(63 days)
The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as long bone can be identified relative to a CT based model or by an individual 3D model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to acetabular cup replacement as part of a partial or total hip arthroplasty (primary or revision).
The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are reusable conventional manual orthopedic surgical instruments modified with a navigation adapter for use with the BrainLAB VectorVision® Hip Image Guided Surgery System.
This 510(k) submission for the "Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications" does not include any clinical trial data or performance studies to demonstrate its acceptance criteria or device performance.
The submission explicitly states:
- "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
- "Clinical Testing: None provided as a basis for substantial equivalence."
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria because the provided document indicates no such clinical study was performed or submitted. The device received substantial equivalence based on non-clinical testing and comparison to legally marketed predicate devices with "similar technological characteristics."
§ 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).