(45 days)
The Manta Ray™ ACP System is an anterior cervical plate that is intended for temporary stabilization of the cervical spine from C2-C7 due to the following indications: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (i.e. fracture/dislocation), Tumor, Spinal stenosis, Deformity (i.e. scoliosis, kyphosis and/or lordosis), Pseudoarthrosis, Failed previous fusion
The Manta Ray™ ACP System is an anterior cervical plate fixation system. The system consists of a number of plates and screws. The plates feature a normal lordotic curvature as well as a transverse plane curvature for anatomic fit and are available in a variety of lengths for one to four level configurations. Screws are available in fixed and variable angle styles to create rigid or semi-rigid constructs as well as multiple lengths to fit individual patient pathologies. All implants are machined from implant grade titanium alloy, Ti-6Al-4V (ELI) per ASTM F-136.
Here's an analysis of the provided text regarding the Manta Ray Anterior Cervical Plate (ACP) System's acceptance criteria and studies:
Based on the provided 510(k) summary, the device is a medical implant, and the approval process for such devices typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study with acceptance criteria for a diagnostic AI. The "Performance Data" section specifically mentions mechanical testing to characterize the device.
Therefore, many of the requested points related to AI performance, ground truth, expert adjudication, and observer studies are not applicable to this type of medical device submission.
Here's the breakdown of what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static Testing: To characterize stiffness and strength. (Implied acceptance: Must meet or exceed properties of predicate devices and/or established biomechanical standards for spinal implants.) | Static testing was performed to characterize the stiffness and strength of the Manta Ray™ ACP System. (Specific numerical results are not provided in this summary.) |
| Fatigue Testing: To characterize fatigue life. (Implied acceptance: Must demonstrate durability matching or exceeding predicate devices and/or biomechanical standards for spinal implants over its intended lifespan.) | Fatigue testing was performed to characterize the fatigue life of the Manta Ray™ ACP System. (Specific numerical results are not provided in this summary.) |
Note: The 510(k) summary does not provide specific numerical acceptance criteria (e.g., minimum stiffness in Nm/deg, or minimum cycles to failure at a given load). These would typically be detailed in the full test reports submitted to the FDA, but are not present in this public summary. The "acceptance criteria" here are inferred from the type of testing performed for spinal fixation devices. The reported device performance is that these tests were performed.
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: Not specified in the summary. For mechanical testing, samples refer to the number of physical devices tested.
- Data Provenance: Not applicable in the context of mechanical testing. The data would originate from the testing facility where the mechanical tests were conducted.
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 device is a physical implant, not a diagnostic AI system requiring expert-established ground truth on patient data. Ground truth for mechanical testing is based on engineering principles and material science.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 not an AI or diagnostic device. This is a spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI or algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Standards / Biomechanical Principles: For mechanical testing, the "ground truth" would be established by industry standards (e.g., ASTM standards for spinal implants) and valid biomechanical testing methodologies that define expected performance characteristics for stiffness, strength, and fatigue life. Failure criteria are defined by these standards.
8. The sample size for the training set
- Not applicable. This is not an AI model requiring a training set. If referring to the design and manufacturing process, there is no "training set" in the AI sense.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.