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The TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK 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 TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK consists of the following major components and subsystems: - The Station (Surgetics or NanoStation), consisting of a mobile computer system and an optical localizer - . Ancillary instruments, a specific motorized cutting block and reflective markers used for reference and registration - TOTAL KNEE SURGETICS software application with iBlock option . The main modification to the predicate device K081232 concerns the modification of the motorized cutting block PRAXITELES®.

The provided text describes a 510(k) summary for the TOTAL KNEE SURGETICS Navigation System with iBlock. Based on the available information, here is an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states, "The TOTAL KNEE SURGETICS Navigation System with iBlock was tested in a non clinical setting (bench testing, specimen)". While it specifies "specimen," it does not provide a specific sample size for the test set or specify the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. The testing appears to be non-clinical (bench testing, specimen), which typically relies on established physical standards or measurements rather than expert consensus on images.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method (such as 2+1 or 3+1). Given it's non-clinical testing on specimens, human adjudication in the typical sense for image interpretation would not be applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, 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 for this device. The study described is a non-clinical performance evaluation, not a study involving human readers or AI assistance. The device is a surgical navigation system, not an AI-based diagnostic tool.

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

The performance testing was a standalone evaluation of the device in a non-clinical setting. The statement "tested in a non clinical setting (bench testing, specimen)" implies testing the system's inherent performance characteristics (accuracy, efficiency) without direct human-in-the-loop clinical scenarios.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing (bench testing, specimen) would likely be established through physical measurements and engineering specifications to determine the accuracy of the system's guidance and its motorized cutting block. This is not explicitly stated as "expert consensus, pathology, or outcomes data," but rather implied by the nature of non-clinical, benchtop testing for a navigation system.

8. The Sample Size for the Training Set

The document does not provide information about a training set size. This device is a navigation system, and the testing described is for its performance, not for an AI model that requires a training set in the conventional sense. The "TOTAL KNEE SURGETICS software application with iBlock option" likely refers to the operational software, not a machine learning algorithm that needs a training set.

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

Since there is no mention of a training set in the context of an AI/machine learning model, there is no information about how its ground truth would have been established.

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The TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES 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 TOTAL KNEE SURGETICS NAVIGATION SYSTEM, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES consists of the following major components and subsystems:

• The Station (Surgetics or NanoStation), consisting of a mobile computer . system and an optical localizer
• Ancillary instruments, specific motorized cutting block and reflective . markers used for reference and registration
• TOTAL KNEE SURGETICS with Praxiteles software ●
  The main modification to the predicate device K060282 concerns the use of a new motorized cutting block PRAXITELES®.

The provided text describes the 510(k) summary for the TOTAL KNEE SURGETICS Navigation System with Praxiteles. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria. Instead, it refers to a qualitative assessment against the predicate device.

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

• Test Set Sample Size: Not explicitly stated. The study involved "non clinical setting (bench testing, specimen)." The number of specimens used is not specified.
• Data Provenance: The study was conducted in a "non clinical setting (bench testing, specimen)." This indicates it was a laboratory or cadaveric study, not on live human patients. The country of origin of the data is not specified, but the submitter is based in France.

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

This information is not provided in the document. The study was non-clinical, so expert involvement in establishing ground truth for clinical cases would not be applicable in the same way.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Given the nature of the non-clinical testing, a typical adjudication method for clinical studies (e.g., 2+1) would not be relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through non-clinical testing, comparing the modified device to a predicate, rather than human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The description of the "bench testing" and "specimen" analysis, focusing on "accuracy and performance of the system," suggests that standalone performance of the device's navigation and motorized cutting block components was evaluated. The device's function is to "aid the surgeon in locating anatomical structures and aligning the endoprostheses," implying the algorithm's performance in guiding and positioning.

7. The Type of Ground Truth Used:

The type of ground truth used is not explicitly stated but can be inferred from the "bench testing, specimen" context. For mechanical accuracy assessments in a non-clinical setting, ground truth would likely be established through:

• Precise measurements using calibrated instruments or reference standards.
• Verification against known anatomical landmarks or pre-defined surgical plans on cadaveric specimens.

8. The Sample Size for the Training Set:

This information is not applicable/provided. The document describes a 510(k) submission for a device, TOTAL KNEE SURGETICS Navigation System with Praxiteles, which is an image-guided surgical navigation system with a motorized cutting block. This type of device typically does not involve machine learning algorithms that require a "training set" in the conventional sense for image classification or prediction tasks. Its core functionality relies on optical tracking and pre-programmed algorithms for surgical guidance and positioning.

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

This information is not applicable/provided for the same reason as in point 8.

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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.

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