(128 days)
The Black Diamond Navigation Instruments are intended to be used during the preparation and placement of Black Diamond pedicle screws during spinal surgery to aid the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Black Diamond Navigation Instruments are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Black Diamond Navigation Instruments are non-sterile, reusable instruments; including probes, bone taps, and inserters that are operated manually. These instruments are intended to be used within the context and limitations of the indications for use for Osseus Fusion System's FDA-cleared Black Diamond system and the Medtronic Synergy Experience StealthStation System S7 (v2.1.0). Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.
The Black Diamond Navigation Instruments are non-sterile, reusable instruments (probes, bone taps, and inserters) intended for use during the preparation and placement of Black Diamond pedicle screws in spinal surgery. The device aims to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures, specifically designed for use with the Medtronic Stealth Station System.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or detailed reported device performance in a table format. It mentions that "nonclinical testing was performed to show that the subject Black Diamond Navigation Instruments are substantially equivalent to the predicate device" and lists the types of testing: Accuracy testing, Compatibility testing, and Performance testing. It concludes that "The results of these evaluations indicate that the Black Diamond Navigation Instruments are equivalent to predicate devices."
Without specific numerical thresholds or performance metrics for acceptance, a table cannot be fully constructed.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Nonclinical testing was performed to show that the subject Black Diamond Navigation Instruments are substantially equivalent to the predicate device." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used to establish ground truth or their qualifications. The testing mentioned is non-clinical, suggesting that expert human assessment in a clinical context for ground truth may not have been the primary method.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The document explicitly states: "No clinical studies were performed." Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a set of "Navigation Instruments" used with the Medtronic Stealth Station System. This implies it's a tool for surgeons, not a standalone AI algorithm. The document mentions "Accuracy testing" and "Performance testing" among the non-clinical tests. While these tests evaluate the device's inherent capabilities (e.g., how accurately it tracks, how it performs mechanically), they are likely evaluating the instrument's standalone performance within the context of the navigation system, rather than an AI algorithm's standalone performance. The text does not explicitly refer to an "algorithm only" standalone performance study.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the non-clinical testing. Given that the device is a navigation instrument for surgery, "Accuracy testing" would likely compare the instrument's reported position/orientation against a known, precise physical reference (e.g., measured by a coordinate measuring machine or similar highly accurate metrology equipment). Such a ground truth would be objective, physical measurements rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This further supports the interpretation that the device is a physical instrument rather than a machine learning algorithm that undergoes a training phase.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned (as the device is not an AI algorithm requiring one in the traditional sense), this information is not applicable and not provided.
§ 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).