(107 days)
The Nakoma ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patents with the following indications:
• Degenerative Disk 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
• Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• Pseudoarthrosis
• Failed previous fusions
• Spondylolisthesis
• Spinal Stenosis
The Nakoma Anterior Cervical Plating (ACP) system is used for spinal fusion surgery to provide support and structural stability. The system consists of a variety of plates and screws, all of which are manufactured from titanium alloy per ASTM F136. Instrumentation necessary for proper implantation is also included.
The plates are available in a range of lengths in Levels 1-5 and feature windows to aid in visualization and locking clips to assist in screw retention. The screws are available in multiple lengths and diameters, feature self-tapping and self-drilling designs and are able to be placed on-axis and at various angles (15° medial/lateral, 10° cephalad/caudal).
This document is a 510(k) premarket notification for the Nakoma ACP System, a spinal intervertebral body fixation orthosis. It includes information about the device's indications for use, its comparison to predicate devices, and the testing conducted to demonstrate substantial equivalence.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance in a pass/fail quantifiable manner, but it does describe the non-clinical testing performed and the conclusion drawn from it. The "acceptance criteria" here are implied to be "perform equivalently to the predicates" as verified by the stated tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static Compression equivalent to predicates (per ASTM F1717) | "the subject devices were found to perform equivalently to the predicates." |
| Static Torsion equivalent to predicates (per ASTM F1717) | "the subject devices were found to perform equivalently to the predicates." |
| Dynamic Compression equivalent to predicates (per ASTM F1717) | "the subject devices were found to perform equivalently to the predicates." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "non-clinical testing" and refers to ASTM F1717 for mechanical tests. It states "the subject devices were found to perform equivalently to the predicates." However, it does not specify the sample size used for these tests. There is no information provided regarding data provenance (country of origin, retrospective/prospective) as these are mechanical tests, not clinical data from patients.
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)
This question is not applicable to the provided document. The device in question is a medical implant (spinal fixation system), and the evaluation discussed is based on non-clinical mechanical testing (ASTM F1717). Therefore, there is no "ground truth" derived from expert consensus on medical images or patient outcomes in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data where disagreements need to be resolved. This document focuses on non-clinical mechanical testing, which does not involve subjective interpretations requiring adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states under "(b)(2) Clinical testing: Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." The device is a spinal implant, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone (algorithm only) performance study was not done. The device is a physical medical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical testing was based on the established performance characteristics and specifications of the predicate devices as determined by ASTM F1717 standards for mechanical testing. The goal was to show equivalence to these established benchmarks.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of this 510(k) submission, as it focuses on demonstrating substantial equivalence of a physical medical device through mechanical testing, not on developing or training an algorithm.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set involved in this submission.
§ 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.