(54 days)
The PEEK Tetris™ Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The PEEK Tetris™ Spinal Implant is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the PEEK Tetris™ Spinal Implant include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).
The PEEK Tetris™ Spinal Implant is a hollow, rectangular frame with lateral fenestrations. The upper and lower aspects of the implants are open and the walls feature spikes, which assist in the positive anchorage and seating of the implants between the superior and inferior vertebral bodies. The frame is forged from PEEK which is radiolucent and incorporates Titanium alloy marker pins so the device can be located within the body. The PEEK Tetris™ Spinal Implant is available in a variety of sizes and a wedge shaped option. This enables the surgeon to choose the size suited to the individual pathology and anatomical condition.
The provided text describes a 510(k) submission for the PEEK Tetris™ Spinal Implant and focuses on demonstrating its substantial equivalence to a predicate device, the Titanium Tetris™.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific numerical performance results. Instead, it relies on demonstrating comparable functional and performance characteristics to the predicate device through testing. The key acceptance criterion is that the PEEK Tetris™ must perform equivalently or superiorly to the Titanium Tetris™ regarding its intended use as a vertebral body replacement.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparable functional design | Demonstrated as comparable |
| Comparable performance characteristics | Demonstrated as comparable |
| Biocompatibility | Fulfilled by analogy to predicate devices using identical patient contact materials and processing |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Representative samples of the device underwent testing to demonstrate comparable functional and performance characteristics to the predicate device."
- Sample Size: "Representative samples" implies a test set was used, but the exact number of devices or experimental units is not specified.
- Data Provenance: The document does not specify the country of origin for the data. It's safe to assume the testing was conducted in a controlled lab environment. It is a prospective study in the sense that the testing was performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a physical medical implant, and its "performance" for regulatory purposes is evaluated through mechanical testing, material characterization, and comparison to a predicate device, not through expert assessment of clinical outcomes or images in a diagnostic context. Ground truth, in this context, would be established by direct physical measurements and material properties obtained from laboratory tests, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human observers (e.g., radiologists interpreting images) where conflicting interpretations need to be resolved. For mechanical testing of an implant, the results are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. An MRMC study is relevant for AI-powered diagnostic or decision-support systems that influence human interpretation. The PEEK Tetris™ is a surgical implant and does not involve AI assistance or human readers in its direct use or regulatory evaluation for this 510(k).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The PEEK Tetris™ is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for evaluating the PEEK Tetris™ (in comparison to the predicate) would be based on:
- Physical and Mechanical Testing: Direct measurements of properties like strength, stiffness, fatigue resistance, and geometric conformity.
- Material Characterization: Verification of the PEEK material composition and its properties.
- Biocompatibility Standards: Compliance with established biocompatibility standards, demonstrated by analogy to other legally marketed devices.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical implant. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as 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.