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The Endoskeleton™ TA Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD, defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. Patients should have received 6 months of non-operative treatment with the devices. The Endoskeleton™ TA Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scolosis and sagittal deformity. The device is to be used with supplemental fixation cleared by the FDA for use in the lumbar spine. These patients may also have up to Grade I spondylolisthesis at the involved level(s).

Endoskeleton™ TA Interbody System is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

The Endoskeleton™ TAS Interbody System device including those with macro-, micro- and nano-roughened surface textured features are indicated for use in skeletally mature patients with symptomatic Degenerative Disc Disease (DDD, defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiosraphic studies), degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. Patients should have received 6 months of non-operative treatment with the devices. The device is a standalone system intended to be used with the bone screws provided and requires no additional supplementary fixation. The Endoskeleton™ TAS Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the Endoskeleton™ TAS Interbody System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The device is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

The Endoskeleton™ TAS Hyperlordotic Interbody System (>16°) devices including those with macro-, micro- and nanoroughened surface textured features are indicated for use in skeletally mature patients with DDD, degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade I spondylolisthesis at the involved levels. Implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. Patients should have received 6 months of non-operative treatment with the devices. The device is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. The Endoskeleton™ TAS Hyperlordotic Interbody System must be used with a posterior supplemental internal spinal fixation cleared by the FDA for use in the lumbar spine.

The Endoskeleton™ TC Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are indicated 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 to T1. The Endoskeleton™ TC Interbody System is indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

The Endoskeleton™ TCS Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or instability, as confirmed by imaging studies(tadiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. The device is indicated to be used with autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. The device is a stand-alone system when used with Endosketon™ TCS Interbody System integrated screws. When used without the integrated screws, the Endoskeleton™ TCS Interbody System requires additional supplemental fixation cleared by the FDA for the cervical spine.

The Endoskeleton™ TL Hyperlordotic Interbody System (≥16) devices with macro-, micro- and nano-roughened surface textured features are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD, defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade I spondylolisthesis at the involved levels. Patients should have received 6 months of non-operative treatment with the Endoskeleton™ TL Hyperlordotic Interbody System. Patients with previous non-fusion spinal surgery at the involved levels may be treated with the device. The Endoskeleton™ TL Hyperloric Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Interbody Device is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. The Endoskeleton™ TL Hyperlordotic Interbody System must be used with an integrated lateral plate and additionally must be used with posterior supplemental internal spinal fixation cleared by the FDA for use in the lumbar spine.

The Endoskeleton™ TL Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD, defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. Patients should have received 6 months of non- operative treatment with the devices. The device must be used with supplemental fixation cleared by the FDA for use in the lumbar spine. These patients may also have up to Grade I spondylolisthesis at the involved levels. The Endoskeleton™ TL Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. Patients with previous non-fusion spinal surgery at the involved levels may be treated with the device. It is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

The Endoskeleton™ TO Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD, defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. Patients should have received 6 months of nonoperative treatment with the devices. The device must be used with supplemental fixation cleared by the FDA for use in the lumbar spine. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. The Endosketon™ TO Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The device is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

The Endoskeleton™ TT Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD, defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. Patients should have received 6 months of nonoperative treatment with the devices. The device must be used with supplemental fixation cleared by the FDA for use in the lumbar spine. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. The Endoskeleton™ TT Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. It is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

The Endoskeleton™ Interbody System implants are available in a variety of sizes and designed with a large hollow region in the center to house autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone. Devices incorporate Titan Surface Technologies™, where superior and inferior surfaces include either Chemtex™ or nanoLOCK™ surface treatment (MMN™) designed to improve fixation to adjacent bone. nanoLOCK™ surface technology (MMN™) provides a microscopic roughened surface with nanoscale features. The nanoLOCK™ Surface Technology is specifically engineered to have nano textured features at a nanometer (10°) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. The nanoLOCK™ surface technology demonstrates the elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document. New bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. Implants are composed of ASTM F136 Ti 6Al-4V ELI titanium alloy and are provided either sterile or non-sterile. The Endoskeleton™ TL Hyp. implants are composed of ASTM F3001 Ti 6Al-4V ELI titanium alloy and are provided sterile.

