Search Results

Navbit Rapid Surgical Plan is intended for pre-operative planning for primary total hip arthroplasty. Rapid Surgical Plan is intended to be used as a tool to assist the surgeon in the selection and positioning of components in primary total hip arthroplasty.

Rapid Surgical Plan is indicated for individuals undergoing primary hip surgery.

The Navbit Rapid Surgical Plan is a non-invasive total hip arthroplasty planning software. It is software as a medical device (SaMD) which provides pre-operative planning for acetabular component orientation for orthopaedic surgeons. The software provides a recommended cup target intended to reduce impingement based on each patient's spinopelvic mobility. The ultimate decision to use the cup target recommended by Navbit is the surgeon's based on their clinical judgement.

The provided text details the 510(k) premarket notification for the Navbit Rapid Surgical Plan (RSP-SW-001) device. It outlines the device's intended use, comparison to a predicate device (RI.HIP MODELER), and the non-clinical testing performed to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The document details the following acceptance criteria (referred to as "Device Measurement Accuracy Evaluation" in the text) and the reported device performance:

2. Sample size used for the test set and the data provenance

The document states that in the "Clinical Measurement Accuracy Evaluation," "representative patient images" were used. However, it does not specify the exact sample size for this test set.

Regarding data provenance:

• The data used for the test set in the "Clinical Measurement Accuracy Evaluation" consisted of "representative patient images." The country of origin and whether the data was retrospective or prospective are not explicitly stated in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• The ground truth for the test set in the "Clinical Measurement Accuracy Evaluation" was "established by surgeons."
• The number of surgeons used to establish this ground truth is not specified.
• Their specific qualifications (e.g., years of experience) are not explicitly stated, beyond them being "surgeons."

4. Adjudication method for the test set

The document states that the ground truth for the "Clinical Measurement Accuracy Evaluation" was "established by surgeons." It does not explicitly detail an adjudication method (e.g., 2+1, 3+1, consensus process) for these surgeons in establishing the ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• A formal MRMC comparative effectiveness study, evaluating human readers with and without AI assistance, was not described for this specific device.
• The focus was on demonstrating that the performance of the planning technicians using RSP is "equivalent to that of the surgeons for the scope of the landmarking tasks involved" during user testing. This is a comparison of two user groups (technicians vs. surgeons) on a reference dataset, rather than an MRMC study on human improvement with AI assistance. Therefore, an effect size of human reader improvement with AI assistance is not provided.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone evaluation was implicitly done as part of the "Device Measurement Accuracy Evaluation." This section describes the performance of the device's underlying measurement capabilities (linear, angular, ratio measurements) against defined limits, independent of human interaction beyond inputting test patterns.

7. The type of ground truth used

• For the "Clinical Measurement Accuracy Evaluation," the ground truth was "established by surgeons" based on landmarking clinical features on radiographs, which can be categorized as expert consensus/opinion (though the consensus process is not detailed).
• For the "Device Measurement Accuracy Evaluation," the ground truth was derived from "test patterns," implying a known, engineered truth against which the device's fundamental measurements were compared.

8. The sample size for the training set

The document does not specify the sample size for the training set used for the Navbit Rapid Surgical Plan algorithm.

9. How the ground truth for the training set was established

The document does not explicitly describe how the ground truth for the training set was established. It mentions that "Navbit RSP uses an algorithm based on clinical recommendations for spinopelvic mobility to provide cup target recommendations" and that "RI.HIP Modeler uses an algorithm based on spinopelvic mobility classifications and hip kinematics in literature to recommend cup targets." This suggests reliance on existing clinical knowledge and literature for algorithm development, but the specifics of how this translated into labeled data for a training set are not provided.

Ask a specific question about this device