(28 days)
The TenZing System is a combination of the SpineAssist System and C-InSight System, allowing the C-InSight application to run on the SpineAssist Workstation: 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 C-InSight software provides a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects particularly in orthopedic applications.
The TenZing system is a device modification of the SpineAssist system, designed to incorporate both the original SpineAssist system and the C-InSight system in one workstation. The TenZing console is identical to the SpineAssist console. The system is intended to be used in a variety of hospital locations (e.g., OR, trauma unit, etc.). The main components of the TenZing System include:
A. Workstation
B. SpineAssist accessories:
Surgical Accessories Kit .
Setup Kit .
C. SpineAssist Device
D. C-InSight accessories:
Spine Target Kit .
Extremities Target Kit .
E. Image Adaptor
F. Spine Assist Disposable kits
G. C-InSight Sterile Sheath Disposable kits
Here's an analysis of the provided text regarding the TenZing System's acceptance criteria and studies, organized by your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K102130) does not explicitly state specific quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) for the Tenzing System. It focuses on demonstrating substantial equivalence to predicate devices and software validation rather than specific performance metrics against pre-defined criteria.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from this document. The document states:
- "There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the TenZing device." (Section 7)
- "The TenZing System software was subject to software validation testing in accordance with the FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices (January 11, 2002)." (Section 8)
- "The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the TenZing device are substantially equivalent to the predicate device cited above." (Section 9)
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on sample sizes for test sets used in performance evaluation, nor does it specify the provenance (country of origin, retrospective/prospective) of data used for any testing. The testing described is "software validation testing," which typically involves internal verification and validation against requirements rather than clinical performance testing with patient data detailed in this type of submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. Software validation testing usually involves internal testing teams and engineers, not external clinical experts for ground truth establishment in the way described for AI/diagnostic devices.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The TenZing System is a surgical navigation and 3D imaging system, not a diagnostic AI system intended to improve human reader performance in interpreting images. Its purpose is to guide surgeons and provide 3D imagery from 2D fluoroscopy.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document describes "software validation testing" (Section 8). This constitutes a form of standalone testing of the algorithm and software components against their specifications and functional requirements. However, specific performance metrics (e.g., accuracy of 3D reconstruction, precision of navigation guidance) from such standalone testing are not detailed in this submission. The "substantial equivalence" argument (Section 9) implies that its standalone performance characteristic is comparable to its predicates.
7. The Type of Ground Truth Used
For the "software validation testing," the ground truth would typically be defined by the system's functional and technical specifications, and the accuracy of its outputs (e.g., 3D reconstruction from 2D, positioning accuracy) would be verified against known inputs and expected computations. It is not based on expert consensus, pathology, or outcomes data in the clinical sense for this type of device.
8. The Sample Size for the Training Set
The document does not mention a training set, as the TenZing System is not described as an AI/machine learning device that requires a training set in the conventional sense. It's a system that combines existing technologies (SpineAssist, C-InSight) and associated software.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for an AI/ML model, this information is not applicable and therefore not provided.
Summary of Device and Approval Context:
The TenZing System (K102130) is a combination device integrating features of two previously cleared Mazor Surgical Technologies systems: SpineAssist (K073467) and C-InSight (K081672). It acts as a workstation to run both applications.
- SpineAssist: Indicated for precise positioning of surgical instruments or implants during general spinal surgery (open or percutaneous procedures).
- C-InSight: Provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D images, for high contrast objects in orthopedic applications.
The approval is based on substantial equivalence to these predicate devices. The primary performance testing mentioned is software validation to FDA guidance. This type of 510(k) submission generally relies on demonstrating that the new device does not raise new questions of safety or effectiveness compared to legally marketed predicates, rather than presenting novel clinical performance data or extensive studies like those required for de novo AI devices.
§ 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).