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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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TRYPTIK®Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous disc levels from C2 to T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. TRYPTIK®Ti cages is used to facilitate intervertebral body fusion in the cervical spine using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. TRYPTIK®Ti cages is to be used with supplemental fixation that has been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Tryptik® Ti is an anterior cervical interbody fusion device intended to provide mechanical support to the cervical spine and maintain adequate disc space until fusion occurs. The interbody device is a box-shaped spacer with a large central cavity that can receive bone graft intended to promote intervertebral fusion. The Tryptik® Ti spacers are all made from medical grade titanium alloy and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished. The Tryptik® Ti interbody spacer has a monolithic design that incorporates solid and porous structures along with superior and inferior rough surfaces intended to increase implant stability into the intervertebral space and bony integration throughout the implant. The Tryptik® Ti spacers are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable – provided non-sterile). Bacterial endotoxin testing on final, finished devices as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

This information is not contained in the provided document. The document is a 510(k) summary for a medical device (TRYPTIK®Ti Anterior Cervical Intervertebral Fusion Devices) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing of mechanical properties. It does not describe a study involving patient data, expert review, or AI performance.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (in terms of clinical outcomes or AI metrics).
2. Sample size used for a test set or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or AI improvement effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (pathology, outcomes data, etc.) for a clinical study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document only states that "Results demonstrate comparable mechanical properties to the identified predicate devices" based on non-clinical tests (Static and Dynamic Axial Compression, Static and Dynamic Shear-compression, Static and Dynamic Torsion according to ASTM F2077-18 and Subsidence according to ASTM F2267-04). It also mentions "Additionally, cadaver lab implantation trials were conducted." However, no specific performance metrics or acceptance criteria for these tests are provided in the summary.

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The Kuros TLIF Cage is intended for use in intervertebral body fusion of the Kuros TLIF cage is inserted via a posterior approach and can be used in one level or two contiguous levels of the lumbar spine (L1 to S1). The Kuros TLIF cage is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is to be used with supplemental posterior spinal fixation systems for use in the lumbar spine that are cleared by the FDA.

The Kuros TLIF cage is intended for the treatment of patients with Degenerative Disk Disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must be skeletally mature and have had at least six months of non-operative treatment.

The Kuros TLIF Cage is an implant interbody fusion surgery and is used to restore intervertebral height and facilitate intervertebral body fusion in the spine. The Kuros TLIF Cage is inserted via a posterior (transforaminal) approach and can be used in one level or two contiguous levels of the lumbar spine (L1 to S1). The Kuros TLIF cage is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and should be used in combination with supplemental posterior spinal fixation systems, intended for use in the lumbar spine and cleared by the FDA.

The Kuros TLIF cage is a rigid spacer, manufactured from PEEK Optima LT1 per ASTM F2026 to maximize biocompatibility, durability, and robustness. The design includes tantalum markers for imaging and has a hollow geometry, allowing the cage to be packed with grafting material per the indications for use. The Kuros TLIF Cages are available in various lengths, and angle variants to accommodate patient anatomy, and are supplied with their specific instrumentation. The device is intended to be used by orthopedic surgeons or neurosurgeons working in a hospital who are trained to use these devices in the patient population specified in the indications for use. The implants are provided sterile to the hospital.

The provided text describes the Kuros TLIF Cage, an intervertebral body fusion device. It details the device's indications for use, description, and comparison to predicate devices, but it does not contain any information about acceptance criteria, device performance metrics, or a study reporting on these metrics.

The document is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's what can be extracted from the document regarding the device and its evaluation, but it explicitly states "No clinical data has been presented." and therefore cannot fulfill most of the request:

Device Name: Kuros TLIF Cage
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX

Indications for Use:
The Kuros TLIF Cage is intended for use in intervertebral body fusion of one or two contiguous levels of the lumbar spine (L1 to S1). It is inserted via a posterior approach and designed for use with autograft and/or allograft (cancellous and/or corticocancellous bone graft) to facilitate fusion. It must be used with supplemental posterior spinal fixation systems cleared by the FDA.

It is intended for the treatment of patients with Degenerative Disk Disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must be skeletally mature and have had at least six months of non-operative treatment.

Description of the Device:
The Kuros TLIF Cage is a rigid spacer made from PEEK Optima LT1 (ASTM F2026). It includes tantalum markers for imaging and has a hollow geometry to be packed with grafting material. It is available in various lengths and angle variants and is supplied with specific instrumentation. The implants are provided sterile.

