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The Spectrum Spine Expandable Cages (SSEC) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

SSEC implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The Spectrum Spine Expandable Cages (SSEC) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SSEC are provided in different shapes to accommodate a lateral surgical approach to the lumbar spine and can expand to the desired height and varying degrees of lordosis. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. SSEC implants are manufactured from radiolucent PEEK (per ASTM 2026), titanium alloy (per ASTM F136), and tantalum markers (per ASTM F560).

The provided document is a 510(k) summary for a medical device called "Spectrum Spine Expandable Cages (SSEC)". This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on a clinical study for AI performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and study data for an AI-powered device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for an AI
• Sample size and data provenance for an AI test set
• Number and qualifications of experts for AI ground truth establishment
• Adjudication methods for AI test set
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results
• Standalone AI performance
• Type of ground truth used for AI
• Training set sample size and ground truth establishment for AI

The information within the document pertains to mechanical and material testing of an intervertebral fusion device (implants), which are entirely different types of tests than those required for an AI-based medical device. The "Performance Data" section discusses:

• Static Axial Compression per ASTM F2077
• Static Compressive Shear per ASTM F2077
• Static Subsidence per ASTM F2267 and ASTM F2077
• Static Expulsion
• Dynamic Axial Compression per ASTM F2077
• Dynamic Compressive Shear per ASTM F2077

These are all mechanical tests to ensure the physical integrity and durability of the spinal implant, not performance metrics for an AI algorithm.

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The Foundation™ 3D Interbody Cervical Cage is 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. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation™ 3D Interbody implants 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 Foundation™ 3D Interbody Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ implants 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 Foundation™ 3D Interbody Cervical Series Interbody System is an additively manufactured implant comprising of cervical interbody spacers. They are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The cervical line has a partially porous construction and an open architecture with a large variety of footprints and lordosis angles to help optimize implant fit.

The Foundation™ 3D Interbody Lumbar Series Interbody System is an additively manufactured implant comprising of lumbar interbody spacers. They are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lumbar lines feature a wide variety of lordosis and footprint options with fully porous architectures and varying pore sizes to offer increased room for bone growth with mechanical stability.

The Foundation™ 3D series of intervertebral body fusion devices are made from the titanium alloy Ti-6AL-4V ELI conforming to the ASTM F-136 specifications.

This document is a marketing clearance (510(k)) for a medical device, specifically an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to previously cleared devices based on mechanical and material testing, rather than clinical performance or AI algorithm performance.

Therefore, the requested information regarding acceptance criteria, study design for AI algorithms, human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for AI training/testing cannot be extracted from this document. This document describes engineering performance tests, not clinical or AI performance studies.

Here's what can be extracted related to the device and its testing:

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

The document lists performance tests conducted, but does not provide specific numerical acceptance criteria or the quantitative results of these tests. It only states that the results "show that the strength of the Foundation™ 3D Interbody is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Regarding the other points, the document does not contain the required information:

• 2. Sample sized used for the test set and the data provenance: Not applicable for mechanical/material testing.
• 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: This is not an AI/software 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, as this refers to physical/mechanical properties, not diagnostic accuracy.
• 8. The sample size for the training set: Not applicable (no AI training involved).
• 9. How the ground truth for the training set was established: Not applicable (no AI training involved).

In summary, this document is a 510(k) clearance for a physical medical implant, not an AI-powered diagnostic device, and therefore does not contain information about AI acceptance criteria, clinical study designs for AI, or ground truth establishment for patient data. The "performance data" section refers to mechanical engineering tests demonstrating the device's physical strength and equivalence to predicate devices, not its diagnostic or clinical efficacy in a patient population aided by an algorithm.

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The EOI FLXfit Intervertebral body fusion device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The EOI FLXfit device is intended to be used with supplemental spinal fixation system and with autogenous bone graft.

EOI FLXfit Intervertebral Body Fusion Device is made From Titanium (Ti6A14V-ELI per ASTM norm F136). This is an articulated-expanded device with height ranges from 8mm through 14mm. The device also expands in height to provide lordosis angle correction of up to 10°. The FLXfit components are manufactured from titanium alloy (ASTM F136). It is implanted via a Transforaminal approach and supplemented by posterior fixation. The device is made from two titanium segments that are serrated on the superior and inferior surfaces. The titanium segments are attached (linked) with titanium wedge pins that provide the means to form the implant into its final articulated shape.

The provided document is a 510(k) summary for the FLXfit Intervertebral Body Fusion Device, which focuses on demonstrating substantial equivalence to predicate devices through mechanical testing. It is not a study that evaluates the performance of a device using clinical or reader studies, especially for AI/ML devices. Therefore, a significant portion of the requested information, such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for clinical performance, is not applicable or available in this document.

However, I can extract the acceptance criteria and reported device performance from the provided mechanical testing data.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance data based on mechanical testing standards, rather than clinical efficacy. The acceptance criterion for this type of submission is typically "substantial equivalence" to predicate devices, meaning the device performs at least as well as or better than the predicate devices under the specified tests. The reported performance is that the device met these criteria.

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

• Test Set Sample Size: Not applicable. The "test set" here refers to physical devices undergoing mechanical testing, not a dataset of patient cases for an AI/ML device. The document does not specify the number of devices tested for each mechanical test.
• Data Provenance: The data comes from "non-clinical testing" and a "usability cadaveric study." No country of origin is specified, but it can be inferred to be from the manufacturer's testing facilities or contract labs. The nature is experimental, not retrospective or prospective clinical data.

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

Not applicable. For mechanical testing, "ground truth" is established by the specifications of the ASTM standards themselves, and the measurement of physical properties, not by expert consensus on clinical cases. The usability study involved cadavers, likely evaluated by surgical or biomechanical experts, but no details are provided on their number or qualifications.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies among human readers for establishing ground truth from patient data. This 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

Not applicable. This is a medical device (intervertebral body fusion device), not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed or described.

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

Not applicable. As noted, this is a physical medical device, not an algorithm.

7. The type of ground truth used

• For Mechanical Testing: The ground truth is defined by the requirements of the ASTM standards (e.g., F2077, F2267) which specify acceptable load-bearing capacities, fatigue life, and other mechanical properties for intervertebral body fusion devices. Substantial equivalence to predicate devices also serves as a comparative "ground truth" for performance.
• For Usability Cadaveric Study: The ground truth would be the direct observation and evaluation of the device's clinical application, expansion mechanism, and intra-operative subsidence in a cadaveric model by qualified personnel (likely surgeons or biomechanical engineers).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical testing or regulatory submission for a physical medical device. This term applies to machine learning models.

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

Not applicable. There is no training set mentioned in this document.

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