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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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TRYPTIK®Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous disc levels from C2 to T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. TRYPTIK®Ti cages are used to facilitate intervertebral body fusion in the cervical spine using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. TRYPTIK®Ti cages are to be used with supplemental fixation that has been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Spineart Tryptik® Ti spinal implants consist in a range of intervertebral body spacers with various shapes and designs so as to be implanted via an anterior cervical approach and to adapt different patient's conditions. The Tryptik® Ti spacers are all made from medical grade titanium alloy conforming to ASTM F136 standard and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished. The subject implants Tryptik® Ti will extend the previously cleared Tryptik® Ti range of implants (K200312) which presents similar design features and the same manufacturing technology, i.e. additive manufacturing (SLM), and join the previously cleared Tryptik® Ti range of implants (K200312) which addresses the same indications and utilize the same instrumentation designed purposely. The Tryptik® Ti spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable – provided non-sterile).

This is a 510(k) premarket notification for a medical device called Tryptik® Ti, an intervertebral body fusion device. The document states that "No additional testing has been performed for the Spineart Tryptik® Ti line extension spinal implants." and relies on an "engineering rationale" to support substantial equivalence to a previously cleared version of the same device and other predicate devices.

Therefore, the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It explicitly states that no additional testing was performed for this particular submission.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

1. Technological characteristics: The device uses the same manufacturing technology (additive manufacturing - SLM) and material (medical grade titanium alloy conforming to ASTM F136 and ASTM F3001) as the primary predicate device.
2. Design features: The device presents similar design features and range of devices, and is designed for the same anterior approach as the previously cleared Tryptik® Ti spinal implants.
3. Indications for use: The indications for use are identical to the predicate device.

The document also mentions that non-clinical tests (Static axial compression, Static shear compression, Static torsion according to ASTM F2077 and subsidence testing according to ASTM F2267) were conducted on the predicate devices, not this current submission.

**Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established**

as this information is not present in the provided text. The submission relies on prior testing of predicate devices and an engineering rationale for substantial equivalence.

Ask a specific question about this device