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The Surgical Planning Software assists healthcare professionals in planning lumbar spinal fusion surgeries. The device allows service providers to plan surgical procedures, including tools for assessing anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

The Ortho Kinematics Surgical Planning Software is a software only accessory to a picture archiving and communications system. It is designed to assess measurements from DICOM compliant images in a cleared PACS device and plan surgical spinal procedures. It offers the ability to plan certain surgical procedures, such as lumbar spine fusion. It offers tools for viewing data, and the ability to facilitate the estimation of a potential post-operative alignment and correction, based on pre-operative measurements, as well as the geometric parameters associated with specific lumbar interbody implant devices.

The provided document is a 510(k) premarket notification for the "Surgical Planning Software version 1.1". It states that the device is substantially equivalent to a predicate device and therefore can be marketed. However, this submission does not contain the detailed acceptance criteria or the study that proves the device meets specific acceptance criteria for a new AI/ML-driven medical device.

Instead, it states:
"Software verification and validation testing was completed for the subject device. The software functioned as intended and all results observed were as expected."
And, "Software verification and validation testing demonstrates that the device performs as intended."

This suggests that the performance review was primarily focused on software functionality and comparison to a predicate device rather than a comprehensive clinical or analytical study with defined acceptance criteria for AI/ML performance metrics.

Therefore, I cannot extract the information required in the prompt as it is not present in the provided text. The document focuses on regulatory approval based on equivalence to a predicate device rather than presenting new performance data against specific acceptance criteria for an AI/ML algorithm.

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The VMA software is a quantitative imaging software application intended to be used to process any diagnostic imaging modality except mammography from digital image files in DICOM format. It is designed for physicians and clinical professionals who are interested in the analysis of alignment and motion in medical images, particularly in musculoskeletal images of the spine. VMA software permits users to review static and dynamic digital lumbar, thoracic, and cervical spine images. In the case of fluoroscopic images, these are acquired with the assistance of the MOTION NORMALIZER patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar and cervical bending and data collection during imaging. VMA software also facilitates quantitative assessment of vertebral alignment and motion in digital medical images. Information about the alignment and motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts, charts, and text.

The subject device consists of the following components and accessories: VMA™ software (for data transfer, post-image processing and analysis), and its accessory device, the MOTION NORMALIZER™ patient handling and data collection device, which is comprised of the MOTION NORMALIZER Upright and Table devices (for patient assistance during image acquisition), and Control Console (for user interface during imaging).

The subject VMA™ software, and its accessory device, the MOTION NORMALIZER patient handling and data collection device, operate as a system ("the VMA™ System") in conjunction with other commercially-available accessory devices to produce quantitative analysis of inter-vertebral motion in adult patients.

None of the software associated with the subject device performs functions that create radiographic images, nor does the software control, operate, or govern the functionality of the imaging device (i.e., C-Arm Fluoroscopy Device).

With respect to the MOTION NORMALIZER™ hardware, this hardware is configured to assist with lumbar and cervical data collection while images are captured with a standard fluoroscope, and this remains unchanged in the modified device relative to the cleared system (K133875). The additional inclusion of the ability to process thoracic images in the modified device pertains to a new ability to process thoracic images that come from a source other than the MOTION NORMALIZER™ hardware.

Image processing operators, who are Ortho Kinematics, Inc. employees, operate the VMA™ software to process images and facilitate template placement for the prescriber. Prescriber users are able to access processed images and measurement results via an online account administered by Ortho Kinematics, Inc. Prescriber users are able to configure account settings that enable the prescriber to be alerted any time specific user-defined measurement thresholds are exceeded.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the specified format. It's important to note that the provided text is a 510(k) summary, which often focuses on substantial equivalence rather than detailed clinical study outcomes. Therefore, some requested information might be very general or not explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific numeric thresholds for performance metrics. Instead, it refers to performance data and validation/verification testing. The acceptance criteria can be inferred as the successful completion of these tests and the device functioning "as intended."

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

The document does not explicitly state the sample size used for any specific "test set" in the context of clinical performance or diagnostic accuracy. The testing mentioned (repeatability, accuracy, software validation) generally refers to engineering and software validation, not necessarily a clinical study with a defined patient test set size. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided. The document focuses on technical validation and comparison to a predicate device, not on diagnostic accuracy based on expert ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods are typically associated with clinical studies involving human interpretation or labeling, which are not detailed here.

