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The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defines as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the C3 to C7 disc levels using autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Amendia Interbody Fusion Devices consist of multiple components comprised of sterile and/or non-sterile, single-use implants fabricated from Titanium alloy (Ti6AI4V ELI, ASTM F136) or Invibio PEEK-Optima® LT1 or Solvay Advanced Polymers Zeniva™ ZA-500 PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers. The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation.

The Amendia Interbody Fusion Devices are comprised of implants designed to treat the cervical and lumbar spine. The implants are available in a range of sizes and shapes to accommodate variations in surqical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. The surface of the ridges on the titanium implants are roughened.

The provided text is a 510(k) Summary for Amendia Interbody Fusion Devices, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving the device meets specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC comparative effectiveness studies cannot be extracted from this document. This document primarily addresses the mechanical and material equivalence of the device to previously approved devices.

Here's what can be inferred about "acceptance criteria" in the context of this 510(k) and the "study" that proves it:

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

• Acceptance Criteria (Implied for 510(k) Clearance): The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This is typically achieved by showing similar intended use, indications for use, materials, performance (mechanical), and fundamental scientific technology.
• Reported Device Performance: The document states: "The substantial equivalence of the Amendia Lumbar Interbody Fusion Devices to the predicate is shown by similarity in intended use, indications for use, materials, performance and fundamental scientific technology."
  • Performance aspects mentioned (though no specific numerical criteria or results are given): The device is made of specific materials (Titanium alloy, PEEK, Tantalum), has various sizes/shapes, a hollow center for bone graft, and ridges for gripping endplates. "Performance testing" is mentioned, implying mechanical and material characterization, but no results are provided.

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/Not provided. Clinical performance testing on a test set (as would be done for an AI device) is not detailed in this document. The "test set" here refers to the device itself and its components undergoing mechanical/material testing.

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/Not provided. Ground truth establishment by clinical experts for a performance study is not described.

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

• Not applicable/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/Not provided. This is a medical device (interbody fusion device), not an AI diagnostic/imaging device that would typically undergo MRMC studies.

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

• Not applicable/Not provided. This is a physical medical device.

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

• For the purpose of substantial equivalence, the "ground truth" would be the established performance and safety profile of the predicate devices, along with adherence to relevant ASTM standards for material and mechanical properties. No clinical ground truth is discussed.

8. The sample size for the training set

• Not applicable/Not provided. The document does not describe a machine learning algorithm or training set.

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

• Not applicable/Not provided.

In summary: This document focuses on demonstrating substantial equivalence for a physical medical implant (Interbody Fusion Device) based on its design, materials, and mechanical properties compared to already cleared predicate devices. It does not present clinical performance data or details about studies that would evaluate diagnostic accuracy or compare human reader performance, which are typical for AI/software devices. The "studies" implied are likely non-clinical (e.g., bench testing for mechanical properties, material biocompatibility, etc.) to show consistency with predicate devices and relevant standards.

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The Overwatch Spine System is intended for non-cervical fixation (T1-S2/Ilium) in skeletally mature patients as an adjunct to following instabilities/deformities in the thoracolumbar and sacral spine: a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) b) spondylolisthesis, c) trauma (i.e., fracture or dislocation), d) spinal stenosis, e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis). f) tumor, g) pseudoarthrosis, and h) failed previous fusion The Overwatch Spine System is intended for the following indications when used in a posterior percutaneous approach for non-cervical pedicle and non-pedical fixation: Degenerative disc disease; spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scolosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion When used for posterior non-cervical pedicle screw fixation in pediatric patients the Overwatch Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Overwatch Spine System consists of spinal implants for fixation of the thoracolumbar and/or sacral spine. The system includes rods, screws, transverse crosslinks, rod connectors, and hooks. The Overwatch screws are self-tapping and are available with either a cancellous or a dualfix thread design. They are available in cannulated and noncannulated configurations, in a variety of diameters and lengths. The system implants are manufactured from Ti-6Al-4V (ASTM F136).

The provided document is a 510(k) premarket notification for a medical device called the "Overwatch Spine System." It describes the device, its intended use, and a summary of performance testing to demonstrate substantial equivalence to legally marketed predicate devices.

