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When used as a cervical intervertebral body fusion device, the Republic Spine Restore Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Republic Spine Restore Cervical Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Republic Spine Restore cervical interbody fusion device, which is intended to be implanted as a single device via an anterior approach.

The provided text is a 510(k) premarket notification for a medical device (Republic Spine Restore Cervical Interbody Fusion System). It does not contain information related to an AI/ML-based medical device study, acceptance criteria, or performance data for such a study.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving a device meets these criteria based on the input provided. The document describes mechanical testing for an implantable device, not a study evaluating an AI system's performance.

To answer your request, I would need a document detailing the clinical performance study of an AI-powered medical device, including information on its acceptance criteria, study design, expert involvement, and ground truth establishment.

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The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle rigid fixation of the spine 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 (T1-S1):

• · Degenerative Disc Disease (DDD);
• · Spondylolisthesis;
• · Trauma (i.e. fracture or dislocation);
• · Spinal stenosis;
• · Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
• · Tumor;
• · Pseudoarthrosis; and
• · Failed previous fusion

The Republic Spine Dark Star Spinal System is a multi-component posterior spinal fixation system which consists of pedicle screws, rods, locking spacers, and cross-linking mechanism. The system is contains non-sterile single use titanium alloy (Ti-6AI-4V ELI) implantable components that comply with ASTM F136. Various sizes of these implants are available. Instrumentation is available for the delivery and removal of the Republic Spine Dark Star Spinal System. The system allows the surgeon to build a spinal implant construct to stabilize and promote spinal fusion.

The provided document is a 510(k) premarket notification for the "Republic Spine Dark Star Spinal System," which is a spinal implant. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to establish acceptance criteria for device performance as would be done for a novel device.

Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical trial for a new medical device. Instead, it relies on demonstrating that the modified device is substantially equivalent to a previously cleared predicate device based on non-clinical performance data and design similarities.

Here's a breakdown of why the requested information cannot be fully provided from this document:

1. A table of acceptance criteria and the reported device performance:
   The document does not explicitly state acceptance criteria for a new clinical study. Instead, it relies on previously tested performance of the predicate device against specific ASTM standards for mechanical strength.

2. Sample sized used for the test set and the data provenance:
   No clinical test set with human or animal subjects is mentioned for the subject device. The non-clinical performance data refers to testing done on the predicate device against engineering standards (ASTM F1717, ASTM F1798-97). Therefore, there is no sample size in terms of test subjects or data provenance from a new study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This is not applicable as there is no clinical test set in the context of this 510(k) submission.

4. Adjudication method for the test set:
   This is not applicable for the same reason as above.

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:
   This is entirely not applicable. The device is a spinal implant (pedicle screw system), 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 device is a physical spinal implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical performance data of the predicate device, the "ground truth" would be the engineering specifications and performance requirements outlined in the ASTM standards.

8. The sample size for the training set:
   Not applicable, as this device does not involve machine learning or AI models with training sets.

9. How the ground truth for the training set was established:
   Not applicable, for the same reason as above.

Summary based on the provided document:

The device (Republic Spine Dark Star Spinal System) is seeking 510(k) clearance, which means it aims to demonstrate substantial equivalence to a predicate device.

Key points from the document regarding "acceptance criteria" and "study":

• The document explicitly states: "Clinical performance data is not required to demonstrate substantial equivalence to the predicate."
• The "study" referenced is non-clinical performance data previously conducted on the predicate device (Republic Spine Dark Star Spinal System, K150283).
• These predicate tests were against established ASTM standards for mechanical strength:
  • Static compression bending per ASTM F1717
  • Static torsion per ASTM F1717
  • Dynamic compression bending per ASTM F1717
  • Torsional, Axial and Flexural Grip ASTM F1798-97
• The subject device (modified Republic Spine Dark Star Spinal System) did not undergo new performance testing because the modifications "do not introduce a new, worst-case compared to the predicate devices tested per the standards identified above."
• The conclusion is that the subject device's mechanical strength is "equivalent or better" than the predicate based on these prior tests.

In essence, the "acceptance criteria" were the performance requirements of the ASTM standards, and the "study" was the non-clinical testing of the predicate device against these standards. The subject device's modifications were deemed not to negatively impact this established performance.

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