(182 days)
The VIPER® and EXPEDIUM® navigated instruments are image guided surgical instruments for use in the implantation of VIPER® and EXPEDIUM® pedicle screws in an open or percutaneous approach. The navigated instruments are designed for use only with Brainlab Image Guided Surgery hardware and software. The navigated instruments are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, where the use of the VIPER® and/or EXPEDIUM® Spine Systems is indicated and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
The VIPER® and EXPEDIUM® navigated instruments are surgical instruments, for use in the implantation of VIPER® and EXPEDIUM® pedicle screws, which have been modified for use with Brainlab image guided surgery (IGS) hardware and software. The navigated instrument shafts mate with modified handles containing tracking arrays with Brainlab proprietary designs, or contain a dedicated interface for receiving a Brainlab owned tracking array. The passive tracking arrays enable the VIPER® and EXPEDIUM® navigated instruments to be tracked by the Brainlab system to virtual computer image space on a patient's preoperative or intra-operative 2D or 3D image data.
Here's a breakdown of the acceptance criteria and study information for the VIPER® and EXPEDIUM® navigated instruments, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in the typical format of a performance study with defined thresholds (e.g., accuracy must be within X mm). Instead, the submission relies on the concept of substantial equivalence to a predicate device.
Therefore, the "acceptance criteria" can be inferred as demonstration that the modified instruments perform similarly to or do not raise new questions of safety and effectiveness compared to the predicate device. The "reported device performance" is a statement that this equivalence has been achieved through verification and validation.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Maintain the same indications for use as the predicate. | Achieved |
| Utilize passive markers/arrays for tracking. | Achieved |
| Function with the same compatible Brainlab navigation software. | Achieved |
| Be non-sterile and reusable, like the predicate. | Achieved |
| Demonstrate compatible technological characteristics and principles of operation to the predicate devices. | Verification and validation of the VIPER® and EXPEDIUM® navigated instruments integration into the Brainlab Navigation Software was performed. (This is the direct performance statement.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in the conventional sense of a clinical trial or performance study involving patients or a large number of simulated cases. The "study" described is an engineering verification and validation of integration.
- Sample Size: Not Applicable (as no test set in the traditional sense is described).
- Data Provenance: Not Applicable (no patient data or specific study location is mentioned for a test set). The verification and validation were likely performed internally by the manufacturer, Medos International, Sárl, and DePuy Spine, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
No information is provided regarding experts or ground truth establishment for a test set. This type of regulatory submission for modifications to an existing device (navigated instruments for an existing navigation system) typically focuses on engineering verification rather than independent clinical validation with expert ground truth.
4. Adjudication Method for the Test Set
Not Applicable, as no test set or expert evaluation requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. The focus is on the substantial equivalence of the modified instruments, not on the comparative effectiveness of human readers with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a way, the entire submission effectively functions as verification of a standalone component within a larger system. The "device" being reviewed (VIPER® and EXPEDIUM® navigated instruments) is an algorithm-only component. Its performance is demonstrated as its ability to integrate with the existing Brainlab Image Guided Surgery hardware and software. There is no human-in-the-loop performance evaluation described for these specific instruments beyond their successful integration into the navigation workflow. The core functionality relies on the Brainlab system's algorithms, and this submission verifies the new instruments' compatibility with that proven system.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI or diagnostic accuracy studies (e.g., pathology, outcomes data, expert consensus) is not directly relevant here. The ground truth for this device's performance is implicitly the correct and accurate tracking and navigation provided by the Brainlab system when using these integrated instruments. Verification would confirm that the instruments are correctly recognized and tracked by the Brainlab system, and that their displayed position accurately reflects their physical position.
8. The Sample Size for the Training Set
Not Applicable. The submission describes a medical device (surgical instruments) that are modified for use with an existing image-guided surgery system. This is not an AI/machine learning algorithm that requires a training set in the sense of predictive modeling. The "training" for the system would be its initial development and calibration, which predates this submission.
9. How the Ground Truth for the Training Set Was Established
Not Applicable, as this is not an AI/machine learning algorithm requiring a training set.
§ 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).