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The UNI-T Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who:

• have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
• receive fusions using autogenous bone graft only; .
• have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
• have the device removed after the development of a solid fusion. .

In addition, the UNI-T Uni-Thread Spinal System is a pedicle screw system intended 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 spondylolisthesis with objective evidence of neurologic impairment ●
• fracture
• . dislocation
• scoliosis ●
• kyphosis
• spinal tumor ●
• failed previous fusion (pseudoarthrosis) ●

The UNI-T Uni-Threaad Spinal System instrumentation consists of screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying to the nature of the spinal pathology. The UNI-T System components are available in titanium alloy manufactured according to ASTM-F136.

The acceptance criteria and study proving the device meets them are not provided in the input text. The document is a 510(k) summary for a spinal system, which primarily focuses on establishing substantial equivalence to a predicate device through design, material, and intended use comparison, along with mechanical testing.

Here's what can be extracted based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Missing Information: The specific acceptance criteria (e.g., specific load endurance, fatigue limits, pull-out strength, range of motion, etc.) for the mechanical testing are not detailed. The actual results of these tests are also not provided, only the statement that equivalence was demonstrated.

2. Sample Size Used for the Test Set and Data Provenance:

• Missing Information: The sample size for the mechanical tests is not mentioned. The data provenance is also not specified (e.g., country of origin, retrospective/prospective). Mechanical testing in this context typically refers to laboratory bench testing rather than clinical data from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Not Applicable: For mechanical testing of a spinal implant, "ground truth" as a clinical diagnosis established by experts is not relevant. The "ground truth" would be the engineering specifications and test standards.

4. Adjudication Method for the Test Set:

• Not Applicable: As this is mechanical testing, there is no adjudication method in the sense of clinical interpretations. Results are typically analyzed against predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No: The document does not describe an MRMC study. The study presented here is focused on mechanical equivalence of the device, not comparative effectiveness with human readers or AI assistance.

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

• No: This device is a mechanical spinal implant, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used:

• Mechanical Testing Standards/Specifications: The "ground truth" for this type of test would be the predetermined engineering and biomechanical specifications and standards (e.g., ASTM standards for spinal implants) against which the device's performance is measured. These specific standards are not detailed in the summary.

8. The Sample Size for the Training Set:

• Not Applicable: This is a physical medical device. There is no concept of a "training set" in the context of an algorithm or AI model development described in this document.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable: As there is no training set mentioned, this question is not applicable.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The study referenced is mechanical testing performed to demonstrate that the UNI-T Uni-Thread Spinal System is equivalent in construct design to currently marketed spinal systems. The basis of substantial equivalence is stated as the components being "identical in design, material, and intended use to other spinal instrumentation system that have been cleared by FDA for posterior spinal use." The mechanical testing serves to support this claim of equivalence.

However, the 510(k) summary does not provide details on:

• The specific types of mechanical tests conducted (e.g., static compression, cyclic fatigue, bending strength).
• The actual quantitative results of these tests.
• The acceptance criteria (e.g., "must meet or exceed predicate device performance for X, Y, Z parameters").
• The number of samples tested.

The overall conclusion reached by the FDA is that the device is "substantially equivalent" based on the information provided, including the implicitly successful mechanical testing results.

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