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The Deploy™ Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with degenerative disease (DDD) at one level or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients should be skeletally mature and have at least six months of non-operative treatment prior to being treated with this system. Additionally, the Deploy™ implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Deploy™ implants are intended to be used with supplemental spinal fixation systems that are cleared for use in the lumbosacral spine.

The Deploy™ Expandable Interbody System is comprised of the interbody implant cages, surgical instruments which include trial instruments to aid in the selection of the appropriate implant size for the patient's anatomy, and sterilization trays. The implants are manufactured from titanium alloy Ti-6AI-4V (ASTM F136, ASTM F3001) and are offered with various heights and shapes for different patient anatomy. Each implant is designed to be inserted and then rotate in-situ, providing immediate fixation and the arm deployed for the graft containment area. Ridges on the superior and inferior surfaces of the titanium implants contact the endplates to resist expulsion forces. The implants are designed to be used in conjunction with supplemental spinal fixation instrumentation. The surgical instruments are manufactured from stainless steel (ASTM F899. ISO 7153-1). The implants and surgical instruments are provided non-sterile and require sterilization prior to use within sterilization trays following validated sterilization parameters as provided within the Instructions for Use.

The provided text is a 510(k) summary for the Deploy™ Expandable Interbody System, which is a medical device. This document focuses on the regulatory clearance for the device and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of AI/software performance.

Therefore, the requested information regarding acceptance criteria, reported device performance in a clinical study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document as it is not a clinical study report for an AI/Software as a Medical Device (SaMD).

The document discusses:

• Device Description: The Deploy™ Expandable Interbody System is comprised of interbody implant cages and surgical instruments, manufactured from titanium alloy.
• Indications for Use: Intervertebral body fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1), and for patients diagnosed with degenerative scoliosis, used with autograft and/or allogenic bone graft and supplemental spinal fixation systems.
• Technological Characteristics: Similar to predicate devices in principle of operation, design, intended use, material composition, and function.
• Summary of Testing: Biocompatibility risk assessment (ISO 10993-1, Part 5) and mechanical testing including static axial compression (ASTM F2077), static compressive shear (ASTM F2077), dynamic axial compression (ASTM F2077), dynamic compressive shear (ASTM F2077), static subsidence (ASTM F2267), and wear debris testing (ASTM F1877). These are engineering performance tests, not clinical performance for diagnostic accuracy.
• Substantial Equivalence Conclusions: The device was shown to be substantially equivalent to predicate systems based on indications for use, design, function, material composition, sizes, and mechanical performance.

This document is a regulatory submission demonstrating the safety and effectiveness of a physical medical implant, not an AI/software product, and thus does not contain the information requested about acceptance criteria and studies for AI/software performance.

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The Southern Spine C Fuse™ Cervical Intervertebral Body Fusion System is intended for single level spinal fusion procedures in skeletally mature patients with degenerative disc disease ("DDD") of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The C-Fuse device is to be implanted via an anterior approach at the C3 to C7 disk levels using autogenous bone graft and is to be combined with supplemental fixation. Patients should have had at least six weeks of non-operative treatment prior to treatment with the device.

The C.Fuse Cervical Intervertebral Body Fusion System is a cervical interbody fusion device designed to be inserted within the intervertebral disc space in order to provide structural stability and act as an adjunct to spinal fixation. The device is trapezoidal in shape, with machined grooves on the superior and inferior surfaces, along with a hollow center core to accept autogenous bone graft. There are two materials used in the manufacture of the Southern Spine C-Fuse Cervical Intervertebral Body Fusion System devices which are the Zeniva® ZA-500 (PEEK) under ASTM F2026 and Tantalum Wire Type R05400 under ASTM F560. There is instrumentation for implantation and a sterilization trav for steam sterilization. The implants are non-sterile and single use. The instrumentation is non-sterile and reusable.

The provided text describes the C-Fuse™ Cervical Intervertebral Body Fusion System, a cervical interbody fusion device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria in a clinical study.

