(95 days)
The Ocata™ Anterior Cervical System is intended for anterior interbody screw fixation of the cervical spine from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine as an adjunct to fusion for patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures and dislocations), tumors, spondylolisthesis, deformity (defined as kyphosis, lordosis, or scoliosis), spinal stenosis, pseudarthrosis, and/or failed previous fusions. This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Ocata Anterior Cervical System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion.
The Ocata Anterior Cervical System consists of a variety of shapes and sizes of bone plates, screws (available in self-drilling or self-tapping, fixed or variable configurations), and associated instruments.
Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The Ocata™ Anterior Cervical System implant components are made from titanium alloy.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Ocata™ Anterior Cervical System.
Upon reviewing the provided document, it becomes clear that this is a 510(k) submission for a medical device (spinal implant), not an AI/ML software or diagnostic device. Therefore, the questions related to AI performance metrics, ground truth establishment, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes for AI are not applicable to this submission.
The document primarily focuses on establishing substantial equivalence to previously marketed predicate devices based on non-clinical mechanical testing.
Here's the information extracted and adapted to the context of a medical implant:
1. A table of acceptance criteria and the reported device performance
For medical implants like the Ocata™ Anterior Cervical System, "acceptance criteria" and "reported device performance" are typically defined by recognized standards for mechanical and material properties. The submission states that tests were conducted according to ASTM standards. The acceptance criteria are implicitly that the device's performance meets or exceeds the requirements of these standards and is comparable to previously cleared predicate devices.
| Acceptance Criteria (Proxy) | Reported Device Performance |
|---|---|
| Plates meet static and dynamic compression requirements per ASTM F1717 | Performed. Results indicate equivalence to predicate devices. (Specific quantitative values are not provided in this summary.) |
| Plates meet torsion requirements per ASTM F1717 | Performed. Results indicate equivalence to predicate devices. (Specific quantitative values are not provided in this summary.) |
| Screws meet torsional yield strength requirements per ASTM F543 | Performed. Results indicate equivalence to predicate devices. (Specific quantitative values are not provided in this summary.) |
| Screws meet driving torque requirements per ASTM F543 | Performed. Results indicate equivalence to predicate devices. (Specific quantitative values are not provided in this summary.) |
| Screws meet axial pullout strength requirements per ASTM F543 | Performed. Results indicate equivalence to predicate devices. (Specific quantitative values are not provided in this summary.) |
| Material (Ti-6Al-4V ELI) conforms to ASTM F136 | Stated that implants are made from Ti-6Al-4V ELI conforming to ASTM F136. |
| Instrument materials (17-4 H900 SS or 465 SS H950) conform to ASTM F899 | Stated that system-specific instruments are made from either 17-4 H900 SS or 465 SS H950 conforming to ASTM F899. |
| Overall mechanical safety and performance equivalent to predicate devices | "The results of these evaluations indicate that the Ocata™ Anterior Cervical System is equivalent to predicate devices." This is the ultimate reported performance outcome relative to the primary predicate (Theken Surgical TetherTM ACFS – K010466) and additional predicates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in the summary for each specific test (e.g., how many plates were tested for compression). However, mechanical testing for medical devices typically involves a statistically relevant number of samples to demonstrate consistency.
- Data Provenance: The tests are non-clinical, mechanical tests. This means the data is generated in a laboratory setting, not from human or animal subjects. The location of the testing facility is not specified, but it would have been performed by or for Kalitec Direct, LLC.
- Retrospective or Prospective: Not applicable as these are laboratory-based mechanical tests.
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)
Not applicable. "Ground truth" in the context of this device refers to the established mechanical properties and material standards (e.g., ASTM F1717, ASTM F543, ASTM F136). The "experts" involved are engineers and materials scientists who perform and interpret these tests according to recognized industry standards, rather than medical experts establishing diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Mechanical testing results are objective measurements that are compared against predefined numerical criteria outlined in the relevant ASTM standards. There is no human adjudication process involved in assessing test results in the same way there would be for image interpretation by clinicians.
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 device is a physical implant, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established engineering standards and material specifications (e.g., ASTM F1717 for static and dynamic compression and torsion, ASTM F543 for screw properties, ASTM F136 for implant material, ASTM F899 for instrument material). The device's performance is deemed acceptable if it meets these standards and is shown to be equivalent to the predicate devices which have already demonstrated safety and efficacy through their own testing and market history.
8. The sample size for the training set
Not applicable. This device is a physical implant, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.