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The SpineAssist™ System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. The SpineAssist™ System may be used in either open or percutaneous procedures.

The SpineAssist™ system is a computer controlled miniature medical image-guided surgery (IGS) system, which serves as a technological platform for solutions that provide unprecedented levels of accuracy, precision and accessibility in performing orthopedic procedures. The SpineAssist™ is designed to assist surgeons in precisely guiding handheld surgical tools in line with a computerized, image-based pre-operative plan along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the SpineAssist device, which positions its articulating arm and tool guide. Using a special bone attachment component (i.e., a clamp and bridge, the Hover-T / Bi-lateral Hover-T bridge, the Bed Mount Hover-T or the Cervical Kit) the SpineAssist device attaches to the bone in the area where the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools according to the computerized, image-based, pre-operative plan.

The main components of the SpineAssist™ system include:
A. SpineAssist™ device
B. Workstation
C. Accessories including the Clamp Kit for less invasive procedures, the MIS platforms: Hover-T, Bi-lateral Hover-T, Bed Mount Hover-T and the Cervical Kit, the last one intended for less invasive procedures.

Here's an analysis of the provided text regarding the SpineAssist™ System's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the performance tests "demonstrate that SpineAssist system meets its design and performance specifications." However, it does not provide specific quantitative acceptance criteria or detailed results for each test (e.g., "accuracy within X mm"). It only indicates that these tests were performed to validate stability and accuracy for the extended intended use.

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The document mentions tests were performed "on cadavers to simulate real clinical procedures." The number of cadavers used is not specified.
• Data Provenance: The cadaver tests were described as simulating clinical procedures, but the origin of the cadavers (e.g., country) is not mentioned. These were non-clinical tests. The study is prospective as it involved performing tests to gather data for the submission.

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

• This information is not provided in the given text. The tests were "stability and accuracy tests... performed on cadavers," implying a technical assessment rather than a human expert consensus for "ground truth" related to device performance metrics.

4. Adjudication Method for the Test Set

• This information is not applicable and not provided. The performance tests described (stability, accuracy) are typically measured objectively by technical instrumentation rather than requiring a human adjudication process like in a diagnostic study.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for a surgical navigation system, not an AI-assisted diagnostic tool. There is no mention of human readers or AI assistance in a diagnostic context.

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

• Yes, standalone (algorithm/device only) performance tests were done. The "Non-Clinical Performance Data" section describes various stability and accuracy tests performed on the SpineAssist™ system itself (e.g., "Bed Mount Hover-T Stability Test," "Cervical Accuracy C1-C6 Test"). These tests evaluate the device's technical specifications without necessarily involving human surgical performance in a comparative study. The software validation is also a standalone assessment of the algorithmic components.

7. The Type of Ground Truth Used

• For the accuracy and stability tests, the ground truth would likely be established through pre-defined anatomical landmarks or precise measurements taken by a high-precision measurement system (e.g., optical tracking, CMM). For example, in an "accuracy" test, the deviation of the navigated tool from a known target trajectory or point would be measured against a gold standard reference. The text doesn't explicitly state the methodology for establishing this ground truth but implies it's based on physical measurements and engineering specifications.

8. The Sample Size for the Training Set

• This information is not applicable and not provided. The SpineAssist™ system is described as a "computer controlled miniature medical image-guided surgery (IGS) system" that processes images and exports coordinates. While it uses "proprietary algorithms," it is not described as a machine learning or AI system that requires a distinct "training set" to develop its core functionality in the sense that a diagnostic AI model would. Its software validation focuses on compliance with standards rather than a machine learning training paradigm.

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

• This information is not applicable and not provided for the reasons stated in point 8.

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The SpineAssist™ System is indicated for precise positioning of surgical instruments or implants during thoracic and lumbar spinal surgery. The SpineAssist™ system may be used in either open or percutaneous procedures.

The SpineAssist™ system is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide unprecedented levels of accuracy, precision and accessibility in performing orthopedic procedures. The SpineAssist™ is designed to assist surgeons in precisely guiding handheld surgical tools or implants in line with a computerized, image-based pre-operative plan along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the SpineAssist device, which positions its articulating arm and tool guide. Using a special bone attachment component (i.e., a clamp and bridge or the Hover-T bridge) the SpineAssist device attaches to the bone in the area where the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools or implants according to the computerized, image-based, preoperative plan.

The main components of the SpineAssist™ system include:

• A. SpineAssist™ device
• B. Workstation
• A. Accessories including clamp, bridge, Hover-T bridge, targets, prism, wedge, etc.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt (e.g., specific quantitative benchmarks for acceptance, detailed performance metrics with numerical results, sample sizes for test and training sets, expert qualifications, or adjudication methods).

However, based on the summary of non-clinical performance data and conclusions, I can infer the general acceptance criteria and report the mentioned performance.

Here's an analysis of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. However, it implicitly suggests that the system's performance for "accuracy" and "safety and effectiveness" during "general spinal surgical procedures" were the key criteria.

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

The document mentions "non-clinical performance data" and lists several "case studies" and "accuracy tests." It does not specify the sample size (e.g., number of cases, number of measurements) for any of these tests.

The data provenance is not explicitly stated. However, given the nature of "non-clinical performance data" for a surgical device involving "accuracy tests" and "case studies," it is highly likely that these were conducted in a controlled laboratory or cadaveric setting, rather than on human patients (since "Clinical Performance Data" is marked as "Not Applicable"). It is likely prospective for the specific tests conducted for this submission. The company is based in Israel, so the studies were likely conducted there or in a partnered facility.

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

The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for the "accuracy tests" or "case studies."

4. Adjudication Method for the Test Set

The document does not provide any information regarding adjudication methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done or reported in this summary. The device is a surgical navigation system, not an AI diagnostic tool that assists human readers in interpreting medical images. "Clinical Performance Data" is explicitly stated as "Not Applicable," further reinforcing that human reader studies are outside the scope of this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the "Non-Clinical Performance Data" listed are all standalone algorithm/system performance tests. The device itself is designed to guide surgical tools based on algorithmic processing of imaging data, and the tests like "General Spinal Accuracy Test," "Hover-T Accuracy Test," and "New Imaging and Lateral to 30 degree Accuracy Test" directly assess the system's performance in this standalone capacity. The lack of "Clinical Performance Data" and MRMC studies further supports that the reported performance reflects the algorithm/system without human-in-the-loop performance for this specific submission.

7. The Type of Ground Truth Used

While not explicitly stated, for "accuracy tests" in a surgical navigation system, the ground truth would typically be established by:

• Precise measurements using highly accurate calibration tools or coordinate measuring machines in a controlled environment (e.g., phantom, cadaveric models).
• Known physical dimensions or fiducial markers on phantoms or cadavers which the system is attempting to target or guide to.
• For "case studies" (e.g., Osteoid Osteoma, Thoracic Hover-T), the "ground truth" might refer to the actual anatomical position or intended trajectory as confirmed by intra-operative imaging or post-operative assessment against the surgical plan.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set.

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

The document does not provide any information regarding how the ground truth for the training set was established.

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