(36 days)
The SOMATOM P45 is intended to produce cross-sectional images of the body by The SOMA TOM 145 13 medical vary ... at different angels or spiral planes* taken at different angles.
(*spiral planes: the axial planes resulting from the continuous rotation of detectors and xray tube, and the simultaneous translation of the patient.)
The Siemens SOMATOM P45 is a whole body X-ray computed tomography system, which I he Slement SOMATON 1-19-15 a wills and functions and functions according to the fan assisted teatures two continuously routing is a command-based program used for paint management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
The provided document is a 510(k) summary for the Siemens SOMATOM Project P45, a computed tomography (CT) system. The document focuses on establishing substantial equivalence to predicate devices and outlines general safety and effectiveness concerns.
Crucially, this document does NOT contain information about specific acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI.
The information provided describes the device's classification, general indications for use (producing cross-sectional images), and adherence to safety standards and risk management. It confirms FDA clearance based on substantial equivalence to existing CT systems.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a different type of document, such as a clinical study report, a performance validation study, or a more detailed technical specification.
Here's a breakdown of why each requested point cannot be answered:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on substantial equivalence to predicate devices for its classification as a CT system, not on specific performance metrics.
- Sample size used for the test set and the data provenance: Not present. No specific test set for performance evaluation is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No performance study is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No performance study is described.
- 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: Not present. This device is a CT scanner, not an AI-assisted diagnostic tool. An AI component is not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This device is a CT scanner, not an algorithm, and no standalone performance testing for diagnostic capabilities is described.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present. No performance study is described.
- The sample size for the training set: Not present. This device is a CT scanner, not an AI model requiring a training set in the conventional sense.
- How the ground truth for the training set was established: Not present. This device is a CT scanner, not an AI model, and no training set is relevant in this context.
In summary, the provided 510(k) document for the SOMATOM Project P45 focuses on regulatory clearance for a general-purpose CT system based on substantial equivalence, and does not contain the detailed performance study information you are seeking.
§ 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.