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When used for posterior pedicle screw or posterior non-pedicle fixation, the Innovasis Vector™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (DDD - defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture, dislocation, failed previous fusion (pseudoarthrosis), and/or tumor resection.

When used for posterior non-cervical screw fixation in pediatric patients, the Innovasis Vector Pedicle Screw System is indicated as an adjunct to freat adolescent idiopathic scoliosis (AIS). Additionally, the Innovasis Vector Pedicle Screw System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

The Vector" Pedicle Screw System is a thoracolumbar system composed of polyaxial pedicle screws, rods, hooks, rod connectors, locking caps, lateral connectors, and transverse cross links. The system is designed with multiple options to address complex, multi-level deformity cases and accommodate various patient anatomies. The Vector Pedicle Screw System is also designed to facilitate percutaneous screw and rod placement via Minimally Invasive Surgery (MIS). The cannulated pedicle screws and extended reduction tabs allow for rod placement and minimal tissue disruption. The system was designed to minimize the number and complexity of procedural steps. Implants are manufactured from Titanium (Ti-6Al-4V ELI) per ASTM F136 or Cobalt Crome (CoCr) per ASTM F562.

This is a 510(k) summary for the Vector™ Pedicle Screw System. The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance. It does NOT describe a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Therefore, most of the requested information cannot be extracted directly from this document.

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

Information that can be extracted:

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

   • Acceptance Criteria (Mechanical Performance): The document states that "All testing performed demonstrated substantially equivalent mechanical performance to legally marketed predicate devices." This implies the acceptance criteria were to be substantially equivalent to the predicates in the tested mechanical properties.
   • Reported Device Performance:
     • Static and Dynamic Compression Bending per ASTM F1717
     • Static Torsion per ASTM F1717
     • Static Axial and Torsional Grip per ASTM F1798
     • The performance for these tests was deemed "substantially equivalent" to predicate devices. Specific quantitative values are not provided in this summary.

2. Sample sized for the test set and the data provenance: Not applicable. This document refers to mechanical testing of components, not clinical data from a test set of patients. The provenance would be the test labs where the mechanical tests were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to clinical or diagnostic accuracy studies, which were not conducted or reported here.

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 pedicle screw system, not an AI diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For the mechanical tests, the ground truth was the established standards and performance of the predicate devices.

8. The sample size for the training set: Not applicable. This refers to mechanical testing, not a training set for an AI model.

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

Summary of what the document addresses vs. what it does not:

This FDA 510(k) summary is for a physical medical device (pedicle screw system), not an AI/software device. The "study" referenced is a series of non-clinical (mechanical) tests to establish substantial equivalence with predicate devices, as opposed to a clinical study demonstrating diagnostic accuracy or clinical effectiveness in patients.

Therefore, the detailed questions about ground truth, expert adjudication, test set/training set sizes, and MRMC studies related to human reader performance with or without AI are not applicable to this document. The document explicitly states: "N/A - no clinical data were necessary."

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