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BrainLAB's Kolibri spine is intended to be an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data being processed by a Kolibri workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure of the spine or vertebra can be identified relative to a CT, X-ray or MR-based model of the anatomy.

Example procedures include but are not limited to:

Spinal implant procedures such as pedicle screw placement Kyphoplasty and Vertebroplasty procedures Placement of temporary or permanent devices such as k-wires, needles, catheters or electrodes Thoracic spine surgery Tumor surgery on the spinal column and adjacent soft tissue Placement of acetabular and SI screws on the pelvis

Kolibri spine is a device that allows surgical planning and navigation. It links a surgical instrument, tracked by a passive marker sensor system to a virtual computer image, which is either based on patient's preoperative 3D data or based on online acquired intraoperative acquired 2D fluoro image(s) of a c-arm.

The device enables the navigation based on 3D data and/or based on acquired fluoro images (Fluoro only).

Based on 3D data, the procedure of linking the surgical instrument to the virtual computer image is achieved by performing certain registration methods.

Based on 2D fluoro images, the registration is done automatically by using the exact spatial position information of the intra-operatively acquired fluoro images.

After registration, the device assists the surgeon in performing certain surgical procedures as described in the indications for use.

The provided document is a 510(k) Summary for the BrainLAB Kolibri spine, an image-guided surgery system. It describes the device's intended use and substantial equivalence to predicate devices but does not contain information regarding specific acceptance criteria, a detailed study proving performance against such criteria, or the methodology (e.g., sample sizes, expert qualifications, ground truth establishment) for any such study.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details on the study that proves the device meets acceptance criteria, as this information is not present in the provided text.

The document primarily focuses on the regulatory submission for clearance, outlining the device's description, intended use, and its substantial equivalence to previously cleared devices. It states that the device "has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system." However, it does not provide the specifics of this validation.

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Ci TKR/UKR is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereo tactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by Ci TKR/UKR.

Example orthopedic surgical procedures include but are not limited to:

Knee Procedures: Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking

Ci TKR/UKR is intended to enable operational planning and navigation in orthopedic surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. Ci TKR/UKR uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position.

Ci TKR/UKR allows 3-dimensional reconstruction of the mechanical axis and alignment of the implants. Ci TKR/UKR software registers the patient data needed for planning and navigating the surgery intraoperatively. No preoperative CT-scanning is necessary.

Ci TKR/UKR software has been designed to read in implant data from DePuy and offers to individually choose the prosthesis during each surgery.

The provided text describes the Ci TKR/UKR (Kolibri Knee) image-guided surgical system, but it does not contain information about the acceptance criteria or a specific study proving the device meets those criteria, nor any performance metrics.

The document is a 510(k) summary and FDA clearance letter, which focuses on establishing substantial equivalence to predicate devices rather than detailing performance studies with specific statistical outcomes or acceptance criteria.

Therefore, I cannot populate the requested table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted based on the document:

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

• No specific acceptance criteria or reported device performance metrics are provided in this document. The document states "The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with predicate devices..." indicating that validation was performed, but the details of that validation (criteria, results) are not included here.

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

• Not specified in the document.

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):

• Not specified in the document.

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

• Not specified in the document.

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:

• Not applicable. This device is an image-guided surgical system, not an AI or diagnostic imaging device that involves human "readers" or "interpreters" in the context of MRMC studies. Its purpose is to assist surgeons in navigation.

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

• This device is inherently "human-in-the-loop" as it's an image-guided surgical system designed to assist a surgeon. The document does not describe standalone algorithm performance for tasks like diagnosis or prediction. Its function is to provide real-time navigation assistance.

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

• Not specified in the document. Given the nature of a navigation system, ground truth would likely relate to the accuracy of instrument positioning relative to planned positions or actual anatomical landmarks, but the method for establishing this is not detailed.

8. The sample size for the training set:

• Not applicable/Not specified. This document does not describe a machine learning model with a distinct "training set." The system uses 3D models generated from patient bone landmarks intraoperatively.

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

• Not applicable/Not specified.

Summary of what is known from the provided text:

• Manufacturer: BrainLAB AG
• Device Name: Ci TKR/UKR (Kolibri Knee)
• Intended Use: Intraoperative image-guided localization system to enable minimally invasive surgery, aiding surgeons to accurately navigate knee prostheses, provide ligament balancing, and measure bone alignment.
• Mechanism: Links a freehand probe (tracked by passive markers) to a virtual computer image space on an individual 3D-model of the patient's bone, generated through acquiring multiple landmarks on the bone surface.
• Key Feature: No preoperative CT-scanning is necessary.
• Regulatory Status: Cleared via 510(k) process based on substantial equivalence to predicate devices (BrainLAB Vector Vision® CT-free knee and BrainLAB Kolibri™ Image Guided Surgery System).
• Validation: The text states, "The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510(k) application was found to be substantially equivalent with predicate devices..."

To answer the detailed questions, a more comprehensive technical report or validation study document would be required, rather than just the 510(k) summary and FDA clearance letter.

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The intended use of the Diego Powered Dissector and Drill System equipped with an image guided surgery system is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.

Sinus applications would embody:

• ethmoidectomy/sphenoethmoidectomy .
• polypectomy .
• septoplasty and .
• procedures such as .
  • antrostomy .
  • endoscopic DCR .
  • frontal sinus drill-out .
  • frontal sinus trephination and irrigation .
  • septal spurs removal .
  • trans-spehnoidal procedures .

Nasopharyngeal/laryngeal procedures would comprise:

• adenoidectomy ●
• laryngeal lesion de-bulking ●
• laryngeal polypectomy .
• tracheal procedures ●
• . tonsillectomy

Head & Neck procedures would encompass:

• . soft tissue shaving
• rhinoplasty (narrowing of the bony vault and revision of the bony pyramid) .
• removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular . regions of the face
• acoustic neuroma removal .

Otology procedures would include:

• mastoidectomy .
• mastoidotomy .

The Diego Powered Dissector and Drill System Handpiece, cleared under 510(k) K020594, has been modified to accept the BrainLAB VectorVision (K003589) and Kolibri (K014256) Image-Guided Surgery System Instrument Adapter that will allow the Dissector blades and burs to be tracked in real time in the surgical field.

The provided text is a 510(k) summary for the Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece. This document is related to a medical device's regulatory review and does not contain information about acceptance criteria or a study proving device performance in the context of typical AI/software device evaluation.

The 510(k) is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the way an AI/software device would. The modifications described are about allowing the existing "Diego Powered Dissector and Drill System Handpiece" to integrate with BrainLAB Image-Guided Surgery Systems (VectorVision and Kolibri) through an adapter. This likely involves mechanical integration and compatibility, rather than a clinical performance study with statistical endpoints.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/software device is not present in this document.

Here's an attempt to answer based on the spirit of the request, highlighting what's missing in the context of your questions, and what can be inferred.

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria for device performance in terms of clinical accuracy or outcome metrics as would be seen for an AI/software device. Instead, the "acceptance criteria" for a 510(k) submission are largely based on demonstrating substantial equivalence to a predicate device, which implies that the modified device will perform as safely and effectively as the predicate.

The document implicitly "reports device performance" by stating its intended use and showing equivalence to predicate devices for navigation. The performance here is in terms of compatibility and retaining the function of the original dissector and drill system while integrating with image guidance.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable/Not provided. This 510(k) submission does not describe a clinical performance study that would use a "test set" in the context of an AI/software device evaluation. The assessment is likely based on engineering verification and validation of the mechanical and functional integration with the IGS systems, rather than a statistical sample of patient data.
• Data Provenance: Not applicable/Not provided for a clinical "test set."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. There is no mention of a "test set" with expert ground truth in this submission, as it's not an AI/software device undergoing such a performance evaluation. The review for 510(k) is about substantial equivalence based on engineering, bench, and potentially pre-clinical (e.g., cadaveric) testing, and comparison to existing predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. As no clinical "test set" requiring expert ground truth or adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not an AI-assisted diagnostic or therapeutic guidance system that would typically undergo an MRMC study to show human reader improvement. The device itself is a surgical tool, and the modification enhances its guidance capabilities, but the submission doesn't include an MRMC study comparing surgeon performance with/without the image-guided assistance provided by this specific adapter.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a manual surgical tool that is guided by an image-guided surgery system. Its function inherently involves a human operator (the surgeon) and the image navigation system. There is no "algorithm only" component that would perform a task independently. The performance is the combined system's ability to track the instrument accurately.

7. Type of Ground Truth Used:

Not applicable in the context of an AI/software device's performance study. For a mechanical device, "ground truth" would relate to engineering specifications, e.g., the true position of the instrument as measured by highly accurate systems, or the physical dimensions and tolerances of the adapter. However, the submission does not detail these engineering verification methods beyond stating the intent to integrate with image-guided systems.

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical surgical instrument; it does not utilize a "training set" for machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for this type of device.

Summary of what the document DOES provide:

• Device Description: A modified handpiece for the Diego™ Powered Dissector and Drill System, designed to accept adapters for BrainLAB Image-Guided Surgery Systems (VectorVision and Kolibri).
• Intended Use: Cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures, with specific examples listed.
• Predicate Devices: BrainLAB Kolibri IGS System (K014256) and BrainLAB Vectorvision2 IGS System (K003589). The modification makes the Gyrus ENT device "compatible" with these predicate image-guided systems.
• Regulatory Classification: Class II, Stereotaxic instrument (HAW).
• 510(k) Clearance: The document is the FDA's clearance letter, stating substantial equivalence to predicate devices, thus permitting marketing.

This 510(k) focuses on the mechanical and functional compatibility of a modified surgical instrument with existing image-guided navigation systems, rather than a new AI/software diagnostic or therapeutic device whose performance would be assessed with detailed statistical studies against clinical ground truth.

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