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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® 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 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 comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate.

The ENDOSKELETON® TL 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 prior to treatment with the ENDOSKELETON® TL Hyperlordotic Interbody Fusion Device. Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. The Interbody Device is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft bone marrow aspirate, or a combination thereof. The ENDOSKELETON® TL Hyperlordotic Interbody Fusion Devicemust be used with an integrated Lateral Plate and Bone Screw and additionally must be used with posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine.

The ENDOSKELETON® TL Interbody Fusion Device implants are available in a variety of lengths, widths, and heights for treatment in Lateral Lumbar Interbody Fusion and are designed with a large hollow region in the center to house autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone, demineralized allograft bone marrow aspirate, or a combination thereof. The new bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. The design incorporates "windows" through the implant to permit visualization of device placement and over time formation of new bone. The superior and inferior surfaces include either the Chemtex® surface treatment or nanoLOCK® surface treatment (MMN™) designed to improve fixation to the adjacent bone. The nanoLOCK® surface technology (MMN™) provides a microscopic roughened surface with nano-scale features. The implants are composed of ASTM F136 Ti 6Al-4V ELI titanium alloy and provided either sterile. An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant inserter and to facilitate placement of the implant into the interbody space.

The subject submission introduces the ENDOSKELETON® TL Hyperlordotic Interbody Fusion Devices are available in a variety of lengths, widths, and heights for treatment in Lateral Lumbar Interbody Fusion and are designed with a large hollow region in the center to house autograft bone comprised of cancellous and/or corticocancellous bone. The design incorporates "windows" through the Interbody Device to permit visualization of the Interbody Device placement and over time formation of new bone. The new bone formation through the Interbody Device is intended to provide long-term structural support and fusion at the implanted disc space. The Interbody Device is treated with nanoLOCK® Surface Technology (MMN™) designed to improve fixation to the adjacent bone. The nanoLOCK® Surface Technology (MMN™) provides a microscopic roughened surface with nano-scale features.

The subject submission also includes Lateral Plate and Bone Screws which are available in a variety of sizes for stabilizing the Interbody Device. The Lateral Plate has one or two hole(s) for receiving integrated Bone Screws and a feature for attachment to the Interbody Device. The Lateral Plate incorporates a lock cover to resist the integrated Bone Screws from backing out. Holding features have been incorporated into the Interbody Device and associated device components to facilitate placement of the system into the interbody space. The Interbody Device and associated device components are composed of ASTM F136 or ASTM F3001 Ti6Al4V ELI titanium alloy and provided sterile.

The provided text describes the regulatory filing for the Endoskeleton® TL Interbody Fusion Device and Endoskeleton® TL Hyperlordotic Interbody Fusion Device. This document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document highlights a mechanical device (intervertebral body fusion device) for spinal fusion, not an AI or software-as-a-medical-device (SaMD) product. Therefore, the acceptance criteria and study designs typically associated with AI/SaMD (e.g., performance metrics like sensitivity/specificity, MRMC studies, ground truth establishment by experts, training/test sets) are not applicable here.

The "performance testing" section refers to biomechanical and material testing (e.g., static and dynamic testing per ASTM standards, particulate/wear analysis, bacterial endotoxin testing) to ensure the device's physical properties and biocompatibility are acceptable, and that it can withstand the forces it will encounter in the body.

Here's how to address your request given the provided context:

The acceptance criteria and study detailed in this document are for a physical medical device (spinal implant), not a software/AI medical device. Therefore, the questions related to AI/SaMD performance metrics, ground truth, expert review, and training/test sets are not applicable.

Here's what can be extracted and inferred from the document regarding the acceptance criteria and the study that proves the device meets them, adapted for a mechanical device:

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

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of clinical data for AI. For biomechanical testing, the "worst-case construct" and "worst-case bone screw configurations" were tested. This implies a representative selection of device variations. The exact number of samples tested per ASTM standard is not provided in this summary but would be detailed in the full testing report submitted to the FDA.
• Data Provenance: Not applicable in the sense of patient data. The "data" comes from laboratory and physical testing of the device prototypes.

