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The GYDER® Hip Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopaedic surgical procedures. The GYDER® Hip Navigation System facilitates the accurate positioning of the acetabular cup only during Anterior Hip Arthroplasty approaches with the patients in supine position.

The GYDER® Hip Navigation System is intended to be used only during Anterior Hip Arthroplasty approaches with the patients in supine position, with acetabular cups that are uncemented and allow for post-impaction measurement and confirmatory measurement.

The GYDER® Hip System is a computer controlled non-invasive surgical tool to aid navigation during Total Hip Arthroplasty via the Anterior Approach. The system includes both reusable and consumable components, designed to work together to assist the surgeon in positioning the acetabular cup in the intended orientation during primary or revision Total Hip Arthroplasty.

The provided text is a 510(k) Summary for the GYDER® Hip System. It details the device's substantial equivalence to a predicate device and includes information on performance testing. However, it does not contain the specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested, particularly for an AI/ML-based device evaluation with expert consensus ground truth.

The excerpt discusses non-clinical testing which includes "System accuracy testing by bench testing for angle measurement accuracy including using ASTM F2554-18" and "Simulated use testing in cadaver with advising surgeons to validate the system meets requirements for user needs and usability in a simulated use environment." This indicates performance validation, but not in the context of an AI/ML model's diagnostic or assistive performance against expert consensus.

Therefore, I cannot provide all the requested information for an AI/ML model study based on this document. I will fill in what can be inferred or explicitly stated regarding performance testing of this stereotaxic instrument, and note where the information for an AI/ML study is not available from the provided text.

Acceptance Criteria and Device Performance (Based on available information for a Navigation System, not AI/ML directly)

Since this is a stereotaxic instrument, not an AI/ML diagnostic or assistive device that would typically rely on a test set of data interpreted by experts for ground truth, many of the requested fields are not applicable or not provided in the context of this 510(k) summary. I will indicate this where appropriate.

Study Details (based on information pertinent to a surgical navigation system):

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

   • Test Set Sample Size: The document mentions "Simulated use testing in cadaver" and "bench testing." It does not specify the number of cadavers or the number of tests performed for quantifiable test set size.
   • Data Provenance: Cadaver studies. The country of origin for the cadaver data is not specified. The studies appear to be prospective, as they are "simulated use testing."

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

   • For this type of device (surgical navigation), "ground truth" is typically established through direct physical measurements on the cadaver (e.g., using a goniometer or an established gold-standard measurement tool) rather than expert consensus on image interpretation.
   • The document mentions "advising surgeons" for usability validation in cadaver studies, but not for establishing a ground truth in the sense of diagnostic interpretation. Their qualifications are not specified beyond being "surgeons."

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

   • Not applicable in the context of this device's performance testing (which involves physical measurements/usability rather than expert interpretation of data).

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study was done, as this is not an AI/ML diagnostic or assistive device for "human readers." It's a surgical navigation system providing real-time guidance. The comparison is against the predicate device's performance, not human reader improvement with AI assistance.

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

   • "System accuracy testing by bench testing for angle measurement accuracy including using ASTM F2554-18" can be considered a standalone performance test for the algorithm's output accuracy against a physical standard. The results indicate it meets the standard.

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

   • For the accuracy testing, the ground truth would be the physical geometric standard defined by ASTM F2554-18 and actual measurements on the bench, or the defined anatomical axes in cadaver studies using validated measurement techniques. It is not expert consensus for image interpretation.

7. The sample size for the training set:

   • Not applicable. This is a navigation system and the document does not indicate the use of machine learning models requiring large training datasets with curated ground truth labels in the same way an AI/ML diagnostic device would. Software verification and validation (listed under "Non-Clinical Testing") would cover traditional software development and testing, not AI model training.

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

   • Not applicable, as no AI model training set is mentioned or implied.

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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.

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