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The Siremobil Compact is a mobile x-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. The Siremobil Compact can operate in four different modes, Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy and cassette exposures which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of a intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

The Siremobil Compact is a mobile x-ray C-ram which consists of a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassette attachment, Laser light localizers, electronics cabinet and a monitor trolley which consists of the digital memory device, image monitor(s), and user interface. The Siremobil Compact is designed to meet the space and clinical requirements of the clinical environments identified below. The Siremobil Compact is designed for easy maneuverability, durability and high efficiency and performance. The system operation is designed to provide the user with an ergonomic clinically optimized interface. The Siremobil Compact can operate in three modes, Fluoroscopy with Last Image Hold, Pulsed Fluoroscopy with Last Image Hold and Digital Radiography, The user can process the images utilizing such techniques as recursive filtration, summation or spatial noise suppression, spatial frequency filtration, motion detector, edge enhancement, and contrast enhancement.

Here's an analysis of the provided text regarding the Siemens Siremobil Compact Mobile X-ray System, focusing on acceptance criteria and study details.

Based on the provided Siemens 510(k) summary (K963093), no specific acceptance criteria or a study proving the device meets them are explicitly detailed in a quantitative manner.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is a common pathway for 510(k) clearance. The provided documentation highlights the device's technological characteristics and intended uses are similar to those of its predicates, implying it will perform in a comparable safe and effective manner.

Here's how to break down the requested information based on the available text:

Acceptance Criteria and Reported Device Performance

Since specific
quantitative acceptance criteria are not provided for the Siemens Siremobil Compact, a table in the traditional sense cannot be created. The document focuses on qualitative descriptions of the device's design and intended operational modes, implying performance similar to predicate devices.

Study Details

1. Sample size used for the test set and the data provenance:

   • Not explicitly stated. The document refers to the device being designed for and operating in various clinical environments (Operating room, Traumatology, Endoscopy, etc.), but it doesn't describe a specific "test set" in terms of patient data or images used for performance evaluation or comparison. This is typical for a 510(k) where substantial equivalence is demonstrated through engineering specifications, design comparisons, and compliance with recognized standards, rather than a clinical trial with a defined patient population.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not stated. No specific "ground truth" establishment process for a test set is described in the provided summary. The evaluation relies on comparing technical specifications and intended uses to predicate devices. The "experts" involved would likely be Siemens' internal engineers and regulatory personnel, and potentially external regulatory bodies like the FDA, who review the submission.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/None stated. No formal adjudication method involving multiple readers or experts for a test set is described.

4. 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 applicable. The Siremobil Compact is a mobile X-ray system, not an AI-powered diagnostic tool. Therefore, a MRMC study evaluating human reader performance with or without AI assistance is not relevant or mentioned.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is an imaging modality, not an algorithm, so standalone performance in that context is not relevant.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable/Indirect. The "ground truth" for demonstrating substantial equivalence primarily relies on engineering specifications, compliance with recognized performance standards (e.g., 21 CFR subchapter J), and the established safety and effectiveness of the predicate devices. There is no mention of patient-level ground truth data (like pathology or outcomes) being used for this specific 510(k) submission.

7. The sample size for the training set:

   • Not applicable. As this is not an AI/machine learning device, there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As there is no "training set," this question is not relevant.

Summary of the K963093 Submission's Approach:

The Siemens K963093 submission for the Siremobil Compact relies on the substantial equivalence pathway to FDA clearance. This means Siemens demonstrated that its new device has the same intended use and similar technological characteristics (design, materials, safety, performance, energy used, operating principles) as legally marketed predicate devices. The "study" in this context is primarily a technical and regulatory comparison rather than a clinical trial with specific performance metrics and patient data analysis against a ground truth. The acceptance is based on the FDA's regulatory review determining that the device is as safe and effective as its predicates.

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