Search Results

The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for external fixation of fractured long bones and bones of the foot, limb lengthening, and deformity correction in adult, children* (3-12), and adolescent* (12-21) patient populations. The DePuy Synthes MAXFRAME™ Multi- Axial Correction System utilizes software for assisting surgeons in treatment planning. *in which the growth plates have fused or will not be crossed.

The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware:
• fracture fixation (open and closed)
• pseudoarthrosis of long bones
• limb lengthening (epiphyseal or metaphyseal distraction)
• joint arthrodesis
• infected fractures or nonunions
• correction of bony or soft tissue deformities
• correction of segmental defects.

The DePuy Synthes MAXFRAME™ Multi Axial Correction System, is an external ring fixation system that consists of MAXFRAME Hardware (schanz screws, pins, struts, rings) and MAXFRAME Web Software, used in treatment of soft tissue and bone deformities.

The subject device MAXFRAME 3D II Software (Moderate Software Level of Concern) is a software re-write of the MAXFRAME Web Software to make it more efficient, simplify software upgrades for functionality and fixing of software anomalies or bugs. Additionally, based on surgeon feedbacks and voice of customer, new functionality has been added around how frames are identified on X-Rays/radiographic images and how the treatment of the deformity can be planned.

This document describes the MAXFRAME™ Multi-Axial Correction System (aka MAXFRAME) software, specifically the MAXFRAME 3D II Software. It is a software re-write of the existing MAXFRAME Web Software, cleared under K161417.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance:

The provided document (510(k) Summary) is a submission for substantial equivalence based on non-clinical performance testing. It does not contain specific acceptance criteria for performance metrics in a quantitative sense (e.g., accuracy, sensitivity, specificity). Instead, it generically states:

Important Note: This is a 510(k) summary for a software update to an existing device. The primary claim is substantial equivalence to the predicate device (MAXFRAME Web Software, K161417), meaning it performs similarly and raises no new questions of safety or effectiveness. As such, detailed quantitative performance metrics often associated with novel AI/ML devices or completely new technologies are typically not disclosed in this type of submission summary. The "acceptance criteria" here are focused on demonstrating that the new software maintains the safety and effectiveness profile of the predicate.

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

The document explicitly states: "Non-clinical Performance Testing: The performance of the subject MAXFRAME 3D II Software has been evaluated by confirming that the outputs meet the input requirements and conform to the user needs and intended uses."

This indicates software verification and validation (V&V) activities were performed. However, the document does not specify a sample size for a "test set" in the context of clinical or image-based evaluation. Given it's a software re-write of an existing system, the testing likely involved functional testing, regression testing, and possibly performance testing against a set of representative cases or simulated scenarios to ensure calculations are correct and the user interface functions as expected.

The document does not specify the data provenance (e.g., country of origin, retrospective or prospective data) for any test cases used during V&V.

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

This information is not provided in the document. As it is a software re-write and not a novel diagnostic AI algorithm, the "ground truth" for V&V would likely be based on:

• Expected outputs from calculations based on well-defined anatomical parameters or clinical scenarios.
• Comparison to results from the predicate software.
• Expert review of UI/UX and functionality rather than diagnostic accuracy.

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

This information is not provided. Given the nature of a software re-write, a formal adjudication process for diagnostic interpretations (like 2+1 review) is unlikely to be the primary method of evaluation. Software V&V typically uses internal testing protocols.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical Performance Data: Clinical data was not necessary for the determination of substantial equivalence." Therefore, there is no information about the effect size of human readers improving with AI assistance.

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

The document describes the device as providing "software for assisting surgeons in treatment planning." The "MAXFRAME 3D II Software" is a component of the "MAXFRAME™ Multi-Axial Correction System," which is an "external ring fixation system." This implies it's an assistive tool for a human-in-the-loop workflow (surgeons using the software for planning), not a standalone diagnostic algorithm designed to provide unassisted outputs.

While standalone software verification and validation was performed on the software alone to ensure its functionality and calculations are correct, this is distinct from proving clinical performance as a standalone diagnostic or assistive device in a clinical setting.

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

The specific type of ground truth used for the software's verification and validation is not explicitly stated. For a software re-write focused on treatment planning and calculation, the "ground truth" would likely be derived from:

• Engineering specifications and requirements: Ensuring the software correctly implements the intended algorithms and calculations.
• Comparison to predicate device's output: Confirming that the new software produces equivalent results to the previous, cleared version for identical inputs.
• Industry standards or clinically accepted formulas: For calculations related to limb lengthening, deformity correction, etc.

It's highly unlikely that expert consensus on diagnostic images, pathology, or outcomes data was used as the ground truth for this software re-write's V&V, given the nature of the device (treatment planning software for an external fixator).

8. The sample size for the training set:

This information is not applicable and not provided. The MAXFRAME 3D II Software is a software re-write of an existing system, and the description does not suggest it employs machine learning or artificial intelligence that would require a "training set" in the conventional sense. It is a deterministic rule-based or algorithmic software for planning.

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

This information is not applicable and not provided, as there is no indication of a machine learning component requiring a training set with established ground truth.

Ask a specific question about this device