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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 with 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 F3D Corpectomy devices are vertebral body replacement devices intended for use in the cervical (C2-T1) and thoracolumbar spine (T1-L5). When used in the cervical spine (C2-T1), F3D Corpectomy devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. When used in the thoracolumbar spine (T1-L5). F3D Corpectomy devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. 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 with bone marrow aspirate as an adjunct to fusion. These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The F3D 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D 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) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The F3D Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The F3D™ Lateral System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non- operative treatment prior to treatment with an intervertebral cage.

The CoreLink® M3™ Stand-Alone ALIF System is a standalone interbody fusion system indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The device may be used with supplemental fixation. Hyperlordotic implants (≥20° lordosis) are intended for use with supplemental fixation (e.g. posterior fixation) that are cleared for use in the lumbar spine. The system is indicated to be used with autograft bone. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The implants are intended to be used with the bone screws and lock provided. The system is designed to be a 3-screw implant, and all three (3) screws must be used. The accompanying lock must be used anytime the device is used with any number of screws. If the physician chooses to use less than the recommended number, or none of the provided screws, then the additional supplemental fixation in the lumbar spine must be used to augment fixation.

Foundation 3D cervical implants are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as disco genic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. Foundation 3D lumbar implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The Foundation™ 3D Interbody Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation™ 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Foundation™ 3D Interbody Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The CoreLink, F3D Interbody System is a collection of additively manufactured, machined implants and associated instruments for surgical site preparation and implantation to provide mechanical support to the cervical and lumbar 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- 6A1-4V (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 F3D Interbody System has open macroscopic 3D pores with a microscopic, roughened surface and nano scale features.

This is a 510(k) summary for the F3D Interbody System, which is a collection of spinal implants. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner one might find for a novel AI/software device.

Therefore, many of the requested points regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies (especially MRMC, standalone AI performance) are not applicable or not provided in this type of regulatory submission for a physical medical device.

However, I can extract information related to the device's performance evaluation as described.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" for a study in the sense of predefined thresholds for clinical performance. Instead, it describes performance testing conducted to characterize the material and its biological interactions, with the implicit acceptance criterion being that the device performs at least as well as or better than the predicate devices for comparable properties, and demonstrates favorable osteoblast functions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in terms of number of human subjects or distinct physical devices for each test. The performance data section describes types of tests performed (e.g., Scanning Electron Microscopy, Osteoblast Adhesion and Proliferation) but does not provide details on the number of samples or replicates for these tests. This is typical for pre-market submissions focusing on material characterization and in vitro biological response rather than clinical trials.
• Data Provenance: Not specified. It's an in vitro and material characterization study, so concepts like "country of origin" or "retrospective/prospective" in a clinical sense are not directly applicable.

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. This is not a study involving expert review of medical images or clinical data to establish a ground truth. The "ground truth" for the material characterization and in vitro biological studies would be the results obtained from the analytical techniques themselves (e.g., SEM images, quantitative assays for collagen, ALP, calcium).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no expert adjudication process for this type of performance data.

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 describes a physical medical device (spinal implants) and material science/biological response testing, not an AI/software device that would involve human readers or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the reported performance data is derived from direct measurements and analytical results from laboratory studies quantifying material characteristics and cellular responses. Examples include:

• Microscopic imagery (SEM, AFM) for nano-scale features.
• Spectroscopic analysis (EDS) for chemical composition.
• Quantitative assays for osteoblast adhesion, proliferation, collagen content, alkaline phosphatase activity, and extracellular calcium deposition.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The studies are for characterizing the material and its biological interactions.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

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