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AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures.

Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro-angiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g. gastro-intestinal imaging, skeletal imaging etc.

AXIOM Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

The intended use and indications for use of the AXIOM Artis with wireless footswitch and with voice control as described in its labeling have not changed from its predicate device the AXIOM Artis Modular Angiographic System.

The Wireless Footswitch uses RF technology in order to establish a short-range, low-power radio communication link between the footswitch (transmitter) and AXIOM Artis system (receiver). Additional hardware (independent of microcontroller) and Siemens own communication protocol layers will provide a safety-oriented signal transmission.

The Voice Control for the AXIOM Artis family allows for the control of selected functions by voice commands. The primary focus will be on image processing functions. Safety relevant functions such as X-ray release and movement control will not be included in the voice control functions.

Both Wireless Footswitch and Voice Control will be made available on the currently marketed Siemens AXIOM Artis family of products.

The provided text describes a 510(k) premarket notification for the Siemens AXIOM Artis with Wireless Footswitch and Voice Control. This submission primarily focuses on establishing substantial equivalence to predicate devices for these new features rather than presenting a detailed clinical study with acceptance criteria and performance data for a diagnostic algorithm.

Therefore, much of the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not available in the provided document, as it is generally not required for this type of submission.

Here's an analysis of the information that can be extracted or inferred from the document:

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

This information is not provided in the document. The submission is for a wireless footswitch and voice control system, which are input devices, not diagnostic algorithms with performance metrics like sensitivity, specificity, or accuracy. The "acceptance criteria" for such devices would typically relate to their functional reliability, safety (e.g., freedom from interference, proper signal transmission), and usability, rather than diagnostic performance. The document states:

• "The Wireless Footswitch and Voice Control are designed for use with the commercially available AXIOM Artis Modular Angiographic systems."
• "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 AXIOM Artis Modular Angiography System is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed."
• "Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing."

These statements suggest that functional performance and safety were evaluated against internal specifications and recognized industry standards, but specific quantitative acceptance criteria and detailed performance results are not reported in this 510(k) summary.

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

This information is not provided and is not relevant for this type of device submission. There was no "test set" in the context of evaluating a diagnostic algorithm's performance on patient data.

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)

This information is not provided and is not relevant for this type of device submission. No ground truth was established for a diagnostic algorithm.

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

This information is not provided and is not relevant for this type of device submission. No adjudication method was used for a diagnostic algorithm.

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

This information is not provided and is not relevant for this type of device submission. The device is not an AI-assisted diagnostic tool; it is a wireless input system (footswitch and voice control).

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

This information is not provided and is not relevant for this type of device submission. The device is not an algorithm, and it explicitly describes a "human-in-the-loop" usage scenario (physician using footswitch and voice commands).

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

This information is not provided and is not relevant for this type of device submission.

8. The sample size for the training set

This information is not provided and is not relevant for this type of device submission. There was no "training set" in the context of machine learning for diagnostic purposes.

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

This information is not provided and is not relevant for this type of device submission.

Summary of what the document does provide regarding device evaluation:

The substantial equivalence determination for the Siemens AXIOM Artis with Wireless Footswitch and Voice Control is based on:

• Comparison to Predicate Devices:
  • Wireless Footswitch: Substantially equivalent to the Stryker Wireless footswitch (K033135).
  • Voice Control: Substantially equivalent to the voice control used on the SIOS - Siemens Integrated Operation System (K994231) and the Philips iU22 Ultrasound System (K042540).
• Safety Features:
  • Uses RF technology for short-range, low-power communication with a safety-oriented signal transmission due to additional hardware and Siemens' proprietary communication protocol.
  • Voice control is limited to image processing functions; "Safety relevant functions such as X-ray release and movement control will not be included in the voice control functions."
  • Instructions for use, visual and audible warnings.
  • System monitoring with blockage of functions and error messages if an error occurs.
  • Adherence to recognized industry practices and final performance testing of all equipment.
• Intended Use: The intended use and indications for use "have not changed from its predicate device," the AXIOM Artis Modular Angiographic System. This implies that the new features do not introduce new risks or indications that would require extensive new clinical validation studies.

In essence, the "study" proving the device meets criteria is primarily a comparative analysis demonstrating substantial equivalence in terms of technological characteristics and safety profiles to existing cleared devices, coupled with a declaration of internal safety and performance testing according to recognized standards. It's not a clinical performance study of a diagnostic AI.

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