Search Results

Lantern® Hip is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic surgical procedures. Lantern® Hip facilitates the accurate positioning of implants relative to these alignment axes. The surgeon in controlling leg length and offset discrepancies.

The Lantern® Hip is indicated for Total Hip Arthroplasty with an anterior hip approach (Direct Anterior Approach) and the patient in the supine position.

The Lantern® Hip (modified device) utilizes a palm- sized computer module and reference sensor to generate positional information in orthopedic procedures, providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

The Lantern® Hip is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. Lantern® Hip facilitates the accurate positioning of implants relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies

The Lantern® Hip consists of the sterile, single-use Lantern® Hip navigation unit (packaging includes reference sensor, CR2 battery and femur sensor battery), the non-sterile reusable reference sensor, the non-sterile reusable femur sensor, and associated non-sterile reusable instrumentation. The Lantern® Hip unit is sterile unless the sterile packaging is opened or damaged.

Here's a breakdown of the acceptance criteria and study information for the Lantern® Hip device, based on the provided FDA 510(k) summary:

The provided document is a 510(k) clearance letter and summary for a device modification, not a primary submission for a novel device. Therefore, the depth of performance study details typically found in an original PMA or De Novo submission is not present. The focus here is on demonstrating substantial equivalence to a predicate device rather than exhaustive standalone performance evaluation against a set of independent acceptance criteria for a new clinical use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a Special 510(k) for a device modification, the "acceptance criteria" primarily revolve around demonstrating that the modified device is as safe, as effective, and performs as well as the existing predicate device. The document doesn't explicitly list quantitative clinical acceptance criteria like sensitivity, specificity, or accuracy targets. Instead, the acceptance criteria are met by comprehensive verification and validation testing, confirming that the changes do not adversely affect performance or safety.

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

The document describes "performance testing" and "verification and validation" but does not specify a sample size for a test set in the traditional sense of a clinical study with patient data. The testing appears to be primarily bench testing and software validation, focused on the technical performance of the device itself rather than its performance on a dataset of patient images or clinical cases.

There is no mention of patient data (e.g., retrospective or prospective, country of origin) being used for this particular submission, as the changes are related to software operating system and hardware materials, not a change in the underlying algorithms that process patient-specific data or interact with patient anatomy directly (beyond what was already established for the predicate).

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

Not applicable for this submission as it's a software and material modification. This type of information would be relevant for devices that interpret medical images or physiological signals where expert review is needed for ground truth. The testing described focuses on the device's functional integrity rather than diagnostic accuracy against a ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. Since there's no mention of expert review of cases or patient data for ground truth establishment, there is no adjudication method described.

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

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study would be relevant if the AI (or computer-assisted) component was new or significantly changed in a way that might impact a human reader's performance. The Lantern® Hip is a computer-controlled system to assist surgery, not a diagnostic AI that assists in image interpretation for human readers.

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

Yes, implicitly. The "Performance Data" section states: "Device performance testing confirms that the Lantern® Hip can be used according to its intended use. The Lantern® Hip has been verified and validated according to OrthAlign's procedures for product design and development." This type of testing of a computer-controlled system for surgical assistance would primarily involve standalone algorithm performance (accuracy of measurements, positional data, calculations) within simulated or laboratory environments, independent of a human surgeon's interaction, to ensure correctness of the system's outputs.

While not explicitly called a "standalone study," the software verification and validation, and general performance testing, would assess the device's technical capabilities without a human in the loop for the core computations.

7. The Type of Ground Truth Used

The ground truth for the device's performance validation would likely be based on engineering specifications, known physical principles, and established measurement standards. For example:

• For software calculations of mechanical axes, the ground truth would be the mathematically correct axes based on defined anatomical landmarks.
• For positional accuracy, the ground truth would be established by high-precision measurement systems (e.g., optical trackers, coordinate measuring machines) to verify the device's reported positions against known physical positions.
• For material biocompatibility, the ground truth would be established by industry standards like ISO 10993.

It is not based on expert consensus, pathology, or outcomes data in this context, as those relate more to clinical diagnosis or patient treatment effectiveness, which is beyond the scope of a modification focusing on software and material changes for a surgical guidance system.

8. The Sample Size for the Training Set

Not applicable. The Lantern® Hip is a computer-controlled stereotaxic instrument that provides positional information and assists with alignment. While it uses algorithms, the document describes it as "determining reference alignment axes" and "facilitates accurate positioning." This suggests algorithms based on geometric calculations and sensor data processing rather than machine learning algorithms that require large training sets of labeled data (like for image recognition or predictive models). Therefore, a "training set" in the context of machine learning is not mentioned or implied.

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

Not applicable. As no machine learning training set is mentioned, this question is not relevant to the information provided.

Ask a specific question about this device

The HSA system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The HSA system facilitates the accurate positioning of implants, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

• · Total Knee Arthroplasty
• · Unicompartmental Knee Arthroplasty: Tibial transverse resection.

The OrthAlign Harvey® Surgical Assistant System is a non-invasive computer assisted surgical navigation system for use in total knee and Unicompartmental knee arthroplasty procedures. The Harvey® Surgical Assistant System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The Harvey® Surgical Assistant System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

In knee arthropolasty procedures, the device assists the surgeon in:

• . Establishing the mechanical axis of the femur. determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur.
• Establishing the mechanical axis of the tibia. determining the varus/valgus andle and . the posterior slope angle of the cutting block relative to the tibia.

In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:

• . Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
  The Harvey® Surgical Assistant System comprises a single use computer module and reusable instrumentation.

