Search Results

KangLi® pedicle screw spinal system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-Sl vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 – S1.

The spinal system consists of pedicle screws, nuts, rods and crosslink etc. It is made of titanium alloy (Ti6Al4V ELI), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The provided text describes the 510(k) premarket notification for the KangLi® Pedicle Screw Spinal System. This is a medical device for spinal fixation, and the document focuses on demonstrating its substantial equivalence to a predicate device, rather than proving a new or novel performance against specific acceptance criteria for a diagnostic or AI-driven medical device.

Therefore, the information requested in your prompt (e.g., acceptance criteria for device performance like sensitivity/specificity, sample size for test sets, expert qualifications for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document because it pertains to a mechanical spinal implant, not a diagnostic or AI-assisted device assessed by such metrics.

The "Non-Clinical Testing" section (item 6) refers to bench tests to ensure the device meets design specifications and is substantially equivalent to the predicate. These tests are mechanical in nature, verifying physical properties and performance under stress, not diagnostic accuracy.

Here's a breakdown of what is available from the text relevant to mechanical equivalent performance:

1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance: Not applicable. These were bench tests, not clinical studies involving patient data or test sets for diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to diagnostic study design, not mechanical testing.

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 is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical properties, the "ground truth" is defined by the objective physical measurements and material properties specified in the ASTM and ISO standards (e.g., strength parameters, biocompatibility, sterilization efficacy).

8. The sample size for the training set: Not applicable. No training set for an AI or diagnostic algorithm was used.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on demonstrating substantial equivalence of a physical medical implant through adherence to established material and mechanical performance standards, not on diagnostic or AI performance metrics.

Ask a specific question about this device