Search Results

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.

Ask a specific question about this device

The CONDUIT™ ATP Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The CONDUIT™ ATP Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using the ATP surgical approach. The inserters have been designed to interface with EIT Cellular Titanium® LLIF Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or other compatible instruments provided with the implants.

The provided text is a 510(k) summary for the CONDUIT™ ATP Inserters, which are surgical tools. It clarifies that these inserters are not a device that uses AI or machine learning. The document describes them as reusable instruments made from orthopedic materials, intended for use in Lumbar Interbody Fusion surgery.

Therefore, the requested information regarding AI/ML device acceptance criteria, performance studies involving AI, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance cannot be provided as these concepts are not relevant to this type of medical device.

The "Performance Data" section of the 510(k) summary indicates that non-clinical testing was conducted to confirm device performance, including:

• Impaction endurance testing
• Formative usability testing
• Thread cyclic testing

These tests are standard for mechanical surgical instruments to ensure their durability and functionality, rather than evaluating AI performance.

The conclusion states that the overall technology characteristics and mechanical performance data lead to the conclusion that the CONDUIT™ ATP Inserters are substantially equivalent to the predicate device, K223671, the CONDUIT™ LLIF Straight Inserters manufactured by DePuy Synthes.

Ask a specific question about this device

The NanoHive Medical Lumbar Interbody System, with a microscopic roughened surface and micro and nano-scale features, is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone and allograft bone comprised of cancellous and/or corticocancellous bone (hereafter bone graft).

The NanoHive Medical Lumbar Interbody System, including the Hive™ PL Interbody System, the Hive™ TL Interbody System, and the Hive™ AL Interbody System, consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology. The titanium takes the form of a highly porous core which is surrounded at the cephalad and caudal ends by protective solid titanium endplates. The implant is anatomic in shape and has teeth to ensure placement is maintained after implantation. The interbody 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 NanoHive Medical Lumbar Interbody System are offered in a variety of lengths, widths and cross sectional geometries to accommodate patient anatomy and surgical approach. The implants of the NanoHive Medical Lumbar Interbody System are also offered in various lordotic configurations to ensure proper stability and alignment of the spine for differing patient anatomy. The implants are provided pre-sterile, in validated sterile packaging, and are one-time use only.

The purpose of this submission is to additional implant size options and sterile packaging configurations to the system.

The provided text does not contain information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is a 510(k) premarket notification summary for the NanoHive Medical Lumbar Interbody System, which is a medical device. It focuses on demonstrating substantial equivalence to legally marketed predicate devices through technological characteristics and mechanical performance testing.

Here's what can be extracted from the document regarding "performance data":

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

The document states:
"The NanoHive Medical Lumbar Interbody System has been tested in the following test modes:

• Static & Dynamic Axial Compression per ASTM F2077
• Static & Dynamic Compression Shear per ASTM F2077
• Subsidence per ASTM F2267

The results of this non-clinical testing show that the strength of the NanoHive Medical Lumbar Interbody System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

However, specific numerical acceptance criteria (e.g., minimum load resistance in Newtons) and the corresponding numerical performance values of the device are not provided. The document only states that the device's strength is "sufficient" and "substantially equivalent."

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

This information is not provided in the document. The document describes mechanical performance testing, not typical clinical or AI performance studies.

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)

This information is not applicable to the type of mechanical performance testing described and is therefore not provided.

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

This information is not applicable and is not provided.

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

An MRMC study was not conducted as this is a mechanical interbody fusion device, not an AI or imaging-based diagnostic/assistive device.

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

This is not applicable as there is no algorithm or AI component mentioned for the device. The "standalone" performance refers to the mechanical properties of the device itself.

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

For mechanical testing, the "ground truth" would be the engineering specifications and test standards (ASTM F2077, ASTM F2267). The device's performance is compared against the requirements within these standards.

8. The sample size for the training set

This is not applicable as there is no mention of a "training set" for this mechanical device.

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

This is not applicable.

Ask a specific question about this device

The CONDUIT™ LLIF Straight Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The CONDUIT™ LLIF Straight Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instruments have been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or to other instruments provided with the implants.

The provided text describes a 510(k) premarket notification for the CONDUIT™ LLIF Straight Inserters, which are instruments used to insert EIT Cellular Titanium® LLIF Cages during Lumbar Interbody Fusion surgery.

However, the document does not contain information related to a study that uses AI or machine learning, nor does it discuss acceptance criteria and device performance in the context of AI. The performance data mentioned refers to non-clinical mechanical testing (impact endurance and thread endurance) for a surgical instrument, not an AI-powered diagnostic or assistive device.

Therefore, I cannot provide a response to your request, as the provided text lacks the necessary information about acceptance criteria and a study proving an AI device meets those criteria.

Ask a specific question about this device

The DePuy CONDUIT™ LLIF SQUID Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

EIT Cellular Titanium® LLIF Cage

The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The DePuy CONDUIT™ LLIF SQUID Inserter is designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instrument has been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instrument is provided non-sterile and made from commonly used orthopedic materials. There are no changes to the implants or to other instruments provided with the implants.

The provided document describes a medical device, the "DePuy CONDUIT™ LLIF SQUID Inserter," and its clearance process through the FDA 510(k) pathway. This pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel performance claims.

Therefore, many of the typical acceptance criteria and study components you'd expect for an AI/ML device (e.g., AUC, sensitivity, specificity, physician performance with/without AI, expert adjudication, ground truth establishment) are not applicable to this submission. This document describes a surgical instrument and its mechanical and functional performance, not an AI/ML diagnostic or therapeutic device.

