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The ARx® Spinal System implants are non-cervical spinal fixation devices intended for posterior spine (T1 to S2/ilium) and posterior hook fixation (T1-L5) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used as a posterior spine thoracic/lumbar system, the ARx® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (6) spinal stenosis, (7) spondylolisthesis.

In order to achieve additional levels of fixation in skeletally mature patients, the ARx® Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.

The ARx® Spinal System consists of screws and longitudinal rods intended to provide temporary stabilization and immobilization following surgery to fuse a portion of the thoracic, lumbar, and/or sacral spine. The ARX® Spinal System consists of an assortment of connectors, cross connectors, rods, hooks and screws. The bone screw, head, and taper lock are assembled together during manufacturing to create the ARX® Spinal System screw assembly component. The ARX® Spinal System implant components are made from titanium alloy (Ti- 6Al-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) as described by ASTM F1537. Do not use any of the ARX® Spinal System components with the components from any other system or manufacturer.

The provided text is a 510(k) summary for a medical device called the "ARx MIS Spinal Screw System." It does not contain information about studies related to software performance, AI algorithms, or diagnostic accuracy that would typically have acceptance criteria, test sets, expert adjudication, or MRMC studies.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Indications for Use: The ARx MIS Spinal Screw System has similar intended uses for posterior spinal fixation in various conditions.
• Design and Function: The device's design and how it works are comparable to the predicate devices.
• Materials: The device uses materials (titanium alloy (Ti-6Al-4V ELI) and cobalt chrome (Co-28Cr-6Mo)) that are either the same as or comparable to those used in predicate devices.
• Mechanical Performance: The document states that dimensional comparisons were performed to demonstrate substantial equivalency, implying mechanical testing was done to ensure the device performs similarly to the predicate.

Therefore, the requested information regarding acceptance criteria for device performance in the context of AI, diagnostic accuracy, or human reader improvement is not applicable to this document.

The "study" referenced is a comparison study to demonstrate substantial equivalency, not a clinical trial or performance study against specific acceptance criteria for a diagnostic or AI-driven device.

Here's a breakdown of why many of your questions cannot be answered by this document:

1. A table of acceptance criteria and the reported device performance: Not applicable. This is not a study assessing performance against specific clinical or computational metrics. The "performance data" mentioned refers to dimensional comparison, not diagnostic accuracy or AI performance.
2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of AI or diagnostic performance.
3. Number of experts used to establish the ground truth... and the qualifications: Not applicable. Ground truth for AI or diagnostic performance is not relevant here.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
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: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

This document is a regulatory submission demonstrating fundamental safety and effectiveness through substantial equivalence for a physical implantable device, not an AI or diagnostic software.

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