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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.

Missing Information from the Provided Document:

1. Sample size used for the test set and the data provenance: Not mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
3. Adjudication method: Not mentioned.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The document focuses on regulatory equivalence, not comparative effectiveness.
5. 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.
6. Type of ground truth used: Not mentioned.
7. Sample size for the training set: Not mentioned.
8. 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.

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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.

Ask a specific question about this device