(62 days)
When intended to promote fusion of the cervical spine (CI-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:
-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies) -Spondylolisthesis
-Spinal Stenosis
-Fracture/dislocation
-Revision of previous cervical spine surgery
-Tumors
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.
The Sure Lok Mini Posterior Cervical/Upper Thoracic System consists of polyaxial screws, rods and hooks. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium alloy. The components will be provided non-sterile.
The provided document describes a 510(k) premarket notification for the "Sure Lok Mini Posterior Cervical/Upper Thoracic System." This submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a study with specific acceptance criteria and performance data for a standalone device in a clinical setting.
Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, and human-in-the-loop performance, are not applicable or not available in this type of submission.
Here's a breakdown of the information that can be extracted or inferred based on the provided text, and where the requested details are not relevant to this submission:
1. Table of acceptance criteria and reported device performance:
This device is a spinal implant for fixation. The "acceptance criteria" here relate to meeting the performance characteristics of predicate devices through mechanical testing and demonstrating substantial equivalence in design, materials, and intended use. The performance is reported in terms of passing these mechanical tests.
| Acceptance Criteria (Based on ASTM F1717) | Reported Device Performance |
|---|---|
| Static Axial Compression Bending test | Passed |
| Static Torsion test | Passed |
| Dynamic Axial Compression Bending test | Passed |
| Dynamic Torsion test | Passed |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of clinical data for diagnostic or AI performance. The "test set" here refers to the physical samples of the device components subjected to mechanical testing. The document does not specify the number of individual components tested but implies sufficient testing to meet ASTM F1717 standards.
- Data Provenance: Not applicable in the context of clinical data. The mechanical testing was performed in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission does not involve clinical data requiring expert ground truth for classification or diagnosis. The "ground truth" for this device's performance is adherence to established mechanical testing standards (ASTM F1717).
4. Adjudication method for the test set:
- Not applicable. This submission does not involve clinical data requiring adjudication. Mechanical test results are objective measurements against defined standards.
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. This is not an AI or diagnostic device. It's a spinal implant. MRMC studies are not relevant to this type of device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI or algorithm-based device. "Standalone" performance as a diagnostic algorithm is not applicable. The device's "standalone" performance is its mechanical integrity under various loads, which was tested.
7. The type of ground truth used:
- Mechanical Testing Standards (ASTM F1717): The "ground truth" for this device's performance relies on its ability to withstand specified mechanical forces and stresses according to a recognized standard (ASTM F1717). This standard dictates the test methods and performance metrics for spinal implant constructs.
- Substantial Equivalence: The ultimate "ground truth" for regulatory clearance is demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, indications, anatomic sites, performance, and material of manufacture.
8. The sample size for the training set:
- Not applicable. This submission does not involve an AI model or a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. As there is no AI model or training set, this question is not relevant.
Summary of the K112025 Submission:
This 510(k) submission for the Sure Lok Mini Posterior Cervical/Upper Thoracic System focuses on demonstrating substantial equivalence to predicate devices. This is achieved by:
- Matching Intended Use and Indications: The device shares the same intended use and indications for fusion of the cervical spine as its predicates.
- Similar Design and Materials: The components (polyaxial screws, rods, hooks) are described as similar in design concept, screw thread type, size, length, locking mechanisms, torque, angulation, and dimensions to predicate systems. All components are fabricated from titanium alloy, the same material as the predicates.
- Mechanical Testing: Performance was verified through mechanical testing performed according to ASTM F1717, a recognized standard for spinal implant constructs. This testing confirmed the device's mechanical integrity under static and dynamic axial compression bending and torsion, demonstrating comparable performance to predicate devices.
The information provided does not pertain to the evaluation of a diagnostic device or an AI algorithm, but rather a physical implant device where regulatory clearance relies on established engineering principles and comparison to existing, cleared products.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.