Therefore, the information you requested regarding acceptance criteria and a study proving device performance in the context of AI/machine learning is not applicable to this document. This device is a physical medical implant, and its performance is evaluated through material testing and mechanical standards.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria and Reported Device Performance (Table): This document does not establish specific performance metrics (like accuracy, sensitivity, or specificity) that would be relevant for an AI/ML device. Instead, it refers to compliance with material and mechanical testing standards.
• Sample Size for Test Set and Data Provenance: This information is relevant for studies involving data analysis, typically in AI/ML. The C-Fuse system is a physical implant; its evaluation involves mechanical testing, which does not use "test sets" in the AI sense.
• Number of Experts and Qualifications: Experts might be involved in evaluating the design or clinical outcomes, but not in establishing ground truth for a "test set" as understood in AI/ML validation.
• Adjudication Method: Not applicable for mechanical and material testing.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is specific to diagnostic imaging or AI applications where human readers' performance is compared with and without AI assistance. This is not relevant to a physical spinal implant.
• Standalone Performance: While the device has standalone performance in terms of its mechanical properties, it's not "standalone" in the AI sense of an algorithm.
• Type of Ground Truth Used: For a physical implant, "ground truth" relates to its material specifications, mechanical integrity, and biological compatibility, not classifications derived from data.
• Sample Size for Training Set and How Ground Truth was Established for Training: These concepts are entirely specific to AI/ML model development and are not relevant to the regulatory submission for a physical medical device.

Instead, the document details the following studies and compliance:

• Study Type: Mechanical and material testing to demonstrate substantial equivalence to predicate devices.
• Acceptance Criteria/Standards Met:
  • ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Devices)
  • ASTM F2267 (Standard Test Method for Measuring Load-Displacement Properties of Spine Implants in a Corpectomy Model)
  • Compliance with 2007 "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" which identifies the above standards.
• Tests Performed:
  • Static axial testing
  • Static compression shear testing
  • Dynamic axial testing
  • Dynamic compression shear testing
  • Static torsion testing
  • Dynamic torsion testing
  • Static subsidence testing
  • Static expulsion testing
• Materials Tested: Zeniva® ZA-500 (PEEK) under ASTM F2026 and Tantalum Wire Type R05400 under ASTM F560.
• Conclusion: "Testing results support the determination of substantial equivalence for the C-Fuse Cervical Intervertebral Body Fusion System against the predicate devices." This means the device met the mechanical and material performance requirements to be considered sufficiently similar to existing approved devices, implying it passed the tests according to the established standards and guidance.

In summary, this document is for a physical medical device, not an AI/ML-driven device, so the requested information about acceptance criteria and studies for AI/ML is not present.

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The StabiLink™ MIS Spinal Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); tumor. It is not intended for stand-alone use.

The Stabilink™ MIS Spinal Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion. The system is implanted via a posterior approach to the spine. The StabiLink™ MIS Spinal Fixation System includes various sizes of Titanium plate constructs. There is instrumentation for implantation and a sterilization tray for steam sterilization. The implants are non-sterile and single use. The instrumentation is non-sterile and reusable.

The provided text describes a 510(k) summary for a medical device called the "StabiLink™ MIS Spinal Fixation System." This document does not describe the acceptance criteria and study for an AI/ML device but rather a traditional spinal fixation system. As such, many of the requested elements for AI/ML device evaluation are not applicable.

However, I can extract information relevant to the performance evaluation for this traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For this traditional medical device, the "acceptance criteria" are implied by the performance standards and comparison to predicate devices, rather than explicit numerical thresholds for metrics like sensitivity or specificity. The study aims to demonstrate substantial equivalence to legally marketed predicate devices.

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

This is not applicable as the study involves mechanical testing of a physical device, not an AI/ML model evaluating patient data. The "test sets" would be the physical implants subjected to various loads. The provenance would be the materials and manufacturing process of the device itself.

