Search Results

The Curiteva Cervical Interbody Fusion is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2 - T1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Implants are intended to be used with autograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the cervical spine. Patients should receive at least six (6) weeks of non-operative treatment with the device.

The Curiteva Cervical Interbody Fusion System implants are available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally box-shaped with an open central chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Curiteva Cervical Interbody Fusion System implants are manufactured from PEEK (per ASTM F2026) with Tantalum markers (per ASTM F560), or Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The PEEK implants are available with or without a medical grade commercially pure titanium (CpTi) plasma coating (per ASTM F1580) on the superior and inferior surfaces.

The provided text describes a 510(k) premarket notification for the Curiteva Cervical Interbody Fusion System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving independent performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment cannot be found in the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

1. A table of acceptance criteria and the reported device performance:

• Cannot be provided directly. The document states that the device was "mechanically tested in the following test modes: static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, expulsion, and wear debris characterization per ASTM F1877." It then concludes that "the strength and performance... is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
• However, the specific acceptance criteria (e.g., minimum compression strength, maximum subsidence) and the reported numerical performance values for the Curiteva device or the predicate devices are not detailed in this document. It only states that the device met the requirements for substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable/Not mentioned. This was a non-clinical mechanical testing study, not a clinical study involving human patient data. Therefore, concepts like "test set," "data provenance," "country of origin," and "retrospective/prospective" do not apply. The "sample size" would refer to the number of devices tested, which is not specified but implicitly sufficient to meet ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. This was mechanical testing, not a study requiring expert clinical assessment or ground truth establishment in a medical imaging context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. An MRMC study is a clinical study typically used for diagnostic devices involving human interpretation of medical images, often with AI assistance. This document describes mechanical testing of an interbody fusion device, which is an implant, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This device is an implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not applicable. For mechanical testing, the "ground truth" is typically defined by the test standards (e.g., ASTM F2077, F2267, F1877) and the physical properties of the materials and device design. The results are quantitative measurements against these standards.

8. The sample size for the training set:

• Not applicable. This refers to a dataset for training machine learning models, which is irrelevant for this mechanical testing submission.

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

Summary of available information related to performance:

The device's performance was evaluated through non-clinical mechanical testing based on established ASTM standards:

• Test Modes:
  • Static and dynamic compression (per ASTM F2077)
  • Static and dynamic torsion (per ASTM F2077)
  • Subsidence (per ASTM F2267)
  • Expulsion
  • Wear debris characterization (per ASTM F1877)
• Conclusion: The results showed that the "strength and performance of the Curiteva Cervical Interbody Fusion System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The document focuses on establishing substantial equivalence, meaning the device performs as safely and effectively as a legally marketed predicate device, rather than defining novel acceptance criteria and demonstrating unique performance against them in a clinical study.

Ask a specific question about this device