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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 surgery and provides intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement.

The Total Hip Arthroplasty (THA) software module version 3.0 is an upgrade to the THA version 2.0 that was cleared for the Aesculap Orthopilot 2. It is designed to provide computer aided navigation for total hip arthroplasty using Aesculap's Orthopilot 2 platform. The Orthopilot 2 uses transmitters that are mounted to the patients bones, or are mobile to palpate anatomical landmarks in conjunction with a camera to monitor the spatial location of the transmitters in relation to each other and/or instruments. THA version 3.0 also allows for the use of ultrasound to provide data for anatomical landmarks.

The provided text describes an upgrade to a surgical navigation system, the Aesculap Orthopilot 2 THA V 3.0, and its substantial equivalence to a previously cleared device. However, it does not contain specific performance data, acceptance criteria, or details of a study that would prove the device meets such criteria.

The document primarily focuses on:

• Device Description and Indications for Use: Explaining what the device does (computer-aided navigation for total hip arthroplasty) and its upgrades (THA version 3.0, ultrasound data integration).
• Regulatory Compliance: Mentioning adherence to Aesculap's internal SOPs and FDA guidance, as well as recognized international standards (IEC 60601-1, IEC 60601-1-2) for safety and electromagnetic compatibility.
• Substantial Equivalence: Stating that the device is substantially equivalent to its predecessor (THA Module 2.0, K050752), which was cleared based on its equivalence to an even earlier version (THA Module 1.0, K013569). This is the primary method of demonstrating safety and effectiveness in a 510(k) submission when no applicable performance standards have been promulgated.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

The document explicitly states under "PERFORMANCE DATA": "No applicable performance standards have been promulgated under FDCA Section 514 for this system." This indicates that the FDA did not require specific performance testing against predefined external standards to grant market clearance for this particular device upgrade as a 510(k). Instead, clearance was based on demonstrating substantial equivalence to a legally marketed predicate device.

To answer your questions, one would need to refer to the original 510(k) submissions (K050752 and K013569) for the predicate devices, or other documentation that might contain detailed performance testing if such testing was performed internally by the manufacturer and submitted as part of the equivalence argument.

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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.

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