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

No MRMC comparative effectiveness study is mentioned. The device is a "quantitative imaging software application" designed to facilitate assessment for "physicians and clinical professionals," but there's no study presented here that evaluates human reader improvement with or without AI assistance.

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

The document describes the VMA software, which performs "quantitative assessment of vertebral alignment and motion" and generates "motion analysis reports." This implies a standalone algorithmic function for measurement generation. The "Image processing operators, who are Ortho Kinematics, Inc. employees, operate the VMA™ software to process images and facilitate template placement for the prescriber" indicates a human-in-the-loop for template placement. However, the subsequent "Quantitative graphical output report generation" suggests the measurements themselves are algorithmically derived from the placed templates. The "repeatability and accuracy testing" performed on the "integrated system" would likely encompass the standalone performance of the measurement algorithms once templates are placed.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the repeatability and accuracy testing mentioned, the type of ground truth is not explicitly stated. Given it's a quantitative measurement device for alignment and motion, the ground truth would likely be a highly precise, perhaps manually derived or phantombased, measurement of the actual alignment and motion against which the device's measurements are compared. It's not explicitly stated to be expert consensus, pathology, or outcomes data in the context of diagnostic performance.

8. The Sample Size for the Training Set

No information regarding a training set or its sample size is provided. This 510(k) summary focuses on the modified device and its substantial equivalence to a predicate, not on a new AI model development cycle.

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

Since no training set is mentioned in the document, there is no information on how its ground truth would have been established.

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The OKI Surgical Planning Software assists healthcare professionals in planning lumbar spinal fusion surgeries. The device allows service providers to plan surgical procedures, including tools for assessing anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

The Ortho Kinematics OKI Surgical Planning Software is a software only accessory to a picture archiving and communications system. It is designed to be used to assess measurements from DICOM compliant images in a cleared PACS device and plan surgical spinal procedures. It offers the ability to plan certain surgical procedures, such as lumbar spine fusion. It offers tools for viewing data, and the ability to facilitate the estimation of a potential post-operative alignment and correction, based on pre-operative measurements, as well as the geometric parameters associated with specific lumbar interbody implant devices.

The provided document (K171617) is a 510(k) premarket notification for the "OKI Surgical Planning Software." It assesses the device's substantial equivalence to a predicate device, "Nemaris, Inc.'s Surgimap 2.0 (K141669)." However, the document does not contain the detailed performance study information typically required to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning advanced AI/machine learning model validation.

This document focuses on:

• Device Description: A software accessory for PACS to assist in lumbar spinal fusion planning.
• Comparison to Predicate Device: Table outlining similar technological characteristics.
• Performance Data: A very high-level statement that "Software verification and validation testing was completed for the subject device. The software functioned as intended and all results observed were as expected."

It does not provide any of the following information pertinent to a detailed performance study proving acceptance criteria:

1. A table of acceptance criteria and the reported device performance: No specific metrics (e.g., accuracy, sensitivity, specificity, AUC) or defined thresholds are mentioned.
2. Sample sizes used for the test set and the data provenance: No information on the number of cases or their origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of expert involvement for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: No information on how discrepancies were resolved.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: No such study is mentioned or implied. The software "assists healthcare professionals" but no improvement metrics are provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this device as "Human Intervention for interpretation and manipulation of images is Required."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
8. The sample size for the training set: Not applicable/not mentioned, as this is not an AI/ML training report.
9. How the ground truth for the training set was established: Not applicable/not mentioned.

Conclusion based on the provided text:

The document states, "Software verification and validation testing was completed for the subject device. The software functioned as intended and all results observed were as expected." This is a general statement indicating that the software was tested for functionality, likely against its design specifications and requirements, as opposed to a clinical or AI/ML performance study with specific acceptance criteria and detailed results.

