Search Results

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.

Ask a specific question about this device

The PEEK-OPTIMA® ALIF Spacer is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The PEEK-OPTIMA® ALIF Spacer is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The PEEK-OPTIMA® ALIF Spacer is a contoured device constructed of Polyetheretherketone (PEEK) medical grade, for spinal applications, inserted into the intervertebral body space of the lumbosacral spine for intervertebral body fusion.

This 510(k) summary describes a medical device, the PEEK-OPTIMA® ALIF Spacer, which is an intervertebral body fusion device. The document focuses on establishing substantial equivalence to previously cleared predicate devices through a comparison of device characteristics and mechanical testing.

Crucially, this document does not describe acceptance criteria, performance data, or a study related to the device's diagnostic or predictive capabilities. Since this is an implantable surgical device, its approval is based on its material properties, design, indications for use aligning with established medical practices, and demonstrable substantial equivalence to already approved devices through mechanical testing. The information provided in the prompt is specific to diagnostic or AI-driven medical devices, which is not applicable here.

Therefore, I cannot populate the table or answer the questions as the provided document does not contain information about acceptance criteria, device performance metrics, sample sizes for testing sets, ground truth establishment, expert adjudication, or any form of clinical study comparing reader performance with or without AI assistance.

The document's purpose is to demonstrate that the PEEK-OPTIMA® ALIF Spacer is substantially equivalent to existing, legally marketed predicate devices based on:

• Intended Use: For intervertebral body fusion in the lumbar spine for patients with degenerative disc disease.
• Design: A contoured device for intervertebral body space.
• Materials: Constructed of PEEK (Polyetheretherketone) medical grade.
• Operational Principles: Functions as a spacer to facilitate fusion with autograft and supplemental fixation.
• Mechanical Testing: The document states that "Based upon the mechanical testing, the PEEK ALIF is substantially equivalent for its intended use to other spacers currently on the market." (Specific details of the mechanical testing, including acceptance criteria and results, are not provided in this summary but would have been part of the full 510(k) submission).

In summary, the provided text describes a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, primarily through material and design characteristics, and mechanical testing, rather than algorithmic performance evaluation.

Ask a specific question about this device

The Solitaire™ PEEK-Optima® Anterior Spinal System is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.

The Solitaire™ Peek-Optima® Anterior Spinal System consists of a spacer with tantalum radiographic markers and bone screws for intervertebral body fusion. The spacer is PEEK with titanium inserts for the bone screw interface. The Solitaire™ Bone screws will be available in different versions of the the the the the the the types.

I am sorry, but the provided text is a 510(k) summary for a spinal system (Solitaire™ PEEK-Optima Anterior Spinal System). It describes the device, its intended use, and its substantial equivalence to predicate devices based on mechanical testing. This document does not contain information about acceptance criteria or a study that evaluates device performance in the way typically expected for an AI/ML medical device submission (e.g., diagnostic accuracy, sensitivity, specificity, or reader studies).

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance studies because the information is not present in the provided text. The document focuses on regulatory equivalence for a physical medical implant, not on the performance metrics of a diagnostic or AI-powered device.

Ask a specific question about this device