Here's a breakdown of the acceptance criteria and study information for the Harvey® Surgical Assistant System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state specific numerical acceptance criteria for the Harvey® Surgical Assistant System's performance. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (OrthAlign Plus® System K162962). The performance testing aims to confirm that the modified device performs "as well as" the existing device.

The reported device performance is described in terms of functional verification and validation, ensuring the device meets its intended use.

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

The provided document does not specify numerical sample sizes for the test set. It mentions "various use sequences" for software testing.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature. However, the evaluation is a premarket notification for a medical device in the United States, so the testing would likely be performed to U.S. regulatory standards.

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

The document does not mention the use of experts or establish ground truth through expert consensus for the performance testing. The testing appears to be functional and software-oriented verification and validation, rather than a clinical study requiring expert interpretation of outcomes.

4. Adjudication Method for the Test Set

As there's no mention of expert involvement or ground truth established by experts, there's no adjudication method described for the test set.

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

No, an MRMC comparative effectiveness study is not described in the provided document. This submission is for a modification to an existing stereotaxic instrument, and the testing focuses on the functional performance of the modified device, not a comparative clinical effectiveness study with human readers.

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

The performance testing described, particularly "Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences," would largely be a standalone (algorithm only) evaluation of the software's ability to process inputs and generate correct outputs. The device itself is a "computer-controlled system intended to assist the surgeon," indicating it provides outputs (angular and positional measurements) that the surgeon then uses. Therefore, the core functional tests of the software would be standalone.

7. The Type of Ground Truth Used

The ground truth for the performance testing appears to be based on:

• Engineering specifications and expected outputs: For software verification and validation, the "ground truth" would be the pre-defined correct functionality, calculations, and expected visual displays based on engineering requirements.
• Predicate device performance: The ultimate "ground truth" for substantial equivalence is the performance of the legally marketed predicate device (OrthAlign Plus® System K162962). The testing aims to show the modified device performs comparably.

8. The Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI model training in the conventional sense. The device is described as a "computer-controlled system" that utilizes algorithms to convert sensor outputs into spatial coordinates. This implies deterministic programming 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 there is no mention of a training set for a machine learning model, the concept of establishing ground truth for a training set does not apply here. The algorithms in this device are likely based on established biomechanical and mathematical principles, validated through traditional software and system engineering methods.

Ask a specific question about this device

The OrthAlign Plus® system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instructures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® system facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length discrepancy in Total Hip Arthroplasty.

Example orthopedic surgical procedures include but are not limited to:

• Total Knee Arthroplasty
• · Total Hip Arthroplasty: Anterior/Posterior
• · Unicompartmental Knee Arthroplasty: Tibial transverse resection

The OrthAlign HipAlign® Sterile Pin Pack is indicated for use with the OrthAlign Plus® System.

Intended Use: The OrthAlign® HipAlign® Sterile Pin Pack is intended to be used with the OrthAlign Plus® system specific to Total Hip Arthroplasty.

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display anqular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes,

The OrthAlign HipAliqn® Sterile Pin Pack is a set of sterile, single use pins used in conjunction with the OrthAlign Plus® system of instruments and electronics. The OrthAlign® HipAlign® Pin Pack includes:

• . Pelvic Fixation pins: 4.0mm in diameter and 90mm to 140mm in length
• Pelvic Fixation pins: 5mm in diameter and 170mm in length
• . Femoral registration markers: 4.0mm to 4.5mm in diameter and 16mm to 25mm in length

This document describes a Special 510(k) Premarket Notification for the OrthAlign HipAlign® Sterile Pin Pack, which is a modification to the previously cleared OrthAlign Plus® System (K171780). The focus of this notification is on the sterility and packaging of the pins and markers used with the system, rather than a a comprehensive AI/ML device. Therefore, the details requested in the prompt regarding AI/ML device performance, such as MRMC studies, training set ground truth establishment, and expert adjudication, are not applicable or available in this document.

However, based on the provided text, we can describe the acceptance criteria and study that proves the device meets the acceptance criteria as it relates to the modification of the device (sterility and packaging).

Device: OrthAlign HipAlign® Sterile Pin Pack, used with the OrthAlign Plus® System.

Purpose of this Submission: To demonstrate substantial equivalence of the modified sterile, single-use pins and markers to the previously cleared non-sterile, reusable pins and markers.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for a modification primarily related to sterility and packaging, the acceptance criteria and performance are focused on these aspects, ensuring the modified components are as safe and effective as the predicate.

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

The document does not specify exact sample sizes for the performance testing (e.g., number of packages tested for integrity, number of sterilization cycles validated). The testing described relates to device components (packaging and sterilization), not patient data or clinical performance studies.

• Sample Size: Not explicitly stated as numerical values for packaging and sterilization tests. It is implied that sufficient samples were used to meet validation standards for these types of tests.
• Data Provenance: The data is generated from in-house laboratory performance testing conducted by OrthAlign, Inc., as part of their design and development procedures. This is neither retrospective nor prospective patient data.

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

Not applicable. The "ground truth" here is compliance with engineering and quality standards for sterile medical devices (e.g., package integrity, sterilization efficacy). These are established through validated test methods and industry standards, not typically through human expert adjudication of medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. This type of submission does not involve adjudication of clinical data or expert consensus. It relies on objective engineering and microbiological test results.

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

No. An MRMC study is relevant for AI/ML diagnostic or assistive devices where human reader performance (e.g., radiologists interpreting images) is being augmented by AI. This submission is for surgical instrumentation components (pins and markers) and their sterility/packaging.

