(64 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 describes a 510(k) summary for the ORIA Spinal Clip System. This document focuses on demonstrating substantial equivalence to a predicate device, as required for certain medical devices by the FDA. Such summaries typically do not include detailed performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies, which are more common for novel or higher-risk devices requiring more extensive clinical validation.
Therefore, many of the requested details cannot be found in the provided text.
Here's an analysis based on the information that is available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical robustness thresholds). The acceptance criterion implicitly revolves around demonstrating "substantial equivalence" to a legally marketed predicate device.
- Reported Device Performance: The document states: "Documentation was provided which demonstrated the ORIA Spinal Clip System Polyaxial Screws to be substantially equivalent to the previously cleared Type "V" screws." This is the core "performance" reported – that it is equivalent to another device. No specific numerical performance metrics are provided for the ORIA Spinal Clip System itself beyond this statement of equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to a legally marketed predicate device | The ORIA Spinal Clip System Polyaxial Screws were demonstrated to be substantially equivalent to the previously cleared Type "V" screws. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified. The document refers to "documentation" being provided, but does not detail the nature of this documentation (e.g., specific study data, design comparisons, material testing results).
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 specified. The "ground truth" here is the established safety and efficacy of the predicate device, against which the new device is compared. There is no mention of a test set requiring expert ground truth establishment in the context of diagnostic accuracy or similar performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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 device is a spinal implant system, not an AI-assisted diagnostic tool or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a spinal implant system, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating substantial equivalence is the established regulatory status and safety/effectiveness profile of the predicate device. The documentation for the ORIA system likely focused on demonstrating similar materials, design, mechanical properties, and intended use to the predicate device, rather than patient outcomes or pathology related to the ORIA system itself.
8. The sample size for the training set
- Not applicable/Not specified. This is a medical device (spinal implant), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is a spinal implant system, not a machine learning algorithm.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.