(262 days)
The Santorini Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable vertebral bodies due to turnor or trauma (ie. fracture). The Santorini Spinal System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The Santorini device may be used with allograft or autograft.
For all the above indications the Santorini implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
The Santorini Corpectomy Cage System consists of a hollow tube structure manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.
The Santorini Corpectomy Cage System is a vertebral body replacement device. The provided text describes the regulatory clearance process for this device and its substantial equivalence to predicate devices, but it does not contain information about "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of device performance metrics like sensitivity, specificity, accuracy, or other statistical measures, nor does it describe AI/ML performance.
Instead, the document focuses on demonstrating substantial equivalence to already legally marketed devices through mechanical testing and comparison of design features, materials, and intended use.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance related to AI/ML, nor can I provide details on sample sizes for test/training sets, expert qualifications, or adjudication methods, as this information is not present in the provided text.
Here's what I can extract based on the information provided regarding the device's comparison to predicate devices:
Summary of Device Comparison and Testing (as per provided text):
The Santorini Corpectomy Cage System's "performance" is assessed through mechanical testing and comparison to predicate devices, rather than through a clinical study with acceptance criteria related to AI/ML performance or diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (in relation to predicate devices) | Reported Device Performance |
|---|---|
| Static compression performance equal to or better than predicate devices | Performed equally to or better than predicate systems |
| Static torsion performance equal to or better than predicate devices | Performed equally to or better than predicate systems |
| Dynamic compression performance equal to or better than predicate devices | Performed equally to or better than predicate systems |
| Dynamic torsion performance equal to or better than predicate devices | Performed equally to or better than predicate systems |
| Subsidence performance equal to or better than predicate devices | Performed equally to or better than predicate systems |
| Expulsion performance equal to or better than predicate devices | Performed equally to or better than predicate systems |
| Design features and sizing substantially the same as predicate systems | Found to be substantially the same as predicate systems |
| Materials (Medical Grade PEEK, Tantalum, Titanium) | Material choice is consistent with predicate devices and regulatory standards (ISO 10993-1 USP Class VI, ASTM F2026, ASTM F560, ASTM F1492, ASTM F67) |
| Intended Use | Substantially equivalent to predicate devices |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes mechanical testing and comparison to predicate devices, not a study involving a "test set" of data in the context of AI/ML or a clinical study with patient data. The "test set" refers to mechanical test samples of the device.
- Data Provenance: The data provenance relates to mechanical testing performed in accordance with ASTM standards (F2077 and F2267). No country of origin for specific "data" or retrospective/prospective nature is mentioned for this type of testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of mechanical testing usually refers to the physical properties and performance measured against established engineering standards (ASTM F2077 and F2267) rather than expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical or image-based studies where multiple readers interpret cases. This document focuses on direct mechanical performance comparison.
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. This document describes a medical device (corpectomy cage) for surgical implantation, not an AI/ML-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- For mechanical testing, the "ground truth" is defined by the established ASTM standards (F2077 and F2267) and the physical measurements obtained from testing the device and predicate devices.
8. The sample size for the training set:
- Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned.
§ 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.