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The MySpine WebPlanner is a surgical pre-operative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of the spinal fixation devices. The MyBalance, a module of the MySpine WebPlanner, allows to perform generic as well as specific measurements of patient's sagittal alignment and to plan spinal surgical procedures ( osteotomies or Lordosis/ Kyphosis correction in spinal fusion surgeries). To properly use the MySpine WebPlanner, and the MyBalance module, clinical judgment and experience are required.

The subject device MySpine WebPlanner & MyBalance is an interactive web application using the patient's radiological images and the related bone segmentations to allow the end-users performing a pre-operative surgical planning. The data and the information displayed in the web interface named WebPlanner are computed and loaded by an internal software named MyPlanner. The MyBalance is an optional module of the MyPlanner, thus available on the WebPlanner interface, and it allows the surgeon to verify the actual patient sagittal alignment and to simulate a sagittal correction in order to determine balance condition after the planned correction. The image format supported is DICOM. The end-user with its credentials can access the MySpine WebPlanner at https://myspine.medacta.com/.

The provided text does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.

The document is a 510(k) summary, which is a regulatory submission to the FDA. It declares the device to be "substantially equivalent" to predicate devices and describes the general purpose and interaction of the system. While it mentions "software verification" and "software validation, including accuracy and repeatability test for MyBalance measurements" as non-clinical studies, it does not provide the specific metrics or results of these tests. It explicitly states: "No clinical studies were conducted."

Therefore, I cannot provide the requested information. The text does not elaborate on:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample sizes used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Explicitly stated "No clinical studies were conducted," so an MRMC study was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: While "accuracy and repeatability test for MyBalance measurements" are mentioned, the specific results or methodology (standalone vs. human-in-the-loop) are not described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document focuses on the regulatory aspects of substantial equivalence rather than detailed performance study results.

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