(90 days)
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)
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Device Performance |
|---|---|---|
| Angle Measurement Accuracy (Bench Testing) | ASTM F2554-18 compliance for angle measurement accuracy | Device meets ASTM F2554-18 for angle measurement accuracy. |
| System Functionality & Reliability (Software) | Integrity of code, functionality, reliability | Verified and validated for various use sequences. |
| System Hardware Performance | Meets functional requirements | Verified and validated to meet functional requirements. |
| Usability (Simulated Use Testing) | Meets requirements for user needs and usability | Validated in simulated use environment with advising surgeons. |
| Biocompatibility | ISO 10993-1 (2018) compliance | Assessment states compliance. |
| Cleaning, Sterilization, Shipping Validation | Validation of specified processes | Validated. |
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):
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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."
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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."
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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).
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable, as no AI model training set is mentioned or implied.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).