(103 days)
The F3D Corpectomy devices are vertebral body replacement devices intended for use in the cervical (C2-T1) and thoracolumbar spine (T1-L5).
When used in the cervical spine (C2-T1), F3D Corpectomy devices are intended for use 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. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period 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.
When used in the thoracolumbar spine (T1-L5), F3D Corpectomy devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion.
These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
The F3D Corpectomy Cage is a spinal vertebral body replacement device which is available in a variety of different heights, footprints, and lordotic options to suit the individual pathology and anatomical conditions of the patient. The F3D Corpectomy cage consists of a static, single-piece vertebral body replacement cage. The F3D Corpectomy devices are intended for use in the cervical (C2-T1) and thoracolumbar spine (T1-L5). They are designed to provide mechanical support to the spine while arthrodesis occurs. The F3D Corpectomy System is made from titanium alloy (Ti-6Al-4V) per ASTM F3001.
The FDA 510(k) summary for the F3D Corpectomy System (K202637) focuses on establishing substantial equivalence to predicate devices through technical characteristics and mechanical performance testing, rather than an AI/ML context. Therefore, many typical AI/ML study components (like expert ground truth, adjudication, MRMC studies, training set details) are not applicable or mentioned.
Here's an analysis of the provided text, outlining the acceptance criteria and the study performed, along with the information that is not available given the nature of this medical device clearance (spinal implant, not an AI/ML device):
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the format of a table with specific thresholds. Instead, it refers to industry standards (ASTM F2077 and ASTM F2267) and concludes that the device's strength is "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength (Static Axial Compression) | Tested per ASTM F2077. Results showed the strength was sufficient for its intended use and substantially equivalent to predicate devices. |
| Mechanical Strength (Static Torsion) | Tested per ASTM F2077. Results showed the strength was sufficient for its intended use and substantially equivalent to predicate devices. |
| Mechanical Strength (Dynamic Axial Compression) | Tested per ASTM F2077. Results showed the strength was sufficient for its intended use and substantially equivalent to predicate devices. |
| Mechanical Strength (Dynamic Torsion) | Tested per ASTM F2077. Results showed the strength was sufficient for its intended use and substantially equivalent to predicate devices. |
| Resistance to Subsidence | Tested per ASTM F2267. Results showed the strength was sufficient for its intended use and substantially equivalent to predicate devices. |
| Resistance to Expulsion | Tested. Results showed the strength was sufficient for its intended use and substantially equivalent to predicate devices. |
| Biocompatibility | Stated as "identical" to predicate devices, implying it meets established biocompatibility standards. |
| Sterilization | Stated as "identical" to predicate devices, implying it meets established sterilization standards. |
| Material Composition (Ti-6Al-4V per ASTM F3001) | Confirmed; stated as "identical" to predicate devices, implying it meets material property requirements. |
| Technological Characteristics & Structural Support Mechanism | Stated as "nearly identical" to predicate devices, with minor differences not raising new safety/effectiveness issues. |
| Sizes | Stated as "identical" to predicate devices, implying it falls within expected dimensions for spinal implants. |
| Indications for Use | Stated as "identical" to predicate devices. This implies the device safely and effectively serves the specified purposes (vertebral body replacement for tumor, trauma, degenerative disorders). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices. The tests are typically performed on a statistically relevant number of physical device samples as required by the ASTM standards, but the exact count is not disclosed in the summary.
- Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting ("Performance Data" section). There is no mention of patient data (retrospective or prospective) or country of origin for such data, as this is a mechanical safety and performance study for a physical implant.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the evaluation is based on mechanical laboratory testing against industry standards, not on interpretation of medical images or patient outcomes requiring expert consensus.
4. Adjudication Method for the Test Set
- This information is not applicable as there is no human interpretation or decision-making process for the mechanical test results that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- This information is not applicable. The F3D Corpectomy System is a physical spinal implant, not an AI/ML-driven diagnostic or assistive device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable. The device is a physical implant and does not involve an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device, in a mechanical testing context, is adherence to established industry-wide performance standards (ASTM F2077 for static/dynamic compression and torsion, ASTM F2267 for subsidence) and demonstrating equivalency to already-cleared predicate devices. These standards represent scientifically validated methodologies for assessing the mechanical robustness and safety of spinal implants.
8. The Sample Size for the Training Set
- This information is not applicable as the device is not an AI/ML product and does not involve a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as the device is not an AI/ML product and does not involve a training set.
§ 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.