The Endoskeleton™ TAS & TAS Hyp. and Endoskeleton™ TCS Interbody systems include integrated fixation screws for stabilizing the implants when placed in the interbody space. Screws are composed of ASTM F136 Ti 6Al-4V ELI titanium alloy and are provided either sterile or nonsterile.

This document is a 510(k) premarket notification from the FDA for a medical device called the Endoskeleton™ Interbody System. It's a clearance letter, not a study report. Therefore, it does not contain the detailed acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you've outlined.

The FDA 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through new clinical trials against predefined acceptance criteria like a PMA (Premarket Approval) application would.

Here's what can be extracted from the document based on your request, and where information is inherently missing due to the nature of a 510(k) clearance:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states "no new mechanical testing was required for this Submission" because "There is no change to the Endoskeleton™ Interbody System product families' design, manufacturing, materials, nor intended use." This implies that performance has been demonstrated through substantial equivalence to predicate devices, rather than new testing against defined criteria for this specific submission.

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

No new test set or data provenance is detailed. The substantial equivalence argument relies on the prior clearance of predicate devices.

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/provided as no new test set requiring expert ground truth establishment is described.

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

This information is not applicable/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:

This information is not applicable/provided. The device is an intervertebral body fusion system, not an AI diagnostic tool.

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

This information is not applicable/provided. This is a physical implant device, not a standalone algorithm.

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

This information is not applicable/provided for this 510(k). The regulatory clearance is based on substantial equivalence to predicate devices, which would have had their own "ground truth" (e.g., clinical outcomes, mechanical testing) established during their initial approval/clearance.

8. The sample size for the training set:

This information is not applicable/provided as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable/provided as this is a physical medical device, not an AI/ML algorithm.

Summary of what the document does provide regarding performance and equivalence:

• Mechanical Testing: According to the document, "no new mechanical testing was required for this Submission" because there were no changes to the product families' design, manufacturing, materials, or intended use. This means its mechanical performance is considered substantially equivalent to the predicate devices.

• Biocompatibility: The implants are made from materials (ASTM F136 Ti 6Al-4V ELI titanium alloy and ASTM F3001 Ti 6Al-4V ELI titanium alloy) that have "a long history of safe and effective use identical to predicate devices and biocompatibility testing is not required."

• Substantial Equivalence: The primary "proof" of meeting acceptance criteria for this 510(k) is the demonstration of substantial equivalence to three predicate devices:

  • EIT Cellular Titanium® Cages- K201605 (S.E. 07/15/2020)
  • Endoskeleton™ Interbody Systems- K192018 (S.E. 08/13/2019)
  • NuVasive Interbody Systems K203201 (S.E. 01/12/2021)

  The substantial equivalence is based on having the same intended use, fundamental scientific technology, material, sizing, and sterilization method as the predicate devices. Modifications described include identification of nanoLOCK™ Surface Technology and expansion/modification of indications based on the cleared indications of the predicate devices.

In conclusion, this document is a regulatory clearance based on substantial equivalence, not a detailed study report demonstrating performance against specific acceptance criteria for a new device.

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The ENDOSKELETON® TA Interbody Fusion Device 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 discogence 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 device may be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). ENDOSKELETON® TA is indicated to be used with autograft bone and/or allograft bone comprised of cancellous bone and/or demineralized allograft bone with bone marrow aspirate.

The ENDOSKELETON® TAS Interbody Fusion device 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 discogence back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of nonoperative treatment prior to treatment with the device is a standalone system that is intended to be used with the bone screws provided and requres no additional supplementary fixation. The Device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous bone and/or demineralized allograft bone with bone marrow aspirate.

Hyperlordotic Devices ≥16°: The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device (≥ 16°) 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. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment with the devices. The device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous bone and/ or demineralized allograft bone with bone marrow aspirate.The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device must be used with a posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine must be used with a posterior supplemental inxation that has been cleared by the FDA for use in the lumbar spine.

The ENDOSKELETON® TC is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The ENDOSKELETON® TC is indicated to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine and be used with autograft bone and/ or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate.

The ENDOSKELETON® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment with the device. The device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous bone and/or demineralized allograft bone with bone marrow aspirate. The device is a stand-alone system when used with ENDOSKELETON® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

The ENDOSKELETON® TL Interbody Fusion Device is indicated for use in spinal 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. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with supplemental fixation systems that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate.

