(182 days)
When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudoarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (1.3 and below); and (4) who are having the device removed after the development of solid fusion mass.
When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORLA Spinal Clip System is indication and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chromic instabilities of the thoracic. lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).
System Components Include: Hooks Nuts Clips Rods Crosslinks Pedicle Screws Sacral Screws Unique Instrumentation
Materials: Certified implant grades of commercially pure titanium alloy and stainless steel are used to make the implants of the system.
The provided text describes the ORIA Spinal Clip System, a medical device for spinal fixation, and its substantial equivalence to other legally marketed devices. However, it does not contain information about acceptance criteria, a specific study proving device performance against such criteria, sample sizes for test/training sets, or details about ground truth establishment as typically found in AI/algorithm-based device submissions.
This document is a 510(k) premarket notification for a traditional medical device (a spinal implant). The evaluation for such devices primarily focuses on substantial equivalence to predicate devices, safety, and mechanical performance, rather than algorithm performance against specific diagnostic or prognostic outcome metrics.
Therefore, many of the requested details are not applicable or present in this specific submission. I will extract the relevant information that is available.
Here's a breakdown of what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicit from Testing) | Reported Device Performance |
|---|---|---|
| Material Standards | Compliance with material standards | Yes, certified implant grades of commercially pure titanium alloy and stainless steel used. |
| Mechanical Testing | Passing static and fatigue tests | - Static Tests: Compression bending, tension bending, and torsion of a typical system configuration indicated design performance was met. |
- Fatigue Tests: All samples fatigue tested according to a modified Cunningham model. Samples performed according to expectations.
- SN Curve: Established, with at least two run out points exceeding 5,000,000 load cycles at clinically useful loads. |
| Biocompatibility | Compliance with biocompatibility standard | Implied as a special control, but no specific test results are reported in this summary. |
| Labeling Requirements | Compliance with specific labeling | Yes, specific warnings and precautions outlined for pedicle screw systems. |
| Sterilization | Achieving a Sterility Assurance Level (SAL) of at least 10^-6 | Validated steam gravity cycle at 250°F (121°C) for 30 minutes. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this type of device submission. The "test set" here refers to physical components undergoing mechanical and material testing, not a dataset for an algorithm. The document doesn't specify the number of samples used for static and fatigue testing, nor the origin of these samples (implied to be manufactured by Eurosurgical, S.A. in France).
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 expert consensus, is related to evaluating diagnostic accuracy of an algorithm. This submission is for mechanical and material performance of an implant. The "ground truth" for mechanical testing would be the physical properties and performance metrics specified by engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used in consensus reading for image analysis or diagnostic decision-making.
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 pertains to the efficacy of AI/software in assisting human interpretation, which is not relevant to a spinal implant hardware submission.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's evaluation is primarily engineering specifications and recognized material/mechanical standards (e.g., ASTM, ISO). For sterilization, it's achieving a specified Sterility Assurance Level.
8. The sample size for the training set
- Not applicable. This submission does not involve an algorithm with a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an algorithm, this question doesn't apply.
§ 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.