However, the document does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered device. The "Summary of Performance Testing" section refers to mechanical testing of the spinal fixation system, not a clinical study involving data provenance, expert ground truth, sample sizes for training/test sets, or comparative effectiveness studies with human readers.

Therefore, I cannot provide the requested information for an AI/ML context based on this document. The document focuses on the mechanical and material equivalence of a physical medical device.

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The Savannah-T® Pedicle Screw System is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine, specifically as follows:

· When intended for pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients the Savannah-T® is indicated for one or more of the following: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); fracture; dislocation; scollosis; kyphosis; spinal tumor; and/or failed previous fusion (pseudarthrosis).

• In addition, when used as a pedicle screw fixation system, the Savannah-T® is indicated for skeletally mature patients having degenerative spondylolisthesis with objective evidence of neurologic impairment and/or severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (1.5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and who are having the device removed after the development of a solid fusion mass.

The Savannah-T® Pedicle Screw System provides structural stability in skeletally mature adults requiring fusion of the lumbar and/or sacral spine. The system consists of mono- and poly-axial pedicle screws, connecting rods, set screws, and transverse crossmembers. The screws are available in cancellous and cortical-cancellous thread designs of various diameters and lengths. The rods are available in straight, lordosed and pre-contoured confiqurations in various lengths. They are manufactured from Ti-6AI-4V (ASTM F136) and are provided non-sterile for single-use.

The provided document is a 510(k) premarket notification letter from the FDA regarding the Savannah-T® Pedicle Screw System and a 510(k) summary. This document does not describe a clinical study or acceptance criteria for a device's performance in terms of diagnostic accuracy or effectiveness against specific clinical outcomes.

Instead, this document focuses on establishing substantial equivalence for a medical implant device (a pedicle screw system) to previously cleared devices. The acceptance criteria and performance data discussed are related to mechanical testing of the device, not a study evaluating its use in patients or comparing its diagnostic capabilities.

Therefore, many of the requested points in your prompt are not applicable to the information contained in this document. I will answer what can be gleaned from the text provided.

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

The document mentions "non-clinical mechanical testing" as the basis for demonstrating substantial equivalence. The specific acceptance criteria are not detailed in terms of numerical thresholds here, but the overall goal is for the device to perform comparably to predicate devices.

Disclaimer: The document does not provide specific numerical acceptance limits or results, only that the device met the criteria for substantial equivalence.

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

• Sample Size for Test Set: This refers to the number of devices or test articles subjected to mechanical testing. The document states, "Non-clinical mechanical testing for the Subject Device was performed on the worst case subject device." This implies a limited number of test articles, often representing the most challenging configuration in a product family, rather than a broad sample size typically associated with clinical studies. The actual number of "worst-case" devices isn't specified, but it would typically be a small, statistically valid number for engineering testing.
• Data Provenance: The document does not specify the country of origin for the mechanical testing data. These are non-clinical (laboratory) tests. The terms "retrospective" or "prospective" do not apply to this type of mechanical testing.

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 question is not applicable. Ground truth, in the context of clinical studies, refers to a definitive diagnosis or outcome usually established by medical experts or pathology. For mechanical testing of an orthopedic implant like a pedicle screw system, the "ground truth" is measured against engineering standards (e.g., ASTM F1717), and the performance is assessed by engineers and materials scientists, not medical experts establishing clinical diagnoses.

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

This question is not applicable. Adjudication methods are used in clinical studies to resolve disagreements among human readers or evaluators in establishing ground truth. Mechanical testing relies on objective physical measurements and engineering analysis, not subjective interpretation of clinical data by multiple experts.

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 question is not applicable. An MRMC study assesses the performance of human readers, often aided by AI, in tasks like interpreting medical images. The Savannah-T® Pedicle Screw System is a physical implant, not an AI diagnostic tool, and the submission primarily concerns its mechanical safety and effectiveness.

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

This question is not applicable. This refers to the performance of an AI algorithm independently. The Savannah-T® Pedicle Screw System is a physical device, and its evaluation did not involve a standalone algorithm performance test.

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

The concept of "ground truth" as typically understood in clinical or AI diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. For mechanical testing, the "ground truth" or reference performance is established by the requirements of the recognized standards (e.g., ASTM F1717) and the performance of the predicate device. The performance of the subject device is then compared against these established mechanical benchmarks.

