(44 days)
The Integra® Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) after laminoplasty procedures. The Integra "Laminoplasty System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.
The Integra® Laminoplasty System consists of plates and screws that are attached to the lamina after a laminoplasty procedure; the system is manufactured from Titanium 6Al-4V ELI per ASTM F136. Implants are available in a range of sizes and shapes, as well as in various screw hole configurations to accommodate variations in patient anatomy. The system also includes instruments to assist with implantation, and a tray for organization and storage
This 510(k) summary for the Integra® Laminoplasty System describes a medical device clearance based on substantial equivalence, rather than a study proving the device meets specific acceptance criteria through AI or clinical performance. Therefore, most of the requested information regarding AI study design, ground truth, and expert evaluation is not applicable.
Here's the information that can be extracted from the provided text, primarily focusing on the non-clinical testing performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Equivalent performance to predicate devices through static and dynamic mechanical testing per ASTM F2193 | Demonstrated equivalent performance to the predicate systems through static and dynamic mechanical testing per ASTM F2193. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The testing involves mechanical evaluation of the device components, not patient data.
- Data Provenance: Not applicable, as this refers to mechanical testing, not a clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F2193) and the results of the physical tests.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Not applicable. Mechanical testing results are typically measured against established engineering standards.
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 MRMC study was done. This document describes a medical device, not an AI system. The submission explicitly states: "No clinical testing was required to demonstrate equivalence."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used
- For the non-clinical testing: The "ground truth" is defined by the performance characteristics and requirements outlined in the ASTM F2193 standard for spinal intervertebral body fixation devices. The device's mechanical performance is compared to that of the legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set.
Summary of the K130830 Submission:
This 510(k) submission for the Integra® Laminoplasty System is based on substantial equivalence to existing legally marketed predicate devices. The primary evidence presented for regulatory clearance is non-clinical mechanical testing conducted according to ASTM F2193. The purpose of this testing was to demonstrate that the new device performs equivalently to the predicate devices in terms of static and dynamic mechanical properties. No clinical studies, AI performance evaluations, or expert consensus on clinical outcomes were required or performed for this clearance.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.