(120 days)
The Zuma System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Zuma System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, The Zuma System is intended for use with bone graft.
Zuma is a vertebral body replacement device fabricated from PEEK OPTIMA® and titanium. Zuma is designed to restore the biomechanical integrity of the spinal column following full or partial vertebrectomy. The interior of the device is open to provide space for placement of grafting material. Bone screws are inserted through the device into adjacent vertebral bodies. Zuma is available in varying depths, widths, and heights to accommodate variations in patient anatomy.
The provided document is a 510(k) summary for the Zuma™ Vertebral Body Replacement Device. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on design, operating principle, materials, intended use, and sterilization methods.
However, the document does not contain the detailed performance data, acceptance criteria, or study results that would typically be associated with a comprehensive evaluation of a medical device's performance against specific metrics. It primarily focuses on demonstrating substantial equivalence to existing devices rather than presenting a standalone performance study with quantifiable acceptance criteria.
Based on the provided text, I can only extract limited information regarding performance and no specific details about the study methodology you requested.
Here's a breakdown of what can and cannot be answered from the provided text:
What can be answered:
- 1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document implies that the acceptance criteria are related to "sufficient strength" and performing "as well as or better than the predicate devices" in terms of safety and effectiveness. However, no specific numerical or qualitative criteria are provided.
- Reported Device Performance:
- "Zuma demonstrated sufficient strength in series of mechanical tests."
- "Analysis indicated that Zuma is as safe, as effective and performs as well as or better than the predicate devices."
- Table: A table cannot be generated with specific numerical values for acceptance criteria or performance from the provided text.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sufficient strength | "Zuma demonstrated sufficient strength in series of mechanical tests." |
| As safe as predicate | "Analysis indicated that Zuma is as safe... as the predicate devices." |
| As effective as predicate | "Analysis indicated that Zuma is as... effective and performs as well as or better than the predicate devices." |
| Performs as well as or better than predicate | "Analysis indicated that Zuma is as safe, as effective and performs as well as or better than the predicate devices." |
What cannot be answered from the provided text:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "series of mechanical tests" but does not specify sample sizes or data provenance.
- 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)
- No information on expert involvement or ground truth establishment is provided. The tests described are "mechanical tests," which typically don't involve expert readers in the same way as imaging or clinical studies.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
- 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
- Not applicable. This is a spinal implant device, not an AI-powered diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a spinal implant device, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical tests, the "ground truth" would typically be defined by engineering standards, material properties, and biomechanical specifications. However, the document does not elaborate on these specifics.
- 8. The sample size for the training set
- Not applicable. This refers to an AI training set, and this device is not an AI algorithm.
- 9. How the ground truth for the training set was established
- Not applicable.
Conclusion:
The provided 510(k) summary serves as a regulatory filing to demonstrate substantial equivalence to predicate devices, focusing on design, materials, and intended use for a spinal implant. It includes a general statement about "sufficient strength in series of mechanical tests" but lacks the detailed performance data, acceptance criteria, and study methodology typically found in clinical trials or comprehensive performance studies for AI/diagnostic devices. The questions you posed are largely geared towards software/AI performance evaluations, which are not relevant to this hardware medical device described.
§ 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.