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The OrthoPilot® Next Generation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in athroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endoprosthesis replacement surgery (such as total knee, unicondylar knee, and total hip systems) and provides intraoperative measurement. It indicates angles and positions for implant placement.

Aesculap's OrthoPilot® Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), passive markers, power supply, various tagged instruments, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or 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. The software modules for the OrthoPilot® Next Generation consist of modules for both a knee suite and a hip suite.

The provided text is a 510(k) premarket notification for a medical device called "OrthoPilot® Next Generation." This type of document is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) submission primarily focuses on demonstrating substantial equivalence, not on providing detailed clinical trial or performance study data with acceptance criteria in the way a PMA (Premarket Approval) application would. The document states:

"There is no change to previous performance data for the OrthoPilot® Next Generation navigation system."

"The intended use and fundamental scientific technology of the OrthoPilot® Next Generation Navigation system remain unchanged including the integration of passive marker spheres cleared as part of K141694. The only difference is an update to the knee software modules (TKA, TKR and UKA) for the integration of passive marker spheres cleared as part of K141694 and the other minor improvements."

This indicates that the current submission (K153396) is for minor software updates and relies on prior clearances (K080547 and K141694) for performance data. Therefore, the detailed information requested regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment, and MRMC studies for this specific submission is not present in the provided text, as this type of information would have been part of the original submissions that established the performance of the core device.

The document refers to compliance with software development standards (IEC 62304) and FDA guidance for software in medical devices, which are process-oriented rather than providing specific performance metrics.

Based only on the provided text, I cannot furnish the detailed information requested in your prompt. The document does not describe a new comprehensive study to prove the device meets specific acceptance criteria for a new clinical performance claim. It is an "update" submission for minor changes building on previously cleared devices.

If this were a PMA application or a de novo submission, or if the original 510(k) for K080547 or K141694 were provided, that information might be available. However, for K153396, the performance is essentially tied to the previous clearances.

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The OrthoPilot® Next Generation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endacement surgery (such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurement. It indicates angles and positions for implant placement.

Aesculap's OrthoPilot® Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), passive markers, power supply, various tagged instruments, an ultrasound module, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or 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. The computer can also accept spatial input for anatomical landmarks from an ultrasound unit. The software modules for the OrthoPilot Next Generation consist of modules for both a knee suite and a hip suite.

The provided text is a 510(k) summary for the "Aesculap OrthoPilot Next Generation" surgical navigation system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of diagnostic or interpretive performance.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy, human reader improvement with AI) cannot be extracted from this document, as it describes a computer-assisted surgical navigation system and not an AI-driven diagnostic device.

However, I can extract information related to the device's performance data based on the context of a surgical navigation system, which focuses on verification and validation of changes to the device.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria (e.g., error margins in millimeters or degrees for navigation) and corresponding reported device performance. Instead, it mentions that the device was verified and validated for certain aspects.

2. Sample size used for the test set and the data provenance

The document does not detail specific "test sets" in the diagnostic sense, nor does it provide sample sizes (e.g., number of procedures, patients, or data points) for the verification and validation activities mentioned. Data provenance (country of origin, retrospective/prospective) is also not discussed. The performance data refers to testing conducted on the device components and software.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The device is a surgical navigation system, and "ground truth" for its performance would likely be related to precision and accuracy measurements in a lab or cadaveric setting, not expert consensus on diagnostic images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable and not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable and not provided. This device is not an AI-driven diagnostic tool to assist human readers. It is a computer-assisted surgical navigation system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept doesn't directly apply here in the context of a diagnostic algorithm. The device, being a surgical navigation system, works with human surgeons in the loop. Its "standalone performance" would be its inherent accuracy and precision in guiding instruments, which is what "navigation performance" verification and validation would cover. However, specific details of this testing are not given.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of "ground truth" for the verification and validation of the navigation system's performance. For a surgical navigation system, "ground truth" would typically involve highly precise measurements of physical placement, angles, or trajectories compared to ideal or calibrated values. This might be established through metrology equipment or other highly accurate measurement systems in a controlled environment.

8. The sample size for the training set

Not applicable and not provided. This document does not describe an AI/machine learning model that requires a training set. The software is proprietary and provides anatomical information to the surgeon.

9. How the ground truth for the training set was established

Not applicable and not provided, as there is no mention of a training set for an AI/ML model.

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The Orthopilot® Next Generation Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endoprosthesis replacement surgery(such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurements of bone alignment. It indicates angles and positions for implant placement.

Aesculap's OrthoPilot Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide optimal anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), power supply, various tagged instruments, an ultrasound module, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or 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. The computer also can accept spatial input for anatomical landmarks from an ultrasound unit.

The provided text is a 510(k) summary for the Aesculap Orthopilot Next Generation, a surgical navigation platform. It states that "No applicable performance standards have been promulgated under FDCA Section 514 for this system" and that "The previously cleared software modules were 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 Staff.'"

Therefore, the document does not contain the information requested regarding specific acceptance criteria, a study proving device performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details on ground truth for training or test sets.

