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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 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.

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The CTLOGICS 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 which uses patient's preoperative image data 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 skull, the pelvis, a long bone, or a vertebra can be identified relative to CT-based model of the anatomical structure.

Example procedures include but are not limited to:

Posterior spinal implant procedures such as pedicle screw placement, kyphoplasty and vertebroplasty procedures, thoracic spine surgery, tumor surgery on the spinal column.

Superolateral and deltopectoral shoulder procedures, such as guiding the glenoid component on the scapula.

The CTLOGICS Navigation System consists of the following major components and subsystems:

• The Surgetics Station or the NanoStation, consisting of a mobile computer . system and an optical localizer
• Ancillary instruments and reflective markers used for reference and . registration
• . CTLOGICS Software

The provided document is a 510(k) summary for the CTLOGICS Navigation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria or an analytical study proving the device meets those criteria, as typically found in clinical validation reports or detailed performance studies. The document primarily focuses on establishing substantial equivalence based on technological characteristics and a general statement about performance.

Here's an analysis based on the available information:

Description of Device and Performance Claims

The CTLOGICS Navigation System is an optically based surgical navigation system intended for use during stereotaxic surgery to aid surgeons in locating anatomical structures. It uses pre-operative image data (CT-based models) and reference to rigid anatomical structures (skull, pelvis, long bone, vertebra).

Performance Statement: "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."

Missing Information Regarding Specific Acceptance Criteria and Detailed Study

The document states that "The CTLOGICS Navigation System was tested to assess that no safety and efficiency issues were raised in the device," and that "the accuracy and performance of the system was adequate for its intended use." However, it does not provide a table of acceptance criteria with specific quantitative targets (e.g., accuracy +/- X mm, precision Y mm). Without these defined criteria, it's impossible to report "device performance" against them in a structured table.

Similarly, the document refers to "analyses" and "testing" but does not describe a specific study (e.g., a formal clinical trial, a cadaver study, or a detailed benchtop accuracy study) with a defined methodology, sample size, or ground truth establishment. The performance claims are high-level and refer to an overall assessment for intended use and comparison to predicate devices, rather than a detailed report of a particular study's findings against pre-defined metrics.

Therefore, the requested table and specific details of the study cannot be fully compiled from this document.

Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information (Based on available document)

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

   • Not specified. The document makes a general statement about "analyses" and "testing" but does not provide details on the sample size or the nature of the data used for testing (e.g., number of cases, type of experiments). Data provenance (country, retrospective/prospective) is also not mentioned.

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

   • Not specified. The document does not describe how ground truth was established for any performance testing.

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

   • Not specified. No information is provided about an adjudication method for a test set.

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:

   • Not specified/Not Applicable. This device is a surgical navigation system, not an AI-assisted diagnostic tool that typically involves "human readers." Therefore, an MRMC study in the traditional sense, comparing human reader performance with and without AI assistance, would not be relevant or described here. The "human" in the loop is the surgeon, and the device assists the surgeon, but the document doesn't detail a study measuring improvement in surgeon performance using quantifiable effect sizes.

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

   • Not explicitly stated in detail. While the system performs navigation functions independently of direct human manipulation during the process, the performance mentioned ("accuracy and performance of the system") likely refers to the overall system's capability. However, the document doesn't isolate and report specific "algorithm-only" performance metrics separate from its intended use in guiding a surgeon.

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

   • Not specified. The document does not provide details on how ground truth was established for any performance evaluation.

7. The sample size for the training set:

   • Not applicable/Not specified. This document does not describe the device as being based on machine learning or AI that would require a distinct "training set." It's a deterministic navigation system that uses pre-acquired patient images, but not in a machine learning training context.

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

   • Not applicable/Not specified. As there's no mention of a training set for machine learning, this question is not relevant to the information provided.

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The UNI 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 : - UniKnee Arthroplasty .

As the equivalent Surgetics ORTHO KNEELOGICS Navigation System and TOTAL KNEE SURGETICS Navigation System, the UNI KNEE SURGETICS navigation System consists of the following major components and subsystems: - The Surgetics Station or the NanoStation, consisting of a mobile computer . system and an optical localizer - Ancillary instruments and reflective markers used for reference and . registration - UNI KNEE SURGETICS software . The main modifications to the predicate devices 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 document, a 510(k) summary for the UNI KNEE SURGETICS Navigation System, describes performance testing. However, it does not detail specific quantitative acceptance criteria or a study designed to prove the device met such criteria in the manner requested.

Instead, the document states that the system was tested to assess that no new safety and efficiency issues were raised compared to its predicate devices. The conclusion is based on an assessment 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 qualitative statement of equivalence rather than a report of specific metrics meeting predefined thresholds.

Therefore, many of the requested details, such as a table of acceptance criteria and reported performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC study results, and detailed ground truth establishment for training sets, are not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. The study was a "non clinical setting (bench testing, specimen)". This implies the use of anatomical specimens or phantoms, rather than human patient data, and was conducted by the manufacturer (Praxim).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set:

• Adjudication Method: Not specified.