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

Not applicable. This device is a physical surgical instrument set. It is not an algorithm, and therefore, standalone performance in the context of AI is irrelevant. The OrthAlign Plus® System itself is a "computer-controlled system intended to assist the surgeon," implying a human-in-the-loop system, but this specific submission focuses on the sterile pins and markers, not the performance of the computer-controlled system's algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this specific submission's performance evaluation is based on:

• Engineering Standards and Test Methods: For packaging integrity (e.g., ASTM standards for dye penetration, peel strength), and environmental conditioning.
• Sterilization Validation Standards: For demonstrating the effectiveness of the sterilization process (e.g., ISO, AAMI standards for EtO sterilization).
• Biocompatibility Standards: Implicit in the use of standard medical-grade materials.

These are objective, quantitative criteria, not subjective expert consensus or clinical outcomes data in the traditional sense of diagnostic AI.

8. The Sample Size for the Training Set

Not applicable. There is no software algorithm or AI model being "trained" in this submission. The device is a physical product (sterile pins and markers).

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

Not applicable, as there is no training set for an AI model.

Ask a specific question about this device

The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty. Ligament balancing is provided by the OrthAlign Plus® System in primary or revision Total Knee Arthroplasty.

Example orthopedic surgical procedures include but are not limited to:

• Total Knee Arthroplasty
• Total Hip Arthroplasty: Anterior/Posterior
• Unicompartmental Knee Arthroplasty: Tibial transverse resection
• Ligament Balancing

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.

The OrthAlign Plus® System is a computer-controlled surgical navigation system intended to assist surgeons in determining reference alignment axes during stereotactic orthopedic surgical procedures. It facilitates accurate implant positioning and aids in controlling leg length and offset discrepancies in Total Hip Arthroplasty (THA), and provides ligament balancing in primary or revision Total Knee Arthroplasty (TKA).

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for accuracy. However, it does describe the performance testing conducted and concludes that the device performs "as well as the predicate devices." The key performance metric highlighted is accuracy in gap distance and angle measurement.

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

• Test Set Sample Size: Not explicitly stated with a numerical value. The document mentions "bench testing with mechanical fixtures" and "simulated use testing in cadaver." The number of mechanical tests or cadavers used is not specified.
• Data Provenance: The cadaver testing implies a prospective experimental setting. The location of the test (e.g., country of origin) is not specified.

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

• Number of Experts: One "advising surgeon" was involved in the simulated use cadaver testing.
• Qualifications: "Advising surgeon" is the only qualification provided. Specific experience or subspecialty is not mentioned.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the traditional sense (e.g., 2+1, 3+1). For the cadaver study, an "advising surgeon" was present, suggesting a direct observation and evaluation of the system's performance in a simulated surgical environment. For bench testing, the ground truth would be objectively measured by the mechanical fixtures themselves.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. The study focuses on evaluating the device's standalone performance and its equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.

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

Yes, a standalone performance evaluation was done. "Bench testing with mechanical fixtures to verify gap distance and angle measurement accuracy" specifically evaluates the algorithm's ability to measure accurately without direct human interpretation or intervention affecting the measurement output. The software verification and validation also fall under standalone testing. The "simulated use testing in cadaver" does involve a human surgeon, but the primary focus is on the system's output and meeting user needs, rather than comparing human performance.

7. The Type of Ground Truth Used

• Bench Testing: Objective measurements from mechanical fixtures were used as ground truth for gap distance and angle measurement accuracy.
• Simulated Use Testing: The "advising surgeon" would have implicitly provided a form of expert consensus/observation regarding the system's ability to meet user needs and usability in a simulated surgical environment. However, this is more for usability and functionality validation rather than a quantitative ground truth for accuracy.

8. The Sample Size for the Training Set

The document does not provide any information about a training set since this is a 510(k) summary for a medical device which is largely a hardware and software system, not an AI/Machine Learning model that undergoes "training" in the traditional sense of data-driven learning. While algorithms are involved, they appear to be rule-based or deterministic rather than machine learning algorithms requiring a distinct "training set."

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

As no training set is mentioned or implied for a machine learning model, the method for establishing ground truth for a training set is not applicable to this submission.

Ask a specific question about this device

The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instructures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty.

Example orthopedic surgical procedures include but are not limited to:

• Total Knee Arthroplasty
• · Total Hip Arthroplasty: Anterior/Posterior
• · Unicompartmental Knee Arthroplasty: Tibial transverse resection

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.

Here's a breakdown of the acceptance criteria and study information for the OrthAlign Plus System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., "accuracy must be within X degrees"). Instead, it describes performance testing that "confirms that the OrthAlign Plus® System can be used according to its intended use" and "meets design input requirements." The performance is reported in terms of general accuracy and reliability.

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

The document does not provide specific sample sizes for the test set used in the performance studies. It mentions "bench testing with mechanical fixtures and foam models," which implies in-vitro testing rather than human subject data.

• Sample Size (Test Set): Not specified (implied to be an unspecified number of mechanical fixtures and foam models).
• Data Provenance: In-vitro (bench testing). No country of origin is specified, but the applicant is US-based. The testing is retrospective in the sense that it's performed on existing models, not prospective patient studies.

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

The document mentions "Customer requirements validation with an advising surgeon," implying at least one expert was involved in validating clinical utility. However, it does not specify the number of experts for establishing ground truth for the accuracy tests (leg length/offset, scale reader). For the bench tests, the "ground truth" would be the known, precisely measured values of the mechanical fixtures and foam models, rather than expert consensus on anatomical structures.

