(133 days)
The Siemens SOMATOM Definition AS Open systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
The Siemens SOMATOM Definition AS Open is a Computed Tomography X- ray Systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle.
This system is a modified version of the cleared Somatom Definition AS/AS+ The modification features a larger gantry bore from the original (K081022). Definition AS, In addition, the gantry tilt accuracy is improved and a new HD FoV, will help provide an optimized solution for radiation treatment planning.
The provided text describes a 510(k) summary for the Siemens SOMATOM Definition AS Open CT system. However, it does not include detailed information about specific acceptance criteria and a study proving device performance in the way requested.
The document focuses on demonstrating substantial equivalence to a predicate device (Siemens SOMATOM Definition AS/AS+). Substantial equivalence means the new device is as safe and effective as a legally marketed predicate device, and it typically doesn't require new clinical studies to demonstrate performance against specific quantitative criteria. Instead, it relies on demonstrating that any differences in technological characteristics do not raise new questions of safety or effectiveness.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in this type of submission.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantitative performance metrics for the device itself in this submission. The acceptance criteria in a 510(k) summary for a substantially equivalent device often revolve around demonstrating that the new device meets the same safety and effectiveness standards as the predicate, often through engineering verification and validation that the modifications do not negatively impact performance.
- Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, spatial resolution) are reported for the SOMATOM Definition AS Open. The submission focuses on describing the changes made from the predicate (larger gantry bore, improved gantry tilt accuracy, new HD FoV) and stating that the Data Measurement System is identical to the 32-row detector layout of the predicate.
2. Sample size used for the test set and the data provenance
- Not Applicable/Not Provided: This information is typically part of a clinical performance study. Since this is a substantial equivalence submission, such a study with a dedicated "test set" and associated sample size and data provenance is not described. The device's performance is inferred from the predicate device and engineering verification of the modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Provided: As no clinical performance study with a distinct "test set" and ground truth establishment is described, this information is not relevant to this submission.
4. Adjudication method for the test set
- Not Applicable/Not Provided: See point 3.
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, not an AI-powered diagnostic device. A MRMC study, especially one involving AI assistance, would not be relevant in this context. The document does not describe any AI component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No: This device is a CT scanner. Its "performance" is about image acquisition, quality, and mechanical accuracy, not the output of a standalone algorithm for diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided: As no clinical performance study is described, no "ground truth" for diagnostic accuracy is established in this submission. The "ground truth" for a CT scanner typically relates to its physical and imaging performance (e.g., spatial resolution measured with phantoms, dose accuracy).
8. The sample size for the training set
- Not Applicable/Not Provided: There is no mention of a "training set" as this is not an AI/machine learning device. The design and validation of a CT scanner involve engineering design, component testing, and system integration, not training on a dataset in the AI sense.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: See point 8.
Summary of what the submission does state regarding device validation:
- Substantial Equivalence: The primary method of "proving" the device meets acceptance criteria is by demonstrating its substantial equivalence to a legally marketed predicate device (Siemens SOMATOM Definition AS/AS+ K081022).
- Modifications: The device is a modified version of the predicate with:
- A larger gantry bore (80 cm).
- Improved gantry tilt accuracy.
- A new HD FoV (Field of View).
- It uses a modified tube collimator adapted to the 80 cm gantry bore.
- The Data Measurement System (DMS) is identical to the 32-row detector layout of the SOMATOM Definition AS.
- Safety and Effectiveness: "Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the Somatom Definition AS Open is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed."
- Industry Standards: Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing to minimize electrical, mechanical, and radiation hazards.
- Intended Use: The intended use remains the same as the predicate: to produce cross-sectional images of the body. The modifications are specifically noted to "provided data that can be used for Radiation Therapy Planning (RTP) by RTP systems."
In essence, for a 510(k) submission showing substantial equivalence for a hardware modification of an existing device, the "study" proving it meets acceptance criteria is often a combination of engineering verification and validation testing to ensure the modifications do not introduce new risks and that the device performs as intended and on par with its predicate. No clinical study with PIs, ground truth, and statistical analysis is described in this document.
§ 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.