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 physical device; ground truth is established through adherence to engineering standards (ASTM) and physical measurements/tests, not through expert clinical consensus of images or outcomes as would be done for an AI device.

4. Adjudication method for the test set:

• Not Applicable. No human adjudication process is described for this type of device testing. Compliance with ASTM standards is determined by the results of the physical tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a surgical implant.

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.

7. The type of ground truth used:

• Mechanical and Biological Standards: Ground truth is established by adherence to recognized industry standards (ASTM), material specifications (ASTM F136 Ti 6Al-4V ELI, ASTM F3001 Ti6Al4V ELI), and biological compatibility testing requirements (LAL for endotoxins). The "ground truth" is that the device physically performs according to these established engineering and safety benchmarks.

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of machine learning for a mechanical device. The design and manufacturing process are refined through engineering principles and iterative testing, not by "training" an algorithm on a dataset.

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

• Not Applicable. As there's no training set, there's no ground truth to establish in this context. The design process for a physical medical device relies on established engineering principles, material science, and prior knowledge from predicate devices.

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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 requires 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 internal spinal fixation that has been cleared by the FDA for use in the lumbar spine.

The ENDOSKELETON® TAS and ENDOSKELETON® TAS Hyperlordotic Interbody Fusion device implants are available in a variety of Anterior Lumbar Interbody Fusion (ALIF) sizes with a variety of lordotic angles, to accommodate patient anatomy; Hyperlordotic implants are those defined by a lordotic angle ≥16°. Implants are designed with a large hollow region in the center to house autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. The new bone formation through the implant is intended to provide long-term structural support and 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 of the IBDs have been acid etched through a previously cleared process called Chemtex® and the IBDs may have also received Titan Spine's nanoLOCK® Surface Technology (MMN™) designed to improve fixation to the adjacent bone. The nanoLOCK® surface technology (MMN™) provides a microscopic roughened surface with nano-scale features.

The implant system includes integrated fixation (screws) for stabilizing the implants when placed in the interbody space. An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the interbody space. Screws include internal hex drive features matched to instrumentation for implantation. All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) and may be provided either sterile or non-sterile.

The purpose of this special 510(k) submission is to add a plate to the Endoskeleton® TAS and TAS Hyperlordotic System. The ENDOSKELETON® TAS Plate is available in a variety of sizes corresponding to the sizes of ENDOSKELETON® TAS and ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device implants. The Plate design incorporates a lock to secure it to the Interbody Fusion Device implant and is engaged after the plate is placed on the anterior face of the ENDOSKELETON® TAS or ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device implant 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® TAS or ENDOSKELETON® TAS Hyperlordotic Interbody Fusion device implant. The subject plate does not include nanoLOCK™ (MMN™) surface treatment, as it does not interface with the bone. The subject Endoskeleton® TAS Plate is only provided sterile by gamma irradiation.

ENDOSKELETON® TAS Plate resists integrated screws from backing out. These plates do not qualify as supplemental fixation and may only be used with ENDOSKELETON® TAS and ENDOSKELETON® TAS Hyperlordotic Interbody fusion devices 12mm and above.

The provided text is a 510(k) summary for the Endoskeleton® TAS Plate, an intervertebral body fusion device. While it describes the device, its intended use, and states that performance bench testing was conducted, it does not provide the detailed information requested regarding the acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert involvement for AI device evaluation.

Therefore, I cannot fully answer your request based on the provided document. The document describes a traditional medical device (implantable plate), not an AI/ML powered device.

However, I can extract what is implied about performance testing for this mechanical device:

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

The document states: "Performance bench testing, including locking plate resistance to screw push-out, was performed to demonstrate substantial equivalence."

• Acceptance Criteria (Implied): The locking plate must demonstrate sufficient resistance to screw push-out to ensure substantial equivalence to predicate devices and maintain safe and effective function. Specific quantitative criteria (e.g., minimum force required to push out a screw) are not provided in this summary.
• Reported Device Performance: The document concludes that based on this testing, the device is "substantially equivalent to the predicate devices." No specific performance values or metrics are reported.

