Search Results
Found 1 results
510(k) Data Aggregation
(252 days)
The Cervage cage is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks on non-operative treatment. The Cervage cage is to be used with supplemental fixation. The Cervage cage is also required to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.
The Cervage cage consists of PEEK cages of various lengths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782). The coated cages are coated with medical grade CP Ti (ASTM F1580) and are provided sterile. The non-coated cages are provided sterile or non-sterile. The device must be used with supplemental fixation. The purpose of this submission is to gain initial marketing authorization in the United States.
This document is a 510(k) premarket notification for a medical device called "Cervage," an intervertebral body fusion device. The FDA's letter indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.
Based on the provided document, here's a detailed breakdown regarding the acceptance criteria and study that proves the device meets them:
Crucially, this document states that "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." Therefore, the information requested regarding a clinical study with detailed performance metrics, sample sizes, expert involvement, and ground truth establishment will largely be absent.
The acceptance criteria for this device seem to be primarily based on non-clinical testing demonstrating mechanical performance, cleaning/sterilization effectiveness, and biocompatibility, as well as a comparison to predicate devices to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance:
Since clinical testing was not required and no specific performance metrics like accuracy, sensitivity, or specificity are provided for an AI/algorithm-based device, the "acceptance criteria" here relate to the mechanical, chemical, and biological properties of the physical implant.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance (from document) |
|---|---|---|
| Material Composition | Biocompatible and industry-standard materials for implants. | Made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782). Coated cages are coated with medical grade CP Ti (ASTM F1580). |
| Mechanical Performance | Ability to withstand physiological loading and maintain structural integrity. | Evaluated for mechanical performance in Static and Dynamic Axial Compression, Static and Dynamic Torsion, Static and Dynamic Compression Shear according to ASTM F2077-14. Subsidence according to ASTM F2267-04 and Expulsion in accordance with ASTM F-04.25.02.02. (The specific numerical performance values are not provided in this summary, but the reference to ASTM standards implies they met the required specifications for these tests). |
| Sterilization & Cleaning | Device can be effectively cleaned and sterilized to prevent infection. | Cleaning and sterilization were evaluated. (Specific methods or validation results are not detailed in this summary, but the mention implies they meet the necessary standards for sterile medical devices). |
| Biocompatibility | Device materials are safe for implantation and do not elicit adverse biological responses. | Implantable device biocompatibility endpoints were evaluated. (No specific tests or results are presented, but this indicates compliance with relevant biocompatibility standards). |
| Substantial Equivalence | Device is as safe and effective as predicate devices. | The Cervage device has the "same intended use and is similar in basic shape, material and performance characteristics to the predicate device." The "technological characteristics do not raise any new questions of safety and efficacy." (This is the overarching "performance" claim for a 510(k) without clinical trials). |
Regarding an AI/Algorithm-based device, which this is not:
The questions regarding sample size, data provenance, expert establishment of ground truth, MRMC studies, standalone performance, training set details, and ground truth for training are not applicable to this 510(k) submission, as it is for a physical intervertebral body fusion device and explicitly states that clinical testing was not required for substantial equivalence.
To reiterate why the following points cannot be answered from the provided document:
- Sample sizes used for the test set and the data provenance: Not applicable; no clinical test set involved. The mechanical testing would have specific sample sizes (e.g., number of devices tested for compression), but that data isn't in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical test set requiring expert ground truth for interpretation.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable; no clinical test set.
- 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 is not an AI/software device, and no clinical study was performed.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an AI/software device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; no clinical data requiring ground truth collection for diagnostic or prognostic purposes.
- The sample size for the training set: Not applicable; no AI algorithm to train.
- How the ground truth for the training set was established: Not applicable; no AI algorithm to train.
In summary, the FDA filing for the Cervage device relies on non-clinical bench testing and comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical trial or AI model validation study.
Ask a specific question about this device
Page 1 of 1