Search Results

The Captiva Spine TirboLOX-C™ Cervical IBFD is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one-disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Captiva Spine TirboLOX-C™ Cervical IBFD is used to facilitate fusion in the cervical spine and is placed via an anterior approach at the C3 to C7 disc levels with autograft bone and/or allogenic bone graft composed of cancellous bone graft. Patients should have at least six weeks of non-operative to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

The Captiva Spine, Inc. TirboLOX-CTM Cervical IBFD is made from a titanium alloy and is created using 3D printing technologies. The implants are available in various footprints to accommodate a variety of patient anatomies and is provided sterile. The device has a window in the center of device to accept autogenous bone and/or allogenic bone graft. The implant is available in the following configurations: lordotic, anatomically correct and parallel

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the requested information about acceptance criteria, study data, ground truth, and AI performance metrics is not applicable here.

The document describes the Captiva Spine TirboLOX-C™ Cervical IBFD, an intervertebral body fusion device. It focuses on demonstrating the device's substantial equivalence to legally marketed predicate devices through a series of non-clinical mechanical tests.

Here's a breakdown of the relevant information present in the document:

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

The document does not provide a table with specific quantitative acceptance criteria alongside performance data. Instead, it states that "The results of this non-clinical testing show that the strength of the TirboLOX-C™ Cervical IBFD is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the device's performance in the listed tests met predetermined criteria acceptable for demonstrating equivalence to the predicate devices, but the exact numerical thresholds are not disclosed.

Device Performance (as reported):

• ASTM F2077-14: Static Axial Compression, Static Shear, Static Torsion, Dynamic Axial Compression, Dynamic Shear, Dynamic Torsion
• ASTM 2267-04: Static Subsidence
• ASTM F1978-12: Abrasion Resistance
• ASTM F1877-16: Wear Debris
• Additionally: Expulsion testing was performed.

The reported performance is qualitative: the device's strength is sufficient for its intended use and substantially equivalent to predicate devices. Specific quantitative results are not provided in this summary document.

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

This information is not provided because it's a mechanical device testing, not a clinical study on human data. The "sample" would refer to the number of devices tested, which is not specified. Data provenance like country of origin or retrospective/prospective is not relevant for this type of non-clinical, in-vitro testing.

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. Ground truth as typically defined for AI/medical imaging studies (e.g., expert consensus on diagnoses) is not relevant for mechanical device testing. The "ground truth" for these tests are the established standards and specifications of the ASTM methods.

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

Not applicable. Adjudication methods are used in clinical trials or expert reviews to resolve disagreements in interpretations, which is not part of mechanical testing.

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

Not applicable. This is a spinal implant, not an AI-powered diagnostic device. No human readers or AI assistance were involved in the testing described in this document.

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 consensus, pathology, outcomes data, etc.)

The "ground truth" for the mechanical performance tests are the established ASTM (American Society for Testing and Materials) standards and test methodologies. These standards define the parameters, procedures, and conditions for evaluating the mechanical properties of medical implants to ensure their safety and effectiveness. The goal is to show the device performs within acceptable limits mandated by these standards and comparably to predicate devices.

8. The sample size for the training set

Not applicable. There is no AI algorithm being described, so there is no training set.

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

Not applicable, as there is no training set.

Ask a specific question about this device