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The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization 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 Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• Spondylolisthesis;
• Trauma (i.e. fracture or dislocation);
• Spinal stenosis;
• Curvature (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 contains non-sterile single use titanium alloy (Ti-6Al-4V ELI per ASTM F136) and Cobalt Chromium (CoCr per ASTM F1537). 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 scope of the Republic Spine Dark Start Spinal System is being extended via a line extension to include additional rods, connectors, hooks and screws. New instrumentation will also be introduced to aid in the implantation of the new implants.

The safety and effectiveness of the fenestrated screw have not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). The fenestrated screws are intended to be used with saline or radiopaque dye.

This is a medical device submission for the Republic Spine Dark Star Spinal System, which is a multi-component posterior spinal fixation system. As such, the acceptance criteria and performance data are based on non-clinical (mechanical) testing rather than clinical performance (like an AI/CAD system would require).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The subject Republic Dark Star Spinal System implants were subjected to the following verification testing per required standards to establish substantial equivalent performance to the predicate device." It does not provide specific numerical results or pass/fail thresholds for these tests, rather it indicates that the tests were performed and the device demonstrated "substantial equivalent performance."

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

For the non-clinical performance data, the "sample size" refers to the number of devices or components tested for each mechanical test. The document does not explicitly state the exact number of samples tested for each ASTM standard.

• Data Provenance: The tests are described as "verification testing" performed on the "subject Republic Dark Star Spinal System implants." This implies in-house laboratory testing conducted by the manufacturer to demonstrate substantial equivalence to the predicate device. There is no information regarding the country of origin of the data as these are mechanical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this type of medical device submission. Ground truth established by experts is typically relevant for diagnostic or clinical evaluation of devices (e.g., AI/CAD systems interpreting images). For mechanical spinal implants, the "ground truth" is defined by the performance requirements of established ASTM standards.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical evaluations or image interpretations where multiple experts assess the same cases. Mechanical testing follows standardized protocols, and results are typically objective measurements.

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 question is not applicable. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of medical images, often with AI assistance. This submission is for a spinal implant.

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

This question is not applicable. "Standalone performance" refers to the evaluation of an AI algorithm without human involvement. This submission is for a physical medical implant, not an algorithm.

7. The type of ground truth used

For this device, the "ground truth" is based on engineering standards and design specifications. The device's performance is compared against the established mechanical properties and performance characteristics required by the referenced ASTM standards (ASTM F1717 and ASTM F1798) and its predicate device.

8. The sample size for the training set

This question is not applicable. "Training set" is a concept used in machine learning for AI algorithms. For a mechanical implant, there is no "training set" in this context. The manufacturing process and design are based on engineering principles and material science, not statistical training data.

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

This question is not applicable for the reasons mentioned in point 8. The "ground truth" for the design and manufacturing of the device is established by adherence to recognized engineering standards, material specifications, and quality control processes.

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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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The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization 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): · Severe Spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra

• · Degenerative spondylolisthesis with objective evidence of neurologic impairment
• · Trauma (i.e. fracture or dislocation)
• · Spinal stenosis
• · Curvature (i.e. scoliosis, kyphosis, and/or lordosis)
• Tumor
• · Pseudoarthrosis (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 contains non-sterile single use titanium alloy (Ti-6Al-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 a medical device called the "Republic Spine Dark Star Spinal System." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel AI/software medical device.

Therefore, the information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment typically requested for an AI/software device is not applicable to this document.

However, I can extract the information that is present concerning the device's performance evaluation, which is focused on mechanical testing for substantial equivalence:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc., as would be expected for an AI/software device. Instead, it states that the device's mechanical strength was evaluated against established standards and found to be "equivalent or better" than 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)

This information is not provided in the document. The testing described is mechanical, not involving human data or clinical study subjects.

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)

Not applicable. The "ground truth" for mechanical testing is derived from controlled laboratory conditions and adherence to ASTM standards.

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

Not applicable, as this refers to a method for establishing clinical ground truth, which was not part of this submission.

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 device is a spinal implant system, not an AI/software medical device requiring human reader interaction or MRMC studies.

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

Not applicable. This device is a physical medical implant.

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

The "ground truth" for the performance evaluation in this context refers to the specified requirements and methodologies outlined in the referenced ASTM standards (ASTM 1717-13, ASTM F543-07, and ASTM F1798-97). These standards define the acceptable mechanical properties and testing procedures for spinal implants.

8. The sample size for the training set

Not applicable. This device undergoes mechanical testing, not machine learning model training.

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

Not applicable. This device undergoes mechanical testing, not machine learning model training.

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