Search Results

The TOTAL HIP SURGETICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures.

The system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the pelvis, the femur can be identified by acquiring multiple landmarks.

Example procedures include but are not limited to:

Hip arthroplasty

As the equivalent TOTAL KNEE SURGETICS navigation system, the TOTAL HIP SURGETICS navigation system consists of the following major components and subsystems:

• The Navigation Station, consisting of a mobile computer system and an . optical localizer
• . Ancillary instruments and reflective markers used for reference and registration
• . TOTAL HIP SURGETICS software

The provided text is a 510(k) summary for the TOTAL HIP SURGETICS Navigation System (K072267). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, nor does it provide the requested information about sample sizes, ground truth establishment, or expert qualifications.

The paragraph titled "8. Performance Testing" makes a general statement: "The TOTAL HIP SURGETICS Navigation System was tested to assess that no safety and efficiency issues were raised in the device. Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate devices." This is a conclusion, not a description of the test itself nor the specific criteria or results.

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

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: The document only states that "Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate devices." No specific metrics or quantitative results are provided.

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).

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

• Not mentioned. The document doesn't detail how "accuracy and performance" were assessed beyond a general statement.

4. Adjudication method for the test set:

• Not mentioned.

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 mentioned. The device is a surgical navigation system, not an AI diagnostic tool primarily evaluated by human reader performance on cases.

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

• The performance testing mentioned (paragraph 8) appears to be for the system as a whole, which inherently involves the algorithm's performance in guiding the surgeon. However, a specific "standalone" study (without a human) is not described.

7. The type of ground truth used:

• Not mentioned.

8. The sample size for the training set:

• Not mentioned. The document primarily focuses on claiming substantial equivalence to predicate devices rather than detailing development and training processes.

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

• Not mentioned.

In summary, this 510(k) summary provides a high-level overview and a claim of substantial equivalence but lacks the detailed performance data, acceptance criteria, and study methodology typically expected for a comprehensive understanding of device validation.

Ask a specific question about this device

The TOTAL KNEE SURGETICS NAVIGATION SYSTEM is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for : . Total Knee Arthroplasty

As the equivalent Surgetics ORTHO KNEELOGICS Navigation System, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM consists of the following major components and subsystems: - The Surgetics Station, consisting of a mobile computer system and an . optical localizer - . Ancillary instruments and reflective markers used for reference and registration - TOTAL KNEE SURGETICS software . The main modifications to the predicate device concern the internal architecture of the software, allowing more easily to integrate new implants and to better adapt the workflow to different surgical techniques. New instruments adapted to new implants are also incorporated.

The provided text for the TOTAL KNEE SURGETICS Navigation System does not contain specific acceptance criteria or a detailed study report with quantitative performance metrics. Instead, it makes a general statement about performance testing and substantial equivalence to a predicate device.

Here's an analysis based on the given information, highlighting what is and is not present:

Acceptance Criteria and Device Performance:

The document states: "Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate device." However, no specific accuracy metrics (e.g., in millimeters, degrees of rotation) or performance thresholds (acceptance criteria) are provided in the document. Therefore, a table of acceptance criteria and reported device performance cannot be generated from this text.

Study Details:

The document mentions "Performance Testing" but does not provide a detailed study design or results.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Sample Size: Not specified.
   • Data Provenance: The testing was "non clinical setting (bench testing, specimen)". No country of origin is mentioned for the data, and it was not human patient data (retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not specified. The document does not describe the establishment of a ground truth by experts for the test set.

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

   • Not specified.

4. 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:

   • A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The device is a surgical navigation system, not an AI-assisted diagnostic tool for human readers.

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

   • The performance testing mentioned was "non clinical setting (bench testing, specimen)." This implies a standalone evaluation of the system's accuracy in a controlled environment, likely without human surgical intervention as part of the test (though it's intended for use with human surgeons). The document states, "Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate device." This indicates a standalone assessment was performed to compare it with the predicate device.

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

   • Not specified. Given it was "bench testing, specimen," the ground truth would likely involve highly precise measurements against known physical standards or anatomical landmarks on the specimens using a highly accurate reference system, but the document does not detail this.

7. The sample size for the training set:

   • Not applicable/Not specified. This is a navigation system, not a machine learning model that typically requires a discrete training set in the sense of a diagnostic AI. The software modifications concern "internal architecture," "integrating new implants," and "adapting the workflow to different surgical techniques," rather than training a predictive algorithm with a large dataset.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified. (See point 7).

