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MySpine MC and Drill Pilot

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 Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guides 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

· 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.

The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical placement of the implants based upon the radiological images of the patients' anatomical landmarks and the selected surgical equipment. 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. Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared pedicle screw system intended to be used.

MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides

MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides are intended to be used with any 510(k) cleared, legally marketed, pedicle screw system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. The SI trajectory of the MySpine Anchor guide is only intended to be used with M.U.S.T. SI Headless Screw System and its cleared indications for use.

MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides (hereinafter referred to as "MySpine guides") are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intraoperatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical placement of the implants based upon the radiological images of the patients' anatomical landmarks and the selected surgical equipment. The MySpine guides are intended for single use only. Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared posterior fixation screw system intended to be used.

MySpine Unilateral Guides are a line extension to Medacta's MySpine pedicle and sacro-iliac screw placement guides. Identically to the other Medacta MySpine products, the subject guides are single use, patient matched, pedicle targeted technology involving the production of patient specific guides for placement of pedicle and sacro-iliac screws based on patient's anatomy. Specifically, the subject MySpine Unilateral Guides have been designed starting from the correspondent bilateral guides which have been modified to allow the drilling of only the left or the right side of vertebra/sacrum through the left or right tube.

Identically to the predicate devices, MySpine Unilateral Guides are manufactured from medical grade nylon for sintering and they can be provided in both non-sterile and sterile version.

This document describes the MySpine Unilateral Guides, a line extension of previously cleared Medacta MySpine pedicle and sacro-iliac screw placement guides. The device is intended to assist in the placement of pedicle screws in the thoracic, lumbar, and sacral spine for fusion procedures.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the typical format of a clinical study. Instead, it describes a "design validation workshop" and a "MySpine Unilateral Guides optional design features rationale" as evidence of performance.

Based on the information, the implicit acceptance criteria are related to the device's ability to maintain existing performance standards despite the design modification (unilateral guides).

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

The document does not provide a specific sample size for a "test set" in the context of a formal clinical or analytical study with defined cohorts. The performance data section primarily refers to:

• "Design validation workshop": The sample size for this workshop (e.g., number of guides tested, number of simulated cases) is not specified.
• "MySpine Unilateral Guides optional design features rationale": This appears to be a theoretical analysis or internal testing, and no sample size is mentioned.

The data provenance is retrospective/internal testing as it refers to a design validation workshop and rationale, not a prospective study on patient data. No country of origin for specific test data is mentioned, but the submitter is Medacta International SA (Switzerland), with the correspondent in the USA.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in the "design validation workshop." The context suggests that the "experts" would likely be engineers, surgeons, or other professionals involved in the device's design and testing.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the "test set" (design validation workshop).

5. 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The device is a physical surgical guide, not an AI or imaging diagnostic tool that would typically involve human readers interpreting results with and without AI assistance. The document explicitly states: "No clinical studies were conducted."

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

This question is not applicable. The MySpine Unilateral Guides are physical surgical guides, not an algorithm or AI system. Therefore, a standalone algorithm performance study was not conducted.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the design validation appears to be based on:

• Engineering specifications/design requirements: Ensuring the guides perform as intended (e.g., maintain accuracy, stability, and guidance parameters).
• Comparison to predicate device performance: The claim of substantial equivalence relies on demonstrating that the new design does not introduce new safety or effectiveness issues compared to already cleared predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. The MySpine Unilateral Guides are physical surgical guides and do not involve a "training set" in the context of machine learning or AI.

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

This question is not applicable as there is no "training set" for this device.

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