(35 days)
The Orthopilot® 2 Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty such as the Search Evolution Knee system and the Gem Knee system in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for total endoprosthesis replacement in accurately positioning the cutting guides intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement.
The Total Hip Arthroplasty (THA) software module version 2.0 is an upgrade to the THA software version 1 that was originally cleared in Aesculap's 510(k) submission #K013569. The Orthopilot 2 provides computer aided navigation for surgical instruments that are mounted to the patients bones, or are mobile to palpate anatomical landmarks. The Orthopilot 2 does this by using optical transmitters in combination with a camera to monitor the transmitters in relation to each other and/or instruments.
The provided document is a 510(k) summary for the Aesculap Orthopilot 2 THA V 2.0.4, a surgical navigation platform. It states that "No applicable performance standards have been promulgated under FDCA Section 514" and that "No applicable performance data was developed in accordance with Aesculap's internal SOP's as well as CDRH's 'General Principles of Software Validation; Final Guidance for Industry and FDA Reviewers, dated January 11, 2002.'"
Therefore, the document does not contain any information regarding specific acceptance criteria for device performance, the results of a study demonstrating the device meets such criteria, or details regarding ground truth, sample sizes, or expert adjudication as requested.
The document primarily focuses on:
- Device Identification: Company, contact, trade name, common name, device class, product code, classification, and review panel.
- Indications for Use: Computer-aided navigation for optimal positioning of endoprostheses in arthroplasty, aiding surgeons in accurately positioning cutting guides and indicating optimized angles for implant placement.
- Device Description: An upgrade to a previous version, providing computer-aided navigation for total hip arthroplasty using an infrared camera and transmitters.
- Performance Data (General Statement): A declaration that no specific performance standards exist under FDCA Section 514 and that internal SOPs and FDA's general software validation guidance were followed.
- Compliance with Standards: Conformance to IEC 60601-1 (medical electrical equipment safety) and IEC 60601-1-2 (electromagnetic compatibility).
- Substantial Equivalence: Claim of substantial equivalence to a previously cleared device (Orthopilot 2, K013569).
- FDA Clearance Letter: Formal FDA letter granting clearance based on substantial equivalence.
In summary, none of the requested information regarding detailed acceptance criteria, study methodologies, or performance results is present in the provided text.
§ 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).