(154 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. A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This document focuses on demonstrating substantial equivalence rather than proving device performance against specific acceptance criteria through a clinical study or a standalone algorithm evaluation.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text because it primarily describes the device, its intended use, and its substantial equivalence to a predicate device. Clinical performance data, often generated through detailed studies with specific acceptance criteria, are typically found in more comprehensive clinical sections of a PMA (Premarket Approval) or sometimes in 510(k) de novo submissions, but are not explicitly detailed in this summary.
Here's an attempt to populate the table and answer the questions based on the type of information present in a 510(k) summary, rather than a clinical trial report:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary focused on substantial equivalence, explicit "acceptance criteria" for device performance in a clinical study context and corresponding "reported device performance" are not typically presented in the way they would be for a novel device undergoing extensive clinical trials or an AI/ML algorithm. Instead, the "performance" demonstrated for substantial equivalence is primarily based on equivalence in design, materials, and function to a predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as per 510(k)) |
|---|---|
| Indications for Use: The device shares the same intended uses as the predicate device. | The ORIA Spinal Clip System has indications for use as a nonpedicle, noncervical posterior system, for severe spondylolisthesis (Grades 3 & 4) at L5-S1, and as a pedicle screw system in the non-cervical spine. These indications are stated to be equivalent to those of the predicate device. |
| Anatomic Sites: The device is used in the same anatomic locations as the predicate device. | The ORIA Spinal Clip System is indicated for use in the lumbar, thoracic, and sacral spine, including L3 and below for specific conditions. This is stated to be equivalent to the predicate device. |
| Design: The fundamental design principles and structure are similar to the predicate device. | The ORIA Spinal Clip System includes components to form a construct for spinal fusion surgery, with various designs and sizes (hooks, screws, rods, connectors, etc.). The design is considered equivalent to the predicate device. |
| Material of Manufacture: The device is made from equivalent materials as the predicate device. | The ORIA Spinal Clip System Lateral Intermediate Connector (AL01) is manufactured from titanium and stainless steel. These materials are stated to be equivalent to the predicate device. |
| Function: The device performs its intended mechanical and biological roles in a similar manner to the predicate device. | The system functions to fit together to form a construct for spinal fusion, providing immobilization and stabilization of spinal segments as an adjunct to fusion. This function is considered equivalent to the predicate device. |
| Safety and Effectiveness: Although not explicitly stated as "acceptance criteria," the overall implication of substantial equivalence is that the device is as safe and effective as the predicate. | The FDA's letter states, "We have reviewed... and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act." This indicates the FDA found sufficient evidence of substantial equivalence for safety and effectiveness without requiring further clinical studies at this stage for performance. |
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 / Not Provided: The 510(k) summary does not describe a "test set" in the context of a clinical study or algorithm evaluation. The substantial equivalence determination is based on a comparison to a predicate device's existing regulatory clearance and established performance, not new clinical data specific to the ORIA Spinal Clip System detailed in this document.
- Data Provenance: Not provided, as no specific test set data is mentioned.
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)
- Not Applicable / Not Provided: No "ground truth" for a test set is described, as no clinical study data is presented. The determination of substantial equivalence relies on regulatory review and comparison by FDA experts to existing cleared devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No adjudication method is mentioned as there is no described test set or clinical study requiring one.
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 / Not Provided: This device is a mechanical spinal implant system, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This device is a mechanical spinal implant system, not an algorithm. Standalone performance for an algorithm is not relevant or described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided: No "ground truth" is established or discussed as no new clinical performance data from a specific study is presented for the ORIA Spinal Clip System itself in this summary. The "ground truth" for showing safety and effectiveness is largely based on the predicate device's established performance and regulatory clearance.
8. The sample size for the training set
- Not Applicable / Not Provided: No "training set" is applicable or described, as this is a mechanical device, not an AI/ML system.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: No "training set" or method for establishing its ground truth is applicable or described.
§ 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.