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The ENDOFIX EXO is indicated for use in interventions where a rigid endoscope is indicated for use. The device is intended to hold and position a rigid endoscope / exoscope during general and neurological diagnostic and therapeutic procedures.

The ENDOFIX EXO is a manually operated surgical device intended to hold endoscopes during general and neurological diagnostic and therapeutic procedures. It emulates an arm which is capable of guiding and positioning an endoscopic camera with several degrees of movement.

lt ensures stable and sensitive positioning of the endoscope and allows the surgeon to work one-handed and/or two-handed. The system provides surgeons with a stable and rocksteady field of vision, even in extreme endoscopic positions. The wide scope of movement provides surgeons with full visibility of the situs. The ENDOFIX exo can be used with both, an endoscope and exoscope.

An integrated DEACTIVATION PUSHBUTTON permits manual movement of the ENDOFIX EXO at the push of a button. In order to reposition a guided endoscopic camera, the ENDOFIX EXO is unlocked by a sterilizable CONTROL at the push of a button. The ENDOFIX EXO is operated by unlocking all 6 axes and subsequent manual positioning using the CONTROL. As soon as the button on the CONTROL is released, all 6 axes are locked again.

Despite its large scope of movement, the ENDOFIX EXO is light-weight and compact and is fastened directly to the OR table by means of a quick-acting clamp. Thus, repositioning with reference to the patient is not necessary even if the OR table is moved in the meantime.

On the rigid endoscope, there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the ENDOFIX EXO.

To allow the surgeon to convert to an open surgery in case of an emergency, the ENDOFIX EXO can be completely mounted or removed by a quick fastener.

During use, the ENDOFIX EXO is covered with a STERILE COVER. The ENDOFIX EXO can be removed from the OR table and stored on the TROLLEY.

The provided text is a 510(k) Summary for the medical device ENDOFIX EXO. It details the device's characteristics, comparison to a predicate device, and the non-clinical tests performed. However, it does not describe any acceptance criteria or studies involving AI / human reader performance.

Here's an analysis based on the provided text for the points that can be addressed:

The document clearly states that the ENDOFIX EXO is a manually operated surgical device. This means the device itself does not involve AI or algorithms for diagnosis or analysis, but rather for physical positioning of an endoscope. Therefore, many of the questions related to AI performance, such as acceptance criteria for algorithm performance, sample size for test/training sets, ground truth establishment for AI, MRMC studies, or standalone algorithm performance, are not applicable to this device as described.

The document discusses non-clinical performance tests to demonstrate the safety and effectiveness of the device compared to its predicate.

Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with reported performance values for specific metrics. Instead, it lists the types of non-clinical tests performed and broadly states that these tests were successful in demonstrating safety and effectiveness.

Non-Clinical Tests Performed:

• Lifetime test
• Lifetime test CONTROL
• Moving after fixation test
• Usability test
• Package drop test

Reported Device Performance (Implicit):
The summary states, "The non-clinical tests have shown that the ENDOFIX EXO device is as safe and effective as the predicate device." It also notes specific findings related to safety:

• Electromagnetic locks were mechanically tested according to IEC 60601-1:2005 + A1:2012, with no risks regarding safety observed.
• Displacement after fixation of the arm was tested, with no risks regarding safety observed.
• The device was tested with 5kg load, though its safe working load is specified as 1kg, and "no problems occurred."
• The absence of a battery in ENDOFIX EXO ensures continuous power operation safety. In case of power failure, the arm continues to hold position, and quick-release fasteners allow safe removal.
• Electrical safety tested according to IEC 60601-1, posing no danger to the user.
• Reprocessing and sterilization process validated, confirming no increased risk.
• Usability test with 15 American physicians did not negatively mention weight, despite the device being heavier than the predicate.

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

• Test Sample Size: Not specified for most tests (e.g., lifetime test, moving after fixation test, package drop test).
  • For the Usability Test: "15 American physicians."
• Data Provenance:
  • Country of Origin: The usability test involved "15 American physicians," suggesting US-based data. For other tests, the origin is not explicitly stated but the applicant is based in Germany.
  • Retrospective or Prospective: Not explicitly stated but implied to be prospective testing for device validation.

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 question is not applicable as this relates to AI/diagnostic performance where expert consensus is needed for ground truth. This device is a mechanical endoscope holder.
• However, for the Usability Test, "15 American physicians" were involved. Their specific qualifications beyond being "physicians" are not detailed.

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

• This question is not applicable as there is no diagnostic or interpretative task requiring adjudication. The tests described are mechanical, electrical, and usability in nature.

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 question is not applicable as the device is a mechanical endoscope holder and does not involve AI for diagnostic assistance or human-in-the-loop performance improvement.

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

• This question is not applicable as there is no algorithm or AI component in this device.

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

• This question is not applicable as the "ground truth" concept as typically applied to diagnostic AI is not relevant here. The "truth" for the mechanical/electrical tests would be adherence to engineering specifications and safety standards (e.g., proper functioning after a lifetime test, no displacement after fixation, meeting electrical safety standards).

8. The sample size for the training set

• This question is not applicable as there is no AI/algorithm component requiring a training set.

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

• This question is not applicable as there is no AI/algorithm component requiring ground truth for a training set.

Ask a specific question about this device

The Virage® Navigation System Instruments are to be used during the preparation and placement of Virage® OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. The Virage® Navigation System Instruments are specifically designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Virage® Navigation Instruments are also compatible with the Zimmer Biomet Universal Power System and the WalterLorenz® Surgical Assist Arm.

The Virage Navigation System is comprised of non-sterile, reusable instruments including drills, taps, and drivers that can be operated manually and/or under a power surgical technique to prepare for and insert Virage OCT polyaxial screws. These instruments are intended to be used with the Medtronic StealthStation® System to assist surgeons in precisely locating anatomical structures. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems allows the surgeon access to real-time, multi-plane 3D images) thereby providing confirmation of hardware placement.

The provided text does not describe a study involving an AI/ML device or its performance against acceptance criteria. Instead, it describes a 510(k) premarket notification for the Virage Navigation System, which is a stereotaxic instrument used in spinal surgery, not an AI/ML device.

The document focuses on demonstrating substantial equivalence to existing predicate devices (Navigated INFINITY™ Instruments and StealthStation® System) through comparisons of technological characteristics, intended use, and performance data. The "performance data" section primarily discusses accuracy testing of the stereotactic instruments according to ASTM F2554-18 and a clinical validation lab to demonstrate compatibility and safety with existing navigation and power systems.

Therefore, I cannot extract the requested information about acceptance criteria, study details for an AI/ML device (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance) because this information is not present in the provided document. The device is a traditional medical instrument, not an AI/ML system.

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