The remaining questions (2-9) are largely irrelevant as this document describes a physical medical device and its bench testing, not an AI-powered device or a clinical study that would involve human readers, ground truth establishment through expert consensus, or training sets for AI models.

To address points 2-9, the information would typically come from a submission for an AI/ML-powered medical device, which would detail diagnostic performance studies.

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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.

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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-operative treatment prior to treatment with the device is intended to 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 or allograft bone comprised of cancellous and/ or corticocancellous 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. 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 requires no additional supplementary fixation. The Device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone.

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 comprised of cancellous and/ or corticocancellous bone. 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.

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 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 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 comprised of cancellous and/ or corticocancellous bone.

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 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 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 comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TC Interbody Fusion Device 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 with the device. The ENDOSKELETON® TC Interbody Fusion Device is indicated to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine and autograft bone comprised of cancellous and/ or corticocancellous bone.

The Endoskeleton® TCS Interbody Fusion Device 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 or allograft bone comprised of cancellous and/ or corticocancellous bone. The device is a standalone system when used with Endoskeleton® TCS interrated 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. This devices. This 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 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 or allograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TA Vertebral Body Replacement 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 Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems that has been cleared by the FDA for use in the lumbar spine. The ENDOSKELETON® TA Vertebral Body Replacement may be used with bone graft material and/or allogeneic bone graft.

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 (Ti6A14V-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 submission seeks to expand the indications of these devices to include use with allograft material.

The predicate Endoskeleton® System (K173535, K170399, and K141953) is provided either non-sterile or sterile via gamma irradiation. The Endoskeleton® TA VBR (K032812) was initially manufactured and submitted by Orthovita, Inc (Malvern, PA). Titan Spine has the 510(k) and maintains the device listing for the device.

The provided document is a 510(k) summary for the Titan Spine Endoskeleton® Interbody Fusion Devices and Vertebral Body Replacement Device. This submission is for a modification to the indications for use, specifically to include the use of allograft material. The document explicitly states that no performance testing was required or performed because the modification relates only to the indications for use and not to the device's design, materials, or function.

Therefore, the study design and associated criteria for "device performance" (as would be tested in a typical clinical or technical performance study) are not applicable or reported in this document. The "proving" of acceptance criteria in this context relies on a literature review to establish substantial equivalence with predicate devices, rather than empirical testing of the device itself.

Since the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of device performance, and the document clarifies that no such testing was conducted, I will state that directly.

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

1. Table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not applicable. No performance testing was conducted.
• Data provenance: Not applicable. The basis for this 510(k) was a comprehensive literature review.

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

• Not applicable. No test set was used for device performance evaluation. The determination of substantial equivalence was based on a literature review which concluded no additional risks for the modified indications.

4. Adjudication method for the test set

• Not applicable. No test set was used.

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 a medical device (spinal implant), not an AI/software device. No MRMC study was conducted.

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

• Not applicable. This is a medical device (spinal implant), not an algorithm/software device.

7. The type of ground truth used

• Not applicable in the context of device performance testing. The "ground truth" for the current submission was established through a comprehensive literature review to assess the safety and equivalence of using allograft material with the existing devices.

8. The sample size for the training set

• Not applicable. No training set was used as no AI/software component is involved, and no performance testing was conducted.

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

• Not applicable. No training set was used.

Summary regarding the "study that proves the device meets the acceptance criteria":

For this specific 510(k) submission (K183557), the device itself (Titan Spine Endoskeleton® Interbody Fusion Devices and VBR Device) was not subjected to new performance testing. The application was a "Special 510(k)" for a modification to the Indications for Use, specifically to add the use of allograft material.

The document explicitly states: "No performance testing was required or performed, as this modification for this Special 510(k) relates only to the indications for use." and "A comprehensive literature review was conducted to assess any additional safety concern for the use of these devices with allograft. The review of the literature concluded that there were no additional risks due to the modification of the indications of these devices to include use with allograft and that these devices are substantially equivalent to the predicate devices."

