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ApolloHipX is indicated for use in assisting in Total Hip Replacement in which the use of radiological imaging may be appropriate.

ApolloHipX is a non-invasive intra-operative, image processing software intended to precisely measure the position of total hip replacement (THR) components. The software operates as a near-real time assistive device for THR, measuring component alignment, to assist in precise placement of THR components. The software is intended to be installed on certified hardware (Apollo Station) located outside the patient field. This is accomplished by:
• Transfer of intra-operative 2D imaging of the patient from a capture source e.g. an X-ray machine
• Registration of the 3D pre-operative patient data to the 2D intra-operative patient imaging
• Calculation and display of the component alignment (for final implants as well as intra-operative instruments e.g., broaches and trials) which can be compared to pre-operative target positions.
ApolloHipX is intended to precisely measure the position of THR components by measuring implant positions relative to bone structures identifiable from radiological images and providing information on component alignment.
Clinical judgment and experience of an orthopaedic surgeon are required to properly interpret the results from the software. The software is not for primary image interpretation.The Apollo Station is the physical structure used to host the power supply and contains two user interfaces (monitor and tablet) from which the user can interact with the software applications. It also houses non-surgical Software that manages the user authentication, system access, data transfer of surgical inputs and communication to Corin's cloudhosted ecosystem. The Apollo Station connects to the imaging device intra-operatively to receive the 2D radiological images.

The provided text describes the ApolloHipX device and its clearance (K241808) by the FDA. However, it does not contain detailed information about the acceptance criteria and the specific study findings in the format requested.

The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (JointPoint K160284). While it mentions "Non-Clinical testing conducted to determine substantial equivalence," and lists several studies like "Algorithm Accuracy Study," it does not provide the acceptance criteria table or the detailed study results that prove the device meets these criteria. It also explicitly states "Not Applicable. No clinical testing performed to support substantial equivalence."

Therefore, based solely on the provided text, I cannot complete most of the requested information.

Here's what can be inferred/extracted from the provided text, and what is missing:

Acceptance Criteria and Device Performance:

A table of acceptance criteria and reported device performance is not provided in this document. The document lists "Algorithm Accuracy Study" as one of the non-clinical tests, implying that accuracy was measured, but no specific criteria or results are detailed.

Study Information (Based on available text):

• Sample size used for the test set and the data provenance: Not specified. The document mentions non-clinical tests including "Algorithm Accuracy Study," "Sawbone study," and "Cadaveric evaluation." The specific number of cases/samples in these studies is not provided, nor is the origin of the data (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. No information is given about the experts involved in establishing ground truth for any of the non-clinical studies.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
• 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: No MRMC study was done. The document states, "No clinical testing performed to support substantial equivalence." The device is intended to assist a surgeon ("Clinical judgment and experience of an orthopaedic surgeon are required to properly interpret the results from the software. The software is not for primary image interpretation."), but there's no study described on human performance with/without the device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: An "Algorithm Accuracy Study" was performed, which would be a standalone assessment. However, the results and specific metrics for this study are not provided.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "Algorithm Accuracy Study," the type of ground truth is not specified. Given it's a non-clinical study for a measurement device, it likely involved highly precise measurements from physical models (sawbones or cadavers) or highly accurate imaging, but the exact method isn't detailed.
• The sample size for the training set: Not specified. The document describes non-clinical tests but does not provide details on the training data used for the algorithm's development.
• How the ground truth for the training set was established: Not specified.

Summary of what is Lacking (and crucial for a complete answer):

The provided FDA 510(k) clearance letter and summary confirm the device's clearance and its intended use as a measurement assistance tool for Total Hip Replacement. However, it explicitly states that no clinical testing was performed. While non-clinical tests like "Algorithm Accuracy Study" are mentioned, the document lacks the specific acceptance criteria, detailed results, sample sizes, ground truth methodology (for both test and training sets), and expert qualifications/adjudication methods that would describe how the device met its performance goals. This information is typically found in the detailed study reports submitted to the FDA, not necessarily in the public 510(k) summary.

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