(30 days)
The Medical Modeling VSP® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as CT based system. The is processed by the VSP® System and the result is an output data file that may then be provided as digital models or used as ingut to a rapid prototyping portion of the system that produces physical outputs including and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating surgical reatment options.
The Medical Modeling VSP® System is a collection of software and associated additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support orthognathic or reconstructive surgery. The system uses electronic medical images of the patient's anatomy with input from the physician, to manipulate original patient images for planning and executing surgery. The system manipulate enginal patient specific outputs including, anatomical models (physical and digital), surgical templates / guides, splints, and patient specific case reports.
Following the Medical Modeling Quality System and specific Work Instructions, trained employees utilize a combination of Commercial Off-The-Shelf (COTS) and trantom software to manipulate 3D medical scan images which can include Computed Tomography (CT), Cone Beam CT (CBCT), 3D scan images from patient physical models (stone models of the patient's teeth), and / or standard (non-bent) or priyered model implant files to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during planning and process telivery of the final outputs. While the process and data-flow can vary and phor to activery of the particular requirements of a given patient and physician, the following description outlines the functions of key sub-components of the system, following doben pour can be the defined system outputs. It should be noted that the system is operated only by trained Medical Modeling employees, and the the oyotan to open area the information. The physician only provides input for priysioian doos not anothy mactive feedback through viewing of digital models of model mempulation are modified by the engineer during the planning session.
The VSP® System is made up of 14 individual pieces of software and additional manufacturing equipment integrated to provide a range of anatomical models (physical and digital), surgical templates / guides and patient-specific case reports for (priyalour and digital), bargham, burgical region. Surgical guides for graft bone harvesting from patient bone such as, but not limited to, the fibula and hip, are also produced by the system.
The VSP® System requires an input 3D image file from medical imaging systems (i.e. CT) and / or a standard or patient contoured implant file. This input is then used, (i.e. ST) and from the prescribing physician to provide the following categories of with ourport reconstructive surgery. Each system output is designed with outpute to oupper roosiewed by the physician prior to finalization and distribution. priysician input, and foviotity direct physician involvement to reduce the criticality of the outputs.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medical Modeling Inc. VSP® System:
This document describes a "Special 510(k) for Modified VSP® System," which focuses on verifying that a modified version of an already cleared device (the predicate device) is substantially equivalent to the original. Therefore, the study details are primarily about demonstrating equivalence rather than establishing entirely new performance criteria or efficacy for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific, quantitative "acceptance criteria" for the VSP® System's performance in the way one might expect for diagnostic accuracy (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are framed around demonstrating equivalence to the predicate device and conformity to specifications for the modifications introduced.
| Acceptance Criteria Category | Reported Device Performance / Assessment Method |
|---|---|
| Substantial Equivalence | "The modified VSP® System conforms to specifications... and that its performance is substantially equivalent to the unmodified VSP® System." (Section 9.1) |
| "All Design, Process, and other Verification and Validation testing... showed conformity to pre-established specifications and acceptance criteria. The tests were performed in order to demonstrate device performance and substantial equivalence of the system to the unmodified version of the device." (Section 9.5) | |
| "Based on a comparison of the intended use and technological characteristics, the modified VSP® System is substantially equivalent to the identified predicate device." (Section 10.1) | |
| Patient Contoured Implant Files | "The final output .STL files the cases designed using a patient contoured implant .STL file as input demonstrated clinical and / or dimensional equivalency to .STL files created using a standard implant .STL file as input." (Section 9.3) |
| Clinical Equivalence (for Implant Files) | "The reconstructive surgeon approved both design, which indicated that there is no clinically significant difference between the implant template .STL file created from a patient contoured implant .STL file and a standard implant .STL file." (Section 9.3) |
| Conformity to Specifications (Software Updates) | "Software installation qualification" and "Software validation" tests were executed for each software version upgrade. (Section 9.4.1.1.1, 9.4.1.1.2) |
| Conformity to Specifications (Additional SLA Hardware) | "Installation Qualification (IQ)", "Operational Qualification (OQ)", "Performance Qualification (PQ)", and "Software Validation" were performed for the additional Stereolithography Apparatus (SLA) model and associated wash tanks. (Section 9.4.1.2.1-9.4.1.2.4) |
| ASTM Standards (Accessories) | "The modified and unmodified VSP® System Accessories are manufactured to ASTM F899-11". (Section 8.1.6) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" with a quantifiable sample size in terms of number of patients or cases. Instead, the testing appears to be focused on specific modifications and their impact.
