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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-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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When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:

• degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• spondylolisthesis
• fracture
• spinal stenosis
• deformities (i.e. scoliosis, kyphosis, lordosis)
• tumors
• failed previous fusion (pseudoarthrosis)

The PLUS Pivot Link Universal System is also 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 PLUS Pivot Link Universal 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 PLUS Pivot Link Universal System spinal instrumentation consists of hooks, 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 PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.

The provided text describes a medical device submission (510(k)) for the PLUS™ Pivot Link Universal System. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of an AI algorithm or diagnostic performance.

The document is a regulatory submission for a spinal instrumentation system, focusing on its design, materials, indications for use, and a claim of substantial equivalence to previously cleared devices based on mechanical testing. It's a traditional medical device submission, not one related to an AI/ML powered device.

Therefore, I cannot provide the requested information for the following reasons:

• No AI/ML Component: The device described in the document is a physical spinal instrumentation system (rods, hooks, screws), not an AI algorithm or a diagnostic imaging device. As such, concepts like "acceptance criteria for device performance" in the context of sensitivity, specificity, AUC, human reader improvement, and ground truth establishment (other than for materials testing) are not applicable to this submission.
• No Performance Study as Described: The document mentions "Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems." This mechanical testing is done to ensure the structural integrity and functionality of the physical components, not to assess diagnostic accuracy or an AI's performance.

If you have a document describing an AI/ML medical device, I would be happy to analyze it for the requested information.

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The C3™ Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion.

The C3™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.

The C3™ Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.

The C3™ Anterior Cervical Plate System is a titanium alloy anterior cervical plate fixation system. The system consists of a number of plates and screws of varying lengths and a variety of cover plates with locking set screws. Screws are available in different diameters, several lengths, and two different styles: fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws.

The provided text describes the "C3™ Anterior Cervical Plate System" and its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices through performance data. However, the document does not contain specific acceptance criteria, detailed study designs, or results that could be used to fill out the requested table for proving the device meets acceptance criteria.

The information provided only mentions "Non-clinical: Static and fatigue testing was performed. Properties of stiffness, strength, and fatigue life were characterized." This is a general statement about the type of testing conducted, but it lacks specific acceptance thresholds, detailed test parameters, or quantitative results to demonstrate compliance with particular criteria.

Therefore, I cannot provide a detailed response to most of your questions as the necessary information is not present in the provided text.

Here's a breakdown of what can be inferred from the text and what cannot:

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

• Cannot be provided. The document states that "Static and fatigue testing was performed. Properties of stiffness, strength, and fatigue life were characterized." However, it does not specify what the acceptance criteria were for these properties (e.g., minimum stiffness values, maximum fatigue cycles without failure, specific strength thresholds) or the reported performance in terms of numerical values to compare against those criteria.

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

• Cannot be provided. The document does not mention any sample sizes used for the non-clinical testing. It also does not discuss any clinical studies, and thus, there is no information on data provenance (country of origin, retrospective/prospective).

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

• Not applicable. This question pertains to studies involving subjective assessments, often in areas like image analysis or diagnostic performance. The provided text only discusses non-clinical mechanical testing of a medical device, which does not involve "ground truth" derived from expert consensus in the same way.

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

• Not applicable. Similar to point 3, this is relevant for studies involving human assessment and disagreement resolution, not for mechanical device testing.

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:

• Cannot be provided. The device is an anterior cervical plate system, a physical implant. The document describes non-clinical mechanical testing, not a diagnostic or AI-assisted system that would involve human readers or MRMC studies.

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

• Cannot be provided. The device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

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

• Not applicable based on the provided text. For mechanical testing, the "ground truth" often refers to the actual mechanical properties measured against engineering specifications or established standards. The text implies standard mechanical testing methodologies for stiffness, strength, and fatigue life, but does not detail the specific "ground truth" definitions or how they were established beyond the characterization through testing.

8. The sample size for the training set:

• Not applicable. The device is a physical implant, not an AI model requiring a training set.

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

• Not applicable. The device is a physical implant, not an AI model.

In summary: The provided 510(k) summary focuses on general non-clinical performance testing (static and fatigue) to demonstrate substantial equivalence for a physical medical device. It does not contain the detailed study information, acceptance criteria, or performance metrics typically requested for AI/diagnostic devices or comprehensive clinical studies.

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