: Stating materials and construction are equivalent to the LightSpeed 3.0 CT Scanner System (K002978).
- Compliance with standards: Adherence to UL 2601-1, IEC 60061-1, IEC 60601-1, 21CFR Subchapter J, and the X-ray requirements of 21CFR1020.30 and 1020.33. These standards, rather than direct performance metrics against a clinical dataset, form the "acceptance criteria" and the "proof" of meeting them is the attestation of compliance.
- Risk Management: Identification and control of potential electrical, mechanical, and radiation hazards through system verification and validation, and adherence to industry/international standards.
In essence, the "study" is a compliance and comparison exercise with a predicate device and established standards, rather than an independent performance study against specific clinical criteria.
§ 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.