- For Patient Contoured Implant Files: "The final output .STL files the cases designed using a patient contoured implant .STL file as input..." (Section 9.3). The text refers to "cases" (plural) but does not provide a specific number.
- For Software Updates: "Four (4) software components were upgraded". Tests were executed "for each software version upgrade." (Section 9.4.1.1). The direct sample size of test cases for these software validations is not detailed.
- For Additional SLA: "An additional SLA model and associated wash tanks have been added..." (Section 9.4.1.2). The testing here (IQ, OQ, PQ, Software Validation) is for the hardware and its integration, not a patient-case-based test set.
Data Provenance: Not explicitly stated, though the context implies internal testing by Medical Modeling Inc. The document does not mention external data, country of origin of data, or if it was retrospective or prospective in the sense of a clinical trial. It describes a "process validation" (Section 9.2) focused on a "worst-case patient contoured implant file" and subsequent digital file outputs that met requirements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- For Patient Contoured Implant Files: "The reconstructive surgeon approved both design..." (Section 9.3). This indicates one expert, identified as "the reconstructive surgeon." The specific qualifications (e.g., years of experience) are not provided beyond the title "reconstructive surgeon."
4. Adjudication Method for the Test Set
- For Patient Contoured Implant Files: The document states, "The reconstructive surgeon approved both design." This suggests a single expert's approval was sufficient, implying no formal adjudication method (e.g., 2+1 or 3+1 consensus) among multiple experts was necessary for this specific part of the testing. The "clinical input and review from the physician during planning and processing" (Section 7.2) and "reviewed by the physician prior to finalization and distribution" (Section 7.4) of system outputs also points to individual physician review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This submission is for a special 510(k) for a modified Virtual Surgical Planning (VSP) system, where the modifications primarily relate to input file types (patient contoured implant files) and internal manufacturing/software processes. The device itself is a software system for surgical planning and creating physical guides/models, not a diagnostic AI system meant to assist human readers in interpretation. The goal was substantial equivalence, not improved human reader performance with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The VSP® System is itself a software component, so in a sense, its underlying algorithms operate in a "standalone" fashion to process inputs and generate outputs. However, the system is explicitly designed with "human-in-the-loop" aspects:
- "The process requires clinical input and review from the physician during planning and delivery of the final outputs." (Section 7.2)
- "The system is operated only by trained Medical Modeling employees, and the physician only provides input for interactive feedback through viewing of digital models... models are modified by the engineer during the planning session." (Section 7.2)
- "Each system output is designed with physician input, and direct physician involvement to reduce the criticality of the outputs." (Section 7.4)
So, while the software performs its functions without direct human intervention at every step of its internal computations, the overall device workflow is inherently human-("clinician and trained employee")-in-the-loop, with outputs subject to expert review and approval. The testing described (e.g., "clinical and/or dimensional equivalency," "reconstructive surgeon approved") assesses the output of the system in the context of its intended use, which includes human oversight.
7. The Type of Ground Truth Used
The ground truth for the "patient contoured implant file" modification was based on:
- Expert Consensus/Approval: "The reconstructive surgeon approved both design, which indicated that there is no clinically significant difference..." (Section 9.3). This relies on the expert judgment of a reconstructive surgeon.
- Dimensional Equivalency: The comparison also sought "dimensional equivalency" (Section 9.3), implying quantitative measurements were involved, compared against established specifications or direct comparison of the designs.
For other internal modifications (software, hardware), the ground truth was conformity to "pre-established specifications and acceptance criteria" (Section 9.5) as demonstrated through standard qualification processes (IQ, OQ, PQ, software validation).
8. The Sample Size for the Training Set
The document does not specify a training set sample size. The VSP® System is not described as a machine learning or AI system that undergoes "training" in the conventional sense (i.e., learning from large datasets to develop an algorithm). It's a system that utilizes a combination of Commercial Off-The-Shelf (COTS) and custom software to manipulate 3D medical scan images based on predefined algorithms and engineering principles (Section 7.2). The modifications described are related to inputs, software updates, and manufacturing hardware, not algorithm retraining.
9. How the Ground Truth for the Training Set Was Established
As no training set is described (see point 8), the concept of establishing ground truth for a training set is not applicable to this submission.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.