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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

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.

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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.

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.

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