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The TiLock? Spinal 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 of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis: spinal tumor; and failed previous fusion (pseudarthrosis).

The Genesys Spine TiLock2 Spinal System is offered in polyaxial screws (solid and cannulated) and monoaxial screws in various lengths and diameters, offset connectors, washers, hooks, rod-to-rod connectors, lock screws, crosslinks, and rods in various lengths and materials.

This document is a 510(k) premarket notification for a spinal system (TiLock2 Spinal System). The key takeaway is that this submission is for minor modifications to an already cleared device, rather than a completely new device. Therefore, it asserts substantial equivalence to its predicate devices without requiring new performance data for the implants themselves.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

This submission is a Special 510(k), which means it relies on demonstrating substantial equivalence to previously cleared predicate devices for minor modifications, rather than presenting new comprehensive performance studies for the device itself. The "study" here is essentially the comparison and justification presented in the 510(k) submission.

• No new performance data was required for this submission. The rationale is that the TiLock2 Spinal System implants remain unchanged from their previously cleared configuration (K100757, K103034, and K152039), and the instrument additions mimic previously cleared instruments with only minor alterations. Therefore, no new testing or analysis was deemed necessary.

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

• Not applicable / Not provided. As no new performance testing was conducted for this specific 510(k) submission (K171838), there is no "test set" of data in the traditional sense that would have a sample size or provenance. The determination of substantial equivalence relied on the previous clearance of the implant components and the assertion that new instruments were minor modifications.

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 / Not provided. There was no new "test set" requiring ground truth establishment by experts for this submission. The regulatory body (FDA) reviews the substantial equivalence argument based on engineering principles, material science, and comparison to predicates.

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

• Not applicable / Not provided. No specific test set with an adjudication method was conducted or referenced in this 510(k).

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 device is a mechanical spinal implant system, not an AI/imaging device. Therefore, MRMC studies and AI assistance are irrelevant in this context.

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

• No. This device is a mechanical spinal implant system. This concept is not applicable.

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

• Not applicable / Not provided directly for this submission. For the original predicate devices, the "ground truth" for their safety and effectiveness would have been established through a combination of:
  • Mechanical testing: Demonstrating compliance with relevant ASTM standards for spinal implants (strength, fatigue, etc.).
  • Material characterization: Verification of material specifications (ASTM F136, ASTM F1537) and biocompatibility.
  • Preclinical studies (if applicable): Though not explicitly mentioned, some predicate devices might have undergone such studies.
  • Clinical experience/literature: Supporting the general safety and effectiveness of similar devices and surgical approaches.
  • FDA assessment: The FDA's review and clearance of the predicate devices (K100757, K103034, K152039, K122145) established their "ground truth" of substantial equivalence.

8. The sample size for the training set

• Not applicable. This device is a mechanical spinal implant system. The concept of a "training set" is generally used for machine learning or AI models, which is not relevant here.

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

• Not applicable. See point 8.

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The TiLock Pedicle 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 the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (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.

The Genesys Spine TiLock Pedicle Screw System is comprised of polyaxial screws (standard and cannulated) and monoaxial screws in various lengths and diameters, lock plugs, cross-links, tulips and rods in various lengths. The Til.ock System allows the placement of either 5.5mm titanium or 5.5mm cobalt chromium rods. The TiLock cannulated polyaxial screws may be implanted via a minimally invasive technique. Manual instrumentation for implantation of the svstem is available for both conventional and minimally invasive procedures. The minimally invasive procedure is performed using k-wire and fluoroscopy, which allows the implanting surgeon to employ two smaller incisions rather than a longer midline incision.

The subject device is the result of modifications to the existing Genesys Spine TiLock rod system which resulted in the inclusion of a 5.5mm straight and prebent cobalt chromium rod to the system. The subject device shares the same intended use and fundamental scientific technology as the predicate device.

The Genesys Spine TiLock Pedicle Screw System is a medical device. Here's a breakdown of the information regarding its acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance

The provided document describes the device's substantial equivalence to predicate devices, rather than establishing specific quantitative performance acceptance criteria for diagnostic output. The primary "acceptance criteria" here is demonstrated substantial equivalence in terms of mechanical and material properties, meaning the modified device performs similarly to or better than previously approved devices.

2. Sample Size and Data Provenance for Test Set

• Test Set Sample Size: Not explicitly stated as a distinct "test set" in the context of typical AI algorithm evaluation. The evaluation is based on design verification results, finite element analysis, and material property analysis. These generally do not involve a "sample size" of patient data or images in the same way. Instead, they refer to the number of simulations, physical tests, or material samples analyzed. The document does not specify these numbers.
• Data Provenance: Not applicable in the context of this type of device submission. The evaluation is non-clinical, focusing on engineering and material properties, not patient data.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Number of Experts: Not applicable. Ground truth, in this context, refers to established engineering standards, material science principles, and mechanical testing protocols.
• Qualifications of Experts: Not explicitly stated. However, it's inferred that the "design verification results" and "finite element and material property analysis" were conducted by qualified engineers and material scientists.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. The evaluation relies on objective engineering and material testing, not subjective human assessment needing adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This device is a pedicle screw system, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: No. This device is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used

• Ground Truth Type:
  • Engineering Standards and Specifications: Mechanical strength, fatigue limits, material compatibility, and overall design integrity according to established biomechanical and medical device standards.
  • Predicate Device Performance: The primary ground truth is the performance characteristics of the legally marketed predicate devices, to which the new device is compared for substantial equivalence.

8. Sample Size for Training Set

• Training Set Sample Size: Not applicable. This device is not an AI algorithm that requires a "training set" of data.

9. How Ground Truth for Training Set was Established

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

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

The study that proves the Genesys Spine TiLock Pedicle Screw System meets its (implied) acceptance criteria is a non-clinical engineering and material science evaluation. This evaluation aimed to demonstrate substantial equivalence to existing predicate devices.

The key components of this study were:

• Finite Element Analysis (FEA): This is a computational method used to predict how a product reacts to real-world forces, heat, vibration, fluid flow, and other physical effects. It simulates the mechanical behavior of the pedicle screw system under various loads and conditions to ensure its structural integrity.
• Material Property Analysis: This involves characterizing the mechanical, chemical, and physical properties of the materials used in the device (e.g., titanium, cobalt chromium). This ensures the materials meet required standards for strength, biocompatibility, and durability.
• Design Verification Results: This encompasses a range of tests and analyses to confirm that the device design meets its intended specifications and functions as expected. This could include bench testing for mechanical performance, dimensional analysis, and other forms of verification.

Conclusion: The regulatory submission states that these non-clinical performance data (finite element, material property analysis, and design verification results) were sufficient to demonstrate that the Genesys Spine TiLock Pedicle Screw System is substantially equivalent to its predicate devices. This means that, based on these engineering and material science studies, the device is considered as safe and effective as other devices already legally marketed for the same intended use. No clinical studies were deemed necessary for this particular submission.

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