(64 days)
ADIRATM Lateral Plate System
The ADIRA™ 2-Hole and 4-Hole Plates, when used with screws only, are intended for use in the treatment of thoracolumbar (T1-L5) spinal instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or failed previous spinal surgery.
The ADIRA™ 1-Hole Plate is intended to stabilize allograft at one level (T1-L5), aiding in spinal fusion and to provide temporary stabilization and augment of a spinal fusion. It may be used alone or with other anterior, lateral, anterolateral, or posterior spinal systems. The device is not intended for load bearing applications.
ADIRA™ Plate-Spacer Assemblies
ADIRA™ Plates may be assembled to a lateral lumbar interbody fusion device (HEDRON® L, TransContinental®, RISE®-L, Modulus® XLIF, CoRoent®, or Cohere® XLIF Spacers) to create a plate-spacer assembly. When assembled to HEDRON® L, TransContinental®, or RISE®-L Spacers, the plate-spacer assembly is indicated for use at one or more levels of the lumbosacral spine (L1-L5), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. When ADIRA™ Plates are assembled to Modulus® XLIF, CoRoent®, or Cohere® XLIF Spacers, the plate-spacer assembly takes on the indications of the interbody device.
ADIRA™ Plate-Spacers are intended to be used with screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, the 2-Hole or 4-Hole Plate-Spacers are intended for stand-alone use in patients with DDD at one or two levels only when
The ADIRA™ Lateral Plate System consists of 4-, 2- and 1-hole thoracolumbar plates of various sizes to accommodate varying patient anatomy and surgical needs. The ADIRA™ plates are used with bone screws to attach to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine. ADIRA™ plates may also be attached to certain lateral lumbar interbody fusion devices (HEDRON L™, TransContinental™, RISE-L™, Modulus® XLIF, Cohere® XLIF, or CoRoent®) with an alignment screw. The plate-spacer assembly is used with bone screws and/or lateral anchors.
The provided text describes a medical device called the ADIRA™ Lateral Plate System and its clearance by the FDA based on substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-based devices with performance metrics like accuracy, sensitivity, specificity, etc.
Instead, the document focuses on regulatory approval for a physical medical implant (thoracolumbar plate system) based on material, design, and mechanical performance. The "Performance Data" section in the document refers to mechanical testing for physical device characteristics, not clinical performance or diagnostic accuracy.
Therefore, many of the requested fields regarding AI/ML device performance metrics, study design, expert adjudication, and ground truth establishment cannot be populated from the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided in the requested format. The document describes mechanical testing (static and dynamic compression bending, static torsion, expulsion testing) against ASTM standards and FDA guidance for spinal systems. It states: "Performance data demonstrate substantial equivalence to the predicate devices." It does not list specific numerical acceptance criteria (e.g., "accuracy > 90%") or reported performance values (e.g., "accuracy = 92%") for AI/ML-related 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 mentioned. This information is typically for clinical or AI/ML performance studies. The testing mentioned is mechanical testing of physical implants, not data-driven studies.
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 mentioned. This is for AI/ML performance studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. This is for AI/ML performance studies.
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. An MRMC study was not done as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. Not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not mentioned. The "ground truth" for mechanical testing would be the physical properties and structural integrity measured against engineering standards.
8. The sample size for the training set
- Not applicable/Not mentioned. Not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/Not mentioned. Not an AI/ML device.
Summary regarding the acceptance criteria and study as requested for AI/ML devices:
The provided FDA 510(k) clearance letter for the ADIRA™ Lateral Plate System does not contain information typically found for AI/ML-based medical devices regarding acceptance criteria, study design for performance evaluation (e.g., accuracy, sensitivity, specificity), sample sizes for test/training sets, expert adjudication, or ground truth establishment.
The device is a physical thoracolumbar plate system, and the "Performance Data" section solely refers to mechanical testing against engineering standards (ASTM F1717) and FDA guidance documents for spinal implant systems, demonstrating "substantial equivalence to the predicate devices."
§ 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.