Here's an analysis based on the information provided, explicitly stating where specific requested details are not relevant or available:

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

For this type of device (a surgical instrument), acceptance criteria are typically related to mechanical integrity, functionality, and compatibility, rather than clinical performance metrics like sensitivity or specificity.

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The "bench tests" and "formative usability test" would have involved a sufficient number of device units and/or simulated use cases to demonstrate robust performance. However, these are not clinical "test sets" in the sense of patient data.
• Data Provenance: The tests are described as "non-clinical testing" and "bench tests," indicating in-house engineering and laboratory testing rather than patient data from a specific country or retrospective/prospective study.

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 mechanical/functional device, not an AI/ML device requiring expert interpretation of medical images or data for ground truth. Ground truth for these tests would be established by engineering specifications and successful completion of physical actions (e.g., the inserter successfully grips the cage).

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

• Not Applicable. As no expert interpretation or diagnostic classification is involved, no adjudication method is relevant.

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, an MRMC study was not done. This device is a surgical instrument, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical surgical instrument, not an algorithm.

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

• For surgical instruments, "ground truth" relates to successful mechanical function, adherence to material specifications, and safe interaction with other components (e.g., the implant cage) and the surgical environment. It is established by:
  • Engineering specifications and standards: The device must meet predefined mechanical strength, endurance, and dimensional tolerances.
  • Functional verification: The device must reliably perform its intended action (e.g., grasp, insert, release an implant).
  • Material conformity: Verification that materials meet specified ASTM standards.

8. The sample size for the training set

• Not Applicable. This is a manufactured physical device, not an AI/ML model that is 'trained' on data.

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

• Not Applicable. No training set for an AI/ML model is involved.

Ask a specific question about this device

The DePuy CONDUIT™ LLIF Angled Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

EIT Cellular Titanium® LLIF Cage

The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nano-scale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The CONDUIT™ Lateral Angled Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instruments have been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or to other instruments provided with the implants.

The provided text describes the DePuy CONDUIT™ LLIF Angled Inserters, an intervertebral body fusion device tool. However, it does not include information about acceptance criteria and a study proving the device meets those criteria, as typically found in submissions for AI/ML-driven medical devices.

The document is a 510(k) summary for a medical device (a surgical tool), not an AI/ML diagnostic or prognostic device. As such, the typical metrics and study designs (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance) for AI evaluation are not applicable or discussed here.

Instead, the performance data section states: "Non-clinical testing was conducted to confirm device performance per intended use including functionality bench test, impact endurance test, thread endurance test, and formative usability test. The results of this non-clinical testing show that the performance of the DePuy CONDUIT™ LLIF Angled Inserters are sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

This indicates that the device's performance was evaluated through bench testing for physical properties and functionality, not through clinical studies involving patient data or AI algorithm performance metrics.

Therefore, I cannot provide the requested information in the structured format because the document does not contain data related to AI/ML device acceptance criteria and studies.

Ask a specific question about this device

The KMTI S141 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1.

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The KMTI S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The Kyocera Medical Technologies, Inc. (KMTI) KMTI S141 Lumbar Interbody Fusion System (also called S141 LIF System) consists of cages which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion. The S141 LIF System includes the Tesera-P, Tesera-T, PEEK Straight TLIF, and PEEK TLIF families. The implants are offered in additively manufactured Titanium Alloy (Titanium-6Aluminum-4Vanadium) per ASTM F2924 and PEEK (Polyetheretherketone) per ASTM F2026.This submission updates the subject titanium alloy material specifications and standards, modifies the additive printing process, and expands the for the previously cleared S141 Lumbar Interbody Fusion System.

The KMTI S141 Lumbar Interbody Fusion System is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. The implants may be inserted via an open or minimally invasive approach. The Tesera P and PEEK PLIF use a posterior approach. The PEEK Straight TLIF, Tesera ST, and Tesera T use an oblique approach. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The superior and inferior surfaces of the Titanium Alloy implant consist of Tesera porous titanium structure to facilitate osseous integration. The superior and inferior surfaces of the S141 PEEK devices have "teeth" to help prevent the device from migration after surgically positioned. Additionally, the S141 PEEK devices contain tantalum markers (per ASTM F560) to assist the surgeon with proper placement of the device. The implants are provided terminally sterilized via gamma irradiation prior to end-user receipt.

This document describes a 510(k) premarket notification for the KMTI S141 Lumbar Interbody Fusion System, which is a medical device for spinal fusion.

Here's the breakdown of the acceptance criteria and the study performed, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The text mentions "mechanical testing" was conducted, but does not provide details on the number of devices or iterations tested.
• Data Provenance: The testing was conducted by Kyocera Medical Technologies, Inc. within the context of a 510(k) submission to the FDA. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective.

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 as the study presented is a mechanical performance study, not a clinical study involving ground truth established by experts.

4. Adjudication method for the test set

• This question is not applicable as the study presented is a mechanical performance study, not a clinical study requiring adjudication of expert opinions.

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. The device is an intervertebral body fusion system, a physical implant, not an AI-powered diagnostic or assistive tool for human readers.

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

• This question is not applicable as the device is a physical implant, not an algorithm.

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

• The "ground truth" for the mechanical testing would be defined by engineering specifications and established performance standards for spinal implants, as derived from the predicate devices and relevant ASTM standards (e.g., ASTM F136, F2924, F2026, F560 mentioned for materials). The device's mechanical strength was compared to these standards and to the performance of predicate devices to establish substantial equivalence.

8. The sample size for the training set

• This question is not applicable This is a mechanical device, not an AI/machine learning system that requires a training set.

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

• This question is not applicable This is a mechanical device, not an AI/machine learning system that requires a training set.

Ask a specific question about this device