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The Matrix HA PEEK Cervical Implant System is intended for spinal fusion procedures at multiple contiguous levels (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Matrix HA PEEK cervical implant system is intended to be used with a supplemental fixation system.

Additionally, the use of hyperlordotic devices (lordotic angle greater than 8°) are intended to be used exclusively with anterior supplemental fixation.

Matrix HA PEEK Cervical IBF devices are manufactured from Hydroxyapatite (HA) filled Polyetheretherketone (PEEK). The specific material is PEEK-OPTIMA HA Enhanced manufactured by Invibio. The Matrix HA Cervical IBF Devices superior and inferior surfaces have ridges designed to interface with the vertebral endplates to help resist rotation and migration. Tantalum (ASTM F560) or titanium (ASTM F136) rods are located at the extremes of the Matrix HA Cervical IBF Devices to allow for radiological confirmation of the device positioning. The anterior face of each interbody has a recessed horizontal slot encapsulating a 6/32 threaded thru hole which is to be used to interface with the inserter. Each device has a uniform wall thickness of 2.5mm.

Matrix HA PEEK Cervical IBF Devices are available in multiple configurations to coincide with the surgical approach and patient needs: parallel, 7° thru 20° lordotic angle and convex. The Matrix HA PEEK Cervical IBF Devices are open rectangular devices with curved lateral walls and rounded edges. The devices are open with cavities to facilitate bony ingrowth.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device called "MATRIX HA PEEK Cervical IBF System."

The document primarily covers:

• The FDA's decision of substantial equivalence for the device to a predicate device.
• Regulatory information and requirements for the manufacturer.
• Indications for Use of the device.
• A 510(k) summary, including:
  • Sponsor/Manufacturer details.
  • Device trade and common names, classification.
  • Predicate device.
  • Device description (material, design features).
  • Intended Use (reiterating the indications).
  • Technological Characteristics (stating they are identical to the cleared device).
  • Non-clinical Testing (referencing testing per ASTM F2077-18 for mechanical function and properties, and establishing substantial equivalence).
  • Conclusion of substantial equivalence.

There is no mention of an AI-powered device, acceptance criteria related to software performance, test set details, expert ground truth establishment, MRMC studies, or standalone algorithm performance. The testing mentioned (ASTM F2077-18) is for the mechanical properties of an intervertebral body fusion device, not for the performance of a diagnostic or therapeutic AI system.

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