(417 days)
mambo™ is intended for anterior operative stabilization of the cervical spine, (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- Degenerative disc disease (DDD), defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis
- Trauma (i.e., fracture or dislocation) .
- Spinal stenosis .
- Curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
- . Tumor
- Pseudoarthrosis .
- Failed previous fusion
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
mambo™ is a modular implant system for the anterior operative stabilization of the cervical spine (C2 to C7), only, consisting of cranial, caudal and extension plates as well as bone and revision screws of different sizes. Settling and clamping screws can be chosen for use of the mambo plate as a load-sharing (dynamic) or load-bearing (rigid) plate. The anterior cervical plates range in size from 20 mm to 142 mm to accommodate one to five segments of fixation. Bone and revision screws are available in lengths ranging from 13 mm to 19 mm.
This document is a 510(k) summary for a medical device called mambo™, an Anterior Cervical System. It is focused on demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through a clinical study. Therefore, much of the requested information (like multi-reader multi-case studies, ground truth establishment, training set details, and specific performance metrics beyond mechanical testing) is not typically part of a 510(k) submission and is not present in this document.
Here's an analysis of the provided information relative to your request:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance according to ASTM F1717 for static compression bending, tension bending, torsion, and dynamic compression bending. | The mechanical test results demonstrated that mambo™ performs as well as or better than the predicate devices (Spider Cervical Plating System, K052292; CLSP, K945700; ABC2 Anterior Cervical Plating System, K974706 and K0000486). |
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: This document describes mechanical testing according to ASTM F1717, not a human clinical trial or a test set involving patient data. The sample sizes for the mechanical tests (e.g., number of constructs tested) are not explicitly stated.
- Data Provenance: Not applicable as this is mechanical testing, not human data.
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. This document pertains to mechanical testing of a physical implant, not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is mechanical testing, not a study requiring adjudication of expert opinions.
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 comparative effectiveness study is not mentioned as this device is a physical implant (anterior cervical system), not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The mambo™ is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: For mechanical testing, the "ground truth" is typically defined by the material properties, design specifications, and the established standards (ASTM F1717 in this case) that dictate acceptable performance ranges. The performance of the predicate devices serves as a benchmark for "as well as or better than."
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not an AI system that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is a physical medical device.
§ 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.