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510(k) Data Aggregation
(56 days)
DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
The DYONICS PLAN Hip Impingement Planning System software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review, respectively.
The Smith & Nephew DYONICS PLAN Hip Impingement Planning System (here in after referred to as DYONICS PLAN software) is a software product that allows orthopedic surgeons and other healthcare professionals to visualize and perform analysis of digital images for assessment of hip preservation treatment options pre-operatively or post-operatively. The software enables the user to import computed tomography (CT) images. display various 2D views of the images, execute image segmentation and 3D rendering of the femur and pelvis. generate anatomic measurements, identify the areas and devree of conflict and simulate the resection of bony lesions, perform a dynamic range of motion analysis of the hip joint, and export the results in an output report. The software automatically generates a default estimate for each step of the analysis based on published literature, and the surgeon should always verify and make adjustments of the parameters based on their clinical judgment. The purpose of the software is to support other clinical findings and patient examination when assessing hip preservation treatment options.
The software is designed to be installed and run locally on a PC-compatible personal computer with a Windows operating system and a graphics card that meets the specified minimum requirements. The software facilitates the importation of CT images in DICOM format and allows the export of the output report in PDF or HTML format which can be referenced pre-operatively, intraoperatively or post-operatively. The user is provided with installation instructions which include the following: a link to a secure website, steps to download the installation file along with a license activation code and password.
The Smith & Nephew DYONICS PLAN Hip Impingement Planning System is a software product designed for orthopedic surgeons and other healthcare professionals to visualize and analyze digital images for assessing hip preservation treatment options.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table outlining quantitative acceptance criteria and reported device performance metrics. Instead, it states that "Software verification and validation testing demonstrates that the DYONICS PLAN does not raise any new questions of safety and efficacy as compared to the predicate device Mimics cleared in K073468." This implies that the device's performance was evaluated to ensure it functions as intended and is comparable to its predicate device, Mimics (K073468), which is a general surgical planning tool.
Given the information, the general acceptance criteria can be inferred as:
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Functional Equivalence | The device performs the same core functionalities as the predicate device relevant to hip impingement planning (e.g., image import, segmentation, 3D rendering, measurement tools, surgical simulation/planning). | "Software verification and validation testing demonstrates that the DYONICS PLAN does not raise any new questions of safety and efficacy as compared to the predicate device Mimics cleared in K073468." |
| Safety and Efficacy | The device does not introduce new safety concerns or demonstrate a lack of efficacy compared to the predicate device. | "Software verification and validation testing demonstrates that the DYONICS PLAN does not raise any new questions of safety and efficacy as compared to the predicate device Mimics cleared in K073468." |
| Intended Use | The device fulfills its intended use of simulating/evaluating hip preservation surgical treatment options pre-operatively or post-operatively, and historical case review. | The device's intended use is clearly stated and is considered met through its functional capabilities. |
| Output Generation | The device accurately generates an output report in PDF or HTML format that can be referenced pre-operatively, intra-operatively, or post-operatively. | The software exports the results in an output report. |
| User Adjustability | The software allows users to verify and adjust automatically generated estimates based on their clinical judgment. | "The software automatically generates a default estimate for each step of the analysis based on published literature, and the surgeon should always verify and make adjustments of the parameters based on their clinical judgment." |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The statement "Software verification and validation testing" is a general declaration without specific details about the clinical data used for this testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide information on the number of experts used to establish ground truth for a test set, nor their specific qualifications.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with or without AI assistance. The submission focuses on substantial equivalence to a predicate device rather than a comprehensive clinical effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is described as "software product that allows orthopedic surgeons and other healthcare professionals to visualize and perform analysis." It also states, "The software automatically generates a default estimate... and the surgeon should always verify and make adjustments... based on their clinical judgment." This indicates that the device is intended to be used with a human-in-the-loop, allowing for surgeon oversight and adjustment. There is no information suggesting a standalone (algorithm-only) performance evaluation.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any testing. However, given the nature of a surgical planning system, it's plausible that ground truth would involve:
- Expert Consensus: For verifying the accuracy of measurements, segmentations, and simulated resections against clinical best practices.
- Radiological Interpretation: Expert review of images and software outputs.
- Published Literature: The software generates default estimates "based on published literature," which effectively serves as a form of established ground truth for these estimates.
8. The Sample Size for the Training Set
The document does not provide information regarding a training set sample size. This type of detail is often associated with machine learning models, and while the device uses "image segmentation and 3D rendering," the specific details of its underlying algorithms and whether they involve a distinct training phase with a labeled dataset are not disclosed.
9. How the Ground Truth for the Training Set Was Established
Since no information about a training set or its sample size is provided, there is no description of how ground truth for a training set was established.
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