• Number of Experts: At least one "advising surgeon" for customer requirements validation.
• Qualifications of Experts: "Advising surgeon" (specific qualifications like years of experience or subspecialty are not provided).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the performance testing. For bench testing with mechanical fixtures, adjudication in the sense of reconciling differing expert opinions on a common case would not be applicable, as the expected values are mechanically determined. For the customer requirements validation, it's likely a qualitative assessment of whether the system met the surgeon's expectations.

• Adjudication Method: Not applicable for accuracy testing; not specified for customer requirements validation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance data focuses on system accuracy and validation against design requirements, not on the improvement of human readers (surgeons) with or without AI assistance.

• MRMC Study Done: No.
• Effect Size with AI vs. Without AI Assistance: Not applicable, as no MRMC study was performed.

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

The performance testing described, particularly the "System accuracy testing: bench testing with mechanical fixtures and foam models to verify leg length and offset and updated scale reader measurement accuracy," represents a form of standalone testing of the algorithm's output against a known physical ground truth. While the overall system is "computer-assisted surgical navigation" (implying human-in-the-loop during actual surgery), the accuracy verification of its measurements on models is essentially a standalone evaluation of its core calculation capabilities.

• Standalone Performance Done: Yes (accuracy testing on mechanical fixtures and foam models).

7. The Type of Ground Truth Used

• Ground Truth Type:
  • Mechanically determined values: For the "system accuracy testing" of leg length, offset, and scale reader measurements, the ground truth was derived from the precisely known measurements of mechanical fixtures and foam models.
  • Design input requirements/Clinical utility: For "customer requirements validation," the ground truth was the satisfaction of predefined design input requirements and the system's utility as assessed by an advising surgeon.

8. The Sample Size for the Training Set

The document primarily describes a device modification (Special 510(k)) and performance testing for that modification. It does not provide information about a "training set" for the algorithms. Given the nature of the device as a "computer-assisted surgical navigation system" that detects, measures, and displays angular and positional changes using inertial sensors, microcontrollers, and digital signal processors, it's less likely to involve a large-scale machine learning training dataset in the same way an image-based AI diagnostic device would. Its "algorithms" convert raw sensor outputs into spatial coordinates.

• Sample Size (Training Set): Not specified.

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

As no training set is explicitly mentioned or described, the method for establishing its ground truth is also not provided. The system's operation appears to be based on physical principles and sensor data processing rather than learning from a large, annotated dataset.

Ask a specific question about this device

The KneeAlign® system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic surgical procedures. The KneeAlign system facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes.

Orthopedic surgical procedures include but are not limited to:

• · Total Knee Arthroplasty
• · Unicompartmental Knee Arthroplasty Tibial Transverse Resection

The KneeAlign® 2 System is a non-invasive computer assisted surgical navigation system for use in knee arthroplasty procedures. The KneeAlign® 2 System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format.

The KneeAlign® 2 System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

In total knee arthroplasty procedures, the device assists the surgeon in:

• . Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur.
• Establishing the mechanical axis of the tibia, determining the varus/valgus . angle and the posterior slope angle of the cutting block relative to the tibia.

In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:

• Establishing the mechanical axis of the tibia, determining the varus/valgus . angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
  The KneeAlign® 2 System comprises a single use computer module and reusable instrumentation.

Acceptance Criteria and Study for KneeAlign 2 System

This device, the KneeAlign 2 System, is a computer-assisted surgical navigation system. Based on the provided FDA 510(k) summary, the substantial equivalence to predicate devices (KneeAlign 2 System K103829 and OrthAlign Plus System K153237) is demonstrated through technological comparison and performance testing. The key addition to the subject device is the ability to navigate tibial transverse resections in unicompartmental knee arthroplasty.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA summary does not explicitly list quantitative "acceptance criteria" for accuracy performance in a tabular format with corresponding "reported device performance" values. Instead, it states that "System accuracy testing: bench testing with mechanical fixtures and foam models to verify navigated resection plane angular and depth accuracy" was performed.

For the purpose of this request, we can infer the acceptance criteria for the added functionality (tibial transverse resection in unicompartmental knee arthroplasty) by the assertion that the device is "as safe and effective as the predicate devices." The predicates were already cleared for their accuracy. Since the only performance data mentioned directly relates to this specific functionality, the "acceptance criteria" here is met by demonstrating the system's ability to accurately navigate these resections.

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

• Sample Size: The document mentions "bench testing with mechanical fixtures and foam models" for accuracy testing. It does not provide specific numerical sample sizes for these tests (e.g., number of resections, number of models). For the simulated use testing, it refers to a "prospective cadaver validation" but again, no specific number of cadavers is given.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but given the company (OrthAlign, Inc.) is based in Aliso Viejo, California, USA, and the submission is to the U.S. FDA, it is highly likely the testing was conducted in the USA.
  • Retrospective or Prospective: The cadaver validation was "prospective." The bench testing with foam models would also be considered prospective as it involves specifically designed tests for the purpose of validation.

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

• Number of Experts: For the "Customer requirements / usability validation," it states "with an advising surgeon." This implies at least one surgeon was involved in the simulated use ground truth establishment.
• Qualifications of Experts: The qualification mentioned is "surgeon." No further details on years of experience, sub-specialty, or board certification are provided in this summary.

