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The C-Thru™ Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used as a vertebral body replacement device, the C.Thru™ Spacers are indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The C-Thru™ Spacers are also indicated to reartial vertebral body replacement for the treatment of fractures of the thoracic and luced to purch The C-Thru™ Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged proiod,

When used as a cervical intervertebral fusion device, the C-Thru Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radia graphic studies. These patients should have had six months of non-operative treatment. The C-Thru Spacers are intended for use with supplemental fixation and autogenous bone graft to facilitate the fusion.

The C-Thru™ Anterior Spinal System consists of a spacer constructed of medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.

This document, K092336, is a 510(k) premarket notification for a medical device called the C-Thru™ Anterior Spinal System, a type of intervertebral fusion device. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device already on the market, rather than conducting new clinical studies to prove effectiveness or meet novel acceptance criteria.

Therefore, the provided text does not contain information regarding traditional acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or comparative effectiveness studies in the context of AI or advanced diagnostic devices.

The document focuses on establishing substantial equivalence based on:

• Technological characteristics: Material, design, and sizing being similar to predicate devices.
• Intended use and indications: Being the same as or similar to predicate devices.
• Mechanical testing: To demonstrate that the device is substantially equivalent for its intended use to other spacers on the market.

Based on the provided text, I cannot complete the requested tables and descriptions because the document does not present a study with acceptance criteria and reported device performance in the way a diagnostic AI device or a new therapeutic device with novel claims would.

Here's why and what information is available:

Regarding Acceptance Criteria and Device Performance:

• No explicit acceptance criteria for device performance are listed. The "acceptance criteria" for a 510(k) submission are typically related to demonstrating substantial equivalence, e.g., showing mechanical properties are comparable to predicates, and that the device doesn't raise new questions of safety or effectiveness.
• No "reported device performance" in terms of clinical outcomes, sensitivity, specificity, or other diagnostic metrics are provided. The document states that "Based upon the mechanical testing, C-Thru™ Anterior Spinal System is substantially equivalent for its intended use to other spacers currently on the market," but it does not provide specific performance metrics from this testing.

Regarding Sample Sizes, Experts, and Ground Truth:

• No information is provided for sample sizes of test or training sets, data provenance, number or qualifications of experts, adjudication methods, or types of ground truth for clinical performance evaluation. This information is typical for diagnostic or AI device studies, not for a 510(k) for a spinal implant based on substantial equivalence to existing technology.
• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This is a physical implant, not an AI diagnostic assistant.
• No standalone (algorithm only) performance study was done. This is not an algorithm.

In summary, the K092336 document is about a specific type of medical device (spinal implant) and its regulatory pathway (510(k) substantial equivalence), which does not involve the kind of performance studies you are asking about, often seen with AI/diagnostic devices.

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