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The DPZ Pedicular Fixation 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 spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The DPZ Pedicular Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e., fracture or dislocation); spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis and failed previous fusion.

The DPZ Pedicular Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

The provided text describes the DPZ Pedicular Fixation System, its intended use, and the non-clinical tests conducted to demonstrate its equivalence to predicate devices. However, it explicitly states: "No clinical studies were performed."

Therefore, I cannot provide information on acceptance criteria based on human performance or studies involving human readers/experts, as no such clinical data is presented in this document.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the non-clinical tests. The document only mentions "The following analyses were conducted."
• Data Provenance: Not explicitly stated, but it refers to "non-clinical tests" which typically involve laboratory or bench testing of the device hardware.

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

• Not applicable. The "ground truth" for non-clinical mechanical testing is based on the specifications within the ASTM F1717 standard and the measured performance of the device compared to predicate devices. Human experts are not involved in establishing this ground truth for a mechanical test.

4. Adjudication method for the test set:

• Not applicable, as this refers to human reader review and consensus, which was not performed.

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 MRMC study was done, as "No clinical studies were performed."

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

• Not applicable. This is a medical device (pedicle fixation system), not an algorithm or AI. The standalone performance refers to the device's mechanical integrity under specified ASTM standards.

7. The type of ground truth used:

• The ground truth for the non-clinical tests was based on the performance requirements and methodologies outlined in the ASTM F1717 standard for spinal implant constructs. The device's performance was then compared to that of predicate devices to establish substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is a non-AI/algorithm medical device. "Training set" refers to data used to train an AI model.

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

• Not applicable for the same reason as above.

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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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