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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.

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The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the provide a constructed images to aid surges to aid surgeons in their planning of orthopaedic surgeries.

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I am sorry, but the provided text from the FDA 510(k) letters for OrthoPlan does not contain any information about acceptance criteria, study details, or performance metrics of the device.

The letters primarily address a substantial equivalence determination and an administrative correction. They state that the device is a "Template for clinical use" (product code HWT) and describe its indications for use as:

"The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the provide a constructed images to aid surges to aid surgeons in their planning of orthopaedic surgeries."

Since the document does not contain the requested information about acceptance criteria and study data, I cannot fulfill your request to describe them.

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