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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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MyKnee® PPS-Pin Positioners are intended to be used as anatomical pin positioners specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding of bone before cutting. MyKnee® PPS-Pin Positioners are intended for use with the GMK Total Knee System and its cleared indications for use. MyKnee® PPS-Pin Positioners are intended for single use only.

The MyKnee® PPS-Pin Positioners are single use femoral and tibial pin positioning patientspecific blocks. The MyKnee® PPS-Pin Positioners are designed and manufactured from patient MRI imaging data so the positioners match the patient's anatomy. The MyKnee® PPS-Pin Positioners are used with Medacta International SA's existing GMK Total Knee System. GMK Primary, GMK Sphere and GMK-Primary Narrow. The pin positioners are developed only for placement of the standard metal instruments (distal/tibial cut guide and 4-in-1 femoral cut guide) following the positions planned by the surgeon.

The MRI images are provided by the hospitals to Medacta International SA prepared according to a specific protocol for an individual patient. Medacta International SA uses these images in combination with Mimics (Materialise) and Solidworks (Dassault Systemes) to import DICOM images from a patient's MRI scans and these scans are then processed into accurate 3D models.

The MyKnee® PPS-Pin Positioners are manufactured from medical grade nylon for sintering which is identical to the predicate devices. MyKnee® PPS-Pin Positioners blocks are available in sizes 1-7 for the femur and sizes 1-6 for the tibia. The pin positioners will be provided in both non-sterile and sterile versions.

Here's a breakdown of the acceptance criteria and the study information for the MyKnee® PPS-Pin Positioners, based on the provided document:

This device is not an AI/ML device, therefore, please note that some of the requested information, such as sample size for the test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, and training set details, are not applicable or not explicitly detailed in the context of a traditional medical device submission for a physical pin positioner. The provided document focuses on demonstrating substantial equivalence to a predicate device through non-clinical studies.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the document as this is not an AI/ML device that would typically have a separate "test set" in that context. The "test" here refers to non-clinical evaluations of physical device properties.
• Data Provenance: The studies were non-clinical, involving design comparisons, breakage evaluations, manufacturing process evaluations, functional/fitting evaluations, and sterilization impact studies of the physical device. This data would be generated in a lab or workshop setting by Medacta International SA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided. The "ground truth" for a physical device like a pin positioner is its physical properties and functionality, which are assessed through engineering and performance testing, not by expert interpretation of data in the same way as an AI/ML diagnostic device.

4. Adjudication Method for the Test Set

Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in interpreting medical images or clinical data, which is not relevant for the testing of this physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states "no clinical studies were conducted." MRMC studies are generally used to evaluate the diagnostic performance of AI/ML systems with or without human-in-the-loop.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The MyKnee® PPS-Pin Positioners are physical, patient-specific surgical guides, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this device.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on engineering and performance specifications, design requirements, and established material properties. This is verified through:

• Measurement against design specifications (dimensional/geometrical comparison).
• Physical testing for durability (breakage evaluation).
• Assessment of manufacturing consistency (manufacturing process evaluation).
• Evaluation of intended function (functional and fitting evaluation), likely in cadaver workshops.
• Compliance with biocompatibility standards (by demonstrating equivalence to predicate materials).
• Compliance with sterilization requirements.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI/ML device, there is no training set or ground truth established for training.

Summary of the Study Proving Acceptance Criteria:

The document describes a series of non-clinical studies to demonstrate substantial equivalence of the MyKnee® PPS-Pin Positioners to the predicate device (MyKnee® Cutting Blocks, K093806). These studies focused on:

• Design Comparison (Dimensional/Geometrical): This compared the subject device to the predicate, noting the key difference as the removal of integrated cut slots. The evaluation concluded this difference did not raise new safety or effectiveness concerns.
• Breakage Evaluation: Assessed the structural integrity and durability of the device.
• Manufacturing Process Evaluation: Verified the consistency and control of the manufacturing process.
• Functional and Fitting Evaluation: Conducted according to written protocols, likely in cadaver workshops, to ensure the pin positioners function as intended in guiding surgical instruments.
• Biocompatibility: Noted that the material (medical grade nylon for sintering) and manufacturing process are identical to the predicate device, for which biocompatibility testing (to ISO 10993-1, -5, -10 for short-term contact) had already been conducted and deemed sufficient.
• Sterilization Studies: Included a "sterilization dimensional and functional impact study" and a "gamma sterilization criticality assessment" to ensure the sterilization process does not compromise the device's integrity or function, and that both non-sterile and gamma-sterilized versions are acceptable.

The conclusion is that these non-clinical studies and comparisons support that the MyKnee® PPS-Pin Positioners are as safe and effective as the predicate devices, and the minor design differences do not raise any new questions of safety or effectiveness, thus proving substantial equivalence for device acceptance. No clinical studies were performed.

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