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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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The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with autograft bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared 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 purpose of this submission is to change the surface treatment. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine. All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI). The only modification being made in this submission is the change to a new surface treatment which was previously cleared by the FDA for the Endoskeleton® System in K141953.

This document is a 510(k) premarket notification decision letter from the FDA regarding the Endoskeleton® TCS System, an intervertebral body fusion device. The focus of the submission is a change to the surface treatment of the device.

Since this document is a regulatory approval and not a study report, it does not contain the detailed information required to describe acceptance criteria, device performance, and study specifics in the format requested. The document states that the modified device is substantially equivalent to previously cleared devices based on a new surface treatment that was already validated. It explicitly says "no additional testing is needed."

Therefore, I cannot provide the requested information in the same way it would be presented for a study. However, I can extract the relevant statements from the document to answer some of your questions, and indicate where the information is not applicable or not provided.

Here's a breakdown of what can be extracted based on the document:

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

• Acceptance Criteria: The document implies that the acceptance criterion for this submission is "substantial equivalence" to previously cleared predicate devices. Specifically, the key acceptance criterion is that the new surface treatment modification and the overall device "does not raise new questions regarding safety and effectiveness."
• Reported Device Performance: The document states that the performance is considered substantially equivalent to the predicate devices and that the modification "presents no additional risk during implantation." The performance related to the surface treatment was previously validated with the Endoskeleton® System (K141953).

A table cannot be fully constructed as specific, quantifiable performance metrics for this particular submission are not provided, nor are explicit acceptance criteria beyond "substantial equivalence."

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

• Sample size for the test set: Not applicable and not provided. The document states that "no additional testing is needed" for this submission because the modification (surface treatment) was previously cleared and validated.
• Data provenance: Not applicable.

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

• Not applicable and not provided. This submission relies on the prior validation of the surface treatment and a comparison to predicate devices, not a new clinical test set requiring expert ground truth establishment.

4. Adjudication method for the test set

• Not applicable and not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a medical device for spinal fusion, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI performance metrics are irrelevant to this submission.

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

• Not applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used

• For this specific submission (K153122), the "ground truth" for demonstrating safety and effectiveness relies on the prior validation of the new surface treatment (NanoFIX™) in a previous submission (K141953) and comparative analysis to predicate devices. It also states that "all original design validations were supported" by the addition of the surface treatment.

8. The sample size for the training set

• Not applicable and not provided. This is not an AI/machine learning device. The validation mentioned refers to engineering and biocompatibility testing for the surface treatment, not a "training set" in the context of data science.

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

• Not applicable. As noted above, this is not an AI/machine learning device. The "ground truth" for the previously validated surface treatment (K141953) would have been established through relevant in-vitro and potentially in-vivo non-clinical studies to assess its mechanical properties, biocompatibility, and intended biological response, following established regulatory guidelines for medical device components and surface modifications. The document does not detail these prior studies.

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

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

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

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

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

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

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

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

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

Not applicable. No new test set or data provenance is mentioned for K151596 as no new performance studies were conducted for this specific modification. The submission relies on the prior clearance (K142940) for such information.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No new test set requiring expert ground truth establishment was created for K151596 since no new performance studies were conducted.

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

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

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

8. Sample Size for the Training Set

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

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

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

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The ENDOSKELETON® TA Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non to treatment with the device. The device may be used with supplemental fixation. These DDD pattents 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® 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 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 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. 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® 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 have up to Grade I spondylolisthesis 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 fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The Endoskeleton® TC is indicated to be used with supplemental fixation and autograft bone.

The Endoskeleton® 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 traditional 510(k) is intended to modify the surface treatment of Endoskeleton devices.

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. The modified surface technology provides a microscopic roughened surface with nano-scale features. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

The provided text describes a 510(k) premarket notification for the Endoskeleton® System, which includes various interbody fusion devices and a vertebral body replacement device. This submission focuses on a modification to the surface treatment of existing devices, rather than a new device with novel indications for use. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily related to demonstrating that the modified device is substantially equivalent to the predicate devices, particularly regarding its mechanical performance, biocompatibility, and integrity.

The document does not detail specific acceptance criteria in the form of numerical thresholds for metrics like sensitivity, specificity, or accuracy, as would be typical for an AI/ML device. Instead, the "acceptance criteria" are implied by the regulatory requirement to demonstrate substantial equivalence to previously cleared devices. The "study" refers to the performance testing conducted to show that the new surface treatment does not negatively impact the device's safety and effectiveness compared to the predicate devices.

Here's a breakdown of the requested information based on the provided text, recognizing the context of a medical device modification rather than an AI/ML diagnostic tool:

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

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

The document refers to mechanical and biocompatibility testing rather than a clinical "test set" in the context of diagnostic accuracy.

• Sample Size: Not explicitly stated. For mechanical and biocompatibility testing of medical devices, sample sizes are typically determined by relevant ISO/ASTM standards (e.g., ISO 10993, ASTM F2077, ASTM F1160) and statistical power analysis specific to the test type. They would refer to the number of device components or animal subjects tested, not patient data.
• Data Provenance: Not applicable in the sense of country of origin of patient data. The provenance of the testing would be controlled laboratory environments where the mechanical and biocompatibility tests were conducted.

