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The CODA Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion is skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck 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, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes nonsterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws.

This document is a 510(k) summary for the CODA™ Anterior Cervical Plate System. It describes the device, its intended use, and provides a conclusion of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot provide the requested information based on the text provided. The document primarily focuses on regulatory approval based on demonstrating equivalence to an already marketed device, rather than detailed performance study results.

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The DAC plate system with proprietary compression technology is indicated for use in skeletally mature patients for stabilization and fixation of fractures, revisions, arthrodeses and reconstruction of small bones of the foot such as:

• Midfoot and hindfoot arthrodeses or osteotomies
• Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocuboid, Lapidus)
• Intercuneiform arthrodeses
• Naviculocuneiform arthrodeses
• Talonavicular arthrodeses
• Calcaneocuboid arthrodeses
• Linsfranc arthrodeses
• Mono-or-bi-cortical osteotomies in the forefoot, midfoot and hindfoot
• First metatarsophalangeal arthrodeses

The DAC Dynamic Active Compression Plate (DAC plate) System is a zero-step locking plate that provides stability and active compression. The system includes screws and plates of varying sizes and configurations to accommodate various patient anatomies. The plates contain nitinol wires housed under tension in sliders kept in place with release pins. When the built-in release pins are removed, the nitinol wires return to their straight condition, creating compression. The implant components of the system are manufactured from titanium alloy (ASTM F136) and nitinol (ASTM F2063). The components of this system should not be used with components of any other system. The implants are provided non-sterile and are supplied with instrumentation to facilitate use of the device components.

This document describes the DAC Dynamic Active Compression Plate (DAC plate) System, for which Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. sought FDA clearance (K200513).

Based on the provided information, the device is a bone fixation system, and the clearance was based on non-clinical evidence demonstrating substantial equivalence to predicate devices, rather than a clinical study involving human patients. Therefore, information related to clinical study design, patient samples, expert reads, MRMC studies, or standalone algorithm performance is not applicable in this context.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-clinical evaluation based on direct comparisons to standards and predicates, the "acceptance criteria" are the established standards, and "reported device performance" refers to the device's ability to meet those standards or demonstrate equivalent mechanical properties to the predicate.

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

Not Applicable. No human-based "test set" or clinical data was used. The evaluation relied on non-clinical, in-vitro mechanical testing, engineering analysis, and MR safety testing performed on device samples.

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

Not Applicable. No human experts were used to establish "ground truth" for a test set in the context of this non-clinical submission. Ground truth was established by adherence to recognized ASTM and ISO standards for mechanical, biological, and MR safety performance.

4. Adjudication method for the test set

Not Applicable. As no human-based test set was used, no adjudication method was required.

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 submission does not involve an AI device or a MRMC comparative effectiveness study.

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

Not Applicable. This is a hardware medical device (bone plate system), not a software or AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's substantial equivalence determination was:

• Adherence to recognized international standards: ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for mechanical properties, biological safety, and MR safety.
• Comparison to predicate devices: Demonstration that the subject device's technological characteristics and performance were equivalent to legally marketed predicate devices, with no new safety or effectiveness issues.

8. The sample size for the training set

Not Applicable. There was no "training set" in the context of an algorithm or AI. This was a physical device subjected to standard engineering and materials testing.

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

Not Applicable. Please refer to point 8.

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When the Fortlink-A is used as a lumbar interbody fusion (IBF) implant, it is indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This IBF device is used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF device is intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of non-operative treatment with an interbody fusion device. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

When Fortilink-C is used as cervical interbody fusion (IBF) implants, these 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. These IBF devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.

When Fortilink-TS and Fortilink-L are used as lumbar interbody fusion (IBF) implants, these devices are indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an interbody fusion device.

The Fortilink® interbody fusion (IBF) devices are designed to be inserted into the intervertebral body space of the spine and are intended for intervertebral body fusion. These implants are manufactured from a radiolucent polymer (PolyEtherKetone (PEKK)) (ASTM F2820) which should support radiographic imaging inside the implant to evaluate fusion status and are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant position. The implant is provided sterile by gamma irradiation and is intended to be used with supplemental fixation cleared for the implanted level. The implant is supplied with instrumentation necessary to facilitate the insertion and removal of the implant, as well as qeneral manual surqical instruments.

The implant is provided in different footpring heights to provide implant options best suited to an individual's pathology and anatomical condition.

This document is a 510(k) Pre-market Notification for the Fortilink® Interbody Fusion Device (IBF) with TETRAfuse® 3D Technology. It seeks clearance for an additional design, the Fortilink-A, and MR Conditional labeling for the entire Fortilink family. The document establishes substantial equivalence to predicate devices based on technological characteristics and performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Providing Evidence of Meeting Acceptance Criteria:

The study described in this document is a non-clinical performance testing study, primarily focusing on mechanical testing and MR Safety testing for the Fortilink® Interbody Fusion Device (IBF) with TETRAfuse® 3D Technology, specifically focusing on the addition of the Fortilink