(168 days)
The CAYMAN Buttress Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L5-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, t) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, i) deformity (i.e., scoliosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.
The Cayman Plate System is a spinal fixation system which consists of screws and plates. All of the components are available in a variety of sizes to more closely match the patient's anatomy.
Materials: The devices are manufactured from CP Titanium and Ti6Al4V per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of the spine.
The purpose of this submission is to add minimally invasive (MI) plates.
Here's an analysis of the provided text regarding the Cayman MI Plates, focusing on the acceptance criteria and the study proving it, as requested.
Based on the provided 510(k) summary, the device in question (Cayman MI Plates) is a Class II spinal intervertebral body fixation orthosis. For such devices, the primary "acceptance criteria" and "study" proving its meeting of these criteria are typically focused on substantial equivalence to existing legally marketed predicate devices, primarily through mechanical and material testing. The regulatory pathway for this type of device (510(k)) does not typically involve traditional clinical efficacy studies with human subjects in the same way a PMA (Pre-Market Approval) device would.
Therefore, many of the requested points related to clinical trials, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable in this context.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied by 510(k) for Spinal Fixation) | Reported Device Performance (from K131533) |
|---|---|
| Material Composition | Manufactured from CP Titanium and Ti6Al4V per ASTM and ISO standards. (Implies adherence to established strength, biocompatibility, and durability for these materials, which are standard for spinal implants). |
| Mechanical Performance (Static Compression Bending) | Previously tested along with predicate devices. The proposed MI plates do not represent a new worst case in subsequent ASTM F1717 testing. |
| Mechanical Performance (Dynamic Compression Testing) | Previously tested along with predicate devices. The proposed MI plates do not represent a new worst case in subsequent ASTM F1717 testing. |
| Mechanical Performance (Static Torsion) | Previously tested along with predicate devices. The proposed MI plates do not represent a new worst case in subsequent ASTM F1717 testing. |
| Design Similarity | Similar in design to predicate plates. |
| Indications for Use Similarity | Similar in indications for use to predicate plates. |
| Safety and Effectiveness Equivalence | Expected to be equivalent in safety and effectiveness to predicate devices. (This is the overarching acceptance criterion for a 510(k); the mechanical and material data support this claim). |
Study Details (Based on available 510(k) information)
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Sample sizes used for the test set and the data provenance:
- The "test set" in this context refers to the mechanical testing samples (e.g., individual plates and screws) used for the engineering tests. The specific number of units tested is not provided in the summary.
- Data Provenance: The testing was conducted according to ASTM F1717 standards, which are internationally recognized American Society for Testing and Materials standards for spinal implant testing. This is a controlled laboratory setting, not human clinical data. The summary does not specify the country of origin beyond the submitter being K2M, Inc. from Leesburg, VA, USA, implying the testing was likely conducted in the US or by a contracted lab.
- Retrospective or Prospective: This is not applicable. Mechanical testing is neither retrospective nor prospective in the clinical sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "ground truth" for a mechanical device like this is defined by engineering specifications and established ASTM/ISO testing standards, not expert clinical consensus on images or outcomes.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Mechanical testing results are objective measurements (e.g., force, displacement, cycles to failure) against pre-defined engineering criteria, not subjective interpretations requiring adjudication.
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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:
- This is not applicable. This device is a physical spinal implant, not an AI or imaging diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. This device is a physical spinal implant, not an AI or imaging diagnostic tool.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the performance specifications defined by industry standards (ASTM F1717) and internal engineering requirements for spinal fixation devices. This includes criteria for material properties, fatigue life, strength, and secure fixation.
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The sample size for the training set:
- This is not applicable. There is no "training set" in the context of mechanical device testing for a 510(k) submission.
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How the ground truth for the training set was established:
- This is not applicable. See point 7.
§ 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.