(145 days)
The MySpine WebPlanner software is designed to be used by a competent person who will generate a preoperative plan that may give relevant information to an authorized orthopedic or neurosurgeon before spinal posterior fixation surgery. The MySpine WebPlanner is a surgical preoperative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of Medacta's spinal fixation and fusion devices in skeletally mature and immature individuals. The MySpine WebPlanner software is designed to support the surgeon in producing a preoperative plan and making preliminary decisions on implant size and positioning. To properly use the MySpine WebPlanner, clinical judgment, and experience are required.
The MySpine WebPlanner is an interactive web application using the patient's radiological images and the related bone segmentations to allow the end-users to perform preoperative surgical planning. The data and the information displayed in WebPlanner web interface are computed and loaded by Medacta International's internal software named MyPlanner. The image format supported is DICOM. The end-user can access the MySpine WebPlanner at https://myspine.medacta.com/.
The purpose of the current submission is to obtain clearance to expand the indications for use of MySpine WebPlanner include surgical planning of fusion devices (i.e., cages).
The provided document is an FDA 510(k) clearance letter for the MySpine WebPlanner device. It does NOT contain information about acceptance criteria or supporting studies. The letter primarily focuses on:
- Substantial Equivalence Determination: The FDA has determined the MySpine WebPlanner is substantially equivalent to a legally marketed predicate device (MySpine WebPlanner & MyBalance, K211386). This means it has met the regulatory requirements for clearance, not necessarily that clinical performance metrics have been explicitly evaluated against numerical acceptance criteria in the provided document.
- Device Description and Indications for Use: It describes the device's function (preoperative surgical planning for spinal fixation and fusion devices) and its intended users.
- Comparison to Predicate Device: It highlights that the key difference between the subject device and the predicate is the expansion of indications to include planning for "fusion devices (i.e., cages)."
- Performance Data (Stated Existence): It merely states that "Software verification and validation studies are provided in support of a substantial equivalence determination." It does not actually provide details or results of these studies, nor does it list specific acceptance criteria or performance metrics.
Therefore, based solely on the provided text, I cannot answer most of your detailed questions regarding acceptance criteria and study specifics. The document confirms a substantial equivalence determination but lacks the granular technical and clinical study data you are requesting.
Here's what I can extract and state based on the provided text, and what is explicitly missing:
Acceptance Criteria and Device Performance
- Acceptance Criteria: Not explicitly stated in the provided document.
- Reported Device Performance: Not explicitly stated in the provided document with numerical metrics. The document only states that "Software verification and validation studies are provided in support of a substantial equivalence determination." This implies the device met internal performance requirements as part of the V&V, but the specific metrics are not published here.
| Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|
| Not explicitly stated | Not explicitly stated with numerical data. The device was found substantially equivalent to its predicate, implying its performance is comparable and acceptable for its intended use, but no specific metrics are published here. |
Missing Information from the Provided Document:
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The document focuses on regulatory equivalence, not comparative effectiveness.
- Standalone (algorithm only) performance: Not explicitly detailed with metrics. While the device is software, its performance in planning is stated to require clinical judgment and experience from the user.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence. It does not delve into the specific technical details of the performance studies (like acceptance criteria, sample sizes, ground truth establishment, or expert involvement) that would have been submitted to the FDA as part of the 510(k) application.
§ 892.2050 Medical image management and processing system.
(a)
Identification. 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.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).