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When used as an intervertebral fusion device with bone graft, cervical:

Xenco Medical Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of non-operative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).

When used as an intervertebral fusion device w/ integrated fixation, cervical (interbody spacer w/ provided plate, bone screws, and locking cover):

Xenco Medical Cervical Interbody System constructs are stand-alone anterior cervical interbody fusion devices intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment with the device. Xenco Medical Cervical Interbody System constructs are to be packed with autogenous bone graft and implanted via an open, anterior approach. Xenco Medical Cervical Interbody System constructs are intended to be used with the plate, bone screws, and locking cover provided and require no additional fixation.

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I am sorry, but since the document you provided is a 510(k) premarket notification letter from the FDA, it outlines the regulatory approval for a medical device (Xenco Medical Cervical Interbody System), but it does not contain any information about acceptance criteria, device performance studies, sample sizes, or ground truth establishment for an AI or software device.

Therefore, I cannot provide the requested information based on the given text.

The document primarily focuses on:

• Confirming substantial equivalence to predicate devices.
• Outlining regulatory requirements for the manufacturer.
• Stating the intended use/indications for use of the cervical interbody system.

It does not discuss the kind of performance studies or validation details that would be found in a submission for an AI-powered diagnostic device, for instance.

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Xenco Medical Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of non-operative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).

Xenco Medical Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Gradel spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Xenco Medical device.

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This document is a 510(k) premarket notification decision letter from the FDA for the "Xenco Medical Cervical Interbody System" and "Xenco Medical Lumbar Interbody System." It confirms that the devices are substantially equivalent to legally marketed predicate devices and can be marketed.

However, the provided text does not contain any information regarding acceptance criteria, device performance, study data, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The document is a regulatory approval letter based on substantial equivalence, not a detailed report of a clinical or performance study.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other details about studies showing the device meets acceptance criteria, as this information is not present in the provided text. The FDA letter states that the review was based on the 510(k) submission, but the content of that submission, including performance data, is not included here.

Ask a specific question about this device

Xenco Medical Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of non-operative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the "Xenco Medical Cervical Interbody System (Argus™)". It discusses substantial equivalence, regulatory compliance, and indications for use.

However, this document does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Therefore, I cannot extract the information needed to answer your questions based on this text.

Ask a specific question about this device

Xenco Medical Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of non-operative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g., anterior plate system).

Not Found

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer for a cervical interbody system. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot generate the requested response.

Ask a specific question about this device