8. The sample size for the training set

This question is not applicable. "Training set" refers to data used to train an AI algorithm or a statistical model. The Savannah-T® Pedicle Screw System is a physical implant, and its evaluation did not involve a training set as described for AI or machine learning.

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

This question is not applicable. As there was no training set in the context of AI or machine learning for this physical device, there was no ground truth established for such a set.

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The Syzygy Stabilization System is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine, specifically as follows:

• When intended for pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients the Syzygy Stabilization System is indicated for one of the following: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); fracture; dislocation; scoliosis; kyphosis; spinal tumor; and/or failed previous fusion (pseudarthrosis).

· In addition, when used as a pedicle screw fixation system, the Syzygy Stabilization System is indicated for skeletally mature patients having degenerative spondylolisthesis with objective evidence of neurologic impairment and/or severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and who are having the device removed after the development of a solid fusion mass.

The Syzygy Stabilization System consists of posted screws, couplers, and associated surgical instruments. The system is used in conjunction with the Amendia Savannah-T pedicle screw and rod system. The Syzygy posted screws are self-tapping with a cancellous thread design. They are available in cannulated and non-cannulated configurations, in a variety of diameters and lengths. The Syzygy posted screws are attached to the pedicles via couplers (medial and cranial) which accept and secure the longitudinal rods to build a rigid construct. The screws and couplers are manufactured from Ti-6AI-4V (ASTM F136) and are provided non-sterile for singleuse.

This document is a 510(k) premarket notification for the Syzygy Stabilization System, a medical device for spinal stabilization. The document does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based device performance evaluation, but rather for a traditional medical device (pedicle screw system).

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study details. The document focuses on mechanical testing of spinal implants and a cadaveric validation study to demonstrate substantial equivalence to predicate devices, which is typical for a 510(k) submission for this type of hardware.

Specifically, the document states:

• Acceptance Criteria & Device Performance: The document refers to "requirements as established by the test protocol and applicable ASTM standards" for mechanical tests, and "substantially equivalent to the Predicate" for the cadaveric validation study. However, it does not provide a table of numeric acceptance criteria or specific device performance metrics in a way that would be applicable to an AI device.
• Study Types: The studies performed were:
  • Static Axial Compression Bending (ASTM F1717-14)
  • Static Axial Tension Bending (ASTM F1717-14)
  • Static Torsion (ASTM F1717-14)
  • Dynamic Axial Compression Bending (ASTM F1717-14)
  • Dynamic Axial Tension Bending (ASTM F1717-14)
  • A Cadaveric validation study.
• The document does not include information on:
  • Sample size used for a test set (in the context of AI data splits)
  • Data provenance (country of origin, retrospective/prospective)
  • Number or qualifications of experts for ground truth
  • Adjudication method
  • Multi-reader multi-case (MRMC) comparative effectiveness study
  • Standalone algorithm performance
  • Type of ground truth (expert consensus, pathology, outcomes data, etc. in an AI context)
  • Sample size for a training set
  • How ground truth for a training set was established

The information provided pertains to the mechanical and general performance characteristics of a physical spinal implant system, not the performance of an AI or algorithmic medical device.

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The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-Sl) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis at the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment.

The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft and requires no additional supplementary fixations. One device is used per intervertebral space.

The Optimus Anterior Lumbar Interbody Fusion (ALIF) system is a zero profile stand-alone interbody that combines the benefits of an anterior fixation plate and fusion device. Optimus is a modular design that consists of a center fixation plate, lordotic end caps and three bone screws for anterior fixation and stability. The bone screws thread into the fixation plate and pass through the superior and inferior openings of the end caps to fixate the implant with the adjacent vertebral bodies.

OPTIMUS is available in a variety of heights (9-13mm posterior), angles (6 to 14 degrees) and two footprints to accommodate variations in patient anatomy. The fixation plates are manufactured from Titanium (ASTM F136), and the end caps are available in PEEK (ASTM F2026) and titanium (Ti-6Al-4V, ASTM F136), and are plasma sprayed with CPtitanium (ASTM F1580). The bone screws manufactured from Titanium (ASTM F136) are Ø5mm and are available in lengths from 24 to 32mm.