4. Adjudication Method for the Test Set

• The document implies that the ground truth for "customer requirements/usability" was established by a single "advising surgeon" during the cadaver validation. There is no mention of an adjudication method involving multiple experts (e.g., 2+1, 3+1). For bench testing, the "ground truth" would be the known and controlled parameters of the mechanical fixtures and foam models.

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, an MRMC comparative effectiveness study was not done. This device is a surgical navigation system, not an AI diagnostic tool primarily aimed at improving human reading proficiency for imaging. The performance testing focuses on the device's accuracy in assisting the surgeon with measurements and positioning during a procedure, not on radiologists interpreting images.

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

• Yes, in essence, standalone performance (in a controlled environment) was done for accuracy. The "System accuracy testing: bench testing with mechanical fixtures and foam models to verify navigated resection plane angular and depth accuracy" evaluates the device's algorithmic and sensor performance independent of a live surgical scenario, under controlled conditions where the "ground truth" (correct angles and depths) is preset. The "human-in-the-loop" (a surgeon) is then involved in the usability and simulated use validation.

7. The Type of Ground Truth Used

• Bench Testing: The ground truth for angular and depth accuracy was established through the known parameters of "mechanical fixtures and foam models." This represents a controlled, engineered ground truth.
• Simulated Use (Cadaver Validation): The ground truth was established by the "advising surgeon" determining if the system "meets design input requirements for its functions." This is a clinical expert consensus/assessment ground truth within a simulated environment.

8. The Sample Size for the Training Set

• This document is a 510(k) summary for a surgical navigation system, not an AI/machine learning device that typically requires a large 'training set'. The principles of operation are based on inertial sensors and calculation of spatial coordinates (not deep learning). Therefore, the concept of a "training set" for an algorithm to learn from data (as in AI) does not apply in the context of this device's validation as described. The device utilizes algorithms based on established physics and geometry.

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

• As explained in point 8, the concept of a "training set" and its associated ground truth establishment is not applicable to the validation of this device as presented in the 510(k) summary. The algorithms are based on known mathematical principles for converting sensor outputs into spatial coordinates. Their accuracy is verified through empirical testing against known standards (bench testing), not "trained" on a dataset.

Ask a specific question about this device

The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty.

Example orthopedic surgical procedures include but are not limited to:

• · Total Knee Arthroplasty
• · Total Hip Arthroplasty: Anterior/Posterior
• · Unicompartmental Knee Arthroplasty: Tibial transverse resection

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in a table format, nor does it provide specific numerical performance metrics for the device. Instead, it describes "performance testing" and states that the "OrthAlign Plus® System can be used according to its intended use" and "performs as well as or better than the predicate devices."

However, we can infer the tested capabilities and the reported validation of those capabilities.

• Simulated use testing in cadavers validated system accuracy vs. the gold standard of radiographic measurement.
• 40 data points (on 5 hips) from cadaver validation showed accurate measurement of intraoperative change in leg length and offset. |
  | Accuracy of Acetabular Shell Insertion Navigation (THA, Anterior, relative to anterior pelvic plane adjusted for pelvic tilt) | - Bench testing with mechanical fixtures and foam models verified updated scale reader measurement accuracy (likely contributing to this).
• Simulated use testing in cadavers validated system accuracy vs. the gold standard of radiographic measurement.
• 38 data points (on 5 hips) from cadaver validation showed accurate navigation of cup placement angles. |
  | Software Integrity and Functionality | Software verification and validation ensured the integrity of the code and functionality and reliability of the software in various use sequences. |
  | Hardware Mechanical Requirements | System hardware verification/validation testing ensured the electronics hardware meets its mechanical requirements. |
  | Electrical Safety | Electrical safety testing to IEC 60601-1:2005 + Corr. 1 (2006) + Corr. 2 (2007) + AM1 (2012) or IEC 60601-1:2012. |
  | Electromagnetic Compatibility | Electromagnetic compatibility testing to IEC 60601-1-2: 2015. |
  | Laser Product Safety | Laser product safety verification to IEC 60825-1:2014. |
  | Instrumentation Cleaning, Sterilization, and Shipping | Validations for the specified processes. |
  | Navigation Device Sterilization, Packaging, Shelf Life, Environmental, Shipping | Validations for the specified ranges of conditions involved in each process. (Summary data for the identical predicate device is referenced for some validations.) |
  | Biocompatibility | System components biocompatibility assessment per ISO 10993-1 (2009). |
  | User Requirements Validation (Simulated Use) | Customer requirements validation with an advising surgeon validated the system meets design input requirements for its functions in a simulated use environment. |

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

• Sample Size (for clinical performance aspects):
  • Intraoperative change in leg length and offset: 40 data points (on 5 hips)
  • Acetabular shell insertion navigation: 38 data points (on 5 hips)
• Data Provenance: Prospective cadaver validation in a simulated operating room environment. The country of origin is not specified.

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

• Number of Experts: A "surgeon" conducted the procedures in the simulated use cadaver testing. It mentions "an advising surgeon" for customer requirements validation. The exact number of independent experts contributing to ground truth establishment for the cadaver study is not explicitly stated beyond "a surgeon."
• Qualifications of Experts: The individual conducting the cadaver procedures is referred to as a "surgeon." No specific years of experience or subspecialty (e.g., orthopedic surgeon) are mentioned, though the context implies an orthopedic surgeon familiar with the procedures.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the sense of multiple reviewers resolving discrepancies. The ground truth (radiographic evaluation) was compared against the device's measurements.

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, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed or described. This device is a surgical navigation system, not an AI-assisted diagnostic tool that aids human readers.

