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When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis).

When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis)

When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients L3 and below who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, receiving fusions using autogenous bone graft only, having the device fixed or attached to the lumbar and sacral spine, having the device removed after the development of a solid fusion mass. Screw fixation is limited to L3 and below.

Posterior pedicle systems are intended to provide immobilization and stabilization 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis).

The SCS Claris Spinal Lengthened Lateral Connectors are available in one size only and are used to connect the rods and screws of the SCS Claris Spinal System.

This is a 510(k) premarket notification for a medical device called the SCS Claris Lengthened Lateral Connector (AL06), which is part of the SCS Claris Spinal System. This document is a summary of the device's characteristics and its substantial equivalence to a previously cleared device. It does not contain information about a study proving the device meets acceptance criteria through performance metrics.

Here's why and what information is available:

• 510(k) Premarket Notification: This regulatory pathway is primarily about demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily proving efficacy or specific performance against a set of acceptance criteria through a clinical study or detailed performance testing. The focus is on showing that the new device is as safe and effective as a predicate device.
• Substantial Equivalence: The document explicitly states: "Documentation was provided which demonstrated the SCS Claris Lengthened Lateral Connector (AL06) to be substantially equivalent to the previously cleared SCS Extremity Connector (AL02). The substantial equivalence is based upon equivalence in indications/intended use, manufacturing methods, interconnection (attachment) mechanism, basic design and materials."

Therefore, the provided text does not contain the detailed study information you requested regarding acceptance criteria and device performance metrics. It focuses on the comparison to a predicate device.

To answer your specific points:

1. A table of acceptance criteria and the reported device performance: This information is not present. The submission relies on substantial equivalence to a predicate device, implying that the predicate's established safety and performance are sufficient.
2. Sample size used for the test set and the data provenance: Not applicable, as performance testing of this nature is not described in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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 spinal implant component, not an AI-powered diagnostic tool.
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.

In summary, the provided 510(k) document is not a performance study report but a regulatory submission based on substantial equivalence. It outlines the device, its intended use, materials, and claims substantial equivalence to another device based on design, materials, manufacturing, and intended use.

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