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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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kneeEOS is a software indicated for assisting orthopedic surgeon in preoperative planning of knee orthopedic surgery. The software allows for overlaying of 3D/2D implants models on radiological images EOS based and 3D reconstruction of bones, and includes tools for performing measurements on the images or 3D model of bones, and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.

kneeEOS 1.0 allows surgeons to perform preoperative surgical planning of total knee arthroplasties. The software provides surgical tools to analyze preoperative data, to set the resection levels, to position and size the femoral and tibial components and to evaluate the final alignment of the leg. The images displayed are x-rays from EOS System (K152788) and 3D model of the knee from sterEOS Workstation (K160914). kneeEOS also displays preoperative parameters and updated values of these parameters after planning. kneeEOS 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 is a 510(k) summary for the ONEFIT medical kneeEOS device. It describes the device, its intended use, and compares it to a predicate device (TraumaCad Release 2.0). However, the document does not contain explicit acceptance criteria, performance metrics, or details of a specific study to prove the device meets said criteria.

Instead, the document states that "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" This general statement indicates that testing was performed according to FDA guidelines for software in medical devices, but it does not provide the specific performance data requested.

Therefore, I cannot populate the table or answer the specific questions about the study from the provided text. The document concludes that the device is "as safe and effective as its predicate" based on "Performance data demonstrate that the kneeEOS is as safe and effective as its predicate," but these performance data are not detailed in this 510(k) summary.

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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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Using 3D data and models obtained with sterEOS workstation, spineEOS software is indicated for assisting healthcare professionals in viewing, measuring images as well as in preoperative planning of spine surgeries. The device includes tools for measuring spine anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software online.

spineEOS 1.0 allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. The images displayed are x-rays from EOS System (K152788) and 3D model of the spine from sterEOS Workstation (K141137). spineEOS also displays preoperative parameters compared with reference values and updated values of parameters after planning. spineEOS is accessible on any computer via ONEFIT Management System (Class I device - Product code LMD - 510(k) Exempt) that provides a secure interface and storage through authentication mechanisms.

The FDA 510(k) summary for spineEOS provides some information regarding its performance data, but it does not contain a detailed study with acceptance criteria, specific reported device performance metrics, sample sizes, or information about experts and ground truth as requested.

The document primarily focuses on establishing substantial equivalence to a predicate device (Surgimap 2.0) by comparing intended use, indications, and technological characteristics.

Here's an analysis of what is available and what is missing from the provided text, structured according to your request:

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

• Missing from the document. The document states: "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'." However, specific acceptance criteria or detailed results of these tests (e.g., accuracy of measurements, success rate of planning tools) are not provided in this 510(k) summary.

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

• Missing from the document. The summary mentions "Software verification and validation testing," but does not specify the sample size of any test set or the provenance of the data used for such testing.

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 from the document. There is no mention of experts, ground truth establishment, or their qualifications for any validation testing.

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

• Missing from the document. No information about adjudication methods for a test set is provided.

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 from the document. The document makes no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating equivalence to the predicate device's existing functionality rather than quantifying human performance improvements.

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

• Implied, but not detailed. The "Software verification and validation testing" would typically involve standalone performance testing of the algorithms and software functionalities. However, the specifics of these tests and their results are not detailed. The spineEOS is described as "assisting healthcare professionals," implying it's a human-in-the-loop device, but standalone testing of its components would be part of standard V&V. Again, no specific results are provided.

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

• Missing from the document. As no specific performance study is detailed, the type of ground truth used is not mentioned.

8. The sample size for the training set

• N/A (or not explicitly stated as a "training set"). The spineEOS is a software for viewing, measuring, and planning based on existing 3D data and models (from sterEOS workstation). It's not described as a machine learning device that requires a distinct "training set" in the sense of a deep learning model. Its validation would focus on the accuracy of its measurements and the functionality of its planning tools against known standards or expert opinion, not on learning from a dataset.

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

• N/A. Since a classical machine learning "training set" is not explicitly mentioned or implied for this type of device, the method for establishing its ground truth is not applicable in that context.

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The ONEFIT Hip Planner software 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 3D model of bones and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.

The ONEFIT Hip Planner software 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. ONEFIT Hip Planner is accessible on any computer via ONEFIT Management System that provides secure interface through authentication mechanisms, web accessible authentication servers and access for authorized users through secure protocols to web server.

The provided document is a 510(k) summary for the ONEFIT Hip Planner, which is a pre-operative planning software for hip replacement surgery. It establishes substantial equivalence to a predicate device, TraumaCAD Release 2.0 (K073714). The performance data section in this document is very brief and does not contain the detailed information requested in your prompt.

Specifically, the document states:

• "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"

This statement indicates that testing was performed, but it does not provide any specific details regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Whether an MRMC comparative effectiveness study was done, or any effect size for human readers with and without AI assistance.
6. Whether a standalone performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Therefore, based solely on the provided text, it is not possible to answer your questions in detail. The document confirms that some performance data demonstrations were done to support the claim of substantial equivalence to the predicate device, but the specifics of these studies are not part of this 510(k) summary. Further information would typically be found in the full 510(k) submission, which is not included here.

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