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510(k) Data Aggregation
(245 days)
PtoleMedic System
The PtoleMedic System is an on-line orthopedic surgical planning software system. MRI images supply data sufficient to allow accurate modeling of anatomy for on-line surgical planning before knee joint replacement surgery. The surgeon preoperatively plans, reviews, adjusts and orients images to select implant size and create an idealized surgical plan for the first bony cuts only.
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
The ProleMedic System software described here utilized an FDA Guidance Document for industry called "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005". This guidance helped determine submission content and provided a determination of a "MODERATE" level of safety concern for the software. Improper use of software planning or processing could result in harm requiring medical intervention to correct.
The PtoleMedic System software access is only available via a web/cloud-based software interface. The program is a surgeon-directed surgical case Planning package primarily but not exclusively directed at total joint replacement and closely related orthopedic indications.
After completing secure log-in, the user registers, enters case information, requests MRI images, specifies implant size and parameters, sets orientation requirements, reviews expected outcome positioning, and ultimately authorizes the desired surgical plan.
Once the case is physician authorized, additional Lento Medical Innovation engineering review of the case requirements begin converting the physician recommended implant plan into personalized surgical instruments to reproduce the physician created plan. Only Lento Medical Innovation personnel may access engineering modules of the PtoleMedic System software. The engineering staff uses proprietary software to convert the plan parameters into manufacturing output. Manufacturing output means anatomically personalized models to help the surgeon visualize the bony cuts' physical orientation. Trained engineers then convert style/brand of implant, sizing requirements, component orientation, and limb alignments into output to make anatomically fitted models for exclusive use by the surgeon and the specifically named patient.
The provided text does not contain detailed information about specific acceptance criteria related to numerical performance metrics (e.g., sensitivity, specificity, accuracy) for the PtoleMedic System, nor does it describe a study specifically designed to quantify the device's performance against such criteria.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Somersault Vault System) and a reference device (Materialise N.V., SurgiCase System) by detailing:
- Its intended use and technological characteristics.
- The software development and validation processes followed.
- Confirmation that the software meets its defined requirements and specifications through various testing phases.
Here's an attempt to extract and present the information based on your request, highlighting what is implicitly or explicitly stated and what is missing from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary from text) |
|---|---|
| Functional Requirements Met: The device should fulfill all predefined functional requirements as outlined in the Software Requirement Specifications (SRS) and Software Design Specifications (SDS). | "The PtoleMedic System software meets its defined requirements and specifications. All identified test faults are corrected, mitigated, or eliminated as or if they occurred. No test variances remain. Final assessment using a software requirements matrix demonstrated software compliance within the scope of the testing. The PtoleMedic System meets all software requirements. All testing confirms system input equals system output." |
| Accuracy and Performance Consistent with Predicate: The planning accuracy and performance of the device should be consistent with the predicate device. | "The V&V testing results on the Vault System and the PtoleMedic System provided consistent planning accuracy and performance." |
| Compliance with Software Validation Guidance: The software development processes and validation activities should conform to FDA Guidance for "Content of Premarket Submissions for Software Contained in Medical Devices." | "Predefined Functional requirements, meeting PtoleMedic System Software Requirement Specifications (SRS), and Software Design Specifications (SDS) demonstrate all attributes and traceability activity, meet US-FDA General Principles of Software Validation and EU-MDR requirements for CE Marking. Software development processes conform with FDA Guidance; 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005'." Verification and Validation activities include accuracy, repeatability, and stress testing per FDA's Guidance for Software Contained in Medical Devices." |
| Safety and Risk Management: The device's safety concerns should be addressed according to ISO 14971:2017 and EN/ISO-13485:2016, and the FDA's level of concern determination (Moderate). | "Safety concerns identified during risk/hazard analysis follow ISO 14971:2017 and EN/ISO-13485:2016. The Food and Drug Administration cleared the Vault System with a "MODERATE" level of concern. The PtoleMedic System is identical. The risk/hazard analysis follows ISO 14971:2017 and EN/ISO-13485:2016 and the FDA guidance for the level of concern determination." |
| Accuracy, Repeatability, and Stress Testing: The device must undergo and pass tests for accuracy, repeatability, and stress. | "Verification and Validation activities include accuracy, repeatability, and stress testing per FDA's Guidance for Software Contained in Medical Devices." (The text states these activities were performed, implying they were passed, but specific results are not provided). |
| Absence of Test Variances: All identified test faults should be corrected, mitigated, or eliminated. | "All identified test faults are corrected, mitigated, or eliminated as or if they occurred. No test variances remain." |
| Imaging Modality Handling: The system should accurately process DICOM MRI images for surgical planning. | "The ProleMedic System provides restricted, secure web-based access for total joint replacement surgical planning. Both systems (PtoleMedic and Vault) use digital DICOM-based data from pre-operative MRI scans of the operative limb... All systems (PtoleMedic, Vault, Materialise) can utilize MRI-based images to size, orient, and position various implant components and locate the desired bony tissue resections. Each software system orients the distal femur and proximal tibia's primary bone cut to facilitate the chosen implants' placement. All systems use DICOM compliant digital image data for Planning, image display, overlay manipulation, and machine code processing to produce anatomic models if requested." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of a clinical performance study using patient data. The testing mentioned refers to software verification and validation (V&V) activities against predefined functional requirements.
- Test Set Sample Size: Not specified. The V&V activities involved "bench and phantom models" for software performance data.
- Data Provenance: Not specified for any specific patient data used in performance evaluation. The "MRI images supply data" for general system functionality, but there's no mention of a specific dataset for performance testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The V&V activities mentioned seem to be primarily software-centric (system requirements tests, unit tests, integration tests, functional tests, system tests), rather than clinical performance evaluation that would typically involve expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
This information is not provided. As no patient-based clinical "test set" requiring expert adjudication is described, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided. The document focuses on demonstrating substantial equivalence through technological comparison and software V&V, not through a comparative effectiveness study involving human readers with and without AI assistance. Therefore, there is no effect size reported for human reader improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document describes the PtoleMedic System as an "on-line orthopedic surgical planning software system" where the "surgeon preoperatively plans, reviews, adjusts and orients images to select implant size and create an idealized surgical plan." This indicates a human-in-the-loop system. While the software has "consistent planning accuracy and performance" validated through V&V, a standalone algorithm-only performance study, independent of human interaction, is not described. The software's output, a "personalized surgical plan" and "anatomically personalized models," is directly derived from and used by human surgeons.
7. Type of Ground Truth Used
For the software verification and validation:
- The "ground truth" implicitly used is the predefined software requirements and specifications (SRS and SDS). The testing aims to confirm that the software's output matches these requirements.
- The text also mentions validation activities used "bench and phantom models". For these, the geometric accuracy or known properties of the phantom models would serve as ground truth for assessing measurements or planning.
There is no mention of ground truth established by expert consensus, histology/pathology, or outcomes data in the context of device performance claims.
8. Sample Size for the Training Set
This information is not provided. The document describes software validation and equivalence, not the development or training of an AI/ML model for which a "training set" would be typically used. It is possible the system uses rule-based logic or traditional image processing rather than machine learning requiring a training set, or if it does use ML, the training set details are not disclosed in this summary.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as details about a "training set" are absent from the document.
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