Search Results

The OPTIX H2 Patient Specific Instrument System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The OPTIX H2 Patient Specific Instrument System is intended for use with Vilex's Hintermann Series H2 Total Ankle System and its cleared indications for use. The OPTIX H2 Patient Specific Instrument System is indicated for single use only and is generated from CT imaging data.

OPTIX H2 Patient Specific Instrument System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Hintermann reusable instruments, facilitate the positioning of the Hintermann Series H2 Total Ankle implants. Vilex's OPTIX H2 PSI System produces a variety of patient specific outputs including surgical guides, anatomic models, and case reports.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study information that would typically be required to fill out all aspects of your request for the OPTIX H2 Patient Specific Instrument System. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a predicate device rather than providing granular performance data against predefined acceptance criteria.

However, I can extract the information that is present and indicate where details are missing.

Here's a breakdown based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

• Missing Details: The document does not specify what the "clinically justified acceptance criteria of the Hintermann Series H2 Total Ankle System" are (e.g., specific angular tolerances, cut depths, etc.), nor does it provide quantitative performance data (e.g., "equivalent implantation within X degrees of rotation" or specific debris generation measurements).

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

• Sample Size: Not explicitly stated. The text refers to "surgical procedures performed during the validation lab," but does not give a number of cases or procedures.
• Data Provenance: The study was a "validation lab" setting, implying a prospective, controlled environment, likely in the US or wherever Vilex, LLC is based. No specific country of origin for patients or data is mentioned, as it appears to be a benchtop/ cadaveric study rather than a clinical trial with patient data.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The study involved "surgical procedures" and assessed "implantation" equivalence, so it implicitly involved surgeons or trained personnel. However, their specific qualifications (e.g., "orthopedic surgeon with 10 years of experience in total ankle arthroplasty") are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document states "An analysis of the surgical procedures performed during the validation lab showed...", but doesn't detail how multiple assessments were reconciled (e.g., 2+1, 3+1, or if a single assessor was used).

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted according to the provided text. This device is a patient-specific instrument system for surgery, not an AI-assisted diagnostic or imaging interpretation tool that would typically involve "human readers" in an MRMC study context.
• Effect Size of Improvement with AI: Not applicable, as this is not an AI-reader assistance device. "Software-assisted design" is mentioned for the guides, but the performance validation described is on the physical instruments' ability to facilitate implantation, not on human interpretation skills.

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

• Standalone Performance: Not applicable in the sense of an "algorithm only" performance study. The device is a physical instrument system. Its "software-assisted design" is part of its creation process, but the validation focuses on the physical instrument's performance in surgery, which inherently involves human interaction.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" implicitly used was the outcome of the surgical procedures performed with both the subject device (OPTIX H2 PSI System) and the predicate device (Hintermann H2 Total Ankle System instrumentation). The comparison aimed to establish "equivalent implantation," suggesting a direct comparison of surgical results (e.g., placement accuracy, bone cuts) facilitated by each system. This is a form of empirical comparison against established surgical practice using the predicate device.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not provided. The device relies on patient-specific CT imaging data to create the guides. The "design of the patient specific guides, models, and pre-operative plan is software-assisted," suggesting algorithms or software are used for individual patient customization, but there is no mention of a traditional "training set" in the context of machine learning model development for a generalized diagnostic/predictive task. Each guide is custom-designed based on an individual patient's CT data.

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

• Training Set Ground Truth: Not applicable for the reasons mentioned in point 8. The "ground truth" for the patient-specific design system relies on accurate interpretation of the individual patient's CT imaging data and established surgical principles for total ankle replacement.

Ask a specific question about this device