(135 days)
Zimmer Ortho Guidance Systems Hip Instruments can be used as accessories to Image Guided Surgery systems and are indicated for any hip orthopaedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone or pelvis, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example procedures for these instruments include, but are not limited to:
Total or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopaedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization or Repair of Pelvic/Femoral Fractures
The Zimmer Ortho Guidance Hip Instruments are orthopaedic manual instruments modified to accept a Medtronic Image Guidance System array and are to be used with the Medtronic StealthStation® System.
This document describes the Zimmer Ortho Guidance™ Systems – Hip Instruments. Based on the provided text, the device is an accessory to Image Guided Surgery systems.
Here's an analysis of the provided information, specifically addressing the requested points:
-
Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria (e.g., accuracy thresholds, precision values) or report specific performance metrics for the Zimmer Ortho Guidance™ Systems – Hip Instruments. It states: "No guidance documents exist for these instruments. QSR validation and verification will be conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems." This implies that the validation focuses on compliance with Quality System Regulations (QSR) rather than direct performance measurement against pre-defined acceptance criteria for the instruments' clinical function. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No test set details are provided. The document explicitly states: "Clinical data and conclusions were not needed for this devices." -
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 applicable, as no clinical or performance testing data is presented, and no ground truth establishment is mentioned. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical or performance testing data is presented. -
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. The device described is an orthopaedic instrument, not an AI-powered diagnostic or assistive tool, and no MRMC study is mentioned. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is an instrument, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical or performance testing data is presented that would require ground truth. -
The sample size for the training set
Not applicable, as this is an instrument and not a machine learning algorithm requiring a training set. -
How the ground truth for the training set was established
Not applicable, as this is an instrument and not a machine learning algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
Based on the provided document, there was no clinical study or specific performance study conducted to "prove the device meets acceptance criteria" in terms of clinical effectiveness or diagnostic performance. The submission for the Zimmer Ortho Guidance™ Systems – Hip Instruments was a 510(k) premarket notification. The review concluded that the device is "substantially equivalent" to a legally marketed predicate device (Catheter Introducer for the StealthStation System manufactured by Medtronic Surgical Navigation, K022126).
The document states:
- "No guidance documents exist for these instruments."
- "QSR validation and verification will be conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems." (This refers to manufacturing and quality control, not clinical performance.)
- "Clinical data and conclusions were not needed for this devices."
Therefore, the "study" that proves the device meets acceptance criteria in the context of this 510(k) submission is the demonstration of substantial equivalence to a predicate device, as determined by the FDA, without the need for new clinical performance data for the instruments themselves. The acceptance criteria were primarily met through the regulatory pathway of substantial equivalence based on device description and intended use, rather than a novel performance study.
§ 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).