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When used as a cervical intervertebral body fusion device, the Summit Spine Channel Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (e.g.anterior cervical plate)and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage

The Summit Spine Channel Cervical Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Summit Spine cervical interbody implant, which may be implanted as a single device via an anterior approach. The Summit Spine Channel Cervical Interbody Fusion System implant components are made of polyether ether ketone (Evonik Vistakeep) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

This is a 510(k) summary for the Summit Spine Channel Cervical Interbody Fusion System, a medical device. This document does not describe a study involving device performance metrics relevant to an AI/Software as a Medical Device (SaMD) product. Instead, it focuses on the substantial equivalence of a physical implantable device to a predicate device.

Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/SaMD product's performance cannot be extracted from this document. The document describes mechanical performance testing for the physical interbody fusion device, not the performance of a software algorithm.

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The Summit Spine Yellowstone Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Summit Spine Yellowstone Lumbar Interbody Fusion System." This type of document is for device clearance and not for AI/software-as-a-medical-device (SaMD) approval.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, and AI performance metrics cannot be found within this document. This document focuses on the regulatory aspects of a physical medical implant, not the performance of an AI algorithm.

Specifically, the document primarily:

• Identifies the device and its manufacturer.
• States the FDA's determination of substantial equivalence to a legally marketed predicate device.
• Outlines the indications for use of the device.
• References applicable regulations and responsibilities for the manufacturer.

To answer your specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The FDA clearance for this type of device typically relies on demonstrating substantial equivalence to a predicate device, which involves comparing design, materials, and intended use, rather than detailed performance metrics like those for AI.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable or not found in this document. This typically refers to clinical study data for AI or drug trials, not mechanical implants like this one.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable or not found.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not found.

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 physical implant, not an AI 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 (expert consensus, pathology, outcomes data, etc): Not applicable. The FDA's substantial equivalence determination for this type of device is based on comparing its characteristics to a predicate device, not on specific ground truth data as for AI.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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