(263 days)
Robotic Integration 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 Robotic Integration Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS Robotic-Assisted Solution for Spine. The Robotic Integration Instruments are indicated for use in surgical spinal procedures, in which:
· the use of EXPEDIUM. VIPER. TriALTIS and SYMPHONY OCT 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 (eg. CT 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 Robotic Integration Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.
The Robotic Integration Instruments used in conjunction with the SYMPHONY OCT system are intended to support indicated cervical and thoracic polyaxial screw placement only.
Robotic Integration Instruments are reusable instruments used for the preparation and placement of DePuy Synthes screws (EXPEDIUM, VIPER, TriALTIS and SYMPHONY OCT), in either open or percutaneous procedures. The Robotic Integration instruments consist of a collection of Array Sleeves. Access Guides, Drills, Taps and Screwdrivers as well as various accessories and are designed for robotic assisted, navigated and nonnavigated use. They can be operated manually or under power. Navigation and Robotic Guidance of these instruments is achieved using the VELYS Robotic-Assisted Solution for Spine and associated and compatible VELYS Spine Instrument Arrays. The Core Instrument is a Navigation Ready Instrument, navigation of this instrument is achieved using a Universal Navigation Adaptor Set (UNAS) Navigation Ring and compatible VELYS Spine Instrument Arrays.
This FDA 510(k) summary for the Robotic Integration Instruments (K233256) does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document states:
- "The performance data for the subject devices consists of the following evaluations: . Accuracy Verification through engineering analysis, . Fulfillment of navigation systems instrument accuracy requirements as stated by the navigation manufacturer, CAD Model Evaluation, ● Simulated Use Evaluation."
However, it does not provide any specific acceptance criteria (e.g., numerical thresholds for accuracy), nor does it present any results from these evaluations. Therefore, I cannot complete the requested tables and information.
To provide the requested details, I would need a more comprehensive performance study report that includes:
- Specific numerical acceptance criteria for metrics like accuracy.
- Reported device performance values from the engineering analysis, simulated use, etc.
- Details of the study methodology, including sample sizes, data provenance, expert qualifications (if applicable), and ground truth establishment.
- Information on any multi-reader multi-case (MRMC) or standalone studies.
Without this information, I can only state that the document mentions the types of evaluations performed but does not provide the results or the specifics of the acceptance criteria.
§ 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).