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

Not applicable. "Ground truth" in this context refers to the physical properties and performance of the device under specific test conditions, which are measured using standardized engineering methods, not human expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. This concept is relevant for studies involving human interpretation or subjective assessment. Mechanical testing relies on objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating human reader performance with and without AI assistance, which is not relevant to a physical spinal fixation device.

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

Yes, in a sense. The "standalone" performance here refers to the device's mechanical performance under specified test conditions, independent of human interaction during operational use beyond implantation. The study focused on the physical characteristics and performance of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established by standardized mechanical testing protocols (e.g., ASTM F1717) using specific testing equipment and methods. The measurements produced by these tests (e.g., load-to-failure, displacement, fatigue life) are compared against the performance of predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for a traditional mechanical device like this.

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

Not applicable. There is no training set. The "ground truth" for the performance evaluation is established by the results of the standardized mechanical tests and the comparative performance against the predicate devices.

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The Southern Spine Anterior Cervical Stabilization System (SSACSS) is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine (C2-T1) during the development of cervical spine fusions in patients with degeneration disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Southern Spine Anterior Cervical Stabilization System (SSACSS) is used as a temporary construct that assists in normal healing and is not intended to replace normal body structures. The system is implanted via an anterior approach to the cervical spine. The SSACSS includes various sizes of Titanium plates with or without Tissue Shields that may be used for One-Level, Two-Level, and Three-Level anterior cervical fusion procedures. There is a selection of Titanium screws and instrumentation for implantation. The implants and delivery instrumentation are provided Non-Sterile.

The provided document is a 510(k) summary for the Southern Spine Anterior Cervical Stabilization System (SSACSS). It outlines the device, its indications for use, and its substantial equivalence to a predicate device.

However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic or AI-driven systems.

This 510(k) is for a physical medical device (an implantable spinal stabilization system). For such devices, "acceptance criteria" are usually related to mechanical and material properties specifications (e.g., strength, durability, biocompatibility, dimensions) and "studies" are typically bench testing to demonstrate these physical properties and substantial equivalence to an existing predicate device.

The study referenced is a "Summary of Testing" that confirms the SSACSS has "the same indications for use, principles of operation, and mechanical characteristics as the predicate devices," and these conclusions were "verified in performance/bench testing."

Given the nature of the device and the provided document, the specific information requested in your prompt (especially regarding AI/ML product evaluation metrics like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance for AI) is not present and not applicable to this type of medical device submission.

Therefore, I cannot populate the table or answer most of your detailed questions. I can only extract what is present in the document about the "study" conducted.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable / Not provided. The "test set" in this context would refer to the materials or prototypes subjected to bench testing. The document does not specify quantities of devices or materials tested. Data provenance for mechanical testing would typically be from laboratory settings, but no details are given.

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

• Not applicable / Not provided. This type of information is relevant for AI/diagnostic devices where expert consensus defines a "ground truth" for disease states. For a physical implant, "ground truth" relates to engineering specifications and mechanical performance, established by standard testing methods, not expert clinical consensus on a test set of data.

4. Adjudication method for the test set:

• Not applicable / Not provided. Adjudication methods (like 2+1) are used for resolving disagreements among multiple human readers in diagnostic studies. This is not relevant for bench testing of a physical implant.

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

• No, not done. This is an implantable medical device, not an AI/ML diagnostic software, so an MRMC study is not applicable.

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

• Not applicable / Not done. This is an implantable medical device; there is no algorithm or standalone performance in the context of AI.

7. The type of ground truth used:

• For the "Summary of Testing," the ground truth implicitly refers to established engineering standards and specifications for spinal implants, as well as the performance characteristics of the predicate device (K021979). The testing verified that the modified device met these implicit "ground truths" by demonstrating substantial equivalence.

8. The sample size for the training set:

• Not applicable / Not provided. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable / Not provided. As there is no training set for an AI/ML device, this question is not relevant.

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