This type of submission (510(k) for a PACS accessory) often relies on demonstrating substantial equivalence to a predicate device primarily through similar functional capabilities and safety principles, rather than extensive clinical performance studies that would be required for a novel diagnostic AI algorithm. The device is a "planning software" that provides "tools for assessing anatomical components" and "facilitate the estimation," requiring "Clinical judgment and experience." It is not an automated diagnostic system. Therefore, the detailed performance study information requested is not present in this regulatory filing.

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The KINEGRAPH VMA™ software is a quantitative imaging software application intended to be used to process digital image files. It is designed for physicians and clinical professionals who are interested in the analysis of motion in medical images, particularly in musculoskeletal images of the spine. KINEGRAPH VMA™ software permits users to review static and dynamic digital lumbar and cervical spine images acquired with the assistance of the MOTION NORMALIZER™ patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar and cervical bending and data collection during imaging. KINEGRAPH VMA™ software also facilitates quantitative assessment of vertebral motion in digital medical images. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts, and text.

The subject device consists of the KINEGRAPH VMA™ software that analyzes images from the MOTION NORMALIZER™ on an Off-the-Shelf ("OTS") imaging workstation. The MOTION NORMALIZER patient handling and data collection device is an accessory device to the KINEGRAPH VMA™ software that is used to assist with subject lumbar bending and data collection while images are captured with a standard fluoroscope. The MOTION NORMALIZER is comprised of two powered, electromechanical patient handling devices connected to and controlled by a console-mounted OTS computer running custom software connected to various OTS hardware accessories. The subject system is able to capture and record radiographic image data, as well as data from the patient handling devices, and to output this data into DICOM compatible digital image files for analysis using the KINEGRAPH VMA™ software. Once images have been created, they can be uploaded to online servers using running KINEGRAPH VMA™ software using an internet connected computer. All software operation and data storage that occurs subsequent to uploading occurs via online servers running KINEGARPH VMA software. Image processing operators, who are Ortho Kinematics, Inc. employees, operate the KINEGRAPH VMA™ software to process images and facilitate template placement for the prescriber. Prescriber users are able to access processed image and measurement results via an online account administered by Ortho Kinematics, Inc. Prescriber users are able to configure account settings that enable the prescriber to be alerted any time specific user-defined measurement thresholds are exceeded.

The provided document, K133875, is a 510(k) summary for the KINEGRAPH VMA™ (Vertebral Motion Analyzer) Software and its accessory device, the MOTION NORMALIZER™ Patient Handling and Data Collection Device (Version 2.2). This special 510(k) is for a modification to a previously cleared device (Version 2.0).

Based on the provided text, the document states: "Validation and verification data (including software validation) demonstrate that the subject device functions as intended, and performs functions substantially equivalent to the predicate device." However, specific acceptance criteria and detailed study results meeting those criteria are not explicitly outlined in the provided pages of the 510(k) summary. The document mentions "repeatability and accuracy testing was performed for the integrated system" and concludes that "In all instances, the KINEGRAPH VMA ™ software and its accessory device, the MOTION NORMALIZER ™, functioned as intended." However, it does not specify what "intended" means in terms of quantifiable metrics or acceptance values.

Therefore, many of the requested details cannot be extracted directly from this summary.

Here's a breakdown of what can and cannot be derived from the provided text:

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 in the provided 510(k) summary.
• Data Provenance: Not specified in the provided 510(k) summary (e.g., country of origin, retrospective or prospective).

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

• Not specified.

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:

• The document describes the KINEGRAPH VMA™ as a quantitative imaging software application that assists physicians and clinical professionals, and "Image processing operators, who are Ortho Kinematics, Inc. employees, operate the KINEGRAPH VMA™ software to process images and facilitate template placement for the prescriber." Prescriber users access processed images and measurement results. This implies a human-in-the-loop system where human operators use the software.
• However, no MRMC comparative effectiveness study is mentioned, nor is any effect size for human improvement with AI assistance. The submission focuses on demonstrating substantial equivalence to a previous version of the device.

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

• The text indicates that "Image processing operators... operate the KINEGRAPH VMA™ software to process images and facilitate template placement." This suggests a human-in-the-loop scenario rather than a standalone algorithm performance evaluation. No standalone performance metrics are provided.

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

• Not specified. The summary mentions "repeatability and accuracy testing" but does not detail how the "true" values for these tests were established.