Therefore, the "proof" that the device (with the expanded indication) meets acceptance criteria comes from a comprehensive literature review demonstrating no additional safety concerns or changes in substantial equivalence due to the inclusion of allograft material. This relies on the established performance and safety profile of the predicate devices and existing knowledge regarding allograft use in similar surgical contexts. There were no specific, quantifiable "acceptance criteria" related to a performance study for this particular submission because no such study was deemed necessary.

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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 prior to treatment with 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.

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. 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.

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 neck 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. 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® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device screws that are the subject of the present submission have been previously cleared as non-sterile. This Special 510(k) submission seeks clearance for the subject Endoskeleton® screws to be provided sterile by gamma irradiation. The current Endoskeleton family is an interbody and vertebral body system 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 material. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.

I am sorry, but based on the text provided, I cannot provide the requested information about acceptance criteria and a study proving device performance. The document describes a 510(k) premarket notification for an interbody fusion device, focusing on substantial equivalence to predicate devices, particularly regarding a change in sterilization method (from non-sterile to sterile via gamma irradiation).

The document does not contain:

• A table of acceptance criteria and reported device performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device, or specific physical performance thresholds for a therapeutic device).
• Details of a study proving the device meets specific performance criteria, as would typically be found in a clinical trial report or a detailed engineering test report.
• Information about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details, as these are typically associated with performance validation studies for AI/software devices or complex diagnostic tools.

Instead, the document focuses on:

• Identifying the device and its indications for use.
• Establishing substantial equivalence to predicate devices, primarily by demonstrating that the new sterilization method (gamma irradiation) for the screws does not alter the fundamental characteristics or safety/effectiveness of the device compared to the previously cleared predicate devices or an earlier clearance that also used gamma sterilization.
• Mentioning "sterilization validation and pyrogen testing" as performance testing related to the change in sterilization, and asserting biocompatibility based on material history and standards, rather than new, detailed performance studies for clinical effectiveness.

Therefore, I cannot fulfill your request as the information is not present in the provided text.

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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 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 must be used with supplemental 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.

This traditional 510(k) is intended to add additional products to the Endoskeleton® TO System that have been additively manufactured from titanium alloy.

The Endoskeleton® TO Interbody Fusion Device implants are available in a variety of sizes for treatment in Posterior Lumbar Interbody Fusion (PLIF) to accommodate patient anatomy and are designed with a large hollow region in the center to house autograft bone material. The Endoskeleton® TO Interbody Fusion Device is offered with or without nanoLOCK® Surface Technology. The nanoLOCK® Surface Technology is identical to the previously cleared product (K141953), which is a microscopic roughened surface with nano-scale features. The version without nanoLOCK® Surface Technology has a macro surface roughness.

The implant system must be used with supplemental fixation for stabilizing the implants when placed in the interbody space.

The implants are composed of medical grade titanium alloy (Ti 6Al-4V ELI) per ASTM F136 and ASTM F3001.

The components included in this submission for additive manufacturing are sterile only.

The provided text describes a 510(k) premarket notification for a medical device, the Endoskeleton® TO Interbody Fusion Device (IBD). This document focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and effectiveness through clinical trials with defined acceptance criteria and human performance metrics.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable to this type of submission. The information provided primarily details mechanical testing to ensure the new manufacturing process (additive manufacturing) does not compromise the device's structural integrity compared to its predicate devices.

However, I can extract information related to the performance testing and its conclusions:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each mechanical test. However, it indicates these were bench tests (mechanical, biocompatibility, cleaning, endotoxin) performed on physical device samples. Therefore, the "data provenance" is derived from these laboratory tests rather than patient data (e.g., country of origin of data, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable as the submission relies on objective mechanical and material science testing against established standards, not interpretation by clinical experts to establish a "ground truth."

4. Adjudication Method

This is not applicable for the same reasons as #3.

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

No MRMC study was performed or mentioned. This type of study is typically relevant for diagnostic imaging devices where human interpretation is a key component. This device is an implantable surgical device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This is not applicable. The device is an implantable medical product, not an algorithm, and does not involve human-in-the-loop performance in the context of its function.

