(80 days)
Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS Spine System as well as with the Brainlab Navigation System and the Medtronic StealthStation® Navigation System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
· the use of EXPEDIUM™, VIPER™, SYMPHONY™ OCT and the TriALTIS™ Spine System is indicated,
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebra, can be identified relative to the aquired image (CT, MR, 2D fluoroscopic image or fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.
The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.
Universal Navigation Adaptor Set (UNAS):
The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebrac can be identified relative to the acquired image (CT. MR, 2D fluoroscopic image or fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instruments, when used with UNAS, can be:
· pre-calibrated with the VELYS Spine System using VELYS Spine Instrument Arrays,
· pre-calibrated and/or manually calibrated with the Brainlab Navigation System,
where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
Via the CROSSNAV Adaptor, the UNAS Navigation Arrays are also compatible with DePuy Synthes Navigation Enabled Instruments indicated for use with the Brainlab Navigation System.
Navigation Enabled Instruments (CROSSNAV™ Instruments) are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™, VIPER™, SYMPHONY™ OCT and TriALTIS™ screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation Enabled Instruments also include the CROSSNAV™ Adaptor to facilitate navigation of the Navigation Enabled Instruments with the VELYS Spine System as well as with the Brainlab Navigation System. Navigation of these instruments is achieved using the VELYS Spine System as well as Brainlab Navigation System and the Medtronic StealthStation Navigation System and their associated tracking arrays.
Universal Navigation Adaptor Set (UNAS)
The Universal Navigation Adaptor Set (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments as well as the Navigation Enabled Instruments. The UNAS can only be used with the VELYS Spine System as well as Brainlab and Medtronic StealthStation navigation systems. The UNAS includes:
- Brainlab compatible UNAS Navigation Arrays,
- VELYS Spine/Brainlab compatible Navigation Rings and
- Medtronic compatible Navigation Ring ST.
The Navigation Rings and Navigation Ring ST mate with compatible DePuy Synthes Navigation Ready Instruments. These instruments include implant site preparation and implant insertion instruments as well as access and discectomy instruments.
When the VELYS Spine/Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument: - a VELYS Spine Instrument Array can be attached and the instrument can be used with the VELYS Spine System as a pre-calibrated instrument, or
- . a UNAS Navigation Array can be attached and the instrument can be used with the Brainlab Navigation System as either a manually calibrated and/or pre-calibrated instrument.
Via the CROSSNAV Adaptor, the UNAS Navigation Arrays are also compatible with DePuy Synthes Navigation Enabled Instruments indicated for use with the Brainlab Navigation System.
When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak" II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only with the Medtronic StealthStation Navigation System.
The provided text does not contain detailed acceptance criteria or a study that proves the device meets those criteria in the typical format seen for AI/ML-enabled devices, which often involve metrics like sensitivity, specificity, or AUC.
Instead, the document is a 510(k) summary for a medical device (CROSSNAV Navigation Enabled Instruments and Universal Navigation Adaptor Set (UNAS)) that primarily focuses on demonstrating substantial equivalence to predicate devices, particularly concerning its compatibility with additional navigation systems.
However, based on the Performance Data section, we can infer some aspects that align with typical acceptance criteria for this type of device, which revolve around accuracy and functional performance.
Here's an interpretation based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Performance Data) | Reported Device Performance (Inferred from Performance Data) |
|---|---|
| Fulfillment of navigation systems instrument accuracy requirements. | Fulfilled (As stated: "Fulfillment of navigation systems instrument accuracy requirements as stated by the navigation manufacturer"). Specific numerical targets not provided. |
| Acceptable CAD Model Evaluation. | Performed (As stated: "CAD Model Evaluation"). Specific outcomes/metrics not provided. |
| Acceptable Simulated Use Evaluation. | Performed (As stated: "Simulated Use Evaluation"). Specific outcomes/metrics not provided. |
| Demonstrated substantial equivalence to predicate devices in design, materials, and performance. | Determined to be substantially equivalent (Stated in Conclusion: "CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays are substantially equivalent to the predicate devices."). |
| Compatibility with additional navigation systems (Brainlab Navigation System). | Established (Stated in G. Summary: "expands the scope...for compatibility with an additional Navigation System, the Brainlab Navigation System"). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of a dataset for AI/ML evaluation. The performance data listed (Fulfillment of navigation systems instrument accuracy requirements, CAD Model Evaluation, Simulated Use Evaluation) suggests bench testing and internal evaluations rather than a clinical trial with a patient test set. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a test set is not available in this document.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document as it does not describe a study involving expert review for ground truth establishment. The evaluations mentioned (accuracy requirements, CAD model, simulated use) typically rely on engineering specifications, measurements, and functional testing.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where multiple human readers interpret data, and a consensus ground truth needs to be established. Since this document does not describe such a study or a test set requiring expert interpretation, an adjudication method is not applicable and not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done or at least is not reported in this document. The device is a navigation instrument, not an AI/ML algorithm that assists human readers in interpreting medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device itself is an instrument used with navigation systems to assist surgeons, implying it is always used with a human in the loop. It is not an AI/ML algorithm that would have standalone performance in isolation. Therefore, a "standalone algorithm only" performance study is not applicable to this device.
7. The Type of Ground Truth Used
Based on the performance data mentioned, the "ground truth" for the evaluations likely involved:
- Engineering specifications and manufacturer requirements: For navigation systems instrument accuracy.
- Design specifications and measurements: For CAD Model Evaluations.
- Pre-defined procedural steps and outcomes: For Simulated Use Evaluations.
This is not clinical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical instrument set, not an AI/ML model that undergoes a training phase with a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the same reason as above.
§ 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).