8. The sample size for the training set:

• Not specified. The document describes a "verification and validation testing" process, but does not provide details about a training set, which is more relevant for machine learning systems. This device processes images but isn't explicitly described as a machine learning/AI device in the sense of needing a distinct "training set" in the context often associated with such algorithms. It's more about image processing and measurement.

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

• Not applicable/Not specified, as no training set details are provided.

Summary of Limitations:

This 510(k) summary is for a modification (version 2.2) of an already cleared device (version 2.0) and focuses heavily on demonstrating substantial equivalence rather than providing detailed performance studies with explicit acceptance criteria and extensive ground truth details for a novel device. The "Performance Data" section is very high-level, stating the device "functioned as intended" without quantifying what "intended" means in terms of performance metrics. The details typically requested for AI/ML device evaluations regarding training data, ground truth establishment, expert involvement, and rigorous statistical studies (like MRMC) are not present in this document.

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The KINEGRAPH VMA™ software is a quantitative imaging software application intended to be used to process digital image files. It is designed for physicians and clinical professionals who are interested in the analysis of motion in medical images, particularly in musculoskeletal images of the spine. KINEGRAPH VMA™ software permits users to review static and dynamic digital lumbar and cervical spine images acquired with the assistance of the MOTION NORMALIZER™ patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar and cervical bending and data collection during imaging. KINEGRAPH VMA™ software also facilitates quantitative assessment of vertebral motion in digital medical images. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts, and text.

The subject device consists of the KINEGRAPH VMA™ software that analyzes images from the MOTION NORMALIZER™ on an Off-the-Shelf ("OTS") imaging workstation. The MOTION NORMALIZER patient handling and data collection device is an accessory device to the KINEGRAPH VMA™ software that is used to assist with subject lumbar bending and data collection while images are captured with a standard fluoroscope. The MOTION NORMALIZER is comprised of two powered. electromechanical patient handling devices connected to and controlled by a consolemounted OTS computer running custom software connected to various OTS hardware accessories. The subject system is able to capture and record radiographic image data. as well as data from the patient handling devices, and to output this data into DICOM compatible digital image files for analysis using the KINEGRAPH VMA™ software.

Here's a summary of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in a table format. Instead, it describes general performance goals and how they were met in comparison to a previous version of the device and other predicates.

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

The document states:

• "The accuracy and repeatability studies included in the submission of the previously-cleared version of the KineGraph VMA System (K112109) for lumbar measurements were re-run with the modified device."
• "Accuracy and repeatability testing was performed for the new cervical measurements."
• "Accuracy and repeatability testing on the new function to produce measurements of intervertebral translation in millimeter units was performed."

However, the specific sample size (number of patients/cases) used for these accuracy and repeatability tests (which serve as the "test set" for performance evaluation) is not explicitly mentioned in this document.

The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the performance studies.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done comparing human readers with and without AI assistance. The testing focuses on the device's accuracy and repeatability, and its equivalence to predicate devices, rather than human performance improvement.

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

Yes, standalone performance testing was conducted. The document states:

• "The accuracy and repeatability studies... for lumbar measurements were re-run with the modified device."
• "Accuracy and repeatability testing was performed for the new cervical measurements."
• "Accuracy and repeatability testing on the new function to produce measurements of intervertebral translation in millimeter units was performed."

These studies assess the device's inherent measurement capabilities (accuracy and repeatability) independently, without considering a human-in-the-loop scenario. The KINEGRAPH VMA™ software itself processes the digital image files to generate quantitative assessments and reports.

7. The Type of Ground Truth Used

The type of ground truth used for the accuracy and repeatability studies is not explicitly defined in the document. Given the nature of "accuracy and repeatability" for measurement devices, it typically implies comparison against:

• Highly precise measurements made by a gold-standard method.
• Measurements derived from phantom studies with known values.
• Consensus measurements from highly experienced human experts (though not explicitly stated here).

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. This is typical for a 510(k) submission where the focus is on verification and validation of the finished device, and the specifics of model training (if applicable to the type of algorithm) are not usually required in this summary. The device appears to be an image processing and measurement software rather than a deep learning AI model that would typically have a distinct training phase described in this way.

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

Since no information about a training set or its sample size is provided, the method for establishing its ground truth is also not mentioned.