The ENDOSKELETON® TO Interbody Fusion Device 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 discogence 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 that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate.

The ENDOSKELETON® TT Interbody Fusion Device 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 discogence 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 that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate.

The current Endoskeleton® System is an interbody and vertebral body family comprised of a variety of sizes and geometries to accommodate various patient anatomy and pathology. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). The center of the implant is hollow and is to be filled with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone. The superior and inferior surfaces include either the Chemtex® surface treatment or nanoLOCK® surface treatment (MMNTM) designed to improve fixation to the adjacent bone. The nanoLOCK® surface technology (MMN™) provides a microscopic roughened surface with nano-scale features. This submission seeks to expand the indications of these devices to include use with demineralized allograft bone with bone marrow aspirate.

The provided text is a 510(k) premarket notification for a medical device called the "ENDOSKELETON® Interbody Fusion Device" system. This document addresses an expansion of indication for use rather than a new device submission. As such, it does not contain information typically found in a study demonstrating primary device performance against acceptance criteria.

Specifically, the document states: "No performance testing was required or performed, as this modification for this Special 510(k) relates only to the indications for use."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them because the provided document explicitly states that no such testing was performed for this specific submission.

The submission is for modifying the indications for use of an already cleared device system to include the use of demineralized allograft bone with bone marrow aspirate. The rationale for substantial equivalence is based on:

1. Literature review: The review concluded that there were "no additional risks due to the modification of the indications for these devices to include use with demineralized allograft bone with bone marrow aspirate."
2. Similarities to predicate devices: The intended use, material, surgical technique, surface treatment, sterility, and design of the subject devices are the same as the predicate devices.

In summary, the document does not contain the information requested about acceptance criteria or performance study details.

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The Endoskeleton® TCS Interbody Fusion Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment with the device. The device is indicated to be used with autograft bone or allograft bone comprised of cancellous bone. The device is a stand-alone system when used with Endoskeleton® TCS Interbody Fusion Device integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton® TCS IBD implants are intended for treatment in Cervical Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a large hollow region in the center to house bone graft material. The superior and inferior surfaces have been acid etched through a previously cleared process called nanoLOCK™ (MMN™) to improve fixation to the adjacent bone.

The purpose of this special 510(k) submission is to add a plate to the Endoskeleton® TCS System. The ENDOSKELETON® TCS Plate Device (Plate) is compatible with the ENDOSKELETON® TCS Interbody Fusion Device product family. The design incorporates a locking screw to secure the Interbody Fusion Device and is engaged after the placed on the anterior face of the ENDOSKELETON® TCS Interbody Fusion Device to resist the integrated screws from backing out. The system includes a holding feature on the Plate to mate with the inserter to facilitate placement onto the ENDOSKELETON® TCS Interbody Fusion Device implant. Use of this plate is an enhancement to the existing Endoskeleton® TCS system and, as such, is optional with the Endoskeleton® TCS Interbody Fusion Device and does not qualify as supplemental fixation. The subject plate does not include nanoLOCK® (MMN™) surface treatment, as it does not interface with the bone.

The construct is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.

All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-EL)) and may be provided either sterile. The subject Endoskeleton® TCS Plate is only provided sterile by gamma irradiation.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance in relation to those criteria, or details regarding a study that proves the device meets specific acceptance criteria.

The document is a 510(k) premarket notification summary for the Endoskeleton® TCS Interbody Fusion Device. It focuses on demonstrating substantial equivalence to previously cleared predicate devices for regulatory clearance, rather than presenting a detailed study evaluating specific performance metrics against pre-defined acceptance criteria.

The "Performance Testing" section states: "Performance bench testing, including locking plate resistance to screw push-out and retention force of the plate holder, was performed to demonstrate substantial equivalence." However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment.
• Information about expert involvement or adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) study or standalone algorithm performance, as this device is a physical interbody fusion device, not an AI or imaging device.

Ask a specific question about this device

The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment pror to treatment with the device is indicated to be used with autograft bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.

