(71 days)
The KINETIC™ Anterior Cervical Plate is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with:
- Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);
- Spondylolisthesis
- Trauma (including fractures or dislocations);
- Spinal cord stenosis;
- Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis);
- Tumors;
- Pseudarthrosis;
- Failed previous fusions.
The KINETIC™ Anterior Cervical Plate consists of various sizes of anterior cervical bone plates, screws and screw locking tabs. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. The KINETIC™ Anterior Cervical Plate components will be supplied clean and "NON-STERILE".
This document is a 510(k) Summary for a medical device called the KINETIC™ Anterior Cervical Plate. It is not a clinical study report that would typically describe the detailed acceptance criteria and a study proving the device meets those criteria in terms of clinical performance (e.g., diagnostic accuracy, treatment efficacy).
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for many Class II medical devices in the United States. In the context of a 510(k), "acceptance criteria" generally refer to the criteria for demonstrating substantial equivalence, often through engineering and bench testing rather than large-scale clinical trials.
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent to predicate devices when tested per ASTM F1717 for Spinal Intervertebral Body Fixation Orthosis. | Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence. (Specific numerical performance metrics are not provided in this summary but would be in the underlying test report). |
| Material: Use of implant grade titanium alloy 6A1-4V ELI per ASTM F-136. | "Manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136." |
| Indications for Use: (Implied) Align with predicate device's indications. | Stated Indications for Use for KINETIC™ Anterior Cervical Plate, which were reviewed by the FDA as substantially equivalent to legally marketed predicate devices. |
| Design and Function: (Implied) Similar to predicate devices. | "The KINETIC™ Anterior Cervical Plate was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Description: The "test set" in this context refers to the physical samples of the KINETIC™ Anterior Cervical Plate and its components that underwent biomechanical testing. The document does not specify the sample size (number of devices or constructs tested) for the ASTM F1717 biomechanical testing.
- Data Provenance: Not explicitly stated, but typically, such biomechanical testing is conducted in a laboratory setting, likely in the country of manufacture or a contract testing facility. This would be considered prospective data generation for the purpose of demonstrating device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This question is not applicable in the context of this 510(k) summary. The "ground truth" for biomechanical testing is established by the specifications of the ASTM F1717 standard and the results of the physical tests performed on the device. It does not involve expert consensus in the way a diagnostic AI device would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods like "2+1" are used in clinical studies or studies involving expert review of images or cases to establish ground truth. Biomechanical testing relies on objective measurements according to a standard protocol.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study applies to diagnostic devices, particularly those involving human interpretation of medical images, often with AI assistance. The KINETIC™ Anterior Cervical Plate is an implantable spinal fixation device, not a diagnostic tool requiring human reader interpretation in that manner.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context refers to the established safety and effectiveness parameters for spinal fixation devices. This is primarily determined by:
- Benchtop biomechanical testing standards: Specifically, ASTM F1717, which dictates how spinal fixation devices should be tested for mechanical properties (e.g., strength, stiffness, fatigue). The "ground truth" is that the device must meet or exceed the performance of predicate devices under these standardized test conditions.
- Material standards: ASTM F-136 for titanium alloy 6A1-4V ELI, which ensures the material meets biocompatibility and mechanical requirements for implantable devices.
- Predicate device history: The regulatory history and known safety/effectiveness of the predicate device (NEO™ Anterior Cervical Plate System K040844 and others) serve as a baseline "ground truth" for substantial equivalence.
8. The sample size for the training set
- This question is not applicable. There is no "training set" in the context of developing this physical medical device. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
- This question is not applicable as there is no training set.
In summary:
This 510(k) summary demonstrates compliance through demonstrating substantial equivalence to a predicate device, primarily relying on adherence to recognized material standards and biomechanical (bench) testing standards (ASTM F1717). It does not involve clinical trials or studies typically seen for diagnostic AI devices, and therefore many of the questions related to expert review, ground truth establishment, and training/test sets for AI are not applicable.
§ 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.