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The OKI Surgical Planning Software assists healthcare professionals in planning lumbar spinal fusion surgeries. The device allows service providers to plan surgical procedures, including tools for assessing anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

The Ortho Kinematics OKI Surgical Planning Software is a software only accessory to a picture archiving and communications system. It is designed to be used to assess measurements from DICOM compliant images in a cleared PACS device and plan surgical spinal procedures. It offers the ability to plan certain surgical procedures, such as lumbar spine fusion. It offers tools for viewing data, and the ability to facilitate the estimation of a potential post-operative alignment and correction, based on pre-operative measurements, as well as the geometric parameters associated with specific lumbar interbody implant devices.

The provided document (K171617) is a 510(k) premarket notification for the "OKI Surgical Planning Software." It assesses the device's substantial equivalence to a predicate device, "Nemaris, Inc.'s Surgimap 2.0 (K141669)." However, the document does not contain the detailed performance study information typically required to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning advanced AI/machine learning model validation.

This document focuses on:

• Device Description: A software accessory for PACS to assist in lumbar spinal fusion planning.
• Comparison to Predicate Device: Table outlining similar technological characteristics.
• Performance Data: A very high-level statement that "Software verification and validation testing was completed for the subject device. The software functioned as intended and all results observed were as expected."

It does not provide any of the following information pertinent to a detailed performance study proving acceptance criteria:

1. A table of acceptance criteria and the reported device performance: No specific metrics (e.g., accuracy, sensitivity, specificity, AUC) or defined thresholds are mentioned.
2. Sample sizes used for the test set and the data provenance: No information on the number of cases or their origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of expert involvement for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: No information on how discrepancies were resolved.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: No such study is mentioned or implied. The software "assists healthcare professionals" but no improvement metrics are provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this device as "Human Intervention for interpretation and manipulation of images is Required."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
8. The sample size for the training set: Not applicable/not mentioned, as this is not an AI/ML training report.
9. How the ground truth for the training set was established: Not applicable/not mentioned.

Conclusion based on the provided text:

The document states, "Software verification and validation testing was completed for the subject device. The software functioned as intended and all results observed were as expected." This is a general statement indicating that the software was tested for functionality, likely against its design specifications and requirements, as opposed to a clinical or AI/ML performance study with specific acceptance criteria and detailed results.

This type of submission (510(k) for a PACS accessory) often relies on demonstrating substantial equivalence to a predicate device primarily through similar functional capabilities and safety principles, rather than extensive clinical performance studies that would be required for a novel diagnostic AI algorithm. The device is a "planning software" that provides "tools for assessing anatomical components" and "facilitate the estimation," requiring "Clinical judgment and experience." It is not an automated diagnostic system. Therefore, the detailed performance study information requested is not present in this regulatory filing.

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