The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton® TCS IBD implants are intended for treatment in Cervical Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a large hollow region in the center to house bone graft material. The superior and inferior surfaces are acid etched to improve fixation to the adjacent bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine. All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI). The primary modification being made in this submission is that the hex size on the screws is being changed from T6 to T8 and as a result the heights now range from 13 – 21.35mm. As a result, there was a small change to the overall length of the screws and a change to the instruments associated with the hex update.

This FDA 510(k) summary for the Endoskeleton® TCS Interbody Fusion Device (K151596) deals with a minor modification to an already cleared device (predicate device K142940). Therefore, the provided text does not contain the detailed information typically found in a new device's acceptance criteria and study report.

Specifically, this document describes a modification to the hex size of the screws used with the device and a slight change in the screw heights. It argues for substantial equivalence to the predicate device without conducting new performance studies for these modifications, relying instead on an "engineering rationale."

Therefore, for this particular submission (K151596), many of the requested sections about acceptance criteria and study details cannot be fully answered. This document provides an engineering rationale for why these minor changes do not impact safety and effectiveness, rather than reporting on new performance studies.

Here's a breakdown based on the provided text, indicating where information is present and where it is explicitly stated as not applicable due to the nature of this 510(k) submission:

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

The document does not provide a table of acceptance criteria or new reported device performance for K151596 because it's a modification to an already cleared device. The manufacturer states that the modifications (hex size and screw height) do not impact the overall function, and thus, no new performance testing was deemed necessary. The "reported device performance" is essentially that the modified device performs equivalently to the predicate device based on engineering rationale.

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. No new test set or data provenance is mentioned for K151596 as no new performance studies were conducted for this specific modification. The submission relies on the prior clearance (K142940) for such information.

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. No new test set requiring expert ground truth establishment was created for K151596 since no new performance studies were conducted.

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

Not applicable. No adjudication method is mentioned for K151596 as no new test set needing adjudication was generated.

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 device is an interbody fusion device, which is a physical implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies are not relevant to this type of medical device.

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

Not applicable. This is a physical implant, not an algorithm, so standalone algorithm performance is not relevant.

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

Not applicable. No new ground truth was established for K151596 as no new performance studies were conducted. The substantial equivalence argument rests on the predicate device's prior approval.

8. The sample size for the training set

Not applicable. This is a physical implant, not a machine learning model, so there is no training set.

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

Not applicable. As above, there is no training set or ground truth for a training set for this physical medical device.

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The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with autograft bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.

The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton® TCS IBD implants are intended for treatment in Cervical Interbody Fusion procedures and are used as single placement devices in the disc space, and are designed with a large hollow region in the center to house autograft bone. The new bone formation through the implant is intended to provide long-term structural support and biologic fusion at the implanted disc space. The design incorporates "windows" through the implant to permit visualization of the graft material and over time formation of new bone. The superior and inferior surfaces are acid etched to improve fixation to the adjacent bone.

The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.

An implant holding feature has been incorporated into the anterior surface of the implant to mate with the implant holder, and to facilitate placement of the interbody space. All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELD).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The provided document describes mechanical performance testing, not clinical studies involving human patients or data. Therefore, the concept of a "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) and sample size (number of cases/patients) is not applicable here.

The document states that mechanical testing was performed on "the subject Endoskeleton® TCS IBD and predicate devices." The specific number of devices tested for each mechanical test is not provided in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This device underwent mechanical testing, not a study requiring expert-established ground truth for clinical outcomes or image interpretation.

4. Adjudication Method for the Test Set

Not applicable. This device underwent mechanical testing, not a study requiring adjudication of clinical data.

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

Not applicable. This document describes the 510(k) submission for a medical device (intervertebral body fusion device) primarily based on mechanical performance and substantial equivalence to predicate devices, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. As noted above, this is a physical medical device, not an algorithm or AI model.

7. Type of Ground Truth Used

The "ground truth" for the mechanical performance testing was based on the results obtained from testing the substantially equivalent predicate devices according to established ASTM standards (ASTM F2077 and ASTM F2267). The subject device's performance was then compared to these predicate device results to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device undergoing mechanical testing, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI model, there is no training set or associated ground truth establishment.

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The ENDOSKELETON® TA Interbody Fusion Device 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 to treatment with the device. The device may be used with supplemental fixation. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Endoskeleton® TAS Interbody Fusion Device 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 with the devices. The device is a standalone system intended to be used with the bone screws provided and requires no additional supplementary fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Endoskeleton® TO IBD 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 disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also I spondylolisthesis or retrolistesis at the involved level(s). It is indicated to be used with autograft bone.

