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EIT Cellular Titanium® Cervical Cage: The EIT Cellular Titanium® Cervical Cages with a microscopic roughened surface and nano-scale features are intervertebral body fusion devices intented for use for anterior cervical interbody firsion 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 - T1. The EIT Cellular Titanium Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. EIT Cellular Titanium Cervical Cages are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion.

EIT Cellular Titanium® ALIF Cage: The EIT Cellular Titanium® ALIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition reguires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment with the devices.

EIT Cellular Titanium® TLIF Cage: The EIT Cellular Titanium® TLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.

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

EIT Cellular Titanium® T/PLIF Cage: The EIT Cellular Titanium® T/PLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition regures the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondvlolisthesis at the involved level(s). These patients may have had a previous non-firsion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment with the devices.

The EIT Cellular Titanium® Technology platform is a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal/Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes. footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system).

The EIT Cellular Titanium® Cages are made from Ti-6A1-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft.

The 3D Printed EIT Cellular Titanium® Cages have a microscopic roughened surface with micro and nano-scale features. The micro and nano features are on all surfaces of the cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure.

The provided text is an FDA 510(k) summary for EIT Cellular Titanium® Cervical and Lumbar Cages. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices for intervertebral body fusion.

It does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The document primarily addresses:

• Device names and regulation numbers.
• Indications for Use.
• Device description (material, manufacturing process).
• Comparison to predicate devices, asserting that the fundamental scientific technology remains unchanged and there's no change to the intended use.
• Stating that performance data remains unchanged compared to predicate devices.

Therefore, I cannot provide details for the following points as they are not present in the provided text:

• A table of acceptance criteria and the reported device performance: This document is for a physical implant, not an AI/ML device, so such performance metrics (like accuracy, sensitivity, specificity for an AI algorithm) are not relevant or listed.
• Sample size used for the test set and the data provenance: Not an AI study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI study.
• Adjudication method for the test set: Not an AI study.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not an AI study.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not an AI study. The "ground truth" for these devices would typically relate to their mechanical properties, biocompatibility, and clinical outcomes, which are assessed through different types of studies (e.g., mechanical testing, animal studies, clinical trials) not detailed here in terms of acceptance criteria for AI performance.
• The sample size for the training set: Not an AI study.
• How the ground truth for the training set was established: Not an AI study.

In summary, the provided document is a regulatory submission for a spinal implant, not an AI/ML device. Therefore, the specific questions regarding acceptance criteria and study design for an AI/ML device cannot be answered from this text.

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The EIT Cellular Titanium® Lumbar Cages - T/PLIF in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

The EIT Cellular Titanium Lumbar Cages - T/PLIF are intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the lumbar spine (L2-S1). Multiple footprints, heights and lordotic angle cages are offered to accommodate varying patient anatomical and physiological requirements. The EIT Cellular Titanium Lumbar Cages - T/PLIF are made from Titanium-6Aluminum-4Vanadium ELI ASTM F3001 through an additive manufacturing process. The design contains solid structures and porous structures formed as a diamond mesh. The hollow geometry of the cages allows them to be packed with autogenous bone graft.

This FDA 510(k) K183447 document is for a medical device called the "EIT Cellular Titanium® Lumbar Cage - T/PLIF," which is an intervertebral body fusion device. The submission focuses on expanding the labeling of a previously cleared device (K172888) to include a transforaminal lumbar interbody fusion (TLIF) surgical approach and correcting a raw material specification.

Therefore, the document does NOT contain information regarding the acceptance criteria of AI/ML device performance or a study proving that the device meets such criteria because it is not an AI/ML device.

Here's a breakdown of what the document does provide:

1. Acceptance Criteria and Reported Device Performance: Not applicable to AI/ML device performance. The document describes the device's indications for use: for degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1, with autogenous bone graft and supplemental fixation. It can be used for patients with up to Grade I spondylolisthesis or retrolisthesis, and those who may have had previous non-fusion spinal surgery. Patients must be skeletally mature and have received 6 months of nonoperative treatment. The performance discussed relates to the device's ability to stabilize the spinal segment, restore intervertebral height, and facilitate interbody fusion.

2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device.

4. Adjudication method: Not applicable as this is not an AI/ML device.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is not an AI/ML device.

6. Standalone (algorithm only without human-in-the loop performance) study: Not applicable as this is not an AI/ML device.

7. Type of ground truth used: Not applicable as this is not an AI/ML device. The "ground truth" for this device would be its demonstrated safety and effectiveness through non-clinical performance testing (e.g., mechanical, biocompatibility) and clinical experience if applicable, compared to predicate devices. The document mentions performance testing summary but does not detail it, only stating that a "technical rationale comparing the current surgical technique with that proposed (a TLIF surgical approach) was supplied."

