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SCARLET® AC-Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage. SCARLET® AC-Ti cages are intended to be used at one or two contiguous levels from C2-T1 to facilitate intervertebral body fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used with two bone screws, the SCARLET® AC-Ti Secured Anterior Cervical Cage is intended to be used as a standalone system and requires no additional supplementary fixation systems.

When used with two anchors or without two bone screws, the SCARLET® AC-Ti cages are to be used with supplemental fixation which has been cleared by the FDA for use in the cervical spine.

The SCARLET® AC-Ti hyperlordotic (12° lordosis) cages are to be used with bone screws and/or anchors and additional supplemental fixation system that has been cleared by the FDA for use in the cervical spine.

Spineart SCARLET® AC-Ti system is a Cervical Intervertebral Body Fusion device with integrated fixation intended to provide mechanical support and stabilization to the cervical spine and maintain adequate disc space until fusion occurs. The system comprises a range of intervertebral spacers implanted via an anterior approach, and having various sizes, heights, footprints, and lordosis to adapt individual pathology and different patients' anatomical conditions. The interbody device is a box-shaped spacer with a central cavity that can receive bone graft, which is intended to promote intervertebral fusion. It has a monolithic design and is crossed by two tunnels that guide the bone screws and/or the anchors insertion into the vertebral endplates. Moreover, SCARLET® AC-Ti comprises integrated fixation by the mean of bone screws and/or anchors that come in various diameters and lengths. The SCARLET® AC-Ti spacers are all made from medical grade titanium alloy conforming to ASTM F136 and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is polished and thread tapping is machined. The screws and anchors are made from Ti-6AI-4V ELI conforming to ASTM F136. The SCARLET® AC-Ti spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable – provided non-sterile). Bacterial endotoxin testing on final, finished devices as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

The provided text does not contain information about acceptance criteria or specific studies proving a device meets them. Instead, it is a 510(k) premarket notification summary for a medical device called SCARLET® AC-Ti, an intervertebral body fusion device.

The document discusses the device's indications for use, description, technological characteristics, and various types of non-clinical performance testing conducted to demonstrate substantial equivalence to previously cleared predicate devices.

Here's a breakdown of the information that is available in the text regarding testing:

• Mechanical testing:

  • Tests Conducted: Static and dynamic Axial Compression, Static and dynamic Shear-compression, Static and dynamic Torsion (according to ASTM F2077-22), and Subsidence (according to ASTM F2267-22).
  • Purpose: To demonstrate comparable mechanical properties to identified predicate devices.
  • Additional Measurements: Mass loss was measured on post-test run-out of SCARLET® AC-Ti worst-case specimens dynamically tested. Expulsion characterization was also conducted.

• MRI Safety Evaluation:

  • Guidance Used: FDA guidance “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment” (Issued October 2023).
  • Testing Completed:
    • ASTM F2052-2021: Measurement of Magnetically Induced Displacement Force
    • ASTM F2213-17: Measurement of Magnetically Induced Torque
    • ASTM F2119-07: Evaluation of MR Image Artifacts from Passive Implants
    • ASTM F2182-19e2: Measurement of Radio Frequency Induced Heating
    • ASTM F2503-23e1: "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment"
  • Conclusion: The device was determined to be MR conditional.

• Human cadaveric testing:

  • Activity: Cadaver lab trials were conducted. (No specific details about metrics or outcomes are provided in this summary).

Based on the provided text, the following information you requested is NOT available:

• A table of acceptance criteria and the reported device performance: The document states that "Results demonstrate comparable mechanical properties to the identified predicate devices," but it does not provide specific numerical acceptance criteria or performance values.
• Sample size used for the test set and the data provenance: No information on sample sizes (e.g., number of units tested for mechanical properties, number of cadavers) or data provenance (country, retrospective/prospective) is provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the studies described are non-clinical, mechanical, and safety evaluations, not expert-based diagnostic performance studies.
• Adjudication method for the test set: Not applicable for the types of tests described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This device is an implant, and the studies described are for physical and safety performance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an AI algorithm.
• The type of ground truth used: For mechanical testing, the "ground truth" would be established engineering standards (ASTM). For MRI safety, it's the physical interaction with MRI fields.
• The sample size for the training set: Not applicable, as there is no mention of a training set for an AI/algorithm.
• How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a physical medical implant and focuses on demonstrating its safety and performance based on engineering standards and comparison to existing devices, rather than clinical efficacy studies with specific acceptance criteria as you might see for a diagnostic device or a drug.

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