(263 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 the with the Medtronic StealthStation® 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 acquired image (CT, MR, 2D fluoroscopic image or 3D 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.
Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™, VIPER™, SYMPHONY™ OCT and TriALTISTM 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. Navigation of these instruments is achieved using the VELYS Robotic-Assisted Solution for Spine as well as the Medtronic StealthStation navigation system and associated tracking arrays.
The provided text describes a 510(k) premarket notification for the "CROSSNAV Navigation Enabled Instruments," which are reusable instruments used in spinal surgery. The documentation focuses on demonstrating substantial equivalence to previously cleared predicate devices. While it lists various performance data evaluations, it does not contain a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or accuracy thresholds with reported device performance metrics.
The document primarily states that the device's technological characteristics, design, materials, performance, and intended use are consistent with those of the predicate devices, and that testing was conducted to confirm this consistency. It mentions "Accuracy Verification through engineering analysis" and "Fulfillment of navigation systems instrument accuracy requirements," but it does not provide the specific acceptance criteria for these, nor the actual measured performance data.
Therefore, I cannot fully answer your request for a table of acceptance criteria and reported device performance with the specific details requested (sample size, expert qualifications, etc.) because that information is not present in the provided document.
However, I can extract the information that is present and indicate what is missing based on your request.
Acceptance Criteria and Device Performance (Information Available in Document)
The document implies that the acceptance criteria revolved around demonstrating substantial equivalence to predicate devices in terms of design, materials, performance characteristics, and intended use. The performance data listed are categories of evaluation rather than specific numerical acceptance criteria.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied from the document's Conclusion) |
|---|---|
| Consistency in design and materials with predicate devices | "The technological characteristics of the CROSSNAV Navigation Enabled Instruments in terms of design, materials and performance are consistent with those of the predicate devices." |
| Accuracy verification | "Accuracy Verification through engineering analysis" was performed. (No specific numerical results or criteria provided) |
| Fulfillment of navigation system instrument accuracy requirements | "Fulfillment of navigation systems instrument accuracy requirements as stated by the navigation manufacturer" was performed. (No specific numerical results or criteria provided) |
| CAD Model Evaluation | "CAD Model Evaluation" was performed. (No specific outcomes provided) |
| Simulated Use Evaluation | "Simulated Use Evaluation" was performed. (No specific outcomes provided) |
| No new questions of safety and effectiveness | "This does not raise new questions of safety and effectiveness based on application of recognized consensus standards and design controls." |
Missing Information (Based on your Request and Not Present in the Document)
- Specific numerical acceptance criteria: The document does not provide a table with quantitative acceptance thresholds (e.g., accuracy within X mm, a certain pass/fail rate for a simulated use).
- Reported device performance (quantified): While it states tests were performed (e.g., "Accuracy Verification"), it does not report the actual measured performance data against specific criteria.
- Sample size used for the test set: Not mentioned.
- Data provenance (country of origin, retrospective/prospective): Not mentioned.
- Number of experts used to establish ground truth: Not applicable for the type of engineering/design validation described.
- Qualifications of experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned and typically not relevant for surgical instruments unless they involve AI for image interpretation or diagnosis. The device is a "Navigation Enabled Instrument," suggesting it assists human surgeons, but the document doesn't detail a study comparing human performance with and without the device.
- Standalone (algorithm only) performance: Not applicable as this is a physical instrument, not a standalone algorithm.
- Type of ground truth used: For the engineering evaluations mentioned (accuracy, simulated use), the ground truth would likely be based on engineering specifications, physical measurements, and perhaps surgical standards, but is not detailed.
- Sample size for the training set: Not applicable and not mentioned, as this is a physical instrument, not an AI model that requires a training set in the typical sense.
- How ground truth for the training set was established: Not applicable.
Summary of what the document provides regarding validation:
The validation approach for the CROSSNAV Navigation Enabled Instruments, as presented in the 510(k) summary, primarily relies on:
- Engineering Analysis: To verify accuracy and adherence to design specifications.
- Fulfillment of Navigation System Accuracy Requirements: Ensuring compatibility and performance within existing navigation systems (VELYS Spine System and Medtronic StealthStation® System).
- CAD Model Evaluation: likely for design integrity and fit.
- Simulated Use Evaluation: To assess performance in a representative environment.
The absence of detailed quantitative performance results and specific acceptance criteria in this public 510(k) summary is common, as these details are typically found in the full submission, which is proprietary. The FDA's clearance implies that the submitted data (which includes the detailed study reports) was sufficient to demonstrate substantial equivalence to the predicate 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).