This document is a 510(k) premarket notification from the FDA regarding the "Optimus ALIF System," an intervertebral body fusion device. The purpose of this specific submission is for a modification to a trial distractor instrument, not the core device itself. As such, the document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance data for the main implant.

Therefore, the requested information regarding acceptance criteria and a study proving device performance (especially for AI/software-as-a-medical-device type evaluations) is not applicable to this document. This submission is for a physical medical device (spinal implant) and its associated instrument, and the "performance testing" mentioned refers to cleaning and sterilization validation, not clinical efficacy or diagnostic accuracy studies typically associated with AI.

Here's why the questions are not applicable and what information can be gleaned:

• 1. A table of acceptance criteria and the reported device performance: This document does not contain such a table. The device is a physical implant, and its performance is assessed through substantial equivalence to a predicate device and via mechanical testing (which is not detailed in this summary). The summary mentions "Cleaning and steam sterilizations were performed to verify method suitability," which are performance tests for those specific aspects, not for the clinical performance of the implant.
• 2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. There isn't a "test set" in the context of diagnostic performance.
• 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 diagnostic device requiring expert interpretation of results.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 not an AI/diagnostic assistance device.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a spinal implant's mechanical performance would come from engineering and biomechanical testing standards, which are not detailed here. Clinical success would be measured through patient outcomes in post-market studies, but this document is a pre-market clearance based on equivalence.
• 8. The sample size for the training set: Not applicable. There is no training set for an AI algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

Information that can be extracted from the document related to the device:

• Device Name: Optimus ALIF System
• Predicate Device: Optimus ALIF System (K132596) - This indicates that the current submission is for a modification to an already cleared device, relying heavily on the equivalence to the original.
• Purpose of Submission: A special 510(k) for a modification to the Optimus Stand-Alone ALIF System, specifically for the trial distractor instrument. This means the core implant design, materials, and function for which it was originally cleared are unchanged ("There are no changes being proposed for the Subject Device with respect to intended use, design, material composition, and function.").
• Performance Testing Mentioned: "Cleaning and steam sterilizations were performed to verify method suitability." This refers to validation of sterilization processes for the instrument, not clinical performance of the implant.
• Conclusion: "Based on comparison to the predicate device, the Subject Device has been shown to be substantially equivalent."

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The Amendia Stand-Alone Cervical System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Amendia Stand-Alone Cervical implant should be packed with autogenous bone graft and implanted with an anterior approach.

The Amendia Stand-Alone Cervical System includes a PEEK spacer component (medical grade Zeniva ZA-500, ASTM F2026) with Tantalum markers (ASTM F560), and a titanium interbody plate and screws (ASTM F136). The spacer component is assembled to the interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.

Based on the provided document, the device in question is the "Amendia Stand-Alone Cervical System," which is an intervertebral body fusion device. The document is a 510(k) premarket notification of intent to market, issued by the FDA.

Crucially, this document is a 510(k) clearance based on substantial equivalence to a predicate device, not an approval based on a clinical study demonstrating performance against acceptance criteria.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found or inferred from this document.

Here's why:

• 510(k) Process: The 510(k) pathway determines if a new device is "substantially equivalent" to a legally marketed predicate device. This often relies on comparative testing (e.g., mechanical, material) to show that the new device performs as safely and effectively as the predicate, rather than new clinical trials establishing efficacy against specific performance metrics in human patients.
• "Performance testing was not necessary": The document explicitly states: "Performance testing was not necessary since the Subject and Predicate Devices are identical with regards to intended use, indications for use, materials, manufacturing processes, and performance specifications." This means no new "performance testing" (which would include clinical studies generating the data you're asking about) was conducted for this specific 510(k) submission to demonstrate the device meets acceptance criteria derived from clinical outcomes.

Given this, I cannot provide the requested information about acceptance criteria or a study that proves the device meets those criteria from this document. The document indicates that no such study was performed or required for this particular 510(k) clearance due to the device's substantial equivalence to an already cleared predicate.

If this were a PMA (Premarket Approval) or a device requiring new clinical data, the submission would contain the detailed study information you are asking for.

Therefore, I will state that the requested information is not available in the provided document, as a clinical study proving performance against acceptance criteria was not conducted for this 510(k) submission.

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The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The Subject Amendia Interbody Fusion Devices (LLIF and OLLIF) are multiple component systems comprised of sterile, single-use implants, designed to treat the lumbar spine.

