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hipEOS software is indicated to be used for assisting healthcare professionals in preoperative planning of total hip arthroplasty (THA). The software allows for overlaying of 3D/2D hip implant models on radiological images or 3D reconstruction of bone, and includes tools for performing measurements on the image or 3D model of bones and for selecting and positioning the hip implant models. Clinical judgments and experience are required to properly use the software.

hipEOS 3.0 allows surgeons to perform preoperative surgical planning of hip surgeries in case of Total Hip Arthroplasty (THA). The software provides surgical tools for the implantation of a Total Hip Prosthesis. This software can be used to plan interventions using implants from different manufacturers. The images displayed are x-rays from EOS System (EOS Imaging) and 3D model of the hip from sterEOS Workstation (EOS Imaging), hipEOS also displays preoperative parameters and updated values of parameters after planning. It exports a planning report containing the planning parameters: model, size and position of implants. hipEOS is accessible on any computer via ONEFIT Management System (Class I device -Product code LMD - 510(k) Exempt) that provides a secure internet interface and storage through authentication mechanisms.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the requested specifications. The "Performance Data" section merely states that "Software verification and validation testing were conducted and documentation was provided," and the software was deemed a "moderate" level of concern. It does not elaborate on the specific acceptance criteria, performance metrics, or the study design.

Therefore, I cannot fulfill your request for the information outlined in bullet points 1 through 9 based solely on the provided text. The document is a 510(k) summary, which typically provides a high-level overview rather than a detailed scientific study report.

To answer your request, I would need a more detailed performance study report or verification and validation documentation for the hipEOS 3.0 device.

Here's what I can extract from the provided text, and where information is missing:

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

• Missing Information: The document does not specify any quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) or present a table of reported device performance against such criteria. It generally states that the device is "as safe and effective as its predicates."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Missing Information: The document does not mention the sample size used for any test set or provide details on data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Missing Information: The document does not describe how ground truth was established for a test set, nor does it specify the number or qualifications of any experts involved in such a process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Missing Information: No information is provided regarding an adjudication method for a test set.

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

• Missing Information: The document does not mention an MRMC comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The device is for "assisting healthcare professionals" in planning, implying human-in-the-loop, but performance data for this interaction is not detailed.

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

• Partial Information / Implication: The device is described as "assisting healthcare professionals," implying a human-in-the-loop context. However, the software performs "measurements on the image or 3D model" and "selecting and positioning the hip implant models," which are functions of the algorithm. The document doesn't explicitly state whether a standalone performance evaluation of these specific automated tasks was conducted, nor does it provide results if it was. The "Performance Data" section is generic.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Missing Information: No information is provided on the type of ground truth used for any evaluations.

8. The sample size for the training set

• Missing Information: The document does not mention a training set or its sample size.

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

• Missing Information: No information is provided on how ground truth was established for a training set.

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hipEOS is indicated for assisting healthcare professionals in preoperative planning of hip replacement surgery. The software allows for overlaying of 3D/2D implant models on radiological images and 3D reconstruction of bone, and includes tools for performing measurements on the image and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.

hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. hipEOS is accessible on any computer via ONEFIT Management System that provides secure internet interface through authentication mechanisms, web accessible authentication servers and access for authorized users through secure protocols to web server.

The provided text does not contain detailed information about specific acceptance criteria or an in-depth study that proves the device meets those criteria, as typically found in a robust clinical validation report. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study that meets strict statistical criteria for a new device.

However, based on the information available in the text, here's what can be inferred and presented:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance metrics (e.g., accuracy, precision of measurements, etc.) nor does it provide specific quantitative results of the device's performance against such criteria. The "Performance Data" section broadly states that "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not mentioned or described in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, which typically relies on comparisons of technological characteristics and intended use rather than a full clinical effectiveness study with human readers.

6. Standalone Performance Study

The document states that "Software verification and validation testing were conducted." This implies that some form of internal testing was performed on the algorithm itself, which could be considered a standalone performance assessment. However, specific details about the methodology, metrics, and results of this standalone performance are not provided. The acceptance of the device is based on "Performance data demonstrate that hipEOS is as safe and effective as the company's cleared ONEFIT Hip Planner device," suggesting a comparison against the predicate rather than a specific standalone performance against defined clinical metrics.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for any testing. Medical device software for surgical planning often relies on expert consensus (e.g., orthopedic surgeons), anatomical measurements from high-resolution imaging, or potentially intraoperative findings as ground truth, but this is not confirmed here.

8. Sample Size for the Training Set

This information is not provided in the document.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document.

Summary of what is present:

• Acceptance Criteria & Performance: Not explicitly stated with quantitative metrics. The overall acceptance is based on demonstrating "substantially equivalent" safety and effectiveness to the predicate device through verification and validation testing.
• Study Details: The document mentions "Software verification and validation testing were conducted" as per FDA guidance for "moderate" level of concern devices. This implies internal testing was performed.
• Focus: The submission focuses on showing the modified hipEOS is substantially equivalent to its predicate device (ONEFIT Hip Planner K142671) by highlighting minor modifications (integration of prosthesis with modular neck and online validation by the surgeon) that "raise no new issues of safety or effectiveness."

To summarize, the provided text, being a 510(k) summary, offers a high-level overview and a declaration of substantial equivalence rather than a detailed technical report of the studies, acceptance criteria, and specific performance metrics typically found in a comprehensive validation study.

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