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The WAVE O Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive unilateral posterior approach. Alternatively, these implants may also be implanted via a transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The WAVE O cage is an expandable PEEK cage of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

This document is a 510(k) summary for the WAVE O Cage, an intervertebral body fusion device. It does not describe a study involving artificial intelligence or a medical imaging device. Therefore, I cannot provide the requested information.

The document explicitly states under section "6. CLINICAL TEST SUMMARY" that "No clinical studies were performed." and under section "5. NON-CLINICAL TEST SUMMARY" that "The results of this testing indicate that the WAVE O Cage is equivalent to predicate devices." This implies that the device's performance was established through non-clinical testing and comparison to predicate devices, not through a study with acceptance criteria and reported device performance in the way described in your request for AI-enabled devices.

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The FUSE Cage is indicated for intervertebral body 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). FUSE implants are to be used with autogenous bone graft and implanted via an open posterior approach. The FUSE Cage 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 FUSE is rectangular in shape and it has a honeycomb structure thru the implant in the superior/inferior direction. There is an oval opening in the M/L direction. There is a roughened surface on the superior and inferior surfaces. There are neutral, 4° and 8° lordosis configurations. The posterior end has a threaded hole for attaching insertion instruments, while the other end is solid and tapered.

The provided text describes a medical device, the AMT FUSE Cage, and its 510(k) summary for FDA clearance. However, it does not contain any information about acceptance criteria, specific device performance metrics, or any study design that would "prove" the device meets such criteria in the context of AI/machine learning or diagnostic accuracy.

The information provided is typical for a 510(k) submission for a non-active implantable medical device, focusing on substantial equivalence to a predicate device based on design, materials, function, and mechanical testing.

Therefore, I cannot populate the requested table or answer most of the questions, as the source document does not contain this type of information.

Here's what I can extract and explain:

Summary of Information from the Provided Text:

The document is a 510(k) premarket notification for the AMT FUSE Cage, a device intended for intervertebral body spinal fusion. The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Missing Information:

The provided text does not contain any information related to:

• Acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• Reported device performance (in terms of diagnostic accuracy or AI performance).
• Sample size used for a test set or training set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used (pathology, outcomes data, expert consensus).
• How ground truth for a training set was established.

This is because the device described is a physical implant (a spinal cage), not an AI/ML-driven diagnostic or image analysis tool. The "study" mentioned refers to non-clinical mechanical tests, not clinical performance or diagnostic accuracy.

What is included (and why the requested AI/ML-related questions are not applicable):

The document states:

• Device Name: FUSE Cages
• Intended Use: Intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. To be used with autogenous bone graft and supplemental fixation via an open posterior approach, after 6 months of non-operative treatment.
• Material: Commercially pure titanium.
• Function: Posterior stabilization of the lumbar spinal column with the technique of Posterior Lumbar Interbody Fusion (PLIF).
• Comparison to Predicate: "The AMT FUSE Cage has the same indications and material, and similar designs as previously cleared devices." (Predicate device: WAVE (K080401)).
• Nonclinical Tests: "Tests performed according to ASTM F2077/F2267 indicate that the AMT FUSE Cage meets required mechanical strengths." These are mechanical strength tests relevant to the physical stability and integrity of the implant, not performance related to AI or diagnostic accuracy.

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SHELL Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. SHELL Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. SHELL Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The WAVE/LOOP Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level 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. WAVE implants are to be used with autogenous bone graft and implanted via an open posterior approach. The WAVE Cage 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 SHELL was especially adapted to the local anatomy in order to secure the surgical result as possible. Its caudal side is flat, its cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. The A/P view is trapezoidal. There are x-ray pins at the four edges, which slightly protrude the cage in order to maximize rotational fixation.

The LOOP is a banana-shaped implant with optimized tip design and an integrated swivel joint for the instrument fixation. Both factors facilitate the implantation. The radial orientated fixation teeth define the direction of implantation and secure the implant position. LOOP is shaped with a 6° lordosis.

The WAVE is rectangular in shape. Cross section is trapezoidal with the lateral side 1mm higher than the medial. WAVE has a neutral and a 6° lordosis. The posterior end has a threaded hole for attaching insertion instruments, while the other end is solid and tapered. The WAVE cages are implanted in pairs.

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)

Function: The SHELL Cage was developed as an intercorporal implant for anterior cervical spondylodesis. The WAVE Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Posterior Lumbar Interbody Fusion (PLIF). The LOOP Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Transforaminal Lumbar Interbody Fusion (T-LIF).

Here's an analysis of the provided information regarding the acceptance criteria and study for the AMT Interbody Fusion Devices:

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical trial report with specific acceptance criteria in the context of diagnostic performance or clinical outcomes. The "acceptance criteria" here refer to mechanical strength and similarity to predicate devices, not AI/algorithm performance.

Description of Acceptance Criteria and Study

The AMT Interbody Fusion Devices (SHELL, WAVE, LOOP Cages) demonstrate their suitability for market by undergoing nonclinical bench testing to demonstrate mechanical strength and by establishing substantial equivalence to previously cleared predicate devices. The "acceptance criteria" primarily revolve around meeting established mechanical standards for interbody fusion devices and demonstrating that the device's technological characteristics, indications for use, and materials are comparable to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes a pre-market notification (510(k)) for a medical device that is a physical implant, not an AI/software device. Therefore, the concept of a "test set" and "data provenance" as typically applied to AI performance studies does not directly apply here.

• Test Set: Not applicable in the context of AI/algorithm performance. The "test" involved ex-vivo mechanical testing of the physical implant devices. The sample size for these mechanical tests (e.g., number of devices tested for ASTM F2077/F2267) is not specified in the summary.
• Data Provenance: Not applicable in the context of AI/algorithm performance. The "data" comes from bench testing of the physical medical devices.

