(263 days)
The Neurostructures Belvedere™ Lateral Plating System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of disco genic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.
The Belvedere™ Lateral Plating System provides an assortment of thoracic and thoracolumbar plates and screws. The plates and screws provided are manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. Multiple variations of the screws are provided in lengths of 20-70mm and diameters of 5.0-6.5mm. The plates are provided in lengths of 36-132mm.
The provided document is a 510(k) premarket notification from the FDA for a medical device called the "Belvedere™ Lateral Plating System." This type of document focuses on establishing substantial equivalence to a predicate device, primarily through mechanical performance testing for spinal implants, rather than clinical studies on patient outcomes or AI performance.
Therefore, many of the requested categories related to AI performance, clinical study design, and ground truth establishment are not applicable.
Here's the information that can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document states that the device was tested according to ASTM F1717-14 standards, and the results show that "the strength of the Belvedere™ Lateral Plating System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
The document does not explicitly state specific numerical acceptance criteria for each test (e.g., minimum bending strength in Nm) nor does it provide the numerical reported device performance values. It only provides a qualitative conclusion of sufficiency and equivalence. To get these specific numbers, one would typically need to refer to the full test reports submitted to the FDA, which are not provided here.
| Test Mode (per ASTM F1717-14) | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Static axial compression bending | Sufficient for intended use and substantially equivalent to predicate devices (Implied by FDA clearance and 510(k) summary) | Strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. (Specific values not provided) |
| Static torsion | Sufficient for intended use and substantially equivalent to predicate devices (Implied by FDA clearance and 510(k) summary) | Strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. (Specific values not provided) |
| Static tension | Sufficient for intended use and substantially equivalent to predicate devices (Implied by FDA clearance and 510(k) summary) | Strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. (Specific values not provided) |
| Dynamic axial compression bending | Sufficient for intended use and substantially equivalent to predicate devices (Implied by FDA clearance and 510(k) summary) | Strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. (Specific values not provided) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in this summary. Mechanical tests typically involve a sample size of components according to ASTM standards, but the exact number of plates and screws tested is not disclosed.
- Data Provenance: The tests are "non-clinical testing," meaning they were conducted in a laboratory setting on the device components, not on human or animal subjects. The data provenance is mechanical testing conducted by the manufacturer or a contracted lab. Neither country of origin of data nor retrospective/prospective is applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical device performance study, not a study requiring expert clinical review to establish ground truth. The "ground truth" for these tests would be the measured physical properties of the materials and constructs themselves according to standardized testing protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for mechanical laboratory testing.
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
Not applicable. This document describes a physical medical device (spinal plating system), not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for mechanical performance is the objective measurement of physical properties (e.g., strength, stiffness, fatigue life) as defined by the ASTM F1717-14 standard.
8. The sample size for the training set
Not applicable. There is no training set mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. No training set exists for this type of device.
§ 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.