The Subject Amendia Interbody Fusion System lumbar (LLIF and OLLIF) implants are fabricated from PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Amendia Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

This document describes the Amendia Interbody Fusion Devices and their substantial equivalence to predicate devices, focusing on the mechanical testing performed. However, it does not contain information regarding an AI/ML device study or performance against acceptance criteria in the context of an AI/ML device.

Therefore, I cannot provide the requested information in the format of acceptance criteria for an AI/ML device, as the document is about a physical medical device (intervertebral body fusion device) and its mechanical performance testing.

The document discusses:

• Device Description: Amendia Interbody Fusion Devices, including materials (PEEK, tantalum, Titanium alloy) and design features (hollow center for autograft, ridges for grip).
• Indications for Use: Intervertebral body spinal fusion procedures for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, with or without Grade I spondylolisthesis/retrolisthesis, used with autogenous bone graft and supplemental fixation, and after at least six months of non-operative treatment.
• Performance Testing: Non-clinical mechanical testing, including static and dynamic axial compression and compression shear (ASTM F2077), subsidence (ASTM F2267), and expulsion testing.
• Conclusion: The device was shown to be substantially equivalent to predicate devices based on design, intended use, material composition, function, and mechanical performance.

To directly answer your numbered points regarding an AI/ML device study, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes mechanical test standards (ASTM F2077, ASTM F2267) but does not provide a table of acceptance criteria and detailed performance results for these. It just states that performance testing "demonstrated the Subject Device is substantially equivalent to the predicate device."
2. Sample sized used for the test set and the data provenance: Not applicable for an AI/ML device. For the mechanical testing, the document states "Non-clinical mechanical testing for the Subject Device was performed on the worst case subject device," implying a limited number of physical samples for mechanical tests, but specific numbers are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable for an AI/ML device. For the physical device, "ground truth" would be established by the physical testing results and engineering standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Rectangular Corpectomy Cage is a vertebral body replacement system indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The Rectangular Cage is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft.

The Rectangular Corpectomy Cage consists of multiple components comprised of sterile, single-use implants fabricated from PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Rectangular Corpectomy Cage is used to replace a collapsed, damaged or unstable vertebral body resected or excised during total and partial vertebrectorny procedures due to tumor or trauma. They are designed to be used in conjunction with supplemental spinal fixation instrumentation.

The Rectangular Corpectomy Cage is comprised of implants designed to treat the thoracolumbar spine. The implants are available in a range of sizes and shapes to accommodate anterior. anterolateral, lateral and posterolateral surgical approaches and patient anatomy. Each cage has a hollow center to allow placement of autograft and/or allograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The provided document is a 510(k) premarket notification for a medical device (Rectangular Corpectomy Cage) and describes its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI device is not available in these documents.

However, I can extract the information related to the performance testing that was conducted to demonstrate substantial equivalence, which serves a similar purpose in the context of this device.

Here's a breakdown of the available information:

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

The document does not explicitly state numerical acceptance criteria with corresponding performance results for these non-clinical tests. Instead, it states that "Design verification demonstrated the Subject Device is substantially equivalent to the predicate device." This implies that the performance of the Rectangular Corpectomy Cage met the standards demonstrated by the predicate devices, though specific values are not presented.

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

• Sample Size: The document mentions that testing was performed "on the worst case subject device." This implies that a limited number of physical devices were tested to represent the entire product line under the most challenging conditions. A specific numerical sample size is not provided, and for non-clinical mechanical testing, it's typically fewer units than for clinical trials.
• Data Provenance: The testing is non-clinical, meaning it's laboratory-based mechanical testing, not human subject data. Therefore, concepts like country of origin for data or retrospective/prospective do not apply.

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. For mechanical testing of a physical medical device, "ground truth" is defined by established engineering and biomechanical principles and standards (e.g., ASTM F2077). The "experts" involved would be the engineers and technicians performing and analyzing these tests.

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

This information is not applicable. Adjudication methods are relevant for human interpretation or clinical outcomes, not for objective mechanical performance tests.

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. An MRMC study is relevant for AI-assisted diagnostic or interpretive devices involving human readers. This document describes a physical implantable device.

