(77 days)
The 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 a CT based system. The input data file 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 input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
The VSP® System utilizes a combination of Commercial Off-The-Shelf (COTS) and custom software to manipulate 3D medical images (CT based systems) to create virtual and physical anatomical models, templates, surgical guides, and surgical plans for reconstructive surgical procedures.
The provided text is a 510(k) Summary for the VSP® System and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a study with a test set, expert ground truth, and statistical analysis as would be done for an AI/ML-driven device.
The VSP® System is described as a software system and image segmentation system for maxillofacial surgery, which processes imaging information (CT-based) to create digital models, physical outputs (anatomical models, surgical guides), and aids in pre-operative simulation. The primary change in the current submission is the addition of a new material (Accura® ClearVue™) for anatomical models, not a change or new feature related to an AI/ML algorithm's diagnostic or predictive performance.
Therefore, the document does not contain the information required to answer the questions regarding acceptance criteria for an AI/ML device, such as performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, expert ground truth establishment, or MRMC studies. The "performance testing" described (Operational Qualification, Performance Qualification, Cleaning Validation, Sterilization Validation, Biocompatibility Validation) are related to manufacturing processes and material safety, not the diagnostic or prognostic performance of a software algorithm on a test dataset.
The only "performance testing" mentioned is:
- Operational Qualification: Assessed manufacturing process over allowable parameters. All test method acceptance criteria were met.
- Performance Qualification: Assessed manufacturing process repeatability at nominal parameters. All test method acceptance criteria were met.
- Cleaning Validation: Performed in accordance with AAMI TIR 30. All test method acceptance criteria were met.
- Sterilization Validation: Performed in accordance with ISO 17665-1:2006 to a SAL of 10^-6. All test method acceptance criteria were met.
- Biocompatibility Validation: Evaluated in accordance with ISO 10993-1. Sensitization, irritation, and acute systemic toxicity testing conducted on the subject device manufactured from Accura ClearVue are within the pre-defined acceptance criteria.
The document explicitly states: "Clinical Performance Data - Clinical testing was not necessary for the determination of substantial equivalence." This further confirms that no study of the software's performance on a diagnostic/predictive task, using clinical data and ground truth, was performed or presented in this 510(k) summary.
In summary, based on the provided text, it is not possible to fill out the requested information as it pertains to an AI/ML driven device's performance study because such a study was not conducted or reported for 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.