7. Type of Ground Truth Used

The "ground truth" used for this submission is based on:

• Established ASTM (American Society for Testing and Materials) standards for mechanical testing.
• ISO (International Organization for Standardization) standards (ISO 10993) for biocompatibility and cleaning validation.
• AAMI (Association for the Advancement of Medical Instrumentation) standard (AAMI ST72) for bacterial endotoxin testing.

The "ground truth" is that the new, additively manufactured device performs mechanically and biologically equivalently to the predicate devices as demonstrated by adherence to these industry and regulatory standards.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an implantable medical device submission of this nature. Machine learning or AI models, which would require training sets, are not involved.

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

This is not applicable for the same reasons as #8.

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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. These DDD patients may also have up to Grade I spondylolisthesis or retrolistiss at the involved level(s). Patients should have received 6 months of non-operative treatment with the devices. The device is a standalone system that is intended to be used with the bone screws provided and requires no additional supplementary fixation. The device is indicated to be used with autograft bone.

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 or retrolisthesis at the involved level(s). Patients should have received 6 months of non to treatment with the devices. The device is indicated to be used with autograft bone. The Endosketon® 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.

The Endoskeleton® TAS Interbody Fusion Device and Endoskeleton® TAS Hyperlordotic Interbody Fusion Device implants are available in a variety of Anterior Lumbar Interbody Fusion (ALIF) sizes with a variety of lordotic angles, to accommodate patient anatomy; Hyperlordotic implants are those defined by a lordotic angle ≥ 16'. Implants are designed with a large hollow region in the center to house autograft bone material. The new bone formation through the implant is intended to provide long-term structural support and 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 include either the previously cleared Chemtex® surface treatment or previously cleared nanoLOCK® surface treatment to improve fixation to the adjacent bone. The nanoLOCK® surface technology provides a microscopic roughened surface with nano-scale features. The implant system includes integrated fixation (screws) for stabilizing the implants when placed in the interbody space.

An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the interbody space. Screws include internal hex drive features matched to instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-ELI).

The provided document is a 510(k) summary for the Endoskeleton® TAS Interbody Fusion Device, particularly focusing on the hyperlordotic variant. This document primarily addresses the substantial equivalence of the device to previously marketed predicate devices rather than a study focused on meeting specific acceptance criteria for a new algorithmic device.

Therefore, the information requested in your prompt (acceptance criteria for an AI/algorithmic device, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) is not present in this regulatory submission for a physical interbody fusion device.

This document describes the following physical device features and mechanical testing:

Device Description:
The Endoskeleton® TAS Interbody Fusion Device and Endoskeleton® TAS Hyperlordotic Interbody Fusion Device are Anterior Lumbar Interbody Fusion (ALIF) implants.

• Sizes and Lordotic Angles: Available in a variety of sizes and lordotic angles, with hyperlordotic implants defined as having a lordotic angle ≥ 16°.
• Design: Large hollow region in the center for autograft bone material, with "windows" for graft material visualization and new bone formation.
• Surfaces: Superior and inferior surfaces feature either Chemtex® or nanoLOCK® surface treatments for improved fixation. nanoLOCK® provides a microscopic roughened surface with nano-scale features.
• Fixation: Includes integrated fixation (screws) for stabilization.
• Material: All implantable components are made from medical-grade titanium alloy (Ti6A14V-ELI).
• Instrumentation: Implant holding feature on the trailing surface for placement; screws have internal hex drive features matching instrumentation.

Performance Testing:
Mechanical testing was performed to demonstrate substantial equivalence to predicate devices.

• Tests: Static compression shear, dynamic compression, dynamic compression-shear, subsidence, and expulsion tests.
• Standards: Performed according to ASTM F2077 and ASTM 2267.
• Additional Study: A cadaver study was performed, with radiographic and CAD analysis.

The document concludes that the mechanical testing data demonstrates that the Endoskeleton® TAS and nanoLOCK® TAS Hyperlordotic Interbody Fusion Devices are substantially equivalent to the predicate devices and do not raise new questions about safety and effectiveness.

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