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The Mecta-C Stand Alone is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms for one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Mecta-C Stand Alone should be packed with autograft bone graft composed of cancellous, cortical and/or corticocancellous bone graft and implanted via an anterior approach.

The Mecta-C Stand Alone implants are the same of the predicate device, Mecta-C Stand Alone cleared within K192906. They are provided sterile in single-use packages, designed for long-term implantation inside the human body and intended to be used during cervical interbody fusion surgeries. The Mecta-C Stand Alone implants are composed of cages, plates, locking screws, lag screws and antibackout screws. The cages are to be inserted between two (2) cervical vertebral bodies to provide support and correction during cervical interbody fusion surgeries. They are made in PEEK uncoated or Titanium coated and they are available in various widths, heights, and lengths, with a fixed 7° of lordosis. The hollow geometry of the implants allows the cages to be packed with bone graft. The plates, designed with different shapes to promote a specific approach or to simplify the procedure in a specific area, are assembled in front of the cage and allow for mounting of a certain number of screws. The screws are placed through the plate and cage in order to fix the device to the vertebral bodies.

The provided text is a 510(k) summary for a medical device (Mecta-C Stand Alone Extension) and outlines its comparison to predicate devices, primarily focusing on materials, design, and mechanical testing. It explicitly states that no clinical studies were conducted for either the predicate device (K192906) or the subject device.

Therefore, the document does not contain information on the acceptance criteria for device performance in a clinical setting, nor does it describe a study involving human subjects or AI algorithms to prove the device meets such criteria.

The "Performance Data" section (VII) refers solely to mechanical and material testing as per ASTM and ISO standards for the predicate device, which are deemed applicable to the subject device because they are "the same." These tests evaluate aspects like static and dynamic compression, shear, torsion, subsidence, expulsion, plate removal, pull-out, insertion/removal torque, wear, imaging properties, and pyrogenicity.

Without explicit information on clinical acceptance criteria or studies from the provided document, I cannot fulfill the request to describe them.

To answer your specific points based only on the provided text, the following would be true or cannot be determined:

1. A table of acceptance criteria and the reported device performance: Not available. The document lists mechanical tests performed on the predicate, but not acceptance criteria for clinical performance or AI algorithm performance.
2. Sample sized used for the test set and the data provenance: Not applicable in the context of clinical/AI performance. The mechanical testing refers to "worst case device" but doesn't specify sample sizes for those tests or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human experts were involved in establishing ground truth for clinical AI performance, as no clinical studies were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set or human adjudication process is described.
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: No, explicitly states "No clinical studies were conducted." Therefore, no MRMC study with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, explicitly states "No clinical studies were conducted." The device is a physical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to clinical or AI performance. For the mechanical tests, the ground truth would be the physical properties and behavior of the device as measured against established standards.
8. The sample size for the training set: Not applicable. No AI algorithm training set is mentioned as no AI component is described.
9. How the ground truth for the training set was established: Not applicable. No AI algorithm training set is mentioned.

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