(77 days)
The SpineAssist System is indicated for precise positioning of surgical instruments during spinal stabilization surgery. The device enables pre-operative planning of the surgical procedure and subsequent spatial positioning and orientation of the surgical tool during intra-operative procedures.
The Hover-T Bridge accessory used in conjunction with the SpineAssist device for minimally invasive surgical procedures, is intended for use for lumbar spinal fusion stabilization surgery.
The SpineAssist device developed by Mazor Surgical Technologies is an accurate imageguided positioning system that extends surgical capability in terms of precision, miniaturization and accessibility. The SpineAssist surgical positioning system assists the surgeon in the operating room to accurately position hand held surgical tools according to a computerized image-based pre-operative plan and to accurately guide surgical tools 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 the Hover-T kit, a special bone attachment component, the SpineAssist device attaches to the bone on which the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools in line with the computerized, image-based, pre-operative plan.
The provided text describes the SpineAssist System and its clearance as a medical device, but it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance.
Specifically, the document is a 510(k) premarket notification approval. While it confirms the device's intended use and substantial equivalence to a predicate device, it does not include a dedicated section detailing specific acceptance criteria for performance, nor does it outline the methodology, results, and detailed characteristics of a study designed to prove the device meets such criteria.
Therefore, I can only provide information based on what is available in the document.
Here's an attempt to answer your questions to the best of my ability with the provided text, while also explicitly stating what information is not available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given document. The 510(k) summary focuses on substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria.
2. Sample size 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 in the given document. The document refers to the device's "precision" and "accuracy" as part of its technological characteristics, but it does not detail any specific test set, its sample size, or its provenance.
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 in the given document. As no specific performance study with a test set is detailed, information about ground truth establishment or experts is absent.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the given 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
This information is not provided in the given document. The device assists surgeons in positioning tools; it's not described as an AI diagnostic or interpretive tool where "human readers" would be a relevant metric for improvement with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not explicitly detailed in the given document. The description states the device "assists the surgeon" and "guides surgical tools," implying a human-in-the-loop system. While it has proprietary algorithms for image processing and coordinate export, a standalone performance evaluation of the algorithms completely independent of human interaction is not described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the given document.
8. The sample size for the training set
This information is not provided in the given document. The document mentions "proprietary algorithms" and processing of images but does not delve into the development or training of these algorithms.
9. How the ground truth for the training set was established
This information is not provided in the given document.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).