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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® 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® 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 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. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Endoskeleton TO is comprised of a variety of implant sizes to accommodate various patient's anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

Here's a breakdown of the acceptance criteria and the study details for the Endoskeleton TO Interbody Fusion Device, based on the provided 510(k) summary:

This device is not an AI/ML powered device but rather a physical interbody fusion device. Therefore, many of the typical questions for AI/ML devices regarding human-in-the-loop, effect size, training data, and ground truth establishment are not applicable.

Acceptance Criteria and Reported Device Performance

Study Details

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

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

   • Sample Size: Not explicitly stated as a number of devices. The document mentions "variety of implant sizes" being tested. However, the testing was conducted on the "Endoskeleton TO Interbody Fusion Device," implying representative samples of the device were used.
   • Data Provenance: This was pre-clinical bench testing performed in a laboratory setting, not clinical data from patients.

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

   • This is not applicable as the "ground truth" for this type of medical device refers to the physical and mechanical properties of the device as measured against established engineering standards (ASTM standards). There are no human experts "establishing ground truth" in the way it applies to diagnostic or prognostic AI/ML devices. The "experts" would be the engineers and technicians conducting the ASTM standard tests.

4. Adjudication method for the test set:

   • Not applicable in the context of mechanical bench testing. The "adjudication" is the direct measurement and comparison of the device's performance against the established ASTM standards and the performance of predicate devices.

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 implant, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

   • Not applicable. This is a physical medical device, not an algorithm. Bench testing is analogous to "standalone" performance for a physical device, in that its mechanical properties are evaluated independently of patient interaction at this stage.

7. The type of ground truth used:

   • For this device, the "ground truth" is defined by established engineering standards (ASTM F2077-03, ASTM F2267-04) and the performance characteristics of legally marketed predicate devices. The device's performance is compared against these benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set:

   • Not applicable. This device does not use a "training set" in the machine learning sense. The device is designed and manufactured, and then its physical properties are tested.

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

   • Not applicable, as there is no "training set." The design and manufacturing processes are guided by engineering principles, material science, and regulatory requirements, not by machine learning training data.

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