The submission focuses on establishing substantial equivalence to a previously cleared device (Orthopilot Total Knee Arthroscopy software module, K080547) rather than providing detailed performance study data for the Orthopilot Next Generation.

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The Orthopilot® Next Generation Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty 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.

Aesculap's OrthoPilot Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide optimal anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), power supply, various taqged instruments, an ultrasound module, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or 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. The computer also can accept spatial input for anatomical landmarks from an ultrasound unit. The software modules for the OrthoPilot Next Generation consist of modules for both a knee suite and a hip suite.

The provided text is a 510(k) summary for the Aesculap Orthopilot Next Generation, a surgical navigation platform. It does not contain information about specific acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment details, expert qualifications, or MRMC study results. The document primarily focuses on establishing substantial equivalence to a predicate device based on hardware upgrades, with the software remaining unchanged from a previously cleared version.

Therefore, most of the requested information cannot be extracted from this document.

Here's a summary of what can be extracted:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or report device performance against such criteria. The basis for clearance is substantial equivalence.

Study Details

The document does not describe a clinical study or performance study that would entail acceptance criteria, sample sizes, ground truth, or expert involvement as described in the prompt.

Information Not Found in the Document:

• Acceptance Criteria Table: No specific quantitative acceptance criteria are listed.
• Reported Device Performance: No performance metrics are provided.
• Sample size for the test set: Not mentioned.
• Data provenance (country of origin, retrospective/prospective): Not mentioned.
• Number of experts and qualifications for ground truth: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable as no such study is described.
• Standalone (algorithm only) performance study: Not mentioned.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• Sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

What is mentioned:

The document states that a "Performance Data" section is included, but it focuses on compliance with promulgated standards and software development principles, rather than clinical performance metrics.

• "No applicable performance standards have been promulgated under FDCA Section 514 for this system."
• "The previously cleared software modules were 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 Staff.'"
• The device complies with:
  • IEC 60601-1 (International Electrotechnical Commission: Medical Electrical Equipment, Part 1: General Requirements for Safety)
  • IEC 60601-1-2 (International Electrotechnical Commission: Medical Electrical Equipment, General Requirements for Safety: Electromagnetic Compatibility - Requirements and Tests)

The basis for clearance is "Substantial Equivalence" to the Aesculap OrthoPilot 2 system (cleared in K013569). The key point for substantial equivalence is that "The OrthoPilot Next Generation navigation system merely represents an across the board upgrade in hardware technology and connectivity" and "The software that has been previously cleared for OrthoPilot 2 is compatible with OrthoPilot Next Generation and remains unchanged." This implies that clinical performance studies were not deemed necessary for this 510(k) clearance due to the software being identical to a previously cleared version and the changes being hardware-only.

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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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The Orthopilot® HTO module is designed to assist an orthopedic surgeon to navigate the two bone cuts to form the wedge for correction of the leg axis.

Orthopilot® HTO (High Tibia Osteotomy) module uses transmitters that are mounted to the patients bones, or are flexible to palpate landmarks and a camera to monitor the spatial location of those transmitters in relation to each other and the medical instruments. These locations are used to locate the centers of rotation of the femur head, ankle and knee. These measurements allow for greater accuracy than mechanical methods of ascertaining cutting angles. The HTO module is only a tool to navigate the instruments for the bone cuts. It is not linked to any specific implant.

The provided document is a 510(k) summary for the Aesculap Orthopilot® HTO module, indicating its purpose is to gain marketing clearance. However, it explicitly states there are no performance standards for such devices and references conformity to applicable ASTM and ISO standards generally. No specific acceptance criteria or detailed study results are included in this document to demonstrate the device meets any particular performance criteria.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document primarily focuses on establishing substantial equivalence to existing devices (Orthopilot® 2 Navigation Platform, Kinamed Orthopilot®, Stryker Navigation System-Knee Module, Brainlab Vector Vision Knee) rather than presenting a detailed performance study with specific metrics and acceptance criteria.

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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. (Does not include an indication for High Tibial Osteotomy (HTO) module).

Orthopilot® 2 Navigation Platform uses transmitters that are mounted to the patients bones, or are flexible to palpate landmarks and a camera to monitor the spatial location of those transmitters in relation to each other and the medical instruments. These locations are used to locate the centers of rotation of the femur head, ankle, knee. These measurements allow for greater accuracy than mechanical methods of ascertaining implantation sites and positions.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) premarket notification for the Orthopilot 2 Navigation Platform. It focuses on regulatory compliance, device description, indications for use, and substantial equivalence to previously cleared devices.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily states that the Orthopilot 2 Navigation Platform complies with general safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, CAN/CSA-C22.2 No. 601.1-M90), but these are performance standards for electrical and medical equipment safety, not clinical performance acceptance criteria for the navigation system's accuracy or efficacy in positioning endoprostheses. The FDA's letter also indicates that no applicable performance standards have been promulgated under Section 514 specifically for this device system.

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