Summary of what is present:

• Device Type: Surgical navigation system (TOTAL KNEE SURGETICS Navigation System).
• Intended Use: Aid surgeons in locating anatomical structures and aligning endoprostheses during Total Knee Arthroplasty.
• Testing Conducted: Non-clinical bench testing on specimens.
• Conclusion: Accuracy and performance were "adequate for its intended use and not reduced in comparison to the predicate device."
• Predicate Device: Surgetics ORTHO KNEELOGICS Navigation System (K031196).
• Modifications from Predicate: Internal software architecture for easier integration of new implants and adaptation of workflow, new instruments for new implants.

In essence, the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, and while it mentions performance testing, it does not provide the granular data or criteria usually expected in a detailed study report for acceptance criteria. The FDA's acceptance of the 510(k) implies that the provided (but non-public) testing information was sufficient for their "substantial equivalence" determination.

Ask a specific question about this device

The Surgetics ORTHO OSTEOLOGICS navigation system is an optically based surgical navigation system. It is intended for use as an aid to the surgeon in tracking bone structures and instruments on a 3D model of the patient's bone which is generated through acquiring multiple landmarks. The system is indicated to assist a surgeon to control the lower limb axis during osteotomy procedures.

Examples of orthopedic surgical procedures include, but are not limited to: Open wedge osteotomy for the lower limb Closed wedge osteotomy for the lower limb

The Surgetics ORTHO OSTEOLOGICS Navigation System consists of the following major components and subsystems:

• The Surgetics Station, consisting of a mobile computer system and an optical . localizer
• Ancillary instruments and reflective markers used for reference and . calibration.
• HTO Monitoring Software for, but not limited to open and closed wedge . osteotomy for the lower limb

The provided text describes performance testing for the Surgetics ORTHO OSTEOLOGICS navigation system, focusing on its accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly refers to "summaries of accuracy testing" but does not explicitly state specific numerical acceptance criteria for accuracy, nor does it provide the exact reported performance values in a table format. It simply states that "summaries of accuracy testing using phantoms, specimen bench testing, and clinical experience with the system were provided."

Without explicit acceptance criteria in the document, I cannot create such a table.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated. The document mentions "accuracy testing using phantoms, specimen bench testing, and clinical experience," implying a test set was used, but the size of these sets is not provided.
• Data Provenance: Not explicitly stated. The manufacturer is based in France ("Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France"), suggesting the testing may have occurred there or in other countries, but this is not specified. It is likely prospective as it involves new testing for the device's clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not explicitly stated. The document mentions "clinical experience," which implies input from medical professionals (surgeons), but the exact number or their specific qualifications (e.g., years of experience, specialty) are not provided.

4. Adjudication Method for the Test Set:

Not explicitly stated. There is no mention of any specific adjudication method (e.g., 2+1, 3+1, none) used for interpreting the test results or establishing ground truth.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

Not explicitly stated. The document does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance, nor does it report any effect size. The system is a surgical navigation aid, not primarily an interpretative AI tool for diagnostic images.

6. Standalone Performance:

Yes, a standalone performance assessment was conducted. The "accuracy testing using phantoms, specimen bench testing" refers to evaluating the algorithm's performance in a controlled environment, which constitutes standalone (algorithm only) testing. The system's purpose is to provide navigation guidance, and its accuracy in doing so is a measure of its standalone performance.

7. Type of Ground Truth Used:

The ground truth for the standalone testing would likely be:

• Phantom Data: Precisely known measurements/geometries on the phantom as the ground truth against which the system's measurements are compared.
• Specimen Bench Testing: Likely involved comparing the system's measurements/tracking against a known gold standard (e.g., high-precision manual measurements or other validated measurement systems) on cadaveric or animal specimens.
• Clinical Experience: While not detailed, "clinical experience" would typically involve surgeons using the system and assessing its practical accuracy and utility during actual procedures, likely against their surgical judgment and possibly intraoperative imaging or direct measurements.

8. Sample Size for the Training Set:

Not explicitly stated. The document does not provide any information regarding the training set size or methodology for the development of the navigation system's algorithms.

9. How Ground Truth for the Training Set Was Established:

Not explicitly stated. Since training set details are omitted, the method for establishing ground truth for any potential training data is also not provided.

Ask a specific question about this device