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The OstaPek® VBR System are vertebral body (partial or total) replacement devices intended for use in the thoracolumbar spine (T1 - L5) to replace and restore height to a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (fracture or disease). The system is to be used in association with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended is the coLigne, AG, GII Spinal Fixation System.

The implants consist of a system of flattened, cuboid, trapezoida & rectangular shaped implants. The OstaPek® VBR System implants offer substantial variation of size and configuration to better approximate the anatomical variation observed in different vertebral levels and patient anatomy. The devices are manufactured with one or more hollowed out central areas to accommodate bone graft material. The superior and inferior surfaces are manufactured in such a way that a series of lands and grooves are formed in the anterior/posterior direction. The purpose of these lands and grooves is to improve stability and bony fixation once the device is inserted. This device is made from the exact same material as the GII Spinal Fixation System, K051089.

The OstaPek® VBR System is a vertebral body (partial or total) replacement device for the thoracolumbar spine (T1 - L5). It is intended to replace and restore height to a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (fracture or disease). The system is to be used in association with bone graft and supplemental spinal fixation (specifically, the coLigne, AG, GII Spinal Fixation System).

This device falls under the classification § 888.3060, Spinal intervertebral body fixation orthosis, Class II, with product code MQP.

Here's an analysis of the provided information regarding the device's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance results in a table format. Instead, it makes a general statement about testing and equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any test set or provide information on data provenance (e.g., country of origin, retrospective or prospective). The "Testing Summary" only generally mentions "fatigue, static and biocompatibility testing." These types of tests typically involve material samples and mechanical setups rather than clinical patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. Given that the testing mentioned is primarily mechanical (fatigue, static) and biocompatibility, it's unlikely that clinical expert ground truth was established in the traditional sense for these specific tests.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the nature of the described testing (mechanical and biocompatibility).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted or reported in this document. The device is a physical implant, not an AI-assisted diagnostic or decision-support tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study in the context of an algorithm or AI was not conducted or reported. The device is a physical implant.

7. Type of Ground Truth Used

The ground truth for the "Testing Summary" would likely be based on engineering standards and specifications for fatigue, static load, and biocompatibility, rather than expert consensus, pathology, or outcomes data. The document states "tested according to accepted engineering and scientific principals." This implies that the performance was compared against established benchmarks or the performance of predicate devices under similar test conditions.

8. Sample Size for the Training Set

An AI training set and its sample size are not applicable as this device is a physical implant and not an AI/algorithm-based product.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no AI training set for this device.

Summary of Device Performance Justification:

The coLigne AG. justifies the OstaPek® VBR System's performance and safety by demonstrating its substantial equivalence to existing predicate devices (Lanx VBR, Concord VBR, Theken LPOD, VBR). This equivalence is asserted in terms of design, material composition, surgical technique, and intended use. The document explicitly states that "fatigue, static and biocompatibility testing is completed... Test results demonstrate that the new implants may be expected to perform in a manner equivalent or superior to the referenced comparison systems." This suggests that the device underwent standard mechanical and biological safety testing, and its performance met or exceeded that of its predicates, though the specific quantitative results are not detailed.

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