Search Results

The Vu c POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c·POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of nonoperative treatment. The Vu c POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Theken Manta Ray or the Theken Tether systems.

The Vu c POD Intervertebral Body Fusion Device consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu c POD spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu c POD Intervertebral Body Fusion Device is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.

The provided text describes a medical device, the Vu c•POD Intervertebral Body Fusion Device, and its clearance process through the FDA's 510(k) pathway. This pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study to establish new performance criteria.

Therefore, the document does not contain details about acceptance criteria, clinical study designs, sample sizes for test or training sets, expert qualifications, or ground truth establishment in the way one would expect for a novel device undergoing a performance study against specific metrics. Instead, it relies on preclinical testing for substantial equivalence.

Here's an attempt to structure the information based on the request, reinterpreting "acceptance criteria" and "study" in the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Study Description (Preclinical Testing for Substantial Equivalence):

The "study" in this context refers to preclinical testing conducted to demonstrate substantial equivalence to previously cleared predicate devices, as required for a 510(k) submission.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable in the context of a clinical test set. The evaluation was based on preclinical mechanical testing and comparison of technological characteristics. The document does not specify the number of devices or samples used for the described preclinical tests (static axial compression, etc.).
• Data Provenance: The preclinical testing was likely performed in a laboratory setting, indicated by adherence to ASTM standards. The document does not specify the country of origin of this data or if it was retrospective or prospective, as these terms are typically used for clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a preclinical mechanical equivalency assessment, not a clinical study requiring expert assessment of patient data for ground truth. The "ground truth" was established by the specified ASTM standards which define acceptable mechanical performance parameters for intervertebral body fusion devices.

4. Adjudication method for the test set

Not applicable. No expert adjudication method (like 2+1, 3+1) was described as this was not a clinical or image-based diagnostic study. The assessment was based on whether the device's mechanical properties met established ASTM standards and were comparable to predicate devices.

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 device is an intervertebral body fusion device (an implant), not a diagnostic AI or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable. This device is a physical implant, not an algorithm or software.

7. The type of ground truth used

The "ground truth" (or basis for comparison) used was:

• Established ASTM Standards: Specifically, ASTM F2077 for static and dynamic mechanical properties, and ASTM F2267 for static subsidence.
• Technological Characteristics of Predicate Devices: The design, materials, function, and indications for use of the US Spine Phantom PLUS Cage System (K082801), Interbody Innovations Zeus Cervical Cage (K081614), LDR Spine MC+ (K080588), LDR Spine ROI-C Cervical Cage (K091088), Synthes Spine Zero-P Cervical Cage (K072981), and SpineArt Tryptik® Cervical Cage (K091873).

8. The sample size for the training set

Not applicable. The concept of a "training set" applies to machine learning algorithms, which is not relevant for this physical medical device.

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

Not applicable, for the same reason as above.

Ask a specific question about this device