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The TIGER® Spine System is intended 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 thoracic, lumbar, and sacral/iliac spine (TT Sifleum): degenerative discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective widence of neurological impairment, frecture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).

The TIGER® Spine System is composed of rods, connectors, and pedicle screws. It can be used for single or multiple level fixations.

The provided text describes a Special 510(k) Summary for the TIGER® Spine System. It focuses on the substantial equivalence of the device to existing predicate devices based on non-clinical testing. Crucially, the document explicitly states that no clinical studies were performed. Therefore, this device submission does not contain information regarding acceptance criteria for a device's performance based on clinical data, nor does it describe a study that proves the device meets such criteria through clinical outcomes.

Instead, the document details non-clinical testing performed to demonstrate mechanical safety and performance in comparison to predicate devices.

Here's a breakdown of the requested information based only on the provided text, acknowledging the absence of clinical performance data:

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

Since this is a non-clinical submission based on substantial equivalence to predicate devices, the "acceptance criteria" are implicitly meeting or exceeding the performance of the predicate device(s) in specified mechanical tests. The "reported device performance" is the conclusion that the TIGER® Spine System is equivalent.

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

The document does not specify the sample size (number of devices or test repetitions) used for the non-clinical mechanical tests. It also does not discuss data provenance as it pertains to patient data, as no clinical studies were performed. The tests are laboratory-based 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. No ground truth based on expert clinical assessment (e.g., radiologists) was established because no clinical studies were performed. The "ground truth" for the non-clinical tests is based on established ASTM standards and comparative analysis to predicate devices.

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

This question is not applicable. No clinical test set requiring adjudication of expert opinions was created.

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. No MRMC study was performed, as no clinical studies involving human readers or AI assistance were conducted.

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

This question is not applicable. No algorithm or standalone software performance was evaluated, as this submission is for a physical spinal implant system.

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

For the non-clinical tests, the "ground truth" is based on established engineering standards (ASTM F1717, ASTM F1798) and the performance characteristics of legally marketed predicate devices. This is a technical, rather than clinical, ground truth.

8. The sample size for the training set

This question is not applicable. There was no training set, as no algorithms requiring training were involved in this submission.

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

This question is not applicable. There was no training set.

Summary of Study (Based on Provided Document):

The submission describes a non-clinical study involving mechanical and dimensional testing of the TIGER® Spine System. The study's purpose was to demonstrate substantial equivalence to existing predicate devices (e.g., Expedium™/Viper™ Spine System, Scient'x Polyaxial LP) for the addition of new components. The study involved:

• Tests performed: Static and dynamic compression (ASTM F1717), static torsion (ASTM F1717), static axial and torsional grip (ASTM F1798), and dimensional comparison.
• Conclusion: The results indicated that the TIGER® Spine System is equivalent to the predicate device(s) in terms of principles of operation, technology, materials, and indications of use.
• Sample Size and Ground Truth: Not explicitly detailed for the specific tests, but generally refers to standard testing protocols. The "ground truth" for this equivalence claim is the established performance and safety profile of the predicate devices.
• Clinical Studies: Explicitly stated as not performed. Therefore, no clinical acceptance criteria or performance studies were conducted or reported in this submission.

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The DePuy Pulse Thoracolumbar Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The DePuy Pulse Thoracolumbar Screw System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The DePuy Pulse Thoracolumbar Screw System consists of a variety of rods, pedicle screws, connectors, set screws and other connection components used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being made for the individual case.
The DePuy Pulse Thoracolumbar Screw System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DePuy Pulse Thoracolumbar Screw System:

This device is not an AI/ML device, but a physical medical device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a physical medical device, and the testing involved mechanical performance on device components, not a test set of data.

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

Not applicable. This is a physical medical device, and the "ground truth" for mechanical testing is defined by the ASTM F-1717 standard's specifications.

4. Adjudication method for the test set

Not applicable. This is a physical medical device, and mechanical test results are typically objective measurements against a standard, not subject to expert adjudication.

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

No. This is a physical medical device, not an AI/ML diagnostic or assistive tool, so an MRMC study is not relevant.

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

No. This is a physical medical device, not an algorithm, so standalone performance is not relevant.

7. The type of ground truth used

The "ground truth" for this device's performance is established by the specified mechanical testing standards (ASTM F-1717) for spinal implant constructs. These standards define the acceptable mechanical properties and behaviors under various loads.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.

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

Not applicable. This is a physical medical device, not an AI/ML device requiring a training set with established ground truth.