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. This is not a study involving expert review of diagnostic data to establish ground truth. The "ground truth" for this submission is established by the specifications of the device itself and the requirements of the standards (ASTM, ISO) for mechanical properties and biocompatibility.

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

Not applicable. This type of adjudication method is used for establishing ground truth in clinical/diagnostic studies, which is not the nature of the testing described here.

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 submission is for a physical medical device (intervertebral body fusion device), not an AI-assisted diagnostic tool.

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

Not applicable. This submission is for a physical medical device.

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

For this device modification, the "ground truth" is a combination of:

• Engineering Specifications and Standard Requirements: The acceptance criteria are based on established ISO and ASTM standards for the mechanical properties and biocompatibility of implantable devices. The device must meet these standards to ensure safety and effectiveness.
• Predicate Device Performance: The primary "ground truth" for demonstrating substantial equivalence is the known, cleared performance of the predicate devices. The modified device must perform comparably to these established devices.

8. The sample size for the training set

Not applicable. This type of "training set" is relevant for AI/ML algorithms, not for the physical device modification described.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm.

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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® 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 with the devices. This device is intended for use supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis 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® TL Interbody Fusion Device (IBD) implants are available in a various sizes with a variety of lordotic angles (0, 7 or 12 degrees), to accommodate patient anatomy. Lengths range from 40 to 60mm, widths from 18 to 26m and heights range from 8 to 16mm. Endoskeleton® TL IBD implants are intended for treatment in Lateral Lumbar Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a farge hollow region in the center to house bone graft material. The new bone formation through the implant is intended to provide long-term structural support and biologic fusion at the implanted disc space. The design incorporates "windows" through the implant to permit visualization of the graft material and over time formation of new bone. The superior and inferior surfaces are acid etched to improve fixation to the adjacent bone. 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. All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-AV-ELI).

Here's an analysis of the provided text regarding the Endoskeleton® TL Interbody Fusion Device, focusing on acceptance criteria and supporting studies:

It's important to note that this document is a 510(k) Summary for a medical device seeking clearance, not a detailed research paper. Therefore, the depth of information regarding clinical studies, ground truth establishment, and expert qualifications is much less than what would be found in a peer-reviewed publication. The focus of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "test set" in the context of human subjects or clinical data. The performance testing described (mechanical testing) likely used device prototypes or manufactured samples. The number of samples for each mechanical test is not provided.
• Data Provenance: Not applicable in the context of a clinical test set. The mechanical testing was performed in vitro, presumably by Titan Spine, LLC or a contracted lab. There is no mention of country of origin for clinical data, as no clinical study is detailed.
• Retrospective/Prospective: Not applicable, as no clinical study is described. The mechanical tests are inherently retrospective in the sense that they are performed on manufactured devices.

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

• This information is not provided in the document. For mechanical testing, the "ground truth" is typically defined by the test standards (ASTM F2077, ASTM F2267) and the performance of the predicate device. There were no human experts establishing a clinical ground truth for this type of submission.

4. Adjudication Method for the Test Set

• This information is not provided and is not applicable to the type of mechanical performance testing described. Adjudication methods are typically used in clinical studies for interpreting ambiguous findings, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is a physical intervertebral fusion device, not an AI software or diagnostic imaging tool that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone performance study was not done. This refers to AI algorithms. The device is a physical implant.

7. The Type of Ground Truth Used

• For the mechanical testing, the "ground truth" was established by established ASTM standards (F2077, F2267) and the performance characteristics of the legally marketed predicate devices. The goal was to demonstrate that the subject device met or exceeded the performance of the predicates under these standardized conditions.

8. The Sample Size for the Training Set

• This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical implant, and the submission does not involve AI or machine learning.

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

• This information is not applicable. As there is no AI component, there is no training set or associated ground truth.

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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 devices. The device may 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 use with autograft bone.

The Endoskeleton TAS is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and includes associated instrumentation. All implantable

This is a 510(k) summary for a spinal implant device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML algorithms, are not present in this document.

The document describes the device, its intended use, technological characteristics, and its substantial equivalence to predicate devices, which is the standard pathway for 510(k) clearance for conventional medical devices.

I cannot provide the requested information based on the input text because it describes a traditional medical device (intervertebral body fusion device), not an AI-powered diagnostic or predictive algorithm. There are no mentions of "acceptance criteria" for algorithm performance, "test sets," "training sets," "ground truth," "experts for ground truth," or "multi-reader multi-case studies" in the context of AI evaluation.

The "study that proves the device meets the acceptance criteria" in this context refers to the demonstration of substantial equivalence to legally marketed predicate devices, which typically involves comparing technological characteristics, intended use, and performance data (like mechanical testing, biocompatibility, etc.) relevant to the physical implant, rather than a clinical study evaluating diagnostic accuracy or AI performance.

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