Summary of Performance Data (as presented in the document):
The Kuros TLIF Cage conforms to the "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - Document issued on: June 12, 2007."
Worst-case devices were subjected to mechanical testing, including:

• Static axial compression
• Dynamic axial compression
• Static compression shear
• Dynamic compression shear
• Subsidence testing (according to ASTM F2267)
• Expulsion testing (according to Endolab protocol)

Results: "Results demonstrate comparable (or better) mechanical properties to the predicate devices."

Crucially, the document explicitly states: "No clinical data has been presented."

Given this information, it is impossible to complete a table of acceptance criteria and reported device performance from this document for the requested metrics as clinical performance data is absent. The acceptance criteria here are related to mechanical properties in comparison to predicate devices, not clinical outcomes.

Therefore, for your specific request:

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

   • Acceptance Criteria (Mechanical): Conformity to "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - Document issued on: June 12, 2007." and mechanical properties comparable to or better than predicate devices across tested parameters (static/dynamic axial compression, static/dynamic compression shear, subsidence, expulsion).
   • Reported Device Performance (Mechanical): The Kuros TLIF Cage demonstrated "comparable (or better) mechanical properties to the predicate devices" for the tested parameters.
   • Clinical Performance: Not reported in this document.

2. Sample size used for the test set and the data provenance: Not applicable for clinical data, as "No clinical data has been presented." For mechanical testing, specific sample sizes are not provided, only that "Worst case devices were subjected to mechanical testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as "No clinical data has been presented."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as "No clinical data has been presented."

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, as "No clinical data has been presented" and this device is a physical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the ground truth would be established by the ASTM standards (ASTM F2077, ASTM F2267) and the Endolab protocol. For clinical performance, no ground truth is discussed as no clinical data was presented.

8. The sample size for the training set: Not applicable, as this is a physical medical device and no clinical "training set" of data is mentioned.

9. How the ground truth for the training set was established: Not applicable for the same reasons as above.

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EIT Cellular Titanium® Cervical Cages: The EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The EIT Cellular Titanium® Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The EIT Cellular Titanium® Cervical Cages is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

EIT Cellular Titanium® PLIF Cages: The EIT Cellular Titanium® PLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.

EIT Cellular Titanium® TLIF Cages: The EIT Cellular Titanium® TLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.

EIT Cellular Titanium® ALIF Cages: The EIT Cellular Titanium® ALIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.

The purpose of this 510(k) was to update the indications for use to include use at multiple levels (e.g., up to 4 levels) for the EIT Cellular Titanium® Cervical Cages as well as other miscellaneous labeling updates.

The EIT Cellular Titanium® Cages are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine. The EIT Cellular Titanium® Cages differentiated in Lumbar cages (L2-S1) and Cervical Cages (C2-T1). The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g., using posterior pedicle screws, anterior plate system or anterior screw and rod system).

The EIT Cellular Titanium® Cages are made from Ti-6AI-4V ELI ASTM F136 with an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

Three different types of Lumbar Cages are included in the portfolio. Each cage type has the same intended use, but is designed for a different surgical approach; ALIF (Anterior Lumbar Intervertebral Fusion Cage), PLIF (Posterior Lumbar Intervertebral Fusion Cage) and TLIF (Transforaminal Lumbar Intervertebral Fusion Cage). One type of Cervical Cage, CIF (Cervical Intervertebral Fusion Cage) is included in the portfolio. Each cage type is supplied sterile and is available in a variety of heights, footprints and lordosis angles to accommodate patient anatomy.

The provided text is a 510(k) premarket notification decision letter from the FDA regarding a medical device, specifically intervertebral body fusion devices. It does not describe acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.

The document discusses the substantial equivalence of the EIT Cellular Titanium® Cages to previously cleared predicate devices based on indications for use, design, function, materials, and performance. The "Performance Testing Summary" section mentions a "comprehensive, clinical literature review" and "Additional MR-Safety testing" in accordance with ASTM standards, but these are related to the safety and fundamental characteristics of the implantable device, not the performance of an AI/ML algorithm.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's criteria (acceptance criteria for an AI/ML device, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) are specific to AI/ML device evaluation, which is not what this document addresses.

The document does not contain information on:

• Acceptance criteria for an AI/ML device's performance.
• A study proving an AI/ML device meets acceptance criteria.
• Sample size used for a test set or data provenance for an AI/ML study.
• Number of experts or their qualifications for establishing ground truth for an AI/ML study.
• Adjudication method for an AI/ML study.
• MRMC comparative effectiveness study or effect size for AI assistance.
• Standalone performance of an algorithm (AI).
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI study.
• Sample size for a training set in an AI context.
• How ground truth for the training set was established for an AI.

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