(108 days)
Intended Use:
FluoroMap is a computer controlled stereotaxic image guided surgery system. It provides static localization information derived from image processing of intra-operatively acquired X-ray images, by superposition of virtual implants and instruments onto those X-ray images.
Indications:
FluoroMap assists the surgeon to determine the needed size and position of orthopedic implants during proximal femur fracture surgery using the Stryker Gamma3 Nail system.
The system should be operated only by trained personnel such as surgeons and clinic staff.
The FluoroMap System is designed as a computer assisted surgical planning device to assist the surgeon in proximal femur fracture surgery.
The FluoroMap System provides static localization information derived through image processing of intra-operatively acquired X-ray images, by superposition of virtual implants and instruments onto those X-ray images.
The FluoroMap System consists of the FluoroMap Software, the FluoroDisc and the Closed Tube Clip. The Closed Tube Clip is a device which contains a radiolucent body with integrated metal marker spheres. The Closed Tube Clip is attached to the implant system of the Gamma3 Nail. The FluoroDisc is a device which contains a radiolucent plate with integrated metal marker spheres. It is attached to a standard C-arm, an intra-operative mobile 2D X-ray imaging device. The FluoroMap Software is a surgery planning system which recognizes the metal marker spheres of the FluoroDisc and the Close Tube Clip and performs a registration of the X-ray images to localize the position of the implant system, e.g. the Gamma3 Nail system. The FluoroMap Software overlays virtual implants and instruments onto the X-ray images and provides visual and numerical information to assist the surgeon in selecting the appropriate implant and to position it precisely.
Here's a breakdown of the acceptance criteria and the study information for the FluoroMap Computer Assisted Surgery System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Characteristic) | Target (Standard/Test/FDA Guidance) | Reported Device Performance (Results Summary) |
|---|---|---|
| Accuracy | 2 mm (maximal deviation between displayed and actual implant position) | Accuracy target met with statistical significance in cadaveric test, saw bone tests, and computer simulation |
| Usability | Meet all specified user needs, comply with usability standard IEC 62366:2007 | In cadaveric test with simulated use case scenarios the specified user needs were validated and the system was usable in accordance with usability standards |
| Safety | Perform risk analysis, identify risk mitigation measures and verify that the measures are effective, comply with risk management standard ISO 14971:2007 | All safety measures are verified to be effective |
| Recognized Consensus Standards | Comply with specific sterility and biocompatibility standards (AAMI/ANSI/ISO 11737-1:2006, AAMI/ANSI/ISO 11737-2:2009, AAMI/ANSI/ISO 11607-1, AAMI/ANSI/ISO 11137-1:2006/(R) 2010, AAMI/ANSI/ISO 11137-2:2006, AAMI/ANSI/ISO 10993-1:2009, AAMI/ANSI/ISO 10993-5:2009, AAMI/ANSI/ISO 10993-10:2010, AAMI/ANSI/ISO 10993-18:2005) | The Closed Tube Clip (patient contact, sterile) tested to comply with all specified standards |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "cadaveric test," "saw bones and computer simulation" for accuracy testing, and "cadaveric test with simulated use case scenarios" for usability.
- Sample Size: The exact number of cadavers or saw bones used is not specified. The number of computer simulations is also not specified.
- Data Provenance: The data is described as non-clinical performance tests using simulated use scenarios. The country of origin of the data is not explicitly stated, but the submitter is based in Germany. The tests were retrospective in the sense that they were conducted for the purpose of the 510(k) submission, not as a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. For usability, it notes "simulated use case scenarios" and compliance with usability standards, implying evaluation by users, but specific details about these users (e.g., surgeons, clinic staff) and their role in establishing ground truth are not provided. For accuracy, the "actual implant position" would serve as the ground truth, but how this "actual" position was precisely measured and verified by experts is not detailed.
4. Adjudication Method for the Test Set
The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was done. The document explicitly states: "No clinical tests have been conducted."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The accuracy and usability tests described appear to be for the overall FluoroMap System, which is a "computer assisted surgical planning device to assist the surgeon." While the "Accuracy" testing would involve the algorithm's performance in localizing implants, the "Usability" testing inherently involves a human user's interaction with the system. Therefore, a purely standalone algorithm-only performance without any human interaction is not explicitly detailed as a separate study. The accuracy results likely reflect the system's ability to localize, but within the context of assisting a user.
7. Type of Ground Truth Used
- Accuracy: The ground truth for accuracy was the "actual implant position" in cadaveric tests, saw bones, and computer simulations. The method for determining this "actual" position is not elaborated beyond its use as a reference for deviation from the displayed position.
- Usability: Ground truth for usability would be derived from subjective assessments against specified user needs and compliance with usability standards during simulated use.
- Safety: Ground truth for safety is established through risk analysis and verification of mitigation measures.
- Standards Compliance: Compliance with recognized consensus standards serves as the ground truth for those categories.
8. Sample Size for the Training Set
The document does not specify a training set sample size. The performance tests described are for verification and validation of the device, not for training an AI model. Given the submission date (2011), the AI/machine learning paradigms prevalent today for deep learning models that require large training sets might not have been applied in the same way, or the "image processing" might be based on more traditional algorithms.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not mentioned, the method for establishing its ground truth is not provided.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).