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The 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-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-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 according to the nature of the spinal pathology. The Uni-Thread System components are available in titanium alloy manufactured according to ASTM-F136.

The provided text describes a 510(k) premarket notification for the Uni-Thread™ Spinal System. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting data from a clinical study with specific acceptance criteria and performance metrics typically associated with AI/ML devices or novel diagnostic tools.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment is not available in the provided text. The submission relies on demonstrating similarity in design, material, and intended use to predicate devices, supported by a "beginning in" (likely meaning 'benchmark' or 'comparison') study to show equivalence of the construct design to currently marketed systems.

Here's a breakdown of why each requested point cannot be addressed from the given document:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria for device performance or report specific performance metrics (e.g., sensitivity, specificity, accuracy) akin to what would be expected for an AI/ML or diagnostic device. The basis for clearance is "substantial equivalence" to predicate devices.

2. Sample sized used for the test set and the data provenance: Not applicable. No "test set" in the context of AI/ML or diagnostic performance evaluation is mentioned. The "beginning in a was performed to demonstrate the equivalence of the construct design" likely refers to mechanical or engineering testing, but details are absent.

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. There is no mention of human experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.

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, not an AI-assisted diagnostic tool, so an MRMC study is irrelevant to its clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. As a physical medical device (spinal system), the concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic or AI performance. The "ground truth" for this device would be its mechanical and material properties meeting established standards, and its design being equivalent to predicate devices.

8. The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. There is no mention of a training set.

In summary, the provided document relates to the clearance of a physical medical device (a spinal implant) based on its substantial equivalence to existing devices, not on the performance metrics of an AI/ML system.

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The 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-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-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 according to the nature of the spinal pathology. The Uni-Thread System components are available in titanium alloy manufactured according to ASTM-F136.

The Uni-Thread™ Spinal System is a pedicle screw spinal system. The provided text, a 510(k) summary, indicates that this device received clearance based on its substantial equivalence to previously cleared devices. This means that the device's safety and effectiveness were demonstrated through comparison to predicate devices rather than a standalone clinical study with predefined acceptance criteria.

Therefore, the typical structure for reporting acceptance criteria and a study proving their fulfillment is not directly applicable here in the way it would be for a de novo device or one requiring a PMA.

Here's a breakdown of the available information based on your request, with an emphasis on how "substantial equivalence" impacts the answers:

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

Since the clearance is based on substantial equivalence, there are no specific, quantitative acceptance criteria for clinical performance in the provided document that the device had to meet in a standalone study. Instead, the "acceptance criteria" were demonstrating equivalence in design, materials, and mechanical performance to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No clinical or human-based test set with a specified sample size is mentioned in the 510(k) summary. The "test set" in this context refers to the mechanical testing samples. The document does not specify the sample size, country of origin, or whether the mechanical testing data was retrospective or prospective.

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 as there was no clinical study described that required expert-established ground truth. The device's equivalence was based on engineering and material comparisons, not diagnostic or therapeutic outcomes requiring expert review.

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

Not applicable for the same reasons as point 3.

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 mechanical implant (pedicle screw system), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is irrelevant.

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

No standalone clinical performance study was conducted or reported in this summary. The device was cleared based on substantial equivalence and mechanical testing, not a clinical trial.

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

For the mechanical testing, the "ground truth" would be the established performance standards or specifications for predicate devices or relevant ASTM standards for spinal implants. This is based on engineering principles and material science, not clinical outcomes or expert consensus on patient data.

8. The sample size for the training set:

Not applicable. This is a medical device, not an AI or machine learning algorithm that requires a training set.

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

Not applicable for the same reasons as point 8.

In summary: The provided 510(k) summary for the Uni-Thread™ Spinal System indicates clearance through the substantial equivalence pathway. This pathway primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through design, material, and mechanical performance comparisons, rather than extensive new clinical trials with predefined acceptance criteria and human subject data analysis.

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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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