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The Eminent Spine Sl Screw System is intended for sacroiliac joint fusion for conditions including degenerative sacroillitis and sacroiliac joint disruptions, to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.

The Eminent Spine Sacroiliac (SI) Screw System is intended for sacroiliac joint fixation for conditions including degenerative sacroiliac joint disruption. The Eminent Spine SI Screw System consists of screws manufactured from Ti-6Al-4V ELI per ASTM F136 using traditional machining methods, as well as 3D-printed titanium alloy Ti-6AI-4V ELI per ASTM F3001. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy. The cannulated screws have open and porous graft windows for the Ø8.5, Ø10.0, Ø11.5, and Ø13.0mm options to allow bone growth through the implant. Optional locking crowns/locking fangs are included for all of the available screw diameters to aid in conforming to patient anatomy.

The provided text is a 510(k) summary for the "Eminent Spine SI Screw System." It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, the document does not contain any information regarding acceptance criteria, reported device performance data, study design, sample sizes, ground truth establishment, or expert qualifications as would be typical for a clinical or performance study evaluating an AI/ML powered medical device.

The "Non-Clinical Testing" section mentions mechanical testing per ASTM F3574, but it only states that the results "support that the strength of the subject SI Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." It does not provide specific acceptance criteria or performance metrics in a way that would allow filling out the requested table.

Therefore, I cannot provide the detailed information requested in the prompt because the necessary details are not present in the provided text. The document is for a traditional medical device (a screw system), not an AI/ML powered device, and thus the type of performance evaluation details requested (e.g., effect size of human readers with AI, standalone algorithm performance) are not applicable or included.

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The Eminent Spine 3D Lumbar Interbody Fusion Systems (PLIF, and ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

The Eminent Spine 3D Lumbar Interbody Fusion Systems are intervertebral body fusion systems used in the spine to replace a collapsed, damaged, or unstable disc. The 3D Lumbar Interbody Fusion Systems (PLIF, TLIF, and ALIF) are comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options, and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.

The provided text describes a 510(k) premarket notification for the "Eminent Spine 3D Lumbar Interbody Fusion Systems." This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than outlining acceptance criteria and a detailed study proving the device meets those criteria in the context of a typical AI/medical device performance study.

Here's an analysis based on the provided text, highlighting what is and isn't available:

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

The document mentions "acceptance criteria" not for clinical or diagnostic performance, but for mechanical testing.

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

This information is not provided in the document. The document refers to mechanical testing, not clinical studies involving patient 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 information is not applicable as the document describes mechanical testing of an implantable device, not an AI or diagnostic device requiring expert interpretation for ground truth establishment.

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

This information is not applicable as the document describes mechanical testing.

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 as the document describes mechanical testing of an implantable device, not an AI-assisted diagnostic tool.

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

This information is not applicable as the document describes mechanical testing of an implantable device.

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

For the mechanical testing, the "ground truth" would be established by the physical testing standards (ASTM F2077, ASTM F2267) and their specified measurement methods and acceptable limits. It's not a biological "ground truth" as typically discussed in diagnostic studies.

8. The sample size for the training set

This information is not applicable as the document describes mechanical testing of a physical device, not an AI algorithm.

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

This information is not applicable as the document describes mechanical testing of a physical device.

Summary of the Study:

The "study" described in this 510(k) summary is a series of mechanical tests designed to ensure the Eminent Spine 3D Lumbar Interbody Fusion Systems possess adequate strength and stability for their intended use. These tests were conducted according to ASTM standards (F2077 for static and dynamic testing, F2267 for subsidence), and an additional test for expulsion. The conclusion is that the device "performs as well as or better than the chosen acceptance criteria," which are implicitly defined by compliance with these ASTM standards and any internal specifications. The purpose of these tests is to demonstrate that the new device is mechanically equivalent to the predicate devices and safe for its intended surgical application, not to evaluate diagnostic performance or AI effectiveness.

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The Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The Cervical Stand-Alone System implants are available in various heights and geometric footprints to accommodate individual patient anatomy and graft material size. Cervical Stand-Alone devices are inserted through an anterior cervical approach and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance, while screws are inserted through the anterior face of the implant for bone fixation. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. The cages are made from medical grade polyetheretherketone (PEEK) per ASTM F2026 with tantalum per ASTM F560 pins, from titanium alloy Ti-6A1-4V ELI per ASTM F136, or from additively manufactured Ti-6Al-4V per ASTM F3001. The integrated fixation screws and screw anti-backout plate are manufactured from Ti-6A1-4V ELI per ASTM F136. These devices are offered non-sterile.

