(28 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) pseudarthrosis, (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 (L3 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 ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).
The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.
The provided text is a 510(k) summary for the ORIA Spinal Clip System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with specific acceptance criteria and outcome metrics. Therefore, many of the requested details about acceptance criteria, specific performance metrics, and study methodologies common in AI/Diagnostic device approvals are not present in this document.
However, I can extract the information that is available and explain why other details are missing.
Here's the analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in Indications/Intended Use | Demonstrated equivalence for the ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & CO07) to the previously cleared OmniAxial Connector (CO04). |
| Equivalence in Manufacturing Methods | Demonstrated equivalence |
| Equivalence in Interconnection (Attachment) Mechanism | Demonstrated equivalence |
| Equivalence in Basic Design | Demonstrated equivalence |
| Equivalence in Materials | Demonstrated equivalence (Titanium alloy ASTM F136-98). |
Explanation of Table Details: The "acceptance criteria" here are implied by the 510(k) process for substantial equivalence. For a 510(k) submission, the primary "acceptance criterion" is that the new device is "substantially equivalent" to a legally marketed predicate device. This is evaluated across various aspects like intended use, technology, materials, and safety/effectiveness. The document states that "Documentation was provided which demonstrated the ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & CO07) to be substantially equivalent..." based on these factors. No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical stress test results with defined pass/fail thresholds) are explicitly stated in this summary as "acceptance criteria."
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/Not mentioned. This document describes a 510(k) for a spinal implant system, not a diagnostic or AI device that typically uses a "test set" of patient data for performance evaluation. The "study" here is a substantial equivalence comparison to a predicate device.
- Data Provenance: Not applicable/Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not mentioned. No "test set" requiring expert ground truth is described.
4. Adjudication method for the test set
- Not applicable/Not mentioned. No "test set" requiring adjudication is described.
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-assisted diagnostic device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in a 510(k) for a device like this is the established safety and effectiveness of the predicate device. The new device leverages this by demonstrating substantial equivalence. The document doesn't detail performance studies of the device itself, but rather its similarity to an already approved device.
8. The sample size for the training set
- Not applicable/Not mentioned. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not mentioned. This device does not involve machine learning or a "training set."
Summary of the "Study" (Demonstration of Substantial Equivalence):
The "study" in this context is the submission of documentation to the FDA to demonstrate substantial equivalence of the ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & CO07) to a previously cleared predicate device, the OmniAxial Connector (CO04).
- Methodology: The manufacturer provided documentation comparing the new device components to the predicate device across several key attributes.
- Proof of Meeting Criteria: The FDA's letter (K030252) confirms that based on the submitted information, the device is determined to be "substantially equivalent." This means the FDA accepted the manufacturer's provided documentation as sufficient proof that the new device meets the implied "acceptance criteria" of being comparable to the predicate device in terms of:
- Indications/Intended Use
- Manufacturing Methods
- Interconnection (attachment) mechanism
- Basic Design
- Materials (Titanium alloy ASTM F136-98)
This type of 510(k) summary typically does not include raw performance data, clinical trial results, or detailed statistical analyses that would be found for novel devices or AI/diagnostic systems. It focuses on the comparison to an already approved product.
§ 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.