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

Yes, the cadaver study described is a standalone performance test of the algorithm and system's accuracy in a simulated surgical environment. The "surgeon" conducts the procedure using the device, and the device's output (measurements and navigation guidance) is then compared to a ground truth (radiographic evaluation). This assesses the system's ability to accurately determine surgical parameters independently, under realistic conditions.

7. The Type of Ground Truth Used

• Radiographic measurement: Used for validating the accuracy of leg length and offset changes, and cup placement angles in the hip arthroplasty procedures on cadavers. This is considered a "gold standard" in the context of the study.

8. The Sample Size for the Training Set

The document does not mention a "training set" or "training data" as this device is a rule-based surgical navigation system rather than a machine learning/AI model that requires training data in the conventional sense. The "performance data" section focuses on verification and validation of the system's design and functionality.

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

As no training set is discussed or implied for a machine learning model, this question is not applicable based on the provided text. The system relies on its inherent algorithms and sensor data, validated against known physical principles and clinically accepted measurement techniques (like radiography) rather than being "trained" on a dataset with established ground truth.

Ask a specific question about this device

The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty: Posterior.

Example orthopedic surgical procedures include but are not limited to:

• · Total Knee Arthroplasty
• · Total Hip Arthroplasty: Anterior/Posterior
• · Unicompartmental Knee Arthroplasty: Tibial transverse resection

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format.

The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.

The provided text describes modifications to an existing orthopedic surgical navigation system, the OrthAlign Plus® System (K153237), to add functionality for unicompartmental knee arthroplasty (UKA) tibial transverse resections. The submission claims substantial equivalence to its prior version (K140331) and the Aesculap OrthoPilot Next Generation (K141694).

However, the document does not contain specific acceptance criteria with numerical targets (e.g., minimum accuracy of X degrees or Y mm) or detailed results from a study demonstrating the device meets those criteria. Instead, it describes general categories of performance testing.

Therefore, I cannot populate the table with acceptance criteria and reported device performance as they are not explicitly stated with specific numerical values in the provided text. I also cannot provide detailed answers for many of the questions as the specific study details (e.g., sample sizes for test/training, expert qualifications, adjudication methods, MRMC studies) are not present.

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

1. Table of Acceptance Criteria and the Reported Device Performance

Missing Information: The document states "System accuracy testing: bench testing with mechanical fixtures and foam models to verify navigated resection plane angular and depth accuracy." However, it does not provide the specific acceptance criteria (i.e., "within X degrees/mm of target") nor the actual measured performance results.

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

• Test Set Sample Size: Not specified. The document mentions "bench testing with mechanical fixtures and foam models" for system accuracy and "cadaver with an advising surgeon" for usability validation, but no sample sizes for these tests are provided.
• Data Provenance: The cadaver study would typically be prospective for that specific test run, but the location/country of origin is not mentioned. Bench testing is laboratory-based.

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

• Number of Experts: "an advising surgeon" (singular) for the cadaver study.
• Qualifications of Experts: The qualification is "advising surgeon." No further details on experience level or specialization are provided.

4. Adjudication method for the test set

• Adjudication Method: Not specified. For the cadaver study, an "advising surgeon" was involved in validating usability, but the method for establishing ground truth or resolving discrepancies is not detailed. For bench testing, mechanical fixtures and foam models would likely have a pre-defined "ground truth" based on their design.

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, an MRMC comparative effectiveness study involving human readers or AI assistance in that context was not mentioned or performed. The device is a surgical navigation system, not an imaging interpretation AI.

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

• Standalone Performance: The described "System accuracy testing: bench testing with mechanical fixtures and foam models to verify navigated resection plane angular and depth accuracy" can be considered a form of standalone testing for the device's accuracy in measuring and displaying angles/positions. However, it's not a purely "algorithm-only" test as it involves hardware components interacting with physical models. The document doesn't explicitly delineate "algorithm-only" performance metrics separate from the integrated system.

7. The type of ground truth used

• Ground Truth Type:
  • For system accuracy testing, the ground truth would be based on the known, precise measurements of the mechanical fixtures and foam models.
  • For usability validation in cadaver, the "ground truth" relates to whether the system meets design input requirements for its functions, likely assessed by the advising surgeon against surgical standards.

8. The sample size for the training set

• Training Set Sample Size: Not applicable/not specified. This device is a surgical navigation system, which primarily relies on algorithms and hardware for real-time measurements rather than a "training set" in the machine learning sense for image recognition or similar AI applications. The algorithms are developed and calibrated, but a "training set" for performance evaluation is not referenced.

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

• Ground Truth for Training Set: Not applicable/not specified. As above, the concept of a "training set" for this type of device is not directly addressed in the document. The algorithms would be designed and tested based on engineering principles and physical measurement accuracy.

Ask a specific question about this device

The OrthAlign Plus System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty: Posterior.

Example orthopedic surgical procedures include but are not limited to:

• Total Knee Arthroplasty
• Total Hip Arthroplasty: Anterior/Posterior

The KneeAlign® 3 System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The KneeAlign® 3 System facilitates the accurate positioning of implants, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

• Total Knee Arthroplasty

The HipAlign® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The HipAlign® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty: Posterior.

Example orthopedic surgical procedures include but are not limited to:

• Total Hip Arthroplasty: Anterior / Posterior

The OrthAlign Plus® System is an innovative non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format.

The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.

