(239 days)
The iPlan Hip Templating system is indicated for the preoperative planning of orthopedic treatments. It is specially developed for the preparation and display of anatomical patient data that has been acquired using xray, CT or MR equipment.
iPlan Hip Templating creates treatment plans in conjunction with 2D / 3D implant models are provided by a separate database. Both 2D and 3D planning are supported, depending on the anatomical information available.
The treatment plan can either be saved or printed as required.
iPlan Hip Templating is a stand-alone system for preoperative orthopedic treatment planning which facilitates digital template planning for anatomical images. Once image scaling has been completed, using an object of known size that is positioned next to the anatomical area of interest during image acquisition, the surgeons can use a range of measurement tools in order to select the optimum implant for the patient. The software overlays 2D / 3D implant models onto the image data and displays the result. The measurement tools can also be used to display preplanned and current values where required.
The digital implant models are provided by a separate implant database. Both 2D implant contours and 3D implant models are available.
Treatment plans can be saved and printed out as required. The information stored in the treatment plan can be loaded to other BrainLAB applications and used to support image guided surgery in a VectorVision system, for example.
Here's an analysis of the provided text regarding the iPlan® Hip Templating device, focusing on acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria (e.g., target accuracy percentages, precision thresholds) or detailed reported device performance in a quantitative manner.
Instead, the document makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and effectiveness of the system | "The validation proves the safety and effectiveness of the system." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide any specific information regarding:
- The sample size used for any test set.
- The country of origin of the data.
- Whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding:
- The number of experts used to establish ground truth.
- The qualifications of those experts.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method used for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, no effect size of human improvement with AI vs. without AI assistance can be determined from this text.
6. Standalone (Algorithm Only) Performance Study
The document mentions that "iPlan Hip Templating is a stand-alone system for preoperative orthopedic treatment planning," implying its intended use as an algorithm-only tool for planning. However, it does not describe a specific standalone performance study in terms of metrics. The phrase "The validation proves the safety and effectiveness of the system" is a general statement about the system as a whole, not a detailed report of standalone algorithmic performance.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any validation or testing.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information regarding how the ground truth for the training set was established.
Summary of Findings:
The provided document (K042543 510(k) Summary) is a high-level regulatory submission focusing on demonstrating substantial equivalence to a predicate device (iPlan!®2 K020631). It asserts that the validation process (per BrainLAB's procedures) proves the safety and effectiveness of the system. However, it lacks the detailed technical information and study results typically found in reports specifically designed to describe acceptance criteria and evidence of meeting them. This type of information is often contained in the full 510(k) submission, which is not fully provided here. The summary focuses on the intended use, device description, and the FDA's concurrence with substantial equivalence rather than granular performance metrics and study details.
§ 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).