The provided FDA 510(k) summary is for a medical device called the "Cervical Stand-Alone System," which is an anterior cervical interbody fusion system. This documentation primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and mechanical performance data, rather than presenting a clinical study with detailed acceptance criteria for an AI/software device.

Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance for an algorithm) are not applicable to this type of device and submission. This is a physical implant, not an AI or software-based medical device.

However, I can extract the relevant "acceptance criteria" (which in this context refers to the performance standards the physical device must meet) and the "study" that proves it.

Here's the information based on the provided text, with clarifications where the questions are not relevant to this type of device:

Device Name: Cervical Stand-Alone System

Device Type: Intervertebral Body Fusion Device (physical implant)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary does not explicitly state numerical "acceptance criteria" values prior to presenting the results. Instead, it states that the device was tested per specific ASTM standards. The "reported device performance" is summarized as the device being "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices" based on these tests. The specific numerical results are not provided in this summary document.

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

• Sample Size for Test Set: Not specified in the document. This would refer to the number of physical devices or test specimens used in the mechanical tests. For mechanical testing of implants, sample sizes are typically small, determined by statistical requirements for engineering studies.
• Data Provenance: The data is from non-clinical mechanical testing conducted on the device itself. It is not patient data, nor is there a concept of "country of origin" as it relates to clinical data. The tests were performed to ASTM (American Society for Testing and Materials) standards.

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

Not applicable. This is a physical device subject to mechanical engineering tests, not a diagnostic or AI device requiring expert ground truth for interpretation of clinical conditions. The "ground truth" for these tests would be the physical properties and failure points measured by specialized testing equipment.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in clinical studies or for establishing ground truth in diagnostic AI performance evaluation. This document describes mechanical device testing.

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

Not applicable. This is a physical medical implant, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

Not applicable. This question pertains to AI algorithms. The Cervical Stand-Alone System is a manufactured physical implant.

7. The type of ground truth used

The "ground truth" for this device's performance is established by engineering measurements against specified ASTM (American Society for Testing and Materials) standards. This involves measuring force, displacement, and cycles to failure under various loading conditions. It is not expert consensus, pathology, or outcomes data related to patient diagnosis or treatment efficacy, but rather the physical and mechanical integrity of the implant.

8. The sample size for the training set

Not applicable. This refers to training data for an algorithm. This device is a physical product, not an algorithm.

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

Not applicable. This refers to establishing ground truth for algorithmic training data.

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The Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of 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, or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The Cervical Plate System is an anterior cervical plating system that consists of plates and selftapping screws. The implants are available in a variety of shapes to accommodate the anatomical condition of patients. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

Here's a breakdown of the acceptance criteria and study information for the Cervical Plate System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the mechanical performance data leads to the conclusion that the device is "substantially equivalent" to the predicate device. However, it does not explicitly provide numerical acceptance criteria or specific numerical results for these tests. It only states that the device's strength is "sufficient" and comparable to predicate devices.

2. Sample Size for Test Set and Data Provenance

This information is not provided in the document. The studies mentioned are mechanical performance tests (in vitro), not clinical studies involving human patients or data. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable here.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the evaluation relies on mechanical testing against ASTM standards, not expert review of clinical data.

4. Adjudication Method for Test Set

This information is not applicable as the evaluation relies on mechanical testing against ASTM standards, not expert review of clinical data.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on the mechanical substantial equivalence of a physical medical device (Cervical Plate System) through in vitro testing, not on evaluating the effectiveness of an AI algorithm or human reader performance.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. The device described is a physical implant (Cervical Plate System), not an algorithm or AI-driven system.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established by ASTM F1717 standards for static and dynamic mechanical properties of spinal intervertebral body fixation orthoses. The document states "The Cervical Plate System has been tested in the following test modes: - Static compression bending per ASTM F1717 . - Static torsion per ASTM F1717 ● - Dynamic compression bending per ASTM F1717".

8. Sample Size for Training Set

This information is not applicable. There is no mention of a "training set" as this is a mechanical device, not an AI or machine learning system that requires training data.

9. How Ground Truth for Training Set Was Established

This information is not applicable for the same reason as above; there is no training set mentioned or implied for this mechanical device.

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