(131 days)
The Siemens SOMATOM Definition AS/ AS+ (Project P46) 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 simulaneous translation of the patient.)
Siemens intends to market a new software version, syngo ® VA48 (SOMARIS/7 VA48) for its SOMATOM Definition AS/AS+ Computed Tomography X-ray systems. The subject device SOMATOM Definition AS/AS+ will be delivered with software version syngo® VA48 (SOMARIS/7 VA48). Additionally software version synqo® VA48 (SOMARIS/7 VA48 will be offered as an optional upgrade for existing SOMATOM Definition AS/AS+ systems. syngo® VA48 (SOMARIS/7 VA48) is a further development to the SOMARIS/7 operating software cleared as part of the predicate devices.
The provided text describes a 510(k) premarket notification for the Siemens SOMATOM Definition AS/AS+ Computed Tomography Systems with a new software version, syngo® VA48. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
However, the document does not contain the specific acceptance criteria or details of a study that proves the device meets those criteria in the context of clinical performance or diagnostic accuracy.
The non-clinical testing section (Page 6 and 7) primarily focuses on:
- Adherence to recognized industry standards: IEC 60601-2-44, IEC 61223-3-5, NEMA XR-25, IEC 61223-2-6, NEMA PS 3.1-3.18, IEC 62304, IEC 60601-1, ISO 14971, NEMA XR-29.
- Software verification and validation: Stating that risk analysis was completed, risk control implemented, and testing results support that software specifications meet acceptance criteria, and that verification/validation was found acceptable.
- Performance tests: General statement that "Performance tests were conducted to test the functionality of... syngo® VA48... The results of these tests demonstrate that the subject device performs as intended."
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an attempt to answer the questions based on the available information, with clear indications where the information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided in the document. The document states that "all the software specifications have met the acceptance criteria" and "the subject device performs as intended" based on non-clinical performance and software verification/validation. However, the specific acceptance criteria (e.g., in terms of imaging performance metrics like spatial resolution, contrast-to-noise ratio, dose reduction effectiveness at specific levels, or diagnostic accuracy) are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/provided for clinical performance data. The document describes "non-clinical testing" and "software verification and validation." There is no mention of a clinical test set or patient data used for defining performance against specific acceptance criteria. The predicate devices were cleared "based on non-clinical supportive information and clinical images" (Page 7), but this refers to the previous clearances, not the current submission's testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/provided. As there's no described clinical test set with ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable/provided. As there's no described clinical test set with ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. The document does not describe an MRMC study or any study involving human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Partially Yes, but not in the context of diagnostic accuracy. The "performance tests" mentioned are likely standalone tests of the software's functionality, adherence to standards, and system performance (e.g., image quality metrics, dose reduction functionality) without human interpretation in a diagnostic setting. However, the specific metrics and results are not detailed.
7. The Type of Ground Truth Used
Not applicable for clinical ground truth. The "ground truth" for the non-clinical and software testing would be the expected functional behavior, adherence to engineering specifications, and compliance with industry standards. No clinical ground truth (e.g., pathology, outcomes data, expert consensus on disease presence) is mentioned as part of this submission's testing.
8. The Sample Size for the Training Set
Not applicable/provided. This submission is for a CT system with updated software, not an AI/ML algorithm that requires a training set in the conventional sense. The software updates are described as "further development" of existing operating software (Page 4).
9. How the Ground Truth for the Training Set Was Established
Not applicable/provided. As there is no mention of a training set.
§ 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.