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The ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, ARTiC-L™ 3D Ti Spinal System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous bone graft. When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.

The ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, ARTIC-XL™ 3D Ti Spinal System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous bone graft. When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.

The ARTIC-L™ and ARTIC-XL™ 3D Ti Spinal Systems with TiONIC™ Technology consist of additively manufactured (AM) titanium spacers of various widths, lengths, heights and lordotic angles and reusable instruments used for implantation and extraction of the subject implant. The instruments may be transported to the customer in cases, trays and lids which can also be used for sterilization. These implants are intended to be surgically placed between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion surgical procedures.

This document describes the regulatory submission for the Medtronic ARTiC-L™ 3D Ti Spinal System and ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology. The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance, biocompatibility, and MRI safety. The document doesn't present a table with explicit numerical acceptance criteria values alongside reported device performance. Instead, it states that the tests were performed "in accordance with" relevant ASTM standards and guidance documents, implying that the acceptance criteria are adherence to these established standards and comparable performance to predicates.

The reported device performance is presented as:

2. Sample Size and Data Provenance

The document does not specify exact sample sizes for the mechanical tests, biocompatibility tests, or design validation beyond referring to the standards by which they were conducted. For mechanical testing, the standards (e.g., ASTM F2077-14) would typically define minimum sample sizes.

The data provenance is not explicitly stated in terms of country of origin. The submission is made by Medtronic Sofamor Danek, USA Inc., and the FDA is a US regulatory body, suggesting the studies were likely conducted in the US or in adherence to US regulatory expectations. The studies described are pre-market design validation and verification activities, inherently prospective in their nature as they involve testing the medical device itself. They are not clinical studies on patient populations.

3. Number of Experts and Qualifications for Ground Truth

This submission does not involve AI or algorithms that require human expert assessment for "ground truth" in the typical sense of image interpretation or diagnostic accuracy. The "ground truth" here is established through bench testing against engineering standards and material properties, and validation through physical models (saw bones/cadavers). Therefore, the concept of "number of experts," their qualifications, or adjudication methods for establishing "ground truth" (as it relates to diagnostic accuracy) is not applicable to this type of device submission. Expertise would lie within the engineering and scientific teams conducting the tests and interpreting the physical and chemical properties.

4. Adjudication Method

Not applicable, as described above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a spinal implant device, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

6. Standalone (Algorithm only) Performance

Not applicable, as there is no standalone algorithm in this context. The device is a physical implant.

7. Type of Ground Truth Used

The ground truth used for this device is based on:

• Engineering standards and material specifications: For biocompatibility, mechanical strength, and MRI safety, adherence to established ASTM and ISO standards defines acceptable performance.
• Physical models/Cadaveric studies: For design validation, including proper fit, function, and surgical feasibility, using saw bones and cadaver models serves as functional ground truth in a pre-clinical setting.

8. Sample Size for Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set.

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