(335 days)
The Vantage PSI 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 Vantage PSI System is intended for use with Exactech's Vantage Total Ankle System and its cleared indications for use.
3D System's Vantage PSI 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 Exactech Vantage Total Ankle reusable instruments, facilitate the positioning of Vantage Total Ankle Implants. 3D System's Vantage PSI System produces a variety of patient specific outputs including surgical guides, anatomic models, and case reports for use with Exactech's Vantage Total Ankle System (K152217 and K183343).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vantage PSI System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with numerical targets and the corresponding device performance tied to those targets. Instead, it describes general compliance with standards and successful meeting of "all test method acceptance criteria" or "pre-defined acceptance criteria."
However, we can infer some performance aspects from the Cadaver Study / Design Validation.
| Acceptance Criteria (Inferred from Study Design) | Reported Device Performance |
|---|---|
| Process Qualification: Manufacturing process and operator repeatability within digital workflow met design specifications. | All test method acceptance criteria were met. |
| Cleaning Validation: Post-cleaning bioburden, protein, and hemoglobin levels met criteria. | All test method acceptance criteria were met. |
| Sterilization Validation: Steam sterilization achieved a | |
| sterility assurance level (SAL) of 10^-6. | All test method acceptance criteria were met. |
| Biocompatibility Validation: Cytotoxicity, sensitization, irritation, and acute systemic toxicity of polyamide and titanium alloy met criteria. | The battery of cytotoxicity, sensitization, irritation, and acute systemic toxicity testing conducted on the subject devices manufactured from polyamide and titanium alloy are within the pre-defined acceptance criteria. The results of the testing adequately address biocompatibility for the output devices and their intended use. |
| Packaging Validation: Compliance with 3D Systems Transportation Test Standard. | All test method acceptance criteria were met. |
| Shelf Life Validation: Verification of stated shelf life duration. | All test method acceptance criteria were met. |
| Debris Validation: Debris generation equivalent or better than published data. | The results of the testing perform equivalent or better than the values found in literature. |
| Cadaver Study / Design Validation: | |
| • 2D analysis: AP tibia varus/valgus, bearing-to-bearing, and lateral tibia measurement accuracy compared to pre-operative plan. | |
| • 3D analysis: Final implant placement accuracy (translations and rotations) compared to pre-operative plan. | |
| • Performance equivalent or better than standard instrumentation. | The results of both 2D and 3D analysis demonstrate the subject device performing equivalent or better than the Vantage Total Ankle standard instrumentation. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Cadaver Study: The document states that the cadaver and design validation studies utilized three surgeon users and compared the subject device to standard instrumentation. The number of cadavers or individual surgical procedures performed is not explicitly stated.
- Data Provenance: Not specified, but given the nature of cadaver studies for device validation, it would be prospective data collection. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The cadaver study involved three surgeon users.
- Their specific qualifications (e.g., years of experience, subspecialty) are not provided. They are simply referred to as "surgeon users."
- It's implied these surgeons contributed to evaluating the outcome, but the document doesn't explicitly state they established the "ground truth." The ground truth appears to be derived from objective measurements (2D and 3D analysis) comparing actual placement to pre-operative plans.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method for the cadaver study's results. It describes 2D and 3D analysis conducted but doesn't detail how discrepancies or interpretations between the three surgeon users, or between the measurements and the pre-operative plan, were resolved or adjudicated.
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. The Vantage PSI System is a patient-specific surgical guide intended for use with total ankle replacement components and guiding bone cutting, not an AI-based diagnostic or interpretative system where human readers would interpret results with or without AI assistance.
- The cadaver study was a comparative performance study between the device and standard instrumentation, not an AI assistance study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself (Vantage PSI System) is a physical surgical guide designed from imaging data via software, not a standalone algorithm that provides a diagnosis or output without human intervention. The "design and development process" involves software creating the guides based on patient imaging. The "performance testing" described primarily pertains to the physical aspects of the device and its manufacturing process, along with its accuracy in facilitating surgical procedures as a tool.
- The closest to "algorithm only" performance would be the accuracy of the software-generated patient-specific guides and models against the patient data, which is implicitly covered by the "Process Qualification" and the "Cadaver Study / Design Validation" where the physical output is compared to the pre-operative plan. However, it's not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the cadaver study, the ground truth appears to be based on objective measurements derived from post-operative imaging (CT scans for 3D analysis, fluoroscopic images for 2D analysis) compared against the pre-operative plan. This combines objective measurement with a pre-defined target.
8. The Sample Size for the Training Set
- The document does not provide information on a separate "training set" sample size. The Vantage PSI System involves designing patient-specific guides based on individual patient imaging (CT data), rather than a machine learning model that requires a discrete training dataset for algorithm development. The "design and development process" converts the CT data into a guide.
9. How the Ground Truth for the Training Set Was Established
- As there is no explicit mention of a "training set" in the context of a machine learning algorithm, the process of establishing ground truth for such a set is not applicable based on the provided text. The "ground truth" for the device's function is the patient's anatomy derived from imaging and the surgeon's pre-operative plan based on that anatomy.
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.