(89 days)
ANAX™ OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. ANAX™ OCT Spinal System is also 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.
In order to achieve additional levels of fixation, ANAX™ OCT Spinal System may be connected to Perfix™ Spinal System and ANAXIN 5.5 Spinal System rods with the rod connectors. Transition rods with differing diameters may also be used to connect ANAX™ OCT Spinal System to Perfix™ Spinal System and ANAX™ 5.5 Spinal System.
ANAX™ OCT Spinal System is manufactured by U&I corporation. ANAX™ OCT Spinal System is for fixation the Cervicocranium (Occiput/C2), the true subaxial region (C3/C6), and the cervicothoracic junction (C7 to T2) by one system. The ANAX™ OCT Spinal System consists of polyaxial screws, polyaxial shank screws, hooks, rods, set screws, transverse(cross) links and occipital plate. Connectors are also provided for surgical convenience. ANAX™OCT Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The singleuse ANAX™ OCT Spinal System components are supplied as non- sterile and are fabricated from medical grade titanium alloy (ASTM F136). All polyaxial screws have self-tapping function in the ANAX™ OCT Spinal System. Specialized instruments made from surqical instrument grade stainless steel are available for the application and removal of the ANAX™ OCT Spinal System implants.
The provided document is a 510(k) premarket notification for the ANAX™ OCT Spinal System. This type of document focuses on establishing substantial equivalence to a predicate device rather than detailing extensive clinical studies with specific acceptance criteria for diagnostic performance. Therefore, most of the requested information regarding diagnostic accuracy, sample sizes for test sets, expert adjudication, MRMC studies, and ground truth for training data is not present in this document.
However, the document does describe performance testing related to the device's mechanical properties.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "The mechanical performance of ANAX™ OCT Spinal System met the acceptance criteria which have been established from the predicate device." and "All tests met all acceptance criteria and that verifies performance of the ANAX™ OCT Spinal System is substantially equivalent to predicate devices."
However, specific numerical acceptance criteria (e.g., minimum load, maximum deflection) for each test are not provided in this summary. The table below outlines the tests performed and the general statement about their performance.
| Test Type | Standard Applied | Reported Device Performance |
|---|---|---|
| Occipito-cervical portion (Worst case constructs): | ASTM F2706 | Met acceptance criteria established from the predicate device. |
| Static compression bending test | Met acceptance criteria established from the predicate device. | |
| Static torsion test | Met acceptance criteria established from the predicate device. | |
| Axial compression fatigue test | Met acceptance criteria established from the predicate device. | |
| Axial torsion fatigue test | Met acceptance criteria established from the predicate device. | |
| Thoracic portion (Worst case constructs): | ASTM F1717 | Met acceptance criteria established from the predicate device. |
| Static compression bending test | Met acceptance criteria established from the predicate device. | |
| Static torsion test | Met acceptance criteria established from the predicate device. | |
| Axial compression fatigue test | Met acceptance criteria established from the predicate device. | |
| Axial torsion fatigue test | Met acceptance criteria established from the predicate device. | |
| Subassembly (Worst case): | ASTM F1798 | Met acceptance criteria established from the predicate device. |
| Axial gripping capacity test | Met acceptance criteria established from the predicate device. | |
| Axial torque gripping capacity test | Met acceptance criteria established from the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "worst case constructs" for the mechanical tests, but does not specify the number of samples or constructs tested for each test.
- Data Provenance: The tests were conducted in a "non-clinical setting (bench testing)". The document does not specify the country where the tests were performed, but the manufacturer is based in the Republic of Korea. It is lab-based testing, not human-origin data.
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 is not applicable as the described study is mechanical bench testing, not a study involving diagnostic interpretation or human expert assessment of a medical condition.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the described study is mechanical bench testing and does not involve expert adjudication of a test set.
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
There is no MRMC or comparative effectiveness study mentioned in the document. The study described is mechanical bench testing of an implantable device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the ANAX™ OCT Spinal System is a physical implantable device, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" is defined by the standards (ASTM F2706, ASTM F1717, ASTM F1798) and the acceptance criteria established from the predicate device. These standards define parameters for measuring mechanical integrity (e.g., load to failure, fatigue life) which serve as the "ground truth" for evaluating the device's performance.
8. The sample size for the training set
This is not applicable as the document describes mechanical testing of a physical device, not an algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also 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.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.