(34 days)
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in the T1-T3 in treating thoracic conditions only, Screws are not intended to be placed in the cervical spine.
The Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system, which consists of a variety of sizes of rods, hooks, screws, multi-axial screws and connecting components, which can be rigidly locked to the rod in a variety of configurations. The Minit System is fabricated from medical grade titanium or titanium alloy that complies with ASTM F136.
This 510(k) premarket notification for the Endius Minit Posterior Cervical and Upper Thoracic Fixation System does not describe an AI/ML device, nor does it present a study with acceptance criteria and device performance in the way requested. This document is for a medical device (spinal fixation system) and relies on demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical testing and comparison of design and materials, rather than clinical performance metrics in a study involving human data.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth cannot be extracted from the provided text.
Here's an attempt to answer the relevant parts, highlighting what is missing due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Test results demonstrate substantial equivalence to predicate devices | Documentation provided that the proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System components are substantially equivalent to: |
- Medtronic VERTEX Reconstruction System (K052180)
- Synthes Spine Cervifix (K991089, K001864)
- Starlock Systems |
Note: The specific numerical acceptance criteria (e.g., minimum load to failure, fatigue cycles) for the mechanical tests are not detailed in this summary. The stated performance is that the device meets the equivalence standard implied by these tests.
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. The submission focuses on mechanical testing of components, not human-patient-derived data.
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)
This information is not provided. The "ground truth" here is the substantial equivalence demonstrated through mechanical testing against predicate devices. This typically involves engineering and biomechanical expertise in the testing and analysis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device relies on mechanical testing for substantial equivalence, not retrospective human data requiring adjudication.
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 not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" used for proving substantial equivalence appears to be mechanical test data compared against performance of predicate devices. This type of device relies on engineering and biomechanical principles rather than clinical outcomes for its 510(k) clearance in this context.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.