Search Results

The MediExpand Cervical Expandable VBR System is intended for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. Use of the MediExpand Cervical Expandable VBR System is limited to single-level or two-level corpectomy and the device is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.

These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The MediExpand Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The MediExpand Cervical Expandable VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system comprises of vertebral body devices of various heights, sizes and footplates to fit the anatomical needs of a wide variety of patients. The devices can be adjusted to the required height after implantation. Once it is adjusted to the desired height the device is mechanically locked in place with fixation screws. The devices have a rectangular space to allow grafting material to be packed inside the devices. Spikes on the footplates improve the anchoring of the implant to the vertebral body. The footplates are available in various lordotic anqles. The devices have threaded holes for anchor screws which can be inserted into the adjacent vertebral bodies. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136 and ISO 5832-3.

The provided text describes the MediExpand Cervical Expandable VBR System, a device intended for use in the cervical spine. However, the document does not provide specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested. Instead, it offers a summary of premarket notification for FDA clearance, focusing on substantial equivalence to predicate devices.

The "Performance Testing" section mentions "Clinical data from Europe have shown the clinical performance and support the use of the MediExpand Cervical Expandable VBR System." It also references "Real World Data (RWD) ... from three sites in Germany" and states, "There were no instances of implant failure, and none of the patients suffered from implant associated damages/injuries." While this suggests positive outcomes, it does not present quantifiable acceptance criteria or a structured study for evaluating those criteria.

Therefore, many of the requested elements cannot be definitively extracted or are not present in the provided text.

Here's a breakdown of what can be a gathered from the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly list acceptance criteria in a quantitative or qualitative manner. It states "There were no instances of implant failure, and none of the patients suffered from implant associated damages/injuries" as a reported performance, but this is a broad statement rather than a specific measure against a predefined criterion.

2. Sample size used for the test set and the data provenance

• Sample size: 338 patients.
• Data provenance: Retrospective Real World Data from three sites in Germany (University Hospital of Ludwig-Maximilians-University (LMU) in Munich, Central Clinic in Bad Berka, Schoen Clinic Hamburg Eilbek, Hamburg).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the text. The RWD mentions outcomes like "no instances of implant failure" or "no implant associated damages/injuries," which would likely be determined by medical professionals, but the number or qualifications of these experts are not detailed.

4. Adjudication method for the test set

This information is not provided in the text.

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

This is not applicable as the device is a medical implant (Spinal Intervertebral Body Fixation Orthosis) and not an AI-assisted diagnostic tool or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a medical implant and not an algorithm.

7. The type of ground truth used

The "ground truth" for the reported performance appears to be clinical outcomes and observations from the "Real World Data" provided by the three German sites, indicating "no instances of implant failure" and "none of the patients suffered from implant associated damages/injuries." This would implicitly involve expert clinical assessment by treating physicians.

8. The sample size for the training set

This is not provided in the text. The document refers to "Real World Data" used to support substantial equivalence, but it doesn't describe a separate "training set" in the context of machine learning or algorithm development.

9. How the ground truth for the training set was established

This information is not provided as there is no mention of a "training set" or its ground truth establishment.

Ask a specific question about this device