(72 days)
The Devex Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar spine. The Devex Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Devex Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Devex Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).
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The provided text describes the Devex Mesh™ System, a spinal intervertebral body fixation orthosis device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way you've outlined for an AI/software device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, primarily through materials and intended use.
Here's an analysis based on the information provided, highlighting what's present and what's missing:
Acceptance Criteria and Device Performance Study (Devex Mesh™ System)
The provided document (K023835) is a 510(k) summary for the Devex Mesh™ System. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting detailed acceptance criteria and a novel clinical study with quantitative performance metrics for a software or AI-driven device.
Key Findings from the Document:
- Device Type: Spinal intervertebral body fixation orthosis device (hardware, not AI/software).
- Purpose: To replace diseased vertebral bodies, treat fractures, achieve anterior decompression, and restore vertebral height in the thoracolumbar spine (T1-L5).
- Materials: Titanium alloy (Ti-6Al-4V).
- Predicate Devices: Surgical Titanium Mesh System (K003043, K020522) and Stackable Cage System (K990148, K001340).
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no specific quantitative acceptance criteria or detailed reported device performance values presented in a table format as would be expected for an AI/software device.
The document states:
- Performance Data: "Biomechanical testing, including static axial compression and dynamic axial compression, were conducted."
This statement confirms that testing was done, but does not provide:
- Specific numerical acceptance thresholds for static or dynamic compression.
- The actual results (e.g., maximum load, fatigue cycles) from these tests.
- A comparison of these results against the predicate device's performance or predefined acceptance criteria.
For a hardware device like this, acceptance criteria would typically involve engineering specifications related to:
- Static compression strength (e.g., ability to withstand a certain load without permanent deformation).
- Dynamic/fatigue strength (e.g., ability to withstand a certain number of loading cycles without failure).
- Corrosion resistance.
- Biocompatibility.
- Sterility.
However, these specific details are not present in the 510(k) summary. The submission likely references internal test reports that contain these data, but they are not included in this summary document.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable (N/A) / Not provided.
For a biomechanical hardware test, the "sample size" refers to the number of devices or constructs tested. The provided text only states that "biomechanical testing... were conducted" but does not specify the number of samples (devices) used for static or dynamic axial compression tests. Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of in-vitro biomechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable (N/A).
For biomechanical testing of a spinal implant, "ground truth" is established by physical measurement standards and engineering principles, not by human experts adjudicating images or clinical outcomes. The "experts" would be the engineers and technicians performing the tests according to established ASTM or ISO standards. Their qualifications would be in mechanical engineering, materials science, or related fields, with experience in orthopaedic implant testing. This information is not provided.
4. Adjudication Method for the Test Set
Not Applicable (N/A).
Adjudication methods (e.g., 2+1) are relevant for clinical studies or studies involving human interpretation (like radiologists reviewing images). For biomechanical testing, the "ground truth" is derived from physical measurements (e.g., load cells, displacement sensors) and engineering calculations based on the test setup and observed device behavior, not through expert consensus on qualitative data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done.
MRMC studies are typically performed for diagnostic imaging devices or AI algorithms that assist human readers. This device is a surgical implant; therefore, an MRMC study is not relevant to its performance assessment as described in this 510(k) summary.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
Not Applicable (N/A).
This question is relevant for AI/software devices. The Devex Mesh™ System is a physical surgical implant, so there is no "algorithm only" performance to be evaluated. The biomechanical tests can be considered "standalone" in the sense that they evaluate the physical device properties without human intervention during the test itself, but this is distinct from the context of AI performance.
7. The Type of Ground Truth Used
For biomechanical testing, the "ground truth" is based on:
- Physical Measurement Standards: Force-displacement curves, ultimate load, and cycles to failure are measured directly using calibrated equipment according to recognized industry standards (e.g., ASTM F451 for static compression of metallic bone plates, or specific standards for vertebral body replacement devices).
- Engineering Principles: The interpretation of these measurements against defined mechanical properties of the material and design.
- Comparison to Predicate: The performance is typically compared to that of the predicate device, demonstrating that the new device is "substantially equivalent" in its mechanical characteristics.
8. The Sample Size for the Training Set
Not Applicable (N/A).
The concept of a "training set" refers to data used to train a machine learning model. This is a physical medical device, not an AI/software algorithm. Therefore, there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
Not Applicable (N/A).
As there is no training set for an AI/software model, this question does not apply to the Devex Mesh™ System.
In summary, the provided 510(k) document (K023835) for the Devex Mesh™ System is for a physical medical device (vertebral body replacement) and focuses on demonstrating substantial equivalence through materials and biomechanical testing. It does not contain the detailed quantitative acceptance criteria or a specific study in the format typically associated with AI/software device submissions. The "performance data" section only states that biomechanical testing was conducted, without providing the specific results or acceptance values.
§ 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.