The Endoskeleton® TT IBD 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 and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also I spondylolisthesis or retrolistesis at the involved level(s). It is indicated to be used with autograft bone.

The Endoskeleton® TC is indicated for use for anterior cervical interbody mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The Endoskeleton® TC is indicated to be used with supplemental fixation and autograft bone.

The Endoskeleton® TL IBD is indicated for use in spinal 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone.

The ENDOSKELETON® TA VBR is for use in the thoracolumbar spine (T1 – L5) to replace all or part of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The ENDOSKELETON® TA VBR is intended for use with supplemental internal spinal fixation systems. The ENDOSKELETON® TA VBR may be used with bone graft material or bone graft substitute.

This special 510(k) is intended to modify the sterilization of the Endoskeleton® system from non-sterile to sterile via gamma irradiation.

The Endoskeleton system is an interbody and vertebral body system comprised of a variety of implant sizes and geometries to accommodate various patient anatomy and pathology. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

The document provided does not describe a study that uses acceptance criteria to prove the device meets these criteria in the context of an AI/ML algorithm or a comparative effectiveness study. Instead, it is a 510(k) premarket notification for a medical device (Endoskeleton® System) that focuses on substantial equivalence to predicate devices, particularly regarding a change in sterilization method from non-sterile to sterile via gamma irradiation.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not present in this document.

However, I can extract the information that is available:

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

The document focuses on substantial equivalence for a change in sterilization method. The "acceptance criteria" here are implied to be that the new sterilization method (gamma irradiation) effectively sterilizes the device without negatively impacting its other characteristics, thus maintaining substantial equivalence to the non-sterile predicate devices.

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. The document describes a 510(k) submission for a physical medical device (interbody fusion system) and a change in its sterilization method, not a study involving a test set for an AI/ML algorithm or data analysis. The "sterilization validation" would typically involve samples of the device and testing for sterility, but the specific sample size and detailed provenance of that testing are not provided in this summary.

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. No ground truth for a test set (in the context of AI/ML or diagnostic performance) is established in this document.

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

Not applicable. No adjudication method for a test set is mentioned.

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/ML device or an MRMC study.

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

Not applicable. This document does not describe an AI/ML algorithm.

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

Not applicable in the context of an AI/ML algorithm. For the sterilization validation, the "ground truth" would be the standard scientific and regulatory methods for proving sterility (e.g., microbial challenges, physical testing), but specific details are not provided.

8. The sample size for the training set:

Not applicable. This document is not about an AI/ML algorithm with a training set.

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

Not applicable. This document is not about an AI/ML algorithm with a training set.

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The Endoskeleton® TC is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The Endoskeleton® TC is indicated to be used with supplemental fixation and autograft bone.

The Endoskeleton® TC is a cervical intervertebral body fusion device. The system is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). The center of the implant is hollow and is to be filled with autograft material. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.

This document is a 510(k) summary for the Endoskeleton® TC intervertebral body fusion device. It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices. Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML device.

The provided text describes a traditional medical device (an implantable fusion device) and its regulatory clearance process, which relies on demonstrating substantial equivalence to already marketed predicate devices through mechanical testing. It does not mention any AI/ML components, software, or algorithms. Therefore, it's impossible to extract the requested information regarding AI/ML device performance, ground truth, expert consensus, or comparative effectiveness studies from this document.

Based on the provided text, I cannot complete the requested tables and descriptions because the document pertains to a physical medical device (an intervertebral body fusion device) and does not describe an AI/ML powered device or a study involving such a device.

The summary focuses on:

• Device Description: A titanium intervertebral body fusion device.
• Intended Use: Anterior cervical interbody fusion for degenerative disc disease.
• Predicate Devices: Other legally marketed interbody devices.
• Non-Clinical Testing: Mechanical tests like axial compression, shear, torsion, subsidence, and expulsion, all performed in vitro (e.g., in a lab setting, not on patient data or with AI).
• Substantial Equivalence: A regulatory pathway showing the new device is as safe and effective as existing ones, primarily based on design, materials, and mechanical performance.

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