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COALITION® Spacers (including COALITION AGX™ and COALITION MIS™) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of nonoperative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION® Spacer is a stand-alone interbody fusion device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant.

The COALITION MIS™ Spacer is an interbody fusion device and is to be used with two titanium alloy screws or anchors which accompany the implants. When used with screws, COALITION MIS™ Spacers are stand-alone interbody fusion devices intended for use at one or two levels of the cervical spine (C2-T1). When used with anchors, COALITION MIS™ Spacers are intended for use at one level of the cervical spine (C2-T1) with additional supplemental fixation such as posterior cervical screw fixation.

The COALITION AGX™ Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When used with the COALITION AGX™ Plate, the plate-spacer assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGX™ Plate acting as the supplemental fixation. The COALITION AGX™ Plate and Spacer assembly is a stand-alone device intended for use at one level of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant.

The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

COALITION® Spacers, COALITION AGX™ Spacers, and COALITION MIS™ Spacers are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. These spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. The COALITION AGX™ Plate is an anterior cervical fixation device that is available in various lengths and widths to fit the anatomical needs of a wide variety of patients. Screws are inserted through the anterior titanium portion of the implants into adjacent vertebral bodies for bony fixation. The COALITION MIS™ Spacer may also be used with anchors inserted through the anterior titanium portion of the implant into adjacent vertebral bodies.

COALITION® and COALITION MIS™ Spacers are manufactured from radiolucent PEEK polymer and titanium alloy, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. COALITION AGX™ Spacers are manufactured from radiolucent PEEK polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026. F136. F1295, and F560. COALITION AGX Plates are made from titanium alloy, as specified in ASTM F136, F1295, and F1472. The COALITION MIS™ Spacer is additionally available in an all-titanium alloy version. The screws and anchors are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

I am sorry, but the provided text describes a medical device (COALITION® Spacers, an interbody fusion device) and its indications for use, along with the regulatory review and basis for substantial equivalence to other devices. This document is an FDA 510(k) clearance letter and summary.

The request asks for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts for ground truth, adjudication method, and MRMC study details for a test set.
3. Standalone algorithm performance.
4. Type of ground truth.
5. Sample size for the training set and how ground truth was established for it.

This document does not contain information about an AI/ML algorithm or a study involving such a device. It describes a physical medical implant (intervertebral body fusion device) and mentions mechanical testing and a cadaveric implantation study to demonstrate substantial equivalence to predicate devices, but not an AI/ML study with acceptance criteria, ground truth, or training/test sets as would be relevant for an AI/ML device.

Therefore, I cannot fulfill the request as the necessary information regarding acceptance criteria, study details, ground truth for an AI device, or training/test set data is not present in the provided text.

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The COALITION® Spacer is a stand-alone interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of nonoperative treatment. The COALITION® Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.

The COALITION® Spacer is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.

The COALITION® Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

The provided text describes a 510(k) summary for the COALITION® Spacer, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing. It does not contain information about clinical studies with human participants, AI algorithms, or the evaluation of diagnostic performance against expert ground truth.

Therefore, many of the requested categories for AI/clinical performance studies cannot be addressed from the given text.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that these tests were conducted and that they demonstrated substantial equivalence, but it does not provide the specific numerical acceptance criteria or the quantitative results from these tests.

Regarding the study that proves the device meets acceptance criteria:

The study described is a mechanical performance study.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated. For mechanical testing of medical devices, sample sizes are typically determined by relevant ASTM standards, but the specific number of units tested for each criterion is not provided in this summary.
• Data Provenance: Not applicable in the context of human data. These are laboratory mechanical tests, not clinical data sets from patients or countries.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods, not expert human interpretation.

4. Adjudication method for the test set:

• Not applicable. This refers to consensus among human experts for clinical data, not mechanical testing results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This study is focused on the mechanical performance of a physical implant, not the diagnostic performance or AI assistance in interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This refers to AI algorithms, which are not mentioned in this device description. The device itself is a physical implant.

7. The type of ground truth used:

• For mechanical testing, the "ground truth" is defined by the specifications and acceptable ranges outlined in the relevant ASTM standards (F2077) and the FDA's "Class II Special Controls Guidance Document: Intervertebral Fusion Device."

8. The sample size for the training set:

• Not applicable for a physical medical device and mechanical testing. There is no "training set" in the context of algorithm development mentioned here.

9. How the ground truth for the training set was established:

• Not applicable. There is no training set for an AI algorithm mentioned.

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The COALITION™ Spacer is a stand-alone interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of nonoperative treatment. The COALITION™ Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.

The COALITION™ Spacer is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.

The COALITION™ Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

The provided text is a 510(k) summary for a medical device called the COALITION™ Spacer, an intervertebral body fusion device. This document describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training/ground truth details typically associated with AI/ML device evaluations.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval for a physical medical implant, not a software or AI/ML diagnostic tool.

Ask a specific question about this device