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

Not applicable. This device is a physical implant, and its performance is evaluated based on engineering and material standards (e.g., ASTM standards) through mechanical testing, not through expert-labeled ground truth for an algorithm.

4. Adjudication Method for the Test Set

Not applicable. There is no human annotation or adjudication process described for the mechanical testing of a physical implant.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical interbody fusion device.

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

No, a standalone performance study (in the context of an algorithm) was not done. This document pertains to a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for the device's technical performance is based on established engineering standards and material specifications. Specifically:

• Mechanical Integrity: Compliance with ASTM F2077/F2267 as objective, quantitative benchmarks for intervertebral body fusion devices.
• Material Composition: Conformance to ASTM F2026 for PEEK-OPTIMA LT1 polymer.
• Substantial Equivalence: Comparison to the known characteristics (indications, materials, design principles) of existing, legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. Since there is no training set for an AI algorithm, there is no ground truth established for it.

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The ART Anterior Spinal System is intended for anterolateral screw fixation of the T6-L5 spine.

Indications for use include:

• degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
• spondylolisthesis
• trauma (i.e., fracture or dislocation) .
• spinal stenosis .
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
• tumor .
• pscudoarthrosis .
• failed previous fusion .

The ART Anterior Spinal System consists of a Plate that attaches to the anterior or antero-lateral vertebral body of the thoraco-lumbar and lumbar spine. One place on each vertebral body. The single size plate is attached to the vertebral body with two diverging Ø6.5mm Screws. The superior portion of the plate is U-shaned to receive a Ø6mm Rod. The inner surface of the U-shaped opening of the plate is threaded to receive a Locking Nut. When tightened the Locking Nut firmly secures the Rod to the Plate. In this manner the Rods connect two or more Plates. Sce schematic in Exhibit III.

A rod connector component, called a Domino, attaches two rods for use in multi-level fusions. Rods can be connected in series or parallel.

The provided text describes a 510(k) premarket notification for a medical device called the "ART Anterior Spinal System." It is a spinal intervertebral body fixation orthosis. However, the document does not contain any acceptance criteria, reported device performance data, details of a study on acceptance criteria, AI components, or human reader effectiveness studies.

The information provided focuses on:

• Device Description: The physical components of the ART Anterior Spinal System.
• Intended Use/Indications for Use: The medical conditions for which the device is designed (e.g., degenerative disc disease, spondylolisthesis, trauma).
• Equivalency: Stating that the device is similar to previously cleared devices (Kaneda SR Anterior Spinal System and M-2 Anterior Plate).
• Nonclinical Tests: A brief mention that "Testing was performed according to ASTM F1717." This refers to a standard for spinal implant testing, but no specific results or acceptance criteria from these tests are detailed.
• Regulatory Information: Communication from the FDA confirming substantial equivalence to predicate devices, classification, and general regulatory requirements.

Therefore, requested information about acceptance criteria, device performance, study details (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone), and AI components cannot be extracted from this document, as it is not present.

To summarize, for the given input:

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

• Not Available. The document states "Testing was performed according to ASTM F1717" but does not provide specific acceptance criteria or the results of these tests.

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

• Not Available. No information on specific test sets, sample sizes, or data provenance is provided. The testing mentioned (ASTM F1717) is for mechanical properties, not clinical data sets.

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 Available. This information is for clinical studies, which are not described in this document.

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

• Not Available. This information is for clinical studies, which are not described in this document.

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 describes a physical medical device (spinal fixation system), not an AI-enabled diagnostic or therapeutic tool for which MRMC studies are typically performed. There is no mention of AI.

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

• Not Applicable. This document describes a physical medical device, not an algorithm.

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

• Not Available. This information is for clinical studies, which are not described in this document. The "ground truth" for a mechanical device would be its physical properties meeting engineering standards.

8. The sample size for the training set:

• Not Applicable. No training set is mentioned as this is a physical medical device clearance, not an AI model.

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

• Not Applicable. No training set is mentioned.

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The ART Posterior Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as a n adjurce to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system ART Posterior Spinal System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The hooks are intended for posterior, nonpedicle screw fixation of the noncervical spine; hook and sacral/iliac screw fixation to the noncervical spine; and hook and sacral screw fixation to the T1-S1 spine.

Pedicle Screws, monoaxial and polyaxial, are available in various lengths and diameters. The Screw is connected to Federe Screws, nonoaxian and polyamin, are a in lengths ranging from 40mm to 500mm. The Screw is inserted the Rod Via a Not Connector and inserted in the bone. As a top loading system the Connector has a Uthrough an opening the Rod. The interior of the U-shaped opening in the Connector is threaded to accept a Shaped Opening that accepts the Rod. The Connector. The necessity for rod bending is reduced by the ability to vary the angle between the screw and connector up to 20°.

A rod connector component, called a Domino, attaches two rods for use in multi-level fusions. Rods can be connected in series or parallel.

A Cross Connector, of varying lengths, attaches to the rods to provide rotational stability to the construct.

Pedicle, laminar and transverse hooks are also part of the system. The rods attach to the hooks and can be used for single or multiple level fixations.

The provided text is a 510(k) summary for a spinal implant system and does not contain any information about an AI/ML device or its performance characteristics.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, or comparative effectiveness studies related to an AI/ML device.

The document describes a "ART Posterior Spinal System" which is a physical medical device (pedicle screw system) and the summary refers to performance testing done according to ASTM F1717, an international standard for spinal implant testing. This standard typically involves mechanical testing of the device rather than clinical performance studies with human subjects or AI/ML algorithm evaluations.

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