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The F3D-C2 Cervical Stand-Alone System is a Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels depending on the assembly. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D-C2 Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) depending on the assembly. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone marrow aspirate as an adjunct to fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment.

The F3D-C2 Cervical Stand-Alone System is an interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implants. When used with screws, the F3D-C2 Cervical Stand-Alone System is intended for use at one or two levels of the cervical spine (C2-T1) and requires no additional fixation. When used with one or more anchors, the F3D-C2 Cervical Stand-Alone System is intended for use at one level of the cervical spine (C2-T1) and requires additional supplemental fixation such as posterior cervical screw fixation.

The CoreLink F3D Cervical Stand-Alone Interbody Fusion System is a collection of additively manufactured and machined implants and associated instruments for surgical site preparation and implantation to provide mechanical support to the cervical spine while arthrodesis occurs. The subject cages are additively manufactured from Ti-6Al-4V per ASTM F3001. Integration consists of additive Ti-6Al-4V (ASTM F3001) anchors (also referred to as nails) or machined Ti-6A-4V (ASTM F136 and ISO 5832-3) screws. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a trapezoidal column to provide surgical stabilization of the spine. The inferior/superior aspects of the spacer incorporate a vertical cavity which can be packed with bone graft.

The provided text describes a medical device, the F3D-C2 Cervical Stand-Alone System, and its FDA 510(k) clearance. However, it does not include information about acceptance criteria, device performance in terms of metrics like sensitivity, specificity, or accuracy, or any study involving human readers or AI.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because such details are not present in the provided document.

The document discusses the regulatory clearance process for a spinal implant and focuses on:

• Device Description: What the F3D-C2 Cervical Stand-Alone System is made of and its components.
• Indications for Use: The medical conditions and patient population for which the device is intended.
• Technological Characteristics: How it compares to predicate devices.
• Non-Clinical Performance Data: A list of mechanical tests performed to demonstrate its safety and effectiveness compared to predicate devices. These tests are physical and mechanical, not related to AI or diagnostic accuracy.

The performance data mentioned are for mechanical tests such as static axial compression, dynamic axial compression, subsidence, and pullout, all referencing ASTM standards. These are physical properties of the implant, not performance metrics for a diagnostic or AI-driven medical device.

To directly answer your numbered points based only on the provided text, I would have to state that the information is not present for most of them:

1. A table of acceptance criteria and the reported device performance: Not provided. The text lists types of mechanical tests (e.g., Static axial compression per ASTM F2077) but does not provide specific acceptance criteria values or reported performance values for these tests.
2. Sample sized used for the test set and the data provenance: Not provided. The mechanical tests typically involve testing multiple units of the device but the sample size is not stated. Data provenance refers to the origin of clinical data, which is not applicable here as these are non-clinical mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are mechanical tests, not clinical studies involving expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 document is about a physical medical implant, not an AI or diagnostic device.
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 in the context you're asking. For mechanical tests, the "ground truth" would be the engineering specifications and established test methods, but not expert consensus or pathology in a clinical sense.
8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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