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The VerteGlide Spinal Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome for the following subset of patients:

• · Patients who may require serial magnetic resonance imaging;
• · Patients with small stature:

· Patients with low body weight, compromised tissue coverage adjacent to spinal implants, or increased risk of implant associated wound healing adverse events;

• · Patients at risk for implant prominence following surgery;
• · Patients with hyperkykyphotic spinal deformities; OR.

· Patients at elevated risk of cardiac arrest/sudden death from anesthesia associated with additional spinal surgery.

The VerteGlide Spinal Growth Guidance System is intended to be removed after skeletal maturity.

The VerteGlide Navigation Compatible Instruments are intended to be used during the preparation and placement of the VerteGlide Spinal Growth Guidance System screws. The VerteGlide Navigation Compatible Instruments have the option to be used with or without Medtronic StealthStation® System. Use of VerteGlide Navigation Compatible Instruments with Medtronic StealthStation® System during spinal surgery can assist the surgeon in precisely locating anatomical structures in the VerteGlide Spinal Growth Guidance System procedures. The Medtronic StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The VerteGlide Spinal Growth Guidance System consists of longitudinal members (rods), anchors (screws), and interconnection components (cross connector and rod clamp) in a variety of sizes to accommodate differing anatomic requirements. The VerteGlide Spinal Growth Guidance System also include surgical instruments.

The VerteGlide Spinal Growth Guidance System offers a solution for early-onset scoliosis (EOS) patients with potential for additional spinal growth. Fusion screws are used at the apex of the curve to rigidly lock the rod in place, while sliding (non-fusion) screws are used above and below the apex to stabilize but allow for continued growth. A unique rod design is used to provide rigid fixation of the fusion screws and further promote sliding of the non-fusion screws. Fixation to the bone is provided using standard fusion and non-fusion pedicle screws. While the non-fusion pedicle screws are rigidly fixed to the bone, they also allow for sliding along the rod axis during normal growth without requiring separate rod lengthening procedures. The VerteGlide Spinal Growth Guidance System allows for deformity correction and minimizes repeat surgeries needed until skeletal maturity.

The components of the VerteGlide Spinal Growth Guidance System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.

The provided text describes the VerteGlide Spinal Growth Guidance System, a medical device. However, it does not detail a study that proves the device meets specific acceptance criteria in the manner requested (i.e., a clinical study with performance metrics like sensitivity, specificity, or accuracy in a diagnostic context).

The document is an FDA 510(k) clearance letter and a 510(k) Summary for a spinal growth guidance system. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria for a diagnostic or AI-driven system.

The "Performance Data" section primarily addresses biocompatibility, MR compatibility, and mechanical performance of the physical implant components. It states these aspects meet relevant ASTM and ISO standards, which serve as acceptance criteria for the hardware itself.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this type of device and submission.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. This was a physical device testing, not an algorithmic performance evaluation on a patient dataset. The "test set" would refer to the physical samples tested for mechanical strength, biocompatibility, etc., the details of which are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be derived from physical measurements and standard testing protocols, not expert clinical interpretation of data.

4. Adjudication method for the test set: Not applicable.

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: Not applicable. This device is a physical spinal implant, not an AI or diagnostic imaging tool. The VerteGlide Navigation Compatible Instruments can be used with a Medtronic StealthStation® System, which is a navigation system, but the submission does not describe an MRMC study comparing human performance with and without this navigation assistance, nor is it the primary focus of the VerteGlide system's clearance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device.

7. The type of ground truth used:
* Biocompatibility: Conformance to ISO 10993-1 standards (chemical/biological assays).
* MR Compatibility: Physical measurements according to ASTM standards for heating, displacement, torque, and artifact generation.
* Mechanical Performance: Physical measurements (e.g., force, displacement, wear) against specified limits and comparison to predicate device performance.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study type:
The study described is a benchtop (in vitro) and material-based performance evaluation to demonstrate that the physical components of the VerteGlide Spinal Growth Guidance System are safe and perform as intended, and are substantially equivalent to a predicate device. This includes:

• Biocompatibility testing: To ensure the materials are not harmful to the body.
• MR Compatibility testing: To determine if the device is safe for use in an MRI environment.
• Mechanical performance testing: To ensure the device components have adequate strength, durability, and functional characteristics (like sliding mechanism) under simulated physiological loads and conditions.

The conclusion states that the data supports the differences between the subject and predicate devices and that the VerteGlide Spinal Growth Guidance System is substantially equivalent. A Post Market Surveillance Study (522 Order) will be issued to address potential safety concerns related to wear debris, indicating that some long-term clinical data will be collected after market entry.

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