(103 days)
Cadence and TraXis are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.
Cadence™ is a hollow device with texture on two opposing flat sides. The device is crafted from titanium alloy (ASTM F136) or PEEK OPTIMATM (polvaryletheretherketone, ASTM F2026) and is offered in a tapered style of various sizes.
TraXisTM is a hollow device with texture on two opposing flat sides. The device is crafted from titanium alloy (ASTM F136) or PEEK OPTIMATM (polyaryletheretherketone, ASTM F2026) and is offered in various lengths, widths and heights.
The provided text describes a 510(k) premarket notification for the Spinal Concepts, Inc. Cadence™ and TraXis™ vertebral body replacement devices. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo study with acceptance criteria and a detailed study report. Therefore, many of the requested elements (like specific numerical acceptance criteria, sample sizes for test/training sets, expert qualifications, and MRMC studies) are not present in this document.
However, I can extract the relevant information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Requirements | Mechanical testing demonstrated that Cadence™ and TraXis™ exhibit the functional requirements to support their use as vertebral body replacements under normal physiologic loads in the spine. |
| Material Equivalence | Crafted from titanium alloy (ASTM F136) or PEEK OPTIMATM (polyaryletheretherketone, ASTM F2026). Predicate device (titanium version of Cadence, K031914) was also titanium. |
| Design Equivalence | Hollow device with texture on two opposing flat sides. Offered in tapered style (Cadence) or various lengths, widths, and heights (TraXis). Similar to predicate device. |
| Intended Use Equivalence | Vertebral body replacement in thoracic and/or thoracolumbar spine (T3 - L5) due to tumor or trauma (fracture), to restore biomechanical integrity with bone graft. This matches the predicate device's intended use. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the document. The mechanical testing mentioned would have involved a sample size of devices, but this detail is not provided.
- Data Provenance: Not specified. The document states "Mechanical Testing," implying a laboratory study, but does not give details on the location or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable/Not mentioned. The "study" mentioned is "Mechanical Testing," which evaluates the physical characteristics of the device, not a diagnostic or prognostic performance requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. Mechanical testing typically involves objective measurements, not adjudication of interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The document describes mechanical testing of a medical device, not a study involving human readers and AI for clinical interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This is a physical medical device, not an algorithm. The "mechanical testing" could be considered a form of standalone performance evaluation for the device itself.
7. Type of Ground Truth Used
- For the mechanical testing, the "ground truth" would be the engineering specifications and biomechanical requirements for a vertebral body replacement device, against which the device's performance (e.g., strength, durability under load) is measured. It is not an expert consensus, pathology, or outcomes data in the clinical sense.
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.