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:

• MRMC Study: No. This device is a surgical navigation system, not an AI-assisted diagnostic tool. No human "readers" are involved in the performance testing described.

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

• Standalone Performance: The described "non clinical setting (bench testing, specimen)" appears to be a standalone performance assessment of the system's accuracy and performance. However, specific metrics are not provided. The system is designed to aid the surgeon, implying a human-in-the-loop during actual clinical use, but the testing described focuses on the system's inherent capabilities.

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

• Type of Ground Truth: Not specified beyond "bench testing, specimen." For a navigation system, ground truth would typically refer to highly accurate measurements of actual anatomical positions or implant alignments, often established using precise measurement tools (e.g., CMM, optical trackers or highly accurate physical models) during bench testing.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable/not specified. The document describes a "navigation system" and software modifications, but not a machine learning model that would typically require a training set in the conventional sense. The "training" here refers to software development and validation, not model training.

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

• Ground Truth for Training Set: Not applicable/not specified.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through qualitative assessment of "accuracy and performance," rather than presenting a detailed, quantitative study against explicit acceptance criteria as would be expected for a novel device or an AI/ML product.

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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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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.

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The Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for assisting the surgeon during:

• Anterior Cruciate Ligament (ACL) surgery by estimating anisometry of potential insertion points based on a digitized anatomical model
• Total Knee Arthroplasty with ZIMMER NEXGEN implant
• UniKnee Arthroplasty with BIOMET OXFORD Phase III implant

The Surgetics ORTHO KNEELOGICS Navigation System (ORTHO KNEELOGICS) 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
• ORTHO KNEELOGICS Navigation applications software

The provided text describes the Surgetics ORTHO KNEELOGICS Navigation System. Here's an analysis of the acceptance criteria and study information available:

1. Table of Acceptance Criteria and Reported Device Performance

Critique: The provided document states that "summaries of accuracy testing using phantoms and specimen bench testing and results of a clinical study were provided," but it does not specify the numerical acceptance criteria (e.g., "accuracy within X mm") or detailed performance data (e.g., "achieved X mm accuracy"). Therefore, while the types of tests performed are mentioned, the actual quantitative criteria and the numerical results matching those criteria are not present in this excerpt. The substantial equivalence argument serves as a form of "acceptance criteria" related to technological characteristics.

2. Sample Size for the Test Set and Data Provenance

The document mentions "results of a clinical study were provided" but does not specify the sample size used for the test set (number of patients or cases) for the clinical study or the phantom/specimen testing.

Data Provenance: Not explicitly stated. The submitter is from France ("Praxim 'Le Grand Sablon' 4, Avenue de l'Obiou 38 700 La Tronche France"), suggesting the possibility of data originating from France or Europe, but this is not confirmed. The document does not specify if the clinical data was retrospective or prospective.

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

The document does not provide information on the number of experts used to establish ground truth for the test set or their specific qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in the test set.

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

The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss any effect size of how much human readers improve with AI vs. without AI assistance. The device is a navigation system used by a surgeon, not an AI diagnostic tool for human readers.

6. Standalone Performance Study

The accuracy testing on "phantoms and specimen bench testing" and the "clinical study" are likely standalone performance studies, as they aim to evaluate the device's accuracy and performance. However, the document does not explicitly label them as "standalone" studies or differentiate them from studies involving human interaction beyond the surgeon's use of the navigation system as intended.

7. Type of Ground Truth Used

The document mentions "accuracy testing using phantoms and specimen bench testing," which implies that the ground truth for these tests would be known true values or measurements derived from precise physical models (phantoms) or anatomical specimens. For the "clinical study," the type of ground truth is not explicitly stated but would typically involve intraoperative measurements, postoperative imaging, or clinical outcomes to assess the accuracy of the navigation system's guidance.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This device is described as an image-guided surgical navigation system that "acquires positional data by tracking reflective markers and digitizing the relative locations of anatomical landmarks," implying it's based on real-time positional data and anatomical models rather than a machine learning model that would require a distinct training set.

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

Since no training set is mentioned or implied for a machine learning model, the document does not describe how ground truth for a training set was established.

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CADImplant is intended for pre-treatment software planning for the placement of dental implants using a CT scan which has been input into the CADImplant treatment planning software.

The CADImplant software is specifically designed for use in dental implant procedures. It allows the dentist to locate dental implants on three planes (axial, sagittal and frontal) on a pre-treatment CT scan in real-time. Additionally, the software allows for the patient's prosthetic template to be pre-drilled according to the planning.

The CADImplant 510(k) summary provides limited information regarding specific acceptance criteria and detailed study results. Based on the provided text, here's an analysis:

Acceptance Criteria and Reported Device Performance

Study Information:

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated in the provided text. The document only mentions "summaries of accuracy testing using phantoms and clinical experience." This implies that phantoms and likely clinical cases were used as test sets, but the number of each is not specified.
   • Data Provenance: Not explicitly stated. The mention of "clinical experience" suggests human patient data was used, but details like country of origin or whether it was retrospective or prospective are not provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated in the provided text.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated.

