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The CONDUIT™ SYNFIX™ Evolution Secured Spacer System is a stand-alone anterior interbody fusion device with a microscope roughened surface and micro and nano-scale features indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the CONDUIT SYNFIX Evolution can be packed with autograft. If used with less than the four integrated bone screws, or for hyperlordotic implants (>20Deg), implants must be used with supplemental fixation systems cleared by the FDA for use in the lumbosacral spine.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The CONDUIT SYNFIX Evolution Secured Spacers are intervertebral body fusion devices intended for lumbar interbody fusion (ALIF). Four Screws are inserted through the anteriorly-located Plate into the adjacent vertebral bodies. The Screws lock securely to the Plate using a tapered-thread locking mechanism.

The CONDUIT SYNFIX Evolution Secured Spacer System is available as non-assembled Cage and Plate components in various heights and geometries to suit individual pathology and anatomical conditions. The Cage and Plate components are intended to be assembled at the point of use prior to implantation.

The CONDUIT SYNFIX Evolution Cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The 3D Printed Conduit Cellular Titanium Cages have a microscopic roughened surface with micro and nano-scale features. The micro and nano features are on all surfaces of the Cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure.

The provided text is a 510(k) clearance letter for a medical device called the "CONDUIT™ SYNFIX™ Evolution Secured Spacer System," which is an intervertebral body fusion device.

Crucially, this document is for a traditional medical device (an implantable hardware system), not an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) product.

Therefore, the information requested in the prompt, such as acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC), sample sizes for test/training sets for AI, expert adjudication of AI ground truth, MRMC studies for AI, or standalone AI performance, is not applicable to this submission.

The acceptance criteria and study proving the device meets them, as described in this 510(k), relate to the mechanical performance, material properties, and biocompatibility of the physical interbody fusion device, not an AI algorithm.

Here's an analysis of the provided information relevant to the device's acceptance criteria and studies:

Acceptance Criteria and Device Performance (for a physical medical device):

The document mentions that mechanical testing was performed to "allow comparison with established acceptance criteria." While the specific numerical acceptance criteria (e.g., minimum load to failure, maximum displacement) are not explicitly detailed in the publicly available summary (which is common for 510(k) summaries), the types of tests conducted and the general conclusion indicate that the device met these criteria.

1. Table of Acceptance Criteria and Reported Device Performance (as inferred for a physical device):

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

• Sample Size: Not specified in the summary document. For mechanical testing of medical devices, "sample size" refers to the number of physical device units tested for each configuration or stress condition. These studies are typically conducted in a laboratory setting.
• Data Provenance: Laboratory testing (mechanical, MR compatibility). The country of origin of the data is not specified but is typically internal lab data or contracted third-party lab data.
• Retrospective or Prospective: Not applicable in the traditional sense for physical device testing. The tests are designed to assess the device's properties under simulated conditions.

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

• Not Applicable. This pertains to AI/software performance evaluation. For physical device testing, "ground truth" is established by calibrated measuring equipment and standardized test methods (e.g., ASTM standards). The "experts" are typically engineers and technicians responsible for conducting the tests and interpreting the results against pre-defined engineering acceptance criteria.

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

• Not Applicable. This relates to human expert consensus for AI ground truth labeling. For mechanical testing, the results are objective measurements from testing equipment validated against industry standards.

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 is specific to AI/software for diagnostic or image-interpretation tasks. No such study was conducted or required for this physical device.

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

• Not Applicable. This is specific to AI/software.

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

• For mechanical testing, the "ground truth" is derived from standardized test methods (e.g., ASTM F2077, F2267) that define specific performance thresholds based on mechanical properties (e.g., ultimate strength, displacement within limits) and material science. The goal is to demonstrate that the device performs equivalently to predicate devices under defined mechanical loads and environmental conditions.

8. The sample size for the training set:

• Not Applicable. This pertains to AI model development.

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

• Not Applicable. This pertains to AI model development.

Conclusion from the 510(k) Summary:

The manufacturer "demonstrated substantial equivalence" by showing that their device performs mechanically and in terms of MR compatibility similarly to legally marketed predicate devices, and that the materials and design are appropriate for the intended use. The reliance on established ASTM standards and comparison to predicate devices are the primary methods for demonstrating safety and effectiveness for this type of medical implant.
The summary explicitly states: "No clinical data was necessary to demonstrate substantial equivalence, nor safety and effectiveness of this system." This further confirms that the evaluation was based on non-clinical (mechanical, material, and MR compatibility) testing and comparison to predicates.

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The Idys® ALIF ZP 3DTi devices (Anterior Lumbar Interbody Fusion) are intended for use in patients with degenerative disc disease (DDD) at one (1) or (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain in discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF ZP 3DTi cages should be used with the integrated fixation screws provided.

The Idys® ALIF ZP 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion

The Idys® ALIF ZP 3DTi consists of interbody fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.

The Idys® ALIF ZP 3DTi cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. The device has shape which restores the intervertebral height and lordosis. The device contains two slots to receive bone graft to promote the fusion process between the endplates. The device has to be used with bone graft.

The Idys® ALIF ZP 3DTi cage is manufactured from medical grade Ti-6Al-4V ELI Titanium alloy compliant with ASTM F3001 and ASTM F136. The screws are made from Ti-6AI-4V ELI per ASTM F136 and are anodized in different colors, according to their length, Idvs® ALIF ZP 3DTi cages are positioned using a set of surqical instruments common for anterior lumbar approach. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages are provided sterile and are for single use only.

This document is a 510(k) summary for the Idys® ALIF ZP 3DTi intervertebral body fusion device. It details product information and demonstrates substantial equivalence to a predicate device, rather than describing a study with acceptance criteria for device performance in detecting or diagnosing a condition. Therefore, the requested information (acceptance criteria, study details, expert involvement, and ground truth characteristics) related to diagnostic performance cannot be extracted from this text.

The document focuses on the mechanical and biocompatibility performance of the device and its substantial equivalence to a previously cleared predicate device due to minor modifications (change in screw design and addition of cage sizes).

Here's what can be extracted regarding the performance data provided for the device itself:

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

2. Sample size used for the test set and the data provenance: Not applicable. These tests are laboratory-based mechanical and biocompatibility evaluations, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this refers to mechanical and biocompatibility testing, not expert-adjudicated clinical performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 document does not describe an AI medical device or a reader study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the presented performance data, which are based on established ISO and ASTM standards for materials and mechanical testing.

8. The sample size for the training set: Not applicable. This is not a study involving machine learning or AI models with training data.

9. How the ground truth for the training set was established: Not applicable.

Summary of Device and Changes:

The document describes a Special 510(k) notice for the Idys® ALIF ZP 3DTi device.

• Original Device: Idys® ALIF ZP 3DTi (K192168)
• Modifications:
  • Change in the screw's design.
  • Addition of new cage sizes (with identical design and shape as previously cleared cages).
• Purpose of Testing: To demonstrate that these modifications do not raise new issues of safety or effectiveness and that the modified device remains substantially equivalent to the predicate device.

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