8. Sample size for the training set: Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

Key Information from the Document:

• Device Name: EIT Cellular Titanium® Lumbar Cage - T/PLIF
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: MAX
• Purpose of Submission: To expand the labeling of a previously cleared device (K172888) to include a transforaminal lumbar interbody fusion (TLIF) surgical approach and to correct a raw material specification reference (from ASTM F136 to ASTM F3001, but the actual material remains Titanium-6Aluminum-4Vanadium ELI).
• Predicate Devices:
  • Primary: Tritanium® PL Cage (K181014)
  • Additional: EIT Cellular Titanium Lumbar Cage - PLIF (K172888), EIT Cellular Titanium Lumbar Cage - PLIF (K170503)
• Conclusion: The device is substantially equivalent to previously cleared devices regarding indications for use, design, function, materials, and performance.

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

The purpose of this Traditional 510(k) is to seek marketing clearance for the EIT Cellular Titanium® Lumbar Cage LLIF to be added to the EIT Spine line of lumbar interbody cages. The EIT Cellular Titanium® Lumbar Cage LLIF is used to restore intervertebral height and to facilitate intervertebral body fusion in the spine using an LLIF (Lateral Lumbar Intervertebral Fusion) approach with autogenous bone graft and/or allogenic bone graft materials. The EIT Cellular Titanium® Lumbar Cage LLIF is intended to be used from L2-S1 in patients with DDD and up to Grade I spondylolisthesis or retrolisthesis at one or two contiguous levels. The device is intended to be used alongside supplemental spinal fixation. either applied anteriorly or posteriorly (e.g., using posterior pedicle screws).

The EIT Cellular Titanium® Lumbar Cage LLIF is made from Ti-6AI-4V ELI (ASTM F3001) by an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows the cage to be packed with autogenous bone graft.

The provided text describes a 510(k) premarket notification for a medical device, the EIT Cellular Titanium® Lumbar Cage LLIF. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding study design and ground truth cannot be extracted directly from this document.

However, I can extract the acceptance criteria related to performance testing that was conducted and the reported device performance in relation to these tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes a 510(k) submission based on mechanical testing and a literature review for an allograft bone material claim. It does not refer to a clinical study with a "test set" of patient data for the device itself.

• Sample Size for Test Set: Not applicable in the context of the provided document as no human clinical study "test set" is described for the device. The "test set" would refer to engineered devices for mechanical, biocompatibility, and MRI safety testing.
• Data Provenance: Not applicable for a clinical test set. The provenance of the testing for the device's physical properties would be from the manufacturer's labs and contracted testing facilities.

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

Not applicable. The ground truth for the device's mechanical, biocompatibility, and MRI safety performance is established by the specified ASTM and ISO standards.

4. Adjudication Method for the Test Set

Not applicable. There's no human-interpreted "test set" that would require an adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. The document does not describe an MRMC comparative effectiveness study for the EIT Cellular Titanium® Lumbar Cage LLIF.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on its ability to meet the specifications of the referenced ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for mechanical performance, biocompatibility, and MRI safety. The "ground truth" for the claim regarding allogenic bone graft materials comes from a "comprehensive clinical literature review."

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical implant and there is no mention of a "training set" in the context of machine learning. If referring to manufacturing controls, the sample size would be related to quality control processes.

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

Not applicable. There is no training set described in the provided document.

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EIT Cellular Titanium® Cervical Cages: The EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices intended 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 - T1. The EIT Cellular Titanium® Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The EIT Cellular Titanium® Cervical Cages is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

EIT Cellular Titanium® PLIF Cages: The EIT Cellular Titanium® PLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.

EIT Cellular Titanium® TLIF Cages: The EIT Cellular Titanium® TLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.

EIT Cellular Titanium® ALIF Cages: The EIT Cellular Titanium® ALIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.

The purpose of this 510(k) was to update the indications for use to include use at multiple levels (e.g., up to 4 levels) for the EIT Cellular Titanium® Cervical Cages as well as other miscellaneous labeling updates.

The EIT Cellular Titanium® Cages are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine. The EIT Cellular Titanium® Cages differentiated in Lumbar cages (L2-S1) and Cervical Cages (C2-T1). The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g., using posterior pedicle screws, anterior plate system or anterior screw and rod system).

The EIT Cellular Titanium® Cages are made from Ti-6AI-4V ELI ASTM F136 with an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

Three different types of Lumbar Cages are included in the portfolio. Each cage type has the same intended use, but is designed for a different surgical approach; ALIF (Anterior Lumbar Intervertebral Fusion Cage), PLIF (Posterior Lumbar Intervertebral Fusion Cage) and TLIF (Transforaminal Lumbar Intervertebral Fusion Cage). One type of Cervical Cage, CIF (Cervical Intervertebral Fusion Cage) is included in the portfolio. Each cage type is supplied sterile and is available in a variety of heights, footprints and lordosis angles to accommodate patient anatomy.