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: Not explicitly stated. The primary focus of this submission is on the CADImplant software itself rather than its comparative effectiveness with or without human readers. The document states its intended use is for "pre-treatment planning for the placement of dental implants," implying assistance to a clinician, but no MRMC study details are provided.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document mentions "accuracy testing using phantoms." It is highly likely that these phantom tests were conducted in a standalone manner to assess the algorithm's performance in measuring implant placement parameters without human intervention. However, the outcomes of this testing are not detailed.

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

   • For phantom testing: The ground truth would typically be the known, precisely engineered dimensions and positions within the phantom.
   • For clinical experience: The ground truth is not specified, but for pre-treatment planning, it would ideally involve post-operative assessment (e.g., actual implant position relative to planned position, anatomical landmarks, patient outcomes regarding implant stability and function). The document only mentions "clinical experience," which is broad.

7. The sample size for the training set: Not explicitly stated.

8. How the ground truth for the training set was established: Not explicitly stated. If machine learning was involved (which is common for "software systems"), ground truth for training data would have been established through expert annotations or referencing known anatomical landmarks from CT scans. However, the document does not elaborate on the training process.

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The Surgetics ENTact Endonasal Navigation System is intended for use as an aid to the surgeon for precisely locating anatomical structures either during open or percutaneous ENT/endonasal or sinus procedures.

The Surgetics ENTact Endonasal Navigation System is specifically designed for use in ENT/endonasal and sinus procedures. It allows the surgeon to locate surgical instruments (e.g., aspirator) on three planes (axial, frontal) on a preoperative CT scan in real-time. The system uses an infrared camera for localization and guidance of the surgical instrument. Additionally, a surgical planning capability using the Consultics Station is provided which allows the surgeon to pre-operatively plan the surgery.

The provided 510(k) summary for the "Surgetics ENTact Endonasal Navigation System" offers limited details regarding acceptance criteria and performance studies. Based on the available text, here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The Surgetics ENTact Endonasal Navigation System was tested for compliance with electrical safety and electromagnetic compatibility standards. In addition, summaries of accuracy testing using phantoms and clinical experience with the system were provided."

However, specific acceptance criteria (e.g., maximum allowable error in millimeters for accuracy) and the detailed results of these tests (e.g., the exact accuracy achieved in phantom studies) are not provided in this summary. Therefore, a complete table cannot be generated from the given information.

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

• Sample Size for Test Set: Not specified. The document mentions "summaries of accuracy testing using phantoms" and "clinical experience with the system" but does not give any numbers for the phantoms used or the number of patients/cases in the clinical experience.
• Data Provenance: The location of the submitter is France (Praxim "Le Grand Sablon" 4. Avenue de l'Obiou 38 700 La Tronche France). This suggests the development and potentially some of the testing occurred in France.
  • Retrospective/Prospective: Not specified. The nature of "clinical experience" is not detailed enough to determine if it was retrospective or prospective.

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

• Not specified. The summary does not provide any information about experts involved in establishing ground truth for any testing.

4. Adjudication method for the test set:

• Not specified. No information is given about how discrepancies, if any, were resolved during testing.

5. 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:

• No, this type of study was not done or reported. The device is an "Image guided surgical navigation system." It aids the surgeon in precisely locating anatomical structures in real-time during procedures by tracking surgical instruments on a pre-operative CT scan. It's not an AI-assisted diagnostic tool for human readers, so an MRMC study comparing human readers with and without AI assistance is not applicable to this device's function as described.

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

• Yes, implicitly in the phantom accuracy testing. The "accuracy testing using phantoms" would likely represent a standalone performance evaluation of the navigation system's ability to track and display instrument positions relative to the phantom, without direct human intervention in the tracking mechanism itself. However, specific metrics and results are not detailed.

7. The type of ground truth used:

• For the "accuracy testing using phantoms," the ground truth would likely be precisely known physical dimensions and coordinates of fiducials or targets on the phantom. Phantoms are designed with known geometries to allow for direct measurement of deviation from the true position.
• For "clinical experience," the ground truth is not specified. In a surgical navigation context, ground truth during clinical experience might involve comparing the system's displayed position to the actual anatomical location as perceived by the surgeon, or potentially to post-operative imaging if available, but this is speculative given the lack of detail.

8. The sample size for the training set:

• Not applicable / Not specified. This device is an image-guided navigation system, not a machine learning model that typically undergoes a distinct "training phase" on a dataset in the way an AI diagnostic algorithm would. Its underlying technology (optical infrared tracking, 3D CT image processing) operates based on established physical and computational principles, not by learning from a large "training set" of labeled data.

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

• Not applicable / Not specified. As noted above, this device doesn't appear to use a training set in the machine learning sense. Its functionality is based on direct measurement and processing.

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