(312 days)
Vertebral body replacement intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The obelisc™ Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of bour grafting material with the obelisc™ Vertebral Body Replacement is optional.
The obelise TM Vertebral Body Replacement device is used for the bridging of substance defects in the anterior human thoracic and lumbar spine. The defect is bridged by distraction of the implant and the vertebral column is straightened. Via a bevel gear drive unit, the necessary height of the implant can be adjusted exactly and fixed in situ. The height can be adjusted via a bevel gear drive unit, with pins to prevent overdistraction. The adjusted height is fixed in position by means of a locking screw. Spikes at the end pieces improve the anchoring of the implant on the end plates of the vertebral bodies. Bone graft material can be placed around the obelise™ Vertebral Body Replacement as needed. The obelisc ™ Vertebral Body Replacement consists of a center piece and two corresponding straight or angled end pieces. The standard diameter of the center pieces is 20 mm. One end has already been produced with a 0° end piece with Ø 20 mm. The end pieces are available in three diameters (20 mm, 26 mm) and with different angles (0°, 5°, 10°). One oval end piece (26 x 30 mm) with an angle of 15° is available. The center piece defines the minimum and maximum expansion height. The distraction heights range from 20 to 132 mm. The implant components of this system are made from alloyed titanium according to ISO 5832-3:2000 and ASTM F-136-02a.
The acceptance criteria for the obelisc™ Vertebral Body Replacement device are based on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study that Proves Device Meets Criteria |
|---|---|---|---|
| Mechanical Performance | Device meets performance standards of ASTM F 2077 - 00 (Test Methods for Intervertebral Body Fusion Devices). | Device was tested according to ASTM F 2077 - 00. | "Summary of Testing" section states: "Mechanical testing was performed in accordance with ASTM F 2077 - 00 (Test Methods for Intervertebral Body Fusion Devices." |
| Intended Use | Vertebral body replacement for use in the thoracolumbar spine (T1-L5) to replace collapsed/unstable vertebral body due to tumor or trauma, used with supplemental spinal fixation systems. | Device has the same intended use as legally marketed predicate devices. | Comparison table explicitly shows identical "Intended use" and "Anatomical sites" to predicate devices (XPAND, VBR™). |
| Material Composition | Constructed from biocompatible material suitable for implantation. | Implant components made from alloyed titanium according to ISO 5832-3:2000 and ASTM F-136-02a. | "Product Description" section and comparison table state "Titanium alloy" as material. |
| Design Characteristics | Similar design principles (e.g., distraction, height adjustment, anchoring) and dimensions (diameter, distraction length) to predicate devices. | Device offers continuous in-situ distraction, various diameters (20-30mm), and distraction lengths (20-132mm), which are comparable to or within the range of predicate devices. | Detailed comparison table provided in the "Substantial Equivalence" section illustrates these similarities. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or human subjects. The described "testing" refers to mechanical performance testing. For these tests, the "sample size" would relate to the number of physical devices or components subjected to mechanical stress. The document does not provide the exact number of devices tested, only that testing was "performed in accordance with ASTM F 2077 - 00."
Regarding data provenance, this document describes an FDA 510(k) submission for a medical device that relies on mechanical testing and comparison to existing predicate devices to demonstrate substantial equivalence, rather than clinical study data. Therefore, there is no mention of "country of origin of the data" or whether it was "retrospective or prospective" in the context of human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a submission for a mechanical device based on engineering and material science, not a diagnostic AI device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for mechanical testing is established by the specifications and methodologies outlined in the ASTM F 2077 - 00 standard. Adherence to this standard validates the mechanical performance.
4. Adjudication Method for the Test Set
Not applicable. There is no ambiguous "test set" data requiring adjudication by experts. Mechanical testing results are objective measurements evaluated against pre-defined engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is not an AI or diagnostic imaging device. An MRMC study is not relevant to this type of medical device submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical vertebral body replacement implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the obelisc™ Vertebral Body Replacement device is based on:
- Mechanical Performance Standards: Specifically, the requirements and methodologies outlined in ASTM F 2077 - 00 for intervertebral body fusion devices. Meeting these standards serves as the ground truth for mechanical integrity and functionality.
- Predicate Device Equivalence: The characteristics (intended use, anatomical sites, material, design principles) of legally marketed predicate devices (K050850 XPAND Corpectomy Spacer and K012254 VBR™ Vertebral Body Replacement Device) serve as a baseline "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of 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.