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The KINEGRAPH VMA™ software is a quantitative imaging software application intended to be used to process digital image files. It is designed for physicians and clinical professionals who are interested in the analysis of motion in medical images, particularly in musculoskeletal images of the spine. KINEGRAPH VMA™ software permits users to review static and dynamic digital lumbar spine images acquired with the assistance of the MOTION NORMALIZER™ patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar bending and data collection during imaging. KINEGRAPH VMA™ software also facilitates quantitative assessment of vertebral motion in digital medical images. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts, and text.

The subject device consists of the KINEGRAPH VMA™ software that analyzes images from the MOTION NORMALIZER™ on an Off-the-Shelf ("OTS") imaging workstation. The MOTION NORMALIZER patient handling and data collection device is an accessory device to the KINEGRAPH VMA™ software that is used to assist with subject lumbar bending and data collection while images are captured with standard fluoroscopes. The MOTION NORMALIZER is comprised of two powered, electromechanical patient handling devices connected to and controlled by a consolemounted OTS computer running custom software connected to various OTS hardware accessories. The subject system is able to capture and record fluoroscopic image data, as well as data from the patient handling devices, and to output this data into DICOM compatible digital image files for analysis using the KINEGRAPH VMA™ software.

The provided document, K112109, does not contain the specific detailed acceptance criteria or a study that rigorously proves the device meets such criteria with quantitative performance metrics for a medical imaging AI device as typically understood today. The information available is very high-level and predates the common expectations for AI/ML device submissions.

However, based on the available text, here's an attempt to structure the information as requested, highlighting what is present and what is conspicuously absent:

Acceptance Criteria and Study for KINEGRAPH VMA™ Software and MOTION NORMALIZER™

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Crucially, the document does not provide quantitative acceptance criteria (e.g., minimum sensitivity, specificity, accuracy thresholds, or specific error margins for motion analysis), nor does it present quantitative performance results against such criteria. The statements are largely qualitative assertions.

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

• Sample Size for Test Set: Not specified. The document states "repeatability and accuracy testing was performed" but does not give any details on the number of cases or subjects used for this testing.
• Data Provenance: Not specified. There is no information provided regarding the country of origin of the data, nor whether it was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Role of Experts: The document does not indicate if experts were used to establish ground truth in the context of performance testing. The KINEGRAPH VMA™ software is an analytical tool for "physicians and clinical professionals," implying their use of the output rather than their role in ground truth establishment for validation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified, and likely not applicable in the context described, as ground truth establishment by experts for specific performance metrics is not detailed.

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

• MRMC Study Done: No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The document describes the device as a software for quantitative analysis and data collection, not a tool for human reader interpretation improvement, which would be the typical context for an MRMC study.
• Effect Size: Not applicable, as no MRMC study was performed or reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

• Standalone Study Done: Yes, in a general sense. The "repeatability and accuracy testing" refers to the performance of the KINEGRAPH VMA™ software and its accessory. The software's function is to "facilitate quantitative assessment of vertebral motion" and generate reports. While a human uses the output, the testing described would be of the algorithm's ability to process images and generate these quantitative assessments. However, the exact methods and quantitative results of this standalone performance are not provided.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. For "accuracy testing," it would imply comparison against a known "true" value. Given the system's function (analysis of motion in musculoskeletal images of the spine), potential ground truth could involve:
  • Phantom studies: Using precisely controlled physical models with known motion characteristics.
  • Manual measurements: Highly precise manual measurements by experts on the same images, though the document doesn't specify this.
  • Clinical correlation/Pathology: Unlikely to be the direct ground truth for motion analysis in this context, but perhaps for clinical utility validation.
    The document only broadly states "accuracy testing was performed," but does not detail how accuracy was determined against a ground truth.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable / Not specified. The KINEGRAPH VMA™ software, from the description, appears to be a rule-based or algorithmic system for quantitative measurement and image processing, rather than an AI/ML system that would require a dedicated training set in the modern sense. There is no mention of machine learning or deep learning, which would necessitate a training set. The term "software" is used, implying traditional programming.

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

• Ground Truth for Training Set: Not applicable, as there is no indication of a training set for an AI/ML model.

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