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The UniSpace® Stand-Alone C Cage is a standalone anterior cervical interbody fusion device indicated for skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The UniSpace® Stand-Alone C Cage implants are to be used with either autogenous bone graff and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. The Cages of the UniSpace® Stand-Alone C Cage must be used with the two internal fixation screws provided. The Cages with ≥ 20° lordosis must be used with an additional supplemental fixation system that has been cleared by the FDA for use in the cervical spine, in addition to the two integrated fixation screws provided.

This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The UniSpace® Stand-Alone C Cage is product for cervical spinal column stability. The implants of the UniSpace® Stand-Alone C Cage consist of the Cages manufactured through additive manufacturing (ASTM F3001) and the machined Variable screws and Locking plates (ASTM F136). The Locking plate consists of a Blocking plate and a Locking screw and is an additional device for the anti-backout of the Variable screw. This optional implant can help users who feel uncomfortable with the primary self-locking mechanism or when rescue screws are utilized. The Cages and Variable screws are provided in a variety of sizes to accommodate each patient's individual clinical case. The Cages are designed to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The Cages of the UniSpace® Stand-Alone C Cage are provided as a sterile pack. The UniSpace® Stand-Alone C Cage is implanted by using the instruments manufactured from stainless steel material that conform to ASTM F899.

The provided text describes the UniSpace® Stand-Alone C Cage, an intervertebral body fusion device. However, it does not contain information about acceptance criteria and device performance in the context of a clinical study or a study involving human readers and AI. The document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence to predicate devices, supported by bench testing.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
• Standalone (algorithm-only) performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

The provided text only details the mechanical (bench) testing performed for the device. Here's what can be extracted regarding the bench testing:

1. A table of acceptance criteria and the reported device performance

The document states: "The mechanical performance of UniSpace® Stand-Alone C Cage falls within the acceptance criteria which have been established from the predicate devices." and "The testing meets all acceptance criteria and verifies that performance of the UniSpace® Stand-Alone C Cage is substantially equivalent to the predicate devices and reference devices."

However, the specific numerical acceptance criteria or the reported device performance metrics (e.g., specific load values, displacement, cycles to failure) are not provided in the text. It only lists the types of tests performed.

The remaining points (2-9) are not applicable as the document describes a bench testing study for a physical medical device (intervertebral cage) and not a study involving AI, human readers, or a test/training set of data for diagnostic purposes.

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The Velofix™ SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Velofix™ SA Cervical Cage implants are to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and implanted via an open, anterior approach. The Velofix™ SA Cervical Cage must be used with the internal screw fixation provided by screws of the Velofix™ SA Cervical Cage. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The Velofix™ SA Cervical Cage consists of spacers, screws, locking plate and set screw. The spacers are available in various heights, width and have only 7° lordotic angle with an open architecture to accept packing of autograft or autogenous bone graft, while the medical grade titanium alloy screws have various diameters and length for fixing the spacers. The locking plate, made of radiolucent PEEK and titanium alloy, is to prevent screw loosening. The medical grade titanium alloy set screw is intended for fixation of the locking plate. The Velofix™ SA Cervical Cage has three types: 1) All PEEK Type, 2) Ti plate Type, 3) Ti plate-N type. The Velofix™ SA Cervical Cage is implanted as a single device via an anterior approach.

The provided text is a 510(k) premarket notification letter and summary for the Velofix™ SA Cervical Cage. It describes the device, its intended use, and its substantial equivalence to predicate devices, primarily based on mechanical performance testing.

However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of software or AI performance. The entire document focuses on the mechanical and material properties of an intervertebral fusion device.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance (for software/AI).
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone (algorithm only) performance.
7. Type of ground truth for software.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is for a medical device (an implantable cage), not a software or AI product. The "performance testing" mentioned refers to mechanical strength evaluation of the physical implant, not algorithmic performance.

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