(20 days)
CustomSurg OrthoPlanner is a software system designed to help surgeons carry out pre-operative planning for surgical procedures, based on their patients' imaging studies.
The software imports diagnostic imaging studies such as x-rays and CT images. In parallel, there is a database of digital representations related to implant materials supplied by their producing companies.
The software can process an imported 3D model of the patient's CT scan to digitally perform the surgical planning. Experience in usage and a clinical assessment are necessary for proper use of the software.
CustomSurg OrthoPlanner is to be used in conjunction with the planned device's instructions for use, the patient's clinical history, symptoms, and other pre-procedural evaluations by a surgeon who is responsible for making all final patient management decisions.
It is not intended to replace the planned device's instructions for use.
CustomSurg OrthoPlanner is a medical software that supports surgeons in orthopedic pre-surgical planning in the musculoskeletal system in a healthcare environment.
It is a web-based application that allows surgeons to upload the required data, provide details of planning the surgery and receive 3D visualization of the submitted plan. To properly use the device, clinical judgment and experience is mandatory and it shall be used in conjunction with diagnostic tools. CustomSurg OrthoPlanner does not perform any diagnostic evaluations and will not have intra-operative functionality.
The provided FDA 510(k) clearance letter for CustomSurg OrthoPlanner does not contain specific details about the acceptance criteria or the study that proves the device meets those criteria. The letter and the 510(k) summary explicitly state:
"Results from internal verification and validation testing performed in accordance with CustomSurg's design control processes confirm that the CustomSurg OrthoPlanner product specifications have been met. Acceptance criteria were achieved for all tests. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate device."
And then: "Not Applicable" for clinical tests.
This means the detailed study results, acceptance criteria, sample sizes, ground truth establishment, and expert qualifications are not provided in the given document. The FDA clearance is based on the claim of substantial equivalence to a predicate device (PeekMed) and internal verification and validation, rather than a separate clinical study whose details are presented in this public letter.
Therefore, I cannot extract the requested information from the provided text.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).