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

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

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

The "ground truth" for this type of non-clinical mechanical testing is established by the specified industry standards (e.g., ASTM F2077) and the physical properties and performance characteristics defined by sound engineering principles for intervertebral body fixation orthoses.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable for the same reason as above.

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The Amendia Cervical Plate System is intended for use in anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), spinal stenosis, deformity (i.e. kyphosis, lordosis or scoliosis), tumor, pseudoarthosis or failed previous fusion.

The Amendia Cervical Plate System is a multiple component system comprised of non-sterile, single-use implantable components fabricated from Titanium alloy (Ti-6Al-4V, ASTM F136). The Amendia Cervical Plate System provides stabilization of cervical segments of the spine. The system consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

This document describes the Amendia Cervical Plate System, a medical device. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for AI/ML-based medical devices.

Instead, this is a 510(k) premarket notification for a traditional medical device (a cervical plate system) where substantial equivalence to a predicate device is being demonstrated. Therefore, most of the requested information (sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth types) is not applicable to this type of submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: In a 510(k) for a traditional device like this, the "acceptance criteria" generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through comparative testing (e.g., mechanical, biocompatibility) rather than clinical performance metrics related to diagnostic accuracy or treatment efficacy as would be seen in an AI/ML context. The document mentions "performance testing" but does not detail the specific tests, their acceptance criteria, or the results.

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

• Sample Size for Test Set: Not applicable. This document does not describe a test set for evaluating diagnostic or predictive performance in the context of AI/ML. The "testing" referred to is likely engineering/mechanical testing to ensure the device meets its design specifications and is comparable to the predicate.
• Data Provenance (country of origin, retrospective/prospective): Not applicable.

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

• Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert consensus on image findings) is not relevant to this submission for a traditional spinal implant.

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

• Not applicable.

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 not an AI-assisted device.

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

• Not applicable. This is not an AI algorithm.

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

• Not applicable. For a traditional medical device like a spinal plate, the "ground truth" for demonstrating safety and effectiveness often comes from engineering standards, material properties, and potentially clinical literature or experience with similar predicate devices, rather than a diagnostic 'ground truth'.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

In summary: The provided document is a 510(k) clearance letter and summary for a traditional medical device (spinal implant). It establishes substantial equivalence to a predicate device based on design, intended use, materials, and "performance specifications." It does not involve AI/ML technology, and therefore, the questions about acceptance criteria, study design, sample sizes, and expert adjudication for AI/ML performance evaluation are not relevant to this specific document.

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The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone and supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Amendia Interbody Fusion Devices consist of multiple components comprised of nonsterile, single-use implants fabricated from Invibio PEEK-Optima® LT1 or Solvay Advanced Polymers Zeniva™ ZA-500 PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation.

The Amendia Interbody Fusion Devices are comprised of implants designed to treat the cervical and lumbar spine. The implants are available in a range of sizes and shapes to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The provided document is a 510(k) premarket notification for Amendia Interbody Fusion Devices, which are medical devices used in spinal fusion procedures. This type of regulatory document focuses on establishing substantial equivalence to existing legally marketed devices, rather than proving efficacy or meeting specific diagnostic performance criteria through clinical studies in the same way a diagnostic AI device would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data specific to an AI/diagnostic device is not applicable to this document.

This document describes a medical device (surgical implants) and its intended use, material composition, and mechanical performance testing (engineering analysis and ASTM standards) to demonstrate equivalence to predicate devices, not the diagnostic performance of a software algorithm.

Here's a breakdown of why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document assesses substantial equivalence based on intended use, indications, material, and mechanical performance (engineering analysis, ASTM F2077, ASTM F1877), not diagnostic accuracy metrics like sensitivity or specificity.
2. Sample size used for the test set and the data provenance: Not applicable. There is no diagnostic "test set" in the context of an interbody fusion device. The document refers to "performance testing" based on engineering analysis and ASTM standards, which would involve physical specimens of the device, not a dataset of patient images or information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for an interbody fusion device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is for resolving discrepancies in diagnostic interpretation, which is not relevant 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 device is a surgical implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for diagnostic accuracy is not relevant.
8. The sample size for the training set: Not applicable. There is no training set for a physical implant.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) and does not contain the type of information requested about acceptance criteria and studies typical for AI/diagnostic software performance.

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