The OrthAlign Plus® System is usable for a total knee arthroplasty or total hip arthroplasty procedure. The System includes two optional configurations: the KneeAlign® 3 System usable for total knee arthroplasty only, and the HipAlign® System usable for total hip arthroplasty only. The OrthAlign Plus® System includes the singleuse OrthAlign Plus® Unit, a KneeAlign® 3 Instrument Set and a HipAlign® Instrument Set. The optional configurations include a modified version of the OrthAlign Plus® Unit and only one of the Instrument Sets.

The OrthAlign Plus System comprises a single use computer module, a reusable reference sensor, a reusable femoral jig, a reusable tibial jig, a reusable posterior hip jig and a reusable anterior hip jig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical and numerical representation of instruments and anatomy on the user display screen.

The optional KneeAlign® 3 and HipAlign® system configurations also comprise the single use computer module, reusable reference sensor and applicable reusable jigs. They utilize the same algorithms, sensor conversions, graphical and numerical representations and surgical techniques as the OrthAlign Plus® System.

The OrthAlign Plus® System, KneeAlign® 3 System, and HipAlign® System are computer-controlled surgical navigation systems for knee and hip arthroplasty procedures.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes general performance testing but does not explicitly state numerical acceptance criteria for accuracy, nor does it provide specific numerical results of device performance against such criteria. Instead, it broadly states that "Device performance testing confirms that the OrthAlign Plus® System can be used according to its intended use" and that the "testing regime demonstrates that the subject device is as safe, as effective, and performs as well as or better than the predicate devices."

The most specific performance mentioned is related to accuracy in measuring leg length and offset.

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

• Sample Size: The simulated use testing for validation of intraoperative change in leg length and offset involved 18 data points on 5 hips.
• Data Provenance: The study was a prospective cadaver validation conducted in a simulated operating room environment. The country of origin is not explicitly stated but is implied to be in the country where OrthAlign, Inc. operates (USA).

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

• Number of Experts: One "advising surgeon" was involved in "Customer requirements validation" and a "surgeon" conducted the procedures in the simulated use testing. It's not explicitly stated how many experts established the ground truth itself, but a surgeon was central to the simulated use.
• Qualifications of Experts: The document mentions an "advising surgeon" and a "surgeon" conducting procedures. Specific qualifications (e.g., years of experience, subspecialty) are not provided.

4. Adjudication Method for the Test Set:

• The document does not explicitly describe an adjudication method involving multiple reviewers for establishing ground truth. The ground truth for the simulated use testing was "radiographic evaluation of the leg length and offset changes."

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, an MRMC comparative effectiveness study was not explicitly described. The device is a "computer-assisted surgical navigation system" intended to assist the surgeon, but the study focuses on the device's accuracy in cadaveric models rather than a comparative effectiveness study of surgeons with and without the device. Therefore, no effect size of human reader improvement with AI assistance is provided.

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

• The document describes "System accuracy testing: bench testing with mechanical fixtures and foam models to verify leg length and offset and updated scale reader measurement accuracy." This bench testing likely represents a form of standalone testing of the algorithm's accuracy in a controlled environment, separate from the cadaver study which involves a surgeon. However, it's not explicitly labeled as "standalone performance."

7. The Type of Ground Truth Used:

• For the validation of intraoperative change in leg length and offset, the ground truth used was radiographic evaluation of the leg length and offset changes.

8. The Sample Size for the Training Set:

• The document does not specify a sample size for a training set. This submission is for a modification to a previously cleared device (K130387) and focuses on validation against its own intended use and substantial equivalence to predicates. It doesn't detail the development and training process for the algorithms.

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

• As a training set is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided in the document.

Ask a specific question about this device

The OrthAlign Plus™ System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus" System facilitates the accurate positioning of implants, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

• Total Knee Arthroplasty o
• Total Hip Arthroplasty: Anterior / Posterior .

The KneeAlign® 3 System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrument and structures during stereotactic orthopedic surgical procedures. The KneeAlign® 3 System facilitates the accurate positioning of implants, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

• · Total Knee Arthroplasty

The HipAlign System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The HipAlign® System facilitates the accurate positioning of implants, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

• · Total Hip Arthroplasty: Anterior / Posterior

The OrthAlign Plus" System is an innovative non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus" " System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format.

The OrthAlign Plus" System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures, providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

In knee arthroplasty procedures, the device assists the surgeon in:

• Establishing the mechanical axis of the femur, determining the varus/valgus angle . and the flexion/extension angle of the cutting block relative to femur.
• Establishing the mechanical axis of the tibia, determining the varus/valgus angle . and the posterior slope angle of the cutting block relative to tibia.

In hip arthroplasty procedures, the device assists the surgeon in:

• Establishing the orientation of the anterior pelvic plane and determining the . inclination angle and the anteversion angle of the shell impactor relative to the anterior pelvic plane.
  The OrthAlign Plus™ System comprises a single use computer module and reusable instrumentation.

The OrthAlign Plus™ System is usable for a total knee arthroplasty or total hip arthroplasty procedure. The System includes two optional configurations: the KneeAlign® 3 System usable for total knee arthroplasty only, and the HipAlign® System usable for total hip arthroplasty only. The OrthAlign Plus" System includes the singleuse OrthAlign Plus™ Unit, a KneeAlign® 3 Instrument Set and a HipAlign® Instrument Set. The optional configurations include a modified version of the OrthAlign Plus" Unit and only one of the Instrument Sets. Indications for Use for each optional configuration are limited to the applicable orthopedic procedure.

The OrthAlign Plus" System comprises a single use computer module, a reusable reference sensor, a reusable femoral jig, a reusable tibial jig, a reusable posterior hip jig and a reusable anterior hip jig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical and numerical representation of instruments and anatomy on the user display screen.