The provided text is a 510(k) premarket notification decision letter from the FDA regarding a medical device, specifically intervertebral body fusion devices. It does not describe acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.

The document discusses the substantial equivalence of the EIT Cellular Titanium® Cages to previously cleared predicate devices based on indications for use, design, function, materials, and performance. The "Performance Testing Summary" section mentions a "comprehensive, clinical literature review" and "Additional MR-Safety testing" in accordance with ASTM standards, but these are related to the safety and fundamental characteristics of the implantable device, not the performance of an AI/ML algorithm.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's criteria (acceptance criteria for an AI/ML device, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) are specific to AI/ML device evaluation, which is not what this document addresses.

The document does not contain information on:

• Acceptance criteria for an AI/ML device's performance.
• A study proving an AI/ML device meets acceptance criteria.
• Sample size used for a test set or data provenance for an AI/ML study.
• Number of experts or their qualifications for establishing ground truth for an AI/ML study.
• Adjudication method for an AI/ML study.
• MRMC comparative effectiveness study or effect size for AI assistance.
• Standalone performance of an algorithm (AI).
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI study.
• Sample size for a training set in an AI context.
• How ground truth for the training set was established for an AI.

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EIT Cellular Titanium® Cervical Cage: The EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The EIT Cellular Titanium® Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

EIT Cellular Titanium® PLIF Cages: The ET Cellular Titanium® PLF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

EIT Cellular Titanium® TLIF Cages: The ETT Cellular Titanium® TLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogemic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

EIT Cellular Titanium® ALIF Cages: The EIT Cellular Titanium® ALIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenc pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

The EIT Cellular Titanium® Cages are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine. The EIT Cellular Titanium® Cages differentiated in Lumbar cages (L2-S1) and Cervical Cages (C2-T1). The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g., using posterior pedicle screws, anterior plate system or anterior screw and rod system).

The EIT Cellular Titanium® Cages are made from Ti-6AI-4V ELI ASTM F136 with an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

Three different types of Lumbar Cages are included in the portfolio. Each cage type has the same intended use, but is designed for a different surgical approach; ALIF (Anterior Lumbar Intervertebral Fusion Cage), PLIF (Posterior Lumbar Intervertebral Fusion Cage) and TLIF (Transforaminal Lumbar Intervertebral Fusion Cage). One type of Cervical Cage, CIF (Cervical Intervertebral Fusion Cage) is included in the portfolio. Each cage type is supplied sterile and is available in a variety of heights, footprints and lordosis angles to accommodate patient anatomy.

The provided text describes a medical device submission (K170503) for various EIT Cellular Titanium® Cages, which are intervertebral body fusion devices. This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text in relation to your request:

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

The document states that the devices were subjected to mechanical testing. The acceptance criteria are implicitly the standards outlined in ASTM F2077-14 and F2267-04. The reported device performance is that the "results demonstrate that the devices are substantially equivalent to the predicate devices." No specific numerical results or detailed performance metrics are given in this summary.

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 does not specify the sample size for the mechanical testing (e.g., number of devices tested for each type of cage and test). The provenance of the data (country of origin, retrospective/prospective) is also not mentioned, as this is a regulatory submission summary focusing on equivalence rather than a clinical trial. The testing is described as "Performance Testing Summary," indicating laboratory mechanical tests rather than clinical data.

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 document describes mechanical testing of medical implants, not a diagnostic or prognostic device that would require human expert-established ground truth. Therefore, this information is not applicable and not provided.

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

As this involves mechanical testing of physical devices against material and performance standards (ASTM standards), there is no adjudication method in the context of expert review for ground truth establishment. The evaluation is based on whether the devices physically meet the specified mechanical requirements.

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 MRMC study was conducted. This device is an intervertebral body fusion cage, not an AI-powered diagnostic or assistive tool.

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

No standalone algorithm performance study was done. This document pertains to a physical medical implant, not an algorithm or AI system.

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

The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards, specifically ASTM F2077-14 and F2267-04 for mechanical properties, and bacterial endotoxin testing for sterility. There is no biological or diagnostic "ground truth" as would be established by pathology or clinical outcomes in the context of a diagnostic device.

8. The sample size for the training set:

Not applicable. This is a medical device (implant) and does not involve AI/machine learning with training sets.

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

Not applicable. This is a medical device (implant) and does not involve AI/machine learning with training sets and ground truth for them.

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