(30 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 intra-operatively, 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 Exacted 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 quides, anatomic models, and case reports.
Here's an analysis of the acceptance criteria and supporting study for the Vantage PSI System, based on the provided FDA 510(k) summary:
- This device is a patient-specific surgical guide system, not an AI device. Therefore, many of the typical AI/ML-specific questions regarding ground truth, expert consensus, and multi-reader studies are not applicable in the way they would be for an AI diagnostic or prognostic tool. The "performance" here relates to its accuracy in guiding surgical procedures compared to existing instrumentation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Ability to assist in positioning total ankle replacement components intra-operatively. | Shown to be substantially equivalent to Exactech instrumentation. |
| Ability to guide bone cutting. | Shown to be substantially equivalent to Exactech instrumentation. | |
| Accuracy | Accuracy in guiding surgical procedures. | Demonstrated sufficient accuracy. |
| Manufacturing Material | Guides and models made from biocompatible nylon. | Manufactured using SLS technology with DuraForm® ProX PA (polyamide) material. (This meets the biocompatibility implied by use in surgery). |
| Device Compatibility | Intended for use with Exactech's Vantage Total Ankle System. | Explicitly stated for use with Exactech's Vantage Total Ankle System. |
| Design Revisions (Impact) | Additional fixation options, corner drill features, optional decoupled talus guide do not introduce technological differences. | The changes "are not technologically different from the predicate Vantage PSI System." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of "patients" or "cases." The testing was described as "Cadaveric comparison testing." This implies a limited number of cadavers were used.
- Data Provenance: Cadaveric. Specific country of origin is not mentioned. It is a prospective study in the sense that the test was conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable in the traditional sense for this device. The "ground truth" for a surgical guide system is its ability to accurately direct cuts and component placement. The comparison was to an existing instrumentation system (Exactech instrumentation), which serves as the benchmark. The "experts" would be the surgeons or engineers performing the cadaveric tests and assessing the outcomes. Their qualifications are not specified in this summary.
4. Adjudication Method for the Test Set
- Not explicitly stated. Given it's a comparison of mechanical accuracy and functionality on cadavers, it's likely measurements were taken and compared directly, rather than requiring a complex expert adjudication process for image interpretation.
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
- This is not applicable as the Vantage PSI System is a physical surgical guide system, not an AI/ML diagnostic or prognostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is not applicable as the Vantage PSI System is a physical surgical guide intended for human use in surgery. Its "performance" is inherently human-in-the-loop.
7. The Type of Ground Truth Used
- The "ground truth" was established by comparing the subject device's guidance and resulting anatomical modifications (e.g., bone cuts, component placement) to those produced by Exactech's established instrumentation system. This comparison was done on cadavers, implying direct measurement or visual assessment of the outcome of the guided procedure.
8. The Sample Size for the Training Set
- This is not applicable. The Vantage PSI System is a custom-manufactured guide based on a patient's individual CT scan. There isn't a "training set" in the machine learning sense for the device itself. The design principles and manufacturing process might be informed by historical data or engineering principles, but not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the same reasons as #8.
§ 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.