(205 days)
The ROI is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from TI to L5) and is intended for use with supplemental internal fixation. The ROI may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.
The ROI vertebral implants consists of a series of flat and wedge shaped implants. The device is used singly or in pairs. The device is offered in nine different configurations to better approximate the anatomical variation observed in different vertebral levels and/or patient anatomy.
The LDR Spine USA, ROI Partial Vertebral Body Replacement System is comprised of a variety of components fabricated and manufactured from Polyetheretherketone (PEEK) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred.
The LDR Spine ROI Partial Vertebral Body Replacement System is a two piece, hollow chamber, rectangular block. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. Tantalum wire markers (ASTM F-560) are inserted into components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively. The device comes in various sizes and is offered in both straight and tapered styles.
The provided text is a 510(k) Premarket Notification summary for a medical device, specifically the Radiotransparent Open Implant (ROI) - Partial Vertebral Body Replacement (PVBR). It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria through clinical performance.
Therefore, many of the requested categories for information, such as "reported device performance," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details," are not applicable or available in this type of regulatory document.
The document primarily describes the device, its intended use, materials, and a comparison to predicate devices, focusing on design, material composition, surgical technique, and indications for use to establish substantial equivalence. The "Testing Summary" states that "Fatigue and static testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to perform in a manner equivalent to the predicate devices." This refers to biomechanical testing, not clinical studies with human subjects or expert assessments.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Device Performance (as far as available from this document)
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicates) | Reported Device Performance (from document) |
|---|---|
| Indications for Use Equivalence | The ROI's indications for use are identical to the EBI CAS Spine Spacer System and the Signus PEEK Tetris™ Spinal Implant: "To replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The ROI may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system." (Note: The predicate "Signus PEEK Tetris™ Spinal Implant" is listed as "Singularly" for how it's used, while ROI is "Singularly or in pairs", but this difference is deemed substantially equivalent). |
| Design Equivalence | ROI is a "Modular Cage," which is considered substantially equivalent to the "Cage" design of the CAS Spine Spacer System and the "Same as CAS SSS" for the PEEK Tetris™ Spinal Implant. |
| Supplied Sterile Equivalence | ROI is supplied "Yes - Gamma radiation," equivalent to predicate devices also supplied sterile (EBI CAS System: "Yes," PEEK Tetris™: "Yes - Gamma radiation"). |
| Material Equivalence | ROI uses "PEEK w/ tantalum markers." This is considered substantially equivalent to the EBI CAS Spine Spacer System ("Titanium") and the PEEK Tetris™ Spinal Implant ("PEEK w/ titanium markers"). Note: While the materials differ (PEEK vs. Titanium, and tantalum vs. titanium markers), the document asserts substantial equivalence, likely based on biocompatibility and mechanical performance for the intended application. |
| Instrument Equivalence | ROI requires "Specialized reusable instruments," consistent with predicate devices. |
| Usage Equivalence | ROI can be used "Singularly or in pairs." This is equivalent to the EBI CAS System ("Same") but differs from the PEEK Tetris™ ("Singularly"). Despite this, it is considered substantially equivalent. |
| Biomechanical Performance | "Fatigue and static testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to perform in a manner equivalent to the predicate devices." (No specific numerical performance data or acceptance criteria are reported in this summary beyond this general statement of equivalence.) |
Additional Requested Information:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The "testing summary" refers to biomechanical engineering tests (fatigue and static testing) on "samples," not a clinical test set with patient data. The specific number of samples for these engineering tests is not provided.
- Data Provenance: Not applicable for a clinical test set. For the engineering tests, the data would be generated from lab testing, not patient data from a specific country or retrospective/prospective collection.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" established by experts for a clinical test set is mentioned. The evaluation is based on engineering testing and comparison to predicate devices, which relies on regulatory review of submitted data and literature, not expert consensus on patient cases.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set or expert adjudication is described.
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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 document is for a physical implant device, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical ground truth. The "ground truth" for demonstrating device safety and effectiveness in this context is the successful completion of "fatigue and static testing" demonstrating equivalence to predicate devices, and the established safety records of the materials (PEEK, Tantalum) and the predicate devices.
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The sample size for the training set:
- Not applicable. No training set is mentioned as this is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable. No training set mentioned.
§ 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.