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MyPAO patient-specific guides are devices intended to be used as anatomical guides are specifically designed based on the CT images of the patient (i.e., pelvis, proximal femur). The guides are intended to assist the surgeon in the positioning of the acetabular fragment during periacetabular osteotomies to treat patients who require to undergo periacetabular osteotomy. MyPAO guides are intended for single use only.

The MyPAO Guides enlarge Medacta's MyPAO realignment system, already including MyPAO Planning report, in order to provide the surgeons a further help in the realignment phase after a Periacetabular Osteotomy.

Specifically, the current submission aims at obtaining the clearance for the changes made to MyPAO Planning report and for the following new devices:

• Reposition PSI guides (Pre-op drill guide, Ilium and Acetabulum Rep Guides, Realignment Arc):
• Preoperative and postoperative bone models;
• Reusable instruments to be used with the guides.

MyPAO Guides are patient specific guides designed on the basis of the patient's preoperative CT scan and subsequent preoperative planning and they aim at replicating the desired correction before the final fixation of the acetabular fragment.

The MyPAO Guides as well as their bone models are single-use and they are provided non-sterile.

The 3D pre-operative planning based on the patient's CT scans is performed through MyPAO software that is the same software already used to generate MyPAO Planning Report. The only change made to the already cleared MyPAO Planning report (K200589) regards the addition of two parameters in the report, i.e. 3D femoral head coverage and acetabular anteversion.

The provided text describes the MyPAO Guides, a medical device intended to assist surgeons during periacetabular osteotomies. While the document mentions performance data and clinical studies, it focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance (510(k)), rather than establishing specific acceptance criteria for an AI/algorithm-driven device and proving its performance against those.

The MyPAO Guides are patient-specific anatomical guides based on CT images and preoperative planning, but the description does not indicate that the core "device" itself is an AI algorithm that makes diagnostic or treatment recommendations. The "MyPAO software" mentioned is for planning, and the guides themselves are physical devices.

Therefore, the information required to answer the prompt (acceptance criteria for an AI device, sample sizes for AI test sets, expert adjudication methods for AI ground truth, MRMC studies, standalone AI performance, etc.) is not present in the provided document, as it pertains to the clearance of physical surgical guides with software for planning.

However, I can extract the relevant performance data related to the clinical study cited for the MyPAO Guides, even though it's not structured as an AI acceptance criteria study.

Here's what can be extracted based on the provided text, interpreted in the context of the prompt's questions, acknowledging the limitations mentioned above:

Acceptance Criteria and Device Performance (for the clinical study performed related to MyPAO Guides, not an AI algorithm):

Details of the Clinical Study Related to MyPAO Guides:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: 10 patients.
   • Data Provenance: The study was a "single-arm study with a literature control." It was "conducted outside of the United States." The data is prospective, involving actual patient treatments.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The "ground truth" for this study was the post-operative correction results compared to the pre-operative planned correction. Measurements were done using "2D planar x-rays to measure the final lateral center edge and acetabular index."
   • The document states "10 patients were treated by three surgeons using the MyPAO surgical planning software and guides." It doesn't specify if these 3 surgeons (or others) were involved in establishing the "ground truth" measurements from the x-rays, or their qualifications.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The document does not describe any specific adjudication method for the measurements.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. The clinical study was a single-arm study evaluating the MyPAO system (guides + planning software) against a literature control for conventional surgical technique accuracy. This is not designed to assess human reader improvement with AI assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • The "MyPAO Guides" are physical devices. The "MyPAO software" is for planning. The study evaluated the system (software + guides) in facilitating surgical outcomes. No standalone algorithm performance study (where an AI algorithm performs measurements or diagnoses without human input) is described. The device's primary function is as an anatomical guide for human surgeons.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth was based on a comparison of pre-operative planned correction versus post-operative correction results measured from 2D planar x-rays. This is a form of outcomes data directly related to the surgical correction achieved. The acceptance criteria themselves were based on literature for conventional surgical accuracy, implying that the "ground truth" for acceptable performance was derived from expert consensus in the broader medical literature.

7. The sample size for the training set:

   • The document describes a 510(k) submission for a physical medical device (MyPAO Guides) assisted by planning software. It is not an AI algorithm clearance with explicit training and test sets in the typical AI/ML sense. Therefore, no "training set" sample size for an AI model is provided or applicable as per the document's content.

8. How the ground truth for the training set was established:

   • As there's no explicitly defined "training set" for an AI algorithm in this context, this question is not applicable to the provided document. The planning software's underlying data or algorithms are not detailed in terms of their "training" in this regulatory submission.

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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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MySpine is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of pedicle screws in the vertebral body. MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Low Profile screw placement guides are intended for the placement of K-wires to assist in the positioning of pedicle screws. Use of the guides involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipments. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Screw placement guides are intended for single use only.

MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1. The device is provided with two options: Drill based and K-wire based. MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body. Use of the guides involves a surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipments. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine MC and Drill Pilot guides are intended for single use only.

MySpine S2-Alar/Alar-Iliac is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine S2-Alan/Alar-Iliac guides (referred to from this point on as, MySpine guides) are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the surgical equipment selected. MySpine guides are intended for single use only.

The MySpine Pedicle Screw Placement Guides are the same of the predicate devices cleared within K200792, K173472 and K153273. Based on the predicate, different screw placement guide configurations are object of this submission, specifically: MySpine Low Profile Guides: for K-wire guidance with conventional screw trajectory; MySpine Drill Pilot Guides: guidance for pedicle path preparation with conventional screw trajectory; MySpine MC/S1 Guides: Drill Pilot and K-wire guidance with cortical bone path; MySpine S2-Alar/Alar Iliac Guides: Drill Pilot guidance with cortical bone path. The MySpine Pedicle Screw Placement Guides are for use in spinal levels T1-S2/S2AI and ilium. The MySpine Pedicle Screw Placement Guides are a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of pedicle screws based on the patient's anatomy. The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent the template used to generate the corresponding MySpine Pedicle Screw Placement Guides fitting the patient's vertebral anatomy. The MySpine Pedicle Screw Placement Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version. The purpose of this submission is to obtain clearance of the MySpine Pedicle Screw Placement Guides for use with any compatible 510(k) cleared pedicle screw system.

The provided text focuses on regulatory approval (510(k) submission) for MySpine Pedicle Screw Placement Guides Extension and does not contain information about specific acceptance criteria, a study proving device performance against such criteria, sample sizes, expert qualifications, or comparative effectiveness with AI assistance.

The document states:

• "The subject devices are the same of the predicate devices (K200792, K173472 and K153273); therefore: no additional testing was required to support this 510(k)."
• "No clinical studies were conducted for the predicate (K200792, K173472 and K153273) nor for the subject devices."

Therefore, I cannot provide the requested information from the given text. The text explicitly mentions that no additional testing or clinical studies were conducted for this 510(k) submission as the devices are considered the same as previously cleared predicate devices, with only a change in indication for use.

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