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The EXPEDIUM and VIPER Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM and VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The proposed cortical fix polyaxial screws for EXPEDIUM and VIPER System are available in various geometries and sizes.

The provided 510(k) summary (K110216) describes the DePuy Spine EXPEDIUM® and VIPER® Systems. This device is a spinal fixation system, and the submission focuses on new cortical fix polyaxial screws for these systems.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "No clinical tests were performed." Therefore, there is no information regarding a test set sample size or data provenance from a human study. The testing performed was mechanical.

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

Not applicable, as no clinical tests were performed. The "ground truth" for the mechanical tests would be the established engineering standards (ASTM F 1798-97) and the physical measurements against those standards. These would be assessed by engineers/technicians performing the tests.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical tests were performed involving human readers or interpretation.

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

No, an MRMC comparative effectiveness study was not done. The submission states, "No clinical tests were performed."

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

Not applicable, as this device is a physical medical implant (spinal fixation system), not a software algorithm.

7. The Type of Ground Truth Used:

For the mechanical tests performed, the "ground truth" is defined by the ASTM F 1798-97 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. The device's performance was compared against the requirements and specifications outlined in this standard.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical implant, not a machine learning or AI algorithm, so there is no training set in the conventional sense. The "development" or "design" process for such a device involves engineering principles, material science, and manufacturing processes, rather than data-driven algorithm training.

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

Not applicable, as there is no training set for this type of device.

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The EXPEDIUM and VIPER Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM and VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM and VIPER Spine System components consist of screws and are available in various geometries and sizes.

The provided document is a 510(k) Summary for the DePuy Spine EXPEDIUM® and VIPER® Systems, which are spinal fixation devices. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials and detailed acceptance criteria for an AI/algorithm.

Therefore, the specific information requested about acceptance criteria, study design for proving device performance against those criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies for AI/software-as-a-medical-device (SaMD) are not applicable to this submission.

Here's an explanation based on the provided document:

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

• Not Applicable. This submission is for mechanical spinal implants, not an AI/software device. The "performance" is assessed through a comparison to predicate devices and mechanical testing, not against specific diagnostic or treatment accuracy acceptance criteria as would be expected for a SaMD.

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

• Not Applicable. There is no "test set" in the context of an AI/software device. The performance was evaluated via non-clinical mechanical testing of the physical implants. The document does not specify the number of units tested, but mechanical tests typically involve a pre-determined number of samples to ensure statistical validity for the specific test (e.g., fatigue or static load).

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. Ground truth, in the context of AI/SaMD, refers to the verified correct output (e.g., diagnosis, measurement) for comparison with the algorithm's output. For mechanical implants, "ground truth" is typically defined by engineering specifications and material properties, verified through testing procedures against established standards (e.g., ASTM F1798). Experts involved would be engineers and material scientists.

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

• Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert opinions when establishing ground truth for AI/SaMD. This is not pertinent to the mechanical testing of spinal implants.

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. MRMC studies are designed to evaluate the impact of an AI algorithm on human reader performance (e.g., radiologists, pathologists). This device is a physical implant, not an AI system.

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

• Not Applicable. This concept applies to AI algorithms and not to physical medical devices like spinal implants.

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

• For mechanical testing: The "ground truth" (or reference standard) for the nonclinical tests would be the established scientific and engineering principles outlined in the cited ASTM standards (F1798). Performance is measured against physical properties and failure points defined by these standards, not against biological or clinical outcomes or expert consensus on images.

8. The sample size for the training set

• Not Applicable. There is no training set as this is not an AI/machine learning device.

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

• Not Applicable. Since there is no training set, this question is not relevant.

Summary of what the document does provide regarding device performance:

The document states that "No clinical tests were performed."
Instead, the device's performance and safety were established through "Nonclinical Test Summary:"

• Static Cantilever Beam in accordance with ASTM F1798
• Dynamic Cantilever Beam in accordance with ASTM F1798
• Axial Slip in accordance with ASTM F1798

These tests are designed to evaluate the mechanical properties and stability of the spinal implants and their interconnection mechanisms, ensuring they meet the requirements for their intended use and are comparable to predicate devices. The "acceptance criteria" here are implied to be the successful completion of these tests in accordance with the ASTM standards, demonstrating structural integrity and mechanical equivalence to the already cleared predicate devices. The specific results of these tests (e.g., actual load values, cycles to failure) are not detailed in this 510(k) summary but would have been submitted to the FDA in a more comprehensive report.

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