The optional KneeAlign® 3 and HipAlign® system configurations also comprise the single use computer module, reusable reference sensor and applicable reusable jigs. They utilize the same algorithms, sensor conversions, graphical and numerical representations and surgical techniques as the OrthAlign Plus™ System.

The OrthAlign Plus™ System is a computer-assisted surgical navigation system for knee and hip arthroplasty procedures. The submission states that performance testing confirms the system can be used for its intended purpose and demonstrates substantial equivalence to predicate devices.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" or specific metrics for accuracy or precision for the OrthAlign Plus™ System. Instead, it relies on a general statement that "Device performance testing confirms that the OrthAlign Plus™ System can be used according to its intended use."

The performance data describe the types of tests conducted:

• Software verification and validation
• System hardware verification and validation testing
• Electrical safety and electromagnetic compatibility testing
• Instrumentation cleaning, sterilization and shipping validations
• System components biocompatibility assessment
• Customer requirements validation
• System accuracy testing: bench testing with mechanical fixtures and foam models
• Simulated use testing: cadaver and virtual testing

While the report confirms these tests were done, it does not provide specific numerical results that would typically be found in a section detailing acceptance criteria versus actual performance. The primary claim for regulatory clearance is "substantially equivalent" to predicate devices, which implies that its performance is comparable to already approved devices, rather than needing to meet distinct, pre-defined quantitative acceptance thresholds presented in this document.

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

• Test Set Description: Simulated use testing through cadaver and virtual studies.
• Knee Arthroplasty (Prospective Cadaver Validation):
  • Simulated operating room environment.
  • 3 labs.
  • 3 surgeons.
  • Procedures performed with both anterior and posterior approaches (though specific numbers for knees are not given, the focus then shifts to hips).
• Hip Arthroplasty – Anterior Approach (Cadaver Labs):
  • 2 cadaver labs.
  • 30 specimens (30 hips).
  • Data Provenance: Prospective, from cadaver labs. Country of origin not specified, but implied to be within the context of the applying company (OrthAlign, Inc. in Aliso Viejo, CA, USA).
• Hip Arthroplasty – Posterior Approach (Cadaver Labs and Virtual Study):
  • 2 cadaver labs.
  • 12 full body specimens (18 hips).
  • Follow-up virtual study (number not specified, but done with software updates).
  • Data Provenance: Prospective, from cadaver labs and a subsequent virtual study. Country of origin not specified, but implied USA.

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

• Number of Experts: 3 surgeons conducted the procedures in the simulated operating room environment for the initial cadaver validation.
• Qualifications of Experts: Referred to simply as "surgeons." No specific experience levels (e.g., years of experience, board certification) are provided in this summary.
• Method of Ground Truth Establishment: Radiographic evaluation of cup placements was used to validate the navigation of cup angles in hip arthroplasty cadaver labs. The specific methodology for how these surgeons' actions or radiographic interpretations formed the "ground truth" (e.g., if they were the "truth" or if their results were compared to another gold standard) is not fully detailed. It implies that the surgeons used the device, and the outcome (cup placement) was then evaluated radiographically.

4. Adjudication Method for the Test Set

The document does not describe an explicit "adjudication method" (like 2+1 or 3+1 consensus) for establishing ground truth, especially concerning expert agreement on image interpretation or surgical outcomes. It mentions "radiographic evaluation of the cup placements," which implies a measurement-based assessment rather than an adjudication of expert opinions on a diagnostic interpretation. The surgeons were performing the procedures, not adjudicating ground truth.

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

• No MRMC comparative effectiveness study was mentioned. The studies described are performance evaluations of the device itself and its assistance to surgeons, not a comparison of human readers with and without AI assistance to quantify an improvement effect size. The device is a navigation system, assisting in real-time surgical guidance, rather than a diagnostic tool interpreted by multiple readers.

6. Standalone Performance

• Yes, standalone (algorithm only) performance seems to be implicitly covered as part of the overall system testing. The description includes "System accuracy testing: bench testing with mechanical fixtures and foam models" and "virtual testing." These types of tests specifically evaluate the algorithms and hardware in isolation or in a controlled simulated environment before human interaction is introduced in cadaver studies. However, a distinct numerical "standalone performance" metric (e.g., x% accuracy without human intervention) is not explicitly stated.

7. Type of Ground Truth Used

• Measurement-based outcomes:
  • For hip arthroplasty cadaver labs, radiographic evaluation of the cup placements was used. This indicates that the "ground truth" was a measurement derived from imaging after the procedure, which was then compared to the intended or desired outcomes guided by the device. This is often considered an objective measurement or an outcome-based ground truth for surgical accuracy.

8. Sample Size for the Training Set

• The document does not specify a separate "training set" sample size or methodology for establishing ground truth for a training set. This is a medical device, specifically a surgical navigation system, rather than a machine learning algorithm that typically requires a large, annotated training dataset in the conventional sense. The "algorithms" mentioned convert sensor outputs into spatial coordinates, suggesting a more deterministic or model-based approach rather than a learning-based approach where a distinct training set (for a neural network, for example) would be used. The "performance data" section focuses on verification and validation of the system rather than training of an AI model.

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

• As a conventional "training set" (for machine learning) is not described, the concept of establishing ground truth for it is also not applicable here based on the provided text. The device’s "algorithms" are likely based on established biomechanical and geometric principles, and their accuracy is verified through the various testing described (bench, virtual, cadaver), not through training on data with pre-established ground truth labels.

Ask a specific question about this device