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The Siemens Siregraph CF is a remote overtable radiographic/fluoroscopic x-ray diagnostic system that was designed for universal implementation in the hospital and clinical environment. The Siregraph CF, remote X-ray system, has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoraic and lung exposures as well as examinations of the urinary tract, lymphography, myelography, venography, arthrography angiography and DSA.

The Siemens Siregraph CF is a multifunctional, overtable X-ray diagnostic system that was developed for remote examinations. The Siregraph CF has a motorized table tilt from +90° to -18°. The Siregraph CF X-ray tube/spot film system is equipped with a motorized telescoping arm which can be extended to a maximum SID of 150 cm, The x-ray tube/spot film device can be programmed to perform linear tomography (planigraphy) at three different angles; 40° with a tomographic range of 113 cm, 20° with a tomographic range of 131 cm and 8° with a tomographic range of 142 cm. In addition to the overtable tube the Siregraph CF can be configured with an overhead tube support for exposures using Bucky Wall Stand.

The provided text describes a traditional medical device (an X-ray diagnostic system) and does not include information about acceptance criteria or a study proving its performance in the context of an AI/ML device. The document is a 510(k) summary for the Siemens Siregraph CF, a remote multi-functional overtable X-ray diagnostic system.

The "study" described in such a 510(k) is typically a demonstration of substantial equivalence to legally marketed predicate devices, not a performance study against specific acceptance criteria in the way a modern AI/ML device would disclose.

Therefore, for almost all the requested categories, the information is not applicable or not provided in this specific 510(k) summary. I will indicate where the information is missing or not relevant to this type of device submission.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Explanation: This 510(k) focuses on demonstrating substantial equivalence to predicate devices for a traditional X-ray system, not on AI/ML performance metrics. Acceptance criteria for an X-ray system would typically involve adherence to safety standards, radiation dose limits, and basic image quality metrics, which are generally covered by compliance with 21 CFR Subchapter J mentioned in the document and proven through internal testing and certification, rather than a specific "performance study" with a defined acceptance criterion and reported metric like for an AI algorithm.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not Applicable / Not Provided.
• Data Provenance: Not Applicable / Not Provided (as this is a hardware device, not an AI/ML software).

Explanation: There is no "test set" in the context of AI/ML evaluation for this type of device submission. The substantial equivalence argument relies on comparing the technological characteristics and intended use of the new device to already cleared predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not Applicable / Not Provided.
• Qualifications of Experts: Not Applicable / Not Provided.

Explanation: Ground truth establishment by experts is relevant for AI/ML performance evaluation, which is not described for this traditional X-ray system.

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

• Adjudication Method: Not Applicable / Not Provided.

Explanation: Adjudication is relevant for resolving discrepancies in expert labeling for AI/ML ground truth, which is not part of this submission type.

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

• MRMC Study: No.
• Effect Size: Not Applicable.

Explanation: MRMC studies are used to evaluate diagnostic performance of humans, often with and without AI assistance. This is a traditional X-ray machine, not an AI-assisted diagnostic tool.

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

• Standalone Study: Not Applicable.

Explanation: This device is a physical X-ray system; it does not have a standalone algorithm in the AI/ML sense.

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

• Type of Ground Truth: Not Applicable / Not Provided.

Explanation: This concept is not relevant to the 510(k) for a physical X-ray machine. Its "performance" is based on meeting engineering specifications, safety standards, and providing images of a quality comparable to predicates.

8. The sample size for the training set

• Sample Size for Training Set: Not Applicable / Not Provided.

Explanation: This is a hardware device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Ground Truth Establishment: Not Applicable / Not Provided.

Explanation: This concept is not relevant to the 510(k) for a physical X-ray machine.

Summary of the "Study" in the K960266 Submission:

The "study" presented in this 510(k) summary is a demonstration of substantial equivalence to legally marketed predicate devices, as required by the FDA for certain medical devices.

• Device Name: Siemens Siregraph CF
• Comparison: The Siregraph CF is compared to existing devices:
  • Sireskop SX (Siemens Medical Systems, Inc., K951358)
  • Prestilix 1600X (GE Medical Systems, K924310)
  • Diagnost 96 (Philip Medical Systems, K912470)
• Method of Equivalence: The submission asserts substantial equivalence based on:
  • Intended Use: "remote overtable radiographic/fluoroscopic x-ray diagnostic system that was designed for universal implementation... medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoraic and lung exposures as well as examinations of the urinary tract, lymphography, myelography, venography, arthrography angiography and DSA." This is shown to be consistent with the predicates.
  • Technological Characteristics: Describing the Siregraph CF as a "platform for specific X-ray components (image intensifier, X-ray tube and housing, spotfilm device, Bucky Wall stand, collimator, generator, etc.) and television systems (Videomed DI and Videomed SX) to create a flexible remote radiographic/fluoroscopic x-ray system." Implied similarity to predicate designs.
  • General Safety and Effectiveness Concerns: Stating adherence to recognized and established industry practice, compliance with 21 CFR Subchapter J, incorporation of safety features (visual/audible warnings, error messages, system blocking), and final performance testing. This demonstrates that it meets the same safety and effectiveness standards as generally accepted for predicate devices.

This 510(k) filing is for a traditional, hardware-based X-ray system and does not contain the types of studies or performance claims associated with AI/ML-driven diagnostic devices.

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