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TRYPTIK2C-Plate® Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions

The TRYPTIK2 C-Plate Anterior Cervical Plate System consists of 1-level, 2-level, 3-level and 4-level plates with cancellous and cortical fixed-angle and variable-angle bone screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7) and functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine. The Plate configurations are ranging in total lengths from 20mm (1-level) to 92mm (4-level). The plate is 2.4mm thick and 16.5mm wide and incorporates integrated expansive rings for anti-back out of the bone screws that functions as a one-step locking mechanism. The Screw range comes in two diameters, Ø 4.0 and Ø 4.5, and length is ranging from 12mm to 22mm.
The TRYPTIK2C-Plate® Anterior Cervical Plates and screws are all made of Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136 with an expansive ring made of Nitinol conforming to ASTM F2063.
The TRYPTIK2 C-Plate Anterior Cervical Plates and screws are delivered sterile (gamma sterilization). The TRYPTIK2 C-Plate Anterior Cervical Plate System is supplied with all the surgical instruments required for its installation. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device

The provided text describes a 510(k) premarket notification for a medical device called the TRYPTIK2c-Plate® Anterior Cervical Plate System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance acceptance criteria through clinical or AI-based testing.

Therefore, the document does not contain the information required to answer the prompt regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment.

The document details:

• Device Name: TRYPTIK2c-Plate® Anterior Cervical Plate System
• Regulation Number: 21 CFR 888.3060
• Regulation Name: Spinal Intervertebral Body Fixation Orthosis
• Regulatory Class: Class II
• Product Code: KWQ
• Indications for Use: Temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by various conditions (degenerative disc disease, trauma, tumor, spondylolisthesis, deformity, pseudarthrosis, failed previous fusions).
• Device Description: Consists of 1-level, 2-level, 3-level, and 4-level plates with cancellous and cortical fixed-angle and variable-angle bone screws. Made of Titanium alloy Ti6Al4V ELI and Nitinol.
• Technological Characteristics Comparison: Claims substantial equivalence to predicate devices in function, material composition, design, range of sizes, and mechanical performance.
• Discussion of Testing: Mentions non-clinical tests:
  • Static push-out testing of the screw per an in-house protocol.
  • Corrosion Testing per ASTM F2129-17.
  • States that results show "very good behavior with regards to the pitting corrosion resistance" and that the device "meets or exceeds the performance of the predicate device."
• Conclusion: Based on design features, technological characteristics, feature comparisons, indications for use, and non-clinical performance testing, the device demonstrated substantial equivalence.

To reiterate, the provided text describes a 510(k) submission which relies on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, not on a clinical study or AI-based performance evaluation against specific, quantified acceptance criteria for a new clinical endpoint or AI output.

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