(85 days)
The AIS Modulift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap Modulift VBR System may be used with bone graft.
The AIS Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.
The provided document is a 510(k) premarket notification for the AIS Modulift VBR System. This type of FDA submission is for medical devices seeking substantial equivalence to already legally marketed predicate devices, not typically for AI/ML-driven devices. Therefore, the information requested in the prompt, which is tailored for AI/ML device studies (e.g., acceptance criteria for algorithm performance, sample sizes for test sets, ground truth establishment by experts, adjudication methods, MRMC studies), is not relevant or applicable to this document.
The document primarily focuses on demonstrating the substantial equivalence of an adjustable vertebral body replacement system to existing predicate devices, focusing on design, intended use, material composition, function, and size.
However, I can extract information regarding the performance data mentioned in the document in the context of device safety and efficacy, which is a different type of performance than what is typically associated with AI/ML systems.
Based on the provided text, here's what can be extracted, acknowledging the mismatch with AI/ML specific questions:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet or exceed performance of predicate devices for expulsion. | The results of the testing showed that the subject AIS Modulift VBR System meets or exceeds the performance of the predicate devices. |
Note: The document implies the acceptance criterion is performing at least as well as the predicate devices in the described tests. The specific quantitative acceptance thresholds are not provided in this summary.
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 for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The testing seems to be laboratory-based ("non-clinical testing").
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. This is a mechanical device, and ground truth is typically established through engineering specifications and test protocols, not human expert consensus on medical images/data.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This refers to consensus among human readers for AI/ML ground truth, which is not relevant here.
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:
- MRMC Study: Not applicable. This type of study is for evaluating AI impact on human performance, which is not relevant for this mechanical device.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This refers to AI algorithm performance, not relevant for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For this mechanical device, the "ground truth" or standard for evaluation would be established engineering principles, material science standards (e.g., ASTM F-136, ASTM F1537), and the performance characteristics of predicate devices in specific mechanical tests (like expulsion). This is distinct from clinical 'ground truth' defined by pathology or expert consensus for AI/ML systems.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set in the AI/ML sense.
Summary of Relevant Performance Data from the document:
The study referenced is "non-clinical testing" as recommended by the FDA Guidance for Spinal System 510(k)'s.
- Test Performed: Expulsion per ASTM Draft Standard F-04.25.02.02.
- Purpose: To demonstrate that the AIS Modulift VBR System is substantially equivalent to other predicate devices.
- Results: The device "meets or exceeds the performance of the predicate devices."
This information confirms that the performance evaluation was based on mechanical testing relevant to physical device function and safety, not on AI/ML diagnostic or prognostic capabilities.
§ 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.