(164 days)
The ORION® Anterior Cervical Plate System is intended for anterior cervical intervertebral body fusions only. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
The ORION® Anterior Cervical Plate System consists of a variety of bone plates and screws. Fixation is provided by the insertion of bone screws through the openings at each end of the plate into the vertebral bodies of the cervical spine. The ORION® Anterior Cervical Plate System features a locking screw which screws into each end of the plate to help secure the positioning of the ORION® screws. The use of the locking screw is not optional. In addition, the central portion of ORION® plates have slots and holes which accommodate 4.35mm diameter ORION® screws. The placement of these central screws is intended to augment fixation by providing additional vertebral body purchase and/or bone graft purchase. The use of the central screws is recommended. Associated instruments are also available to facilitate the implantation of the device. The implant components will be made from titanium alloy as described by ASTM F-136 or ISO 5832-3 and may be supplied either sterile or non-sterile.
The request asks for details about the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) summary for the ORION® Anterior Cervical Plate System.
However, the provided text does not contain acceptance criteria or details of a study with specific performance metrics for the ORION® Anterior Cervical Plate System. Instead, it states:
- "The ORION® Anterior Cervical Plate System was claimed to be substantially equivalent to commercially available cervical plating systems."
- "Information concerning these devices was supplied in support of establishing equivalence."
- "Mechanical test data were provided in support of this notification."
This indicates that the submission relied on demonstrating substantial equivalence to predicate devices and likely included mechanical testing to support the device's physical properties. It does not provide the specific performance criteria or the results of those tests in a format that would allow filling out the requested table.
Therefore, many of the requested fields cannot be answered definitively from the provided text.
Here's an attempt to answer based on the available information, with clear indications of what is not provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated, inferred from claims of substantial equivalence and mechanical tests) | Reported Device Performance (Not explicitly stated in terms of specific thresholds or results) |
|---|---|---|
| Mechanical Strength | The device, including plates and screws, is expected to withstand physiological loads and stresses encountered in the anterior cervical spine without failure (e.g., fracture, loosening, deformation) as demonstrated by mechanical testing. | "Mechanical test data were provided in support of this notification." (Specific results, e.g., bending strength, torsional rigidity, fatigue life, or comparison to predicate values, are not provided). The FDA found the device "substantially equivalent," implying these tests were satisfactory. |
| Biocompatibility | Materials (titanium alloy as described by ASTM F-136 or ISO 5832-3) are expected to be biocompatible, non-toxic, and non-allergenic when implanted in the human body. | The materials specified (titanium alloy per ASTM F-136 or ISO 5832-3) are commonly accepted as biocompatible for implantable medical devices. (Specific test results are not provided, but adherence to these standards implies they meet acceptance criteria for biocompatibility). |
| Device Functionality | The system should effectively provide temporary stabilization for anterior cervical intervertebral body fusions, including secure fixation of screws into vertebral bodies and proper functioning of the locking screw mechanism. | Implied by the claim of substantial equivalence to commercially available cervical plating systems. (Specific functional performance metrics, e.g., screw pull-out strength, locking mechanism reliability, are not provided in numerical terms). The device's design, including mandatory locking screws, is described. |
| Sterilization (if sterile) | For sterile products, the sterilization method must achieve a specified sterility assurance level (SAL). | The device "may be supplied either sterile or non-sterile." (Specific sterilization validation results are not provided). |
| Indications for Use | The device must meet the specified indications for use: temporary stabilization during cervical spinal fusions for degenerative disc disease, trauma, tumors, deformity, pseudanthrosis, and/or failed previous fusions. It must not be approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. | The FDA cleared the device for the stated indications for use and explicitly prohibited promotion for pedicular screw fixation. This indicates the device met the criteria for its intended use and did not meet the criteria for the prohibited use. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not provided. The documentation mentions "mechanical test data" but does not specify the number of samples tested for each type of component or for the system as a whole.
- Data Provenance: The mechanical tests were performed to support the 510(k) submission, likely by the manufacturer (Sofamor Danek USA). The country of origin for the data is implicitly the USA, where Sofamor Danek is based. The nature of mechanical testing makes it inherently prospective data collection for the purpose of the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. For a purely mechanical device tested for substantial equivalence, "ground truth" related to expert assessment in the clinical sense (e.g., radiological interpretation) is not typically established for the mechanical testing itself. The "experts" involved would be engineers and material scientists conducting the tests, and potentially biomechanical experts reviewing the results against established standards or predicate device performance. Their number and specific qualifications are not stated.
4. Adjudication method for the test set
- Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 typically refer to clinical endpoint adjudication where multiple experts independently assess cases for a definitive outcome. This is not relevant for the mechanical testing of a spinal implant. The "adjudication" for the mechanical tests would be the review of the raw data, test reports, and compliance with test standards by the manufacturer's internal quality/regulatory team and the FDA reviewers.
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
- No. This is a medical device for spinal fixation, not an AI-powered diagnostic or imaging interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a physical, implantable medical device. The concept of an "algorithm only" or "standalone" performance without human interaction is not applicable as there is no algorithm or AI component.
7. The type of ground truth used
- For the mechanical testing, the "ground truth" would be the physical properties and performance characteristics of the device measured through standardized biomechanical tests (e.g., ultimate tensile strength, fatigue life, intersegmental ROM, pull-out strength). These measurements are then compared against established standards or the performance of legally marketed predicate devices.
- For the claim of substantial equivalence, the "ground truth" is adherence to the design and material specifications, and performance data that is comparable to predicate devices.
8. The sample size for the training set
- Not applicable / Not provided. This device does not involve a "training set" in the context of machine learning or AI. While manufacturers gain experience and refine designs over time (which could be metaphorically considered "training"), there is no formalized training set as used in the AI context.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no "training set" as defined in AI/ML, the establishment of its ground truth is not relevant.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.