Search Results

OpenLoc-L Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor, stenosis; and failed previous fusion (pseudoarthrosis).

The OpenLoc-L Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in sketally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the OpenLoc-L Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

This system is comprised of screws, set screws, rods, crosslink, Hook and connectors. The components of this system are manufactured by Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm.

This is a 510(k) premarket notification for a spinal fixation system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study design for AI/ML performance is not applicable. The document describes a medical device, the OpenLoc-L Spinal Fixation System, and its substantial equivalence to a predicate device based on mechanical performance testing.

Here's an analysis of the provided text in the context of the device described:

Device Description:
The OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device. It consists of screws, set screws, rods, crosslinks, hooks, and connectors. These components are made from Titanium alloy (ASTM F136) and CoCrMo alloy (ASTM F1537).

Indications for Use:
The system is intended for use as a posterior pedicle screw fixation system (T1-S2/ilium) or as an anterolateral fixation system (T8-L5) in skeletally mature patients. It is an adjunct to fusion for indications such as degenerative disc disease, spondylolisthesis, trauma, deformities (scoliosis, kyphosis, lordosis), tumor, stenosis, and failed previous fusion. It is also specifically indicated for severe spondylolisthesis (Grades 3 and 4) of L5-S1 and for immobilization and stabilization of spinal segments in acute and chronic instabilities or deformities.

Predicate Device:
The predicate device is the LnK Spinal Fixation System (K143363).

Acceptance Criteria and Study for a Spinal Fixation System (Mechanical Testing):

Since this is a mechanical device, the acceptance criteria are typically based on established industry standards for mechanical performance, and the study involves bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

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

   Acceptance Criteria (based on ASTM F543-13 and comparison to predicate)	Reported Device Performance
   General Performance: Substantially equivalent mechanical performance to predicate device (LnK Spinal Fixation System K143363) regarding pullout strength.	Pullout Testing: Results demonstrate substantially equivalent performance to the legally marketed predicate device.
   Material Compatibility, Sterility, and Design: Materials (Ti-6Al-4V ELI, Co-Cr-Mo alloy), non-sterile status, and design (screw diameters/lengths, rod diameters/lengths, hook types) should be equivalent to the predicate device.	The subject device utilizes the same materials (ASTM F136 & F1537) and has similar design specifications (screw and rod dimensions, hook types) as the predicate.

2. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify the exact number of screws or constructs tested. For mechanical testing per ASTM standards, a sufficient number of samples (e.g., typically 5-10 per test condition, depending on the standard and variability) would be used to achieve statistical significance.
   • Data Provenance: The testing was performed in the context of a 510(k) submission, meaning it's pre-market data generated by the manufacturer (L&K BIOMED Co., Ltd.) to demonstrate product safety and effectiveness. The country of origin of the testing lab is not explicitly stated, but the submission is from Korea. The testing would be prospective in the sense that it was conducted specifically for this submission.

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 to mechanical performance testing of a spinal fixation system. "Ground truth" in this context would refer to the physical testing standards (e.g., ASTM F543-13) and engineering principles, not expert clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods are relevant for human interpretation tasks (e.g., image reading) where multiple experts or readers are involved. For mechanical bench testing, the results are quantitative measurements against predefined 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:

   • Not applicable. This is a question for AI/ML device performance, not a mechanical spinal implant. No human readers or AI assistance are involved in evaluating the mechanical performance of a pedicle screw system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This pertains to AI/ML software. The device in question is a physical spinal implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the mechanical performance testing, the "ground truth" is defined by the ASTM F543-13 standard for pullout testing. This standard specifies the methodology and acceptable criteria for evaluating the pullout strength of metallic medical bone screws. Substantial equivalence to the predicate device, which would have also demonstrated compliance with such standards, is the benchmark.

8. The sample size for the training set:

   • Not applicable. There is no "training set" for physical mechanical devices. This concept is relevant for AI/ML models.

9. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

In summary, the provided document details a 510(k) submission for a traditional mechanical medical device, not an AI/ML product. The evaluation criteria are based on mechanical bench testing and comparison to an existing predicate device using recognized industry standards (e.g., ASTM).

Ask a specific question about this device