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BrainLAB's VectorVision spine is intended for use as an intraoperative image-quided localization system for 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 that is processed by a VectorVision 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, such as the skull, the pelvis, a long bone 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:

• · Navigated spinal procedures in support of standard approaches (e.g. anterior, lateral, oblique)
• · Spinal implant procedures such as
  • · Pedicle screw placement
  • · Anterior plating
• · Kyphoplasty and vertebroplasty procedures
• · Placement of other temporary or permanent devices such as k-wires, needles, catheters or electrodes
• · Thoracic spine surgerv
• · Tumor surgery on the spinal column and adjacent soft tissue
• Placement of acetabular and SI screws on the pelvis

VectorVision spine is a device that allows surgical planning and navigation. It links a surgical instrument. (tracked by passive marker sensor system) to a location on a virtual computer image, which is either based ou patient's preoperative 3D information of a CT or MR dataset or based on patient's 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,

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

Based on 3D data, the procedure of linking the surgical instrument to the virtual computer image is achieved by performing registration methods as paired point matching, surface matching, region matching or CT fluoro matching. The last registration method uses 2D fluoro images to register the previously acquired 3D dataset. Thus, CT fluoro matching combines 2D fluoro imaging with 3D datasets,

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

Here’s an analysis of the provided text regarding the acceptance criteria and study for the VectorVision spine device:

The provided 510(k) summary for the BrainLAB VectorVision spine (K053159) does not explicitly state specific acceptance criteria or provide a detailed study report with performance metrics for the device itself.

Instead, the submission primarily focuses on establishing substantial equivalence to predicate devices (BrainLAB VectorVision CT / Fluoro K010968 and BrainLAB Kolibri spine K042721) based on the intended use and device description.

The key statement regarding validation is:
"VectorVision spine 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."

This indicates that internal validation was performed, but the specific details of that validation (e.g., acceptance criteria, test results, statistical analysis) are not presented in this publicly available summary. Such detailed information is typically kept by the manufacturer and is part of the full 510(k) submission, not necessarily released in the abbreviated summary.

Therefore, many of the requested points cannot be answered from the provided text.

Here's an attempt to answer the questions based only on the provided text, noting limitations:

Acceptance Criteria and Study for BrainLAB VectorVision spine (K053159)

This 510(k) summary focuses on demonstrating substantial equivalence by outlining the device's intended use and functionality, rather than presenting a detailed study with explicit acceptance criteria and corresponding performance metrics. The summary states that the device was "verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system." However, the specifics of these validation activities, including numerical acceptance criteria or performance results, are not provided in this document.

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

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

Not specified in the provided 510(k) summary. The internal verification and validation studies are not detailed.

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 provided 510(k) summary. Given the nature of a surgical navigation system, "ground truth" for performance testing would likely involve highly precise measurement tools and potentially expert surgeons in a simulated or cadaveric setting, but no details are given.

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

Not specified in the provided 510(k) summary.

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 a surgical navigation system, not an AI-assisted diagnostic imaging device for "human readers" in the typical sense of MRMC studies. Its purpose is to guide surgeons, not to interpret images or improve human diagnostic accuracy in a reading task.

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

The device is inherently a "human-in-the-loop" system, assisting surgeons. While its underlying algorithms have standalone performance characteristics (e.g., registration accuracy), the overall device performance is always in the context of aiding a surgeon. No details on purely "algorithm only" performance are provided in isolation from the human user.

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

Not specified in the provided 510(k) summary. For a surgical navigation system, ground truth would typically refer to the true anatomical position or the true position of tracked instruments, often established by high-precision physical measurements or imaging techniques.

8. The sample size for the training set

Not applicable. This device, being a system for surgical navigation in 2005, is not described as utilizing machine learning or AI models in the same way modern devices do, which would typically rely on a "training set." Its functionality is based on established image processing, registration algorithms, and passive marker tracking.

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

Not applicable, as there is no mention of a "training set" in the context of contemporary AI/ML.

In summary: The provided 510(k) document is a summary of the device's intended use and design, culminating in the FDA's finding of substantial equivalence to predicate devices. It does not contain the detailed technical data, specific acceptance criteria, or performance study results that would typically be included in the full technical file or detailed clinical study reports.

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BrainLAB VectorVision Spine Module is intended to be an intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's images data being processed by a BrainSCAN workstation (K915819). The system is indicated for any medical condition where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra can be identified relative to a C.I hased model of the anatomy where surgically appropriate.

intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's images data being processed by a BrainSCAN workstation (K915819).

This document is a 510(k) clearance letter for the BrainLAB VectorVision Spine system. It indicates FDA clearance for marketing but does not contain detailed information about acceptance criteria or specific study results that prove the device meets those criteria. Such information is typically found in the 510(k) summary or the full submission, which is not provided here.

Therefore,Based on the provided document (FDA 510(k) clearance letter for BrainLAB VectorVision Spine), the detailed information requested regarding acceptance criteria and a study proving device performance is not available.

This document is a regulatory approval letter, indicating that the device has been found substantially equivalent to a predicate device. It does not contain the technical details of performance studies or acceptance criteria that would typically be found in a 510(k) summary or the full submission.

Therefore, for each of your points, the answer is:

1. A table of acceptance criteria and the reported device performance: Not provided in this document.
2. Sample size used for the test set and the data provenance: Not provided in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in this 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 provided in this document. The device is an image-guided localization system, not an AI-assisted diagnostic tool for human readers in the context of MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not provided in this document. The device is described as an "intraoperative image guided localization system to enable open or percutaneous surgery," which implies human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in this document.
8. The sample size for the training set: Not provided in this document.
9. How the ground truth for the training set was established: Not provided in this document.

To obtain this information, one would typically need to review the full 510(k) submission or the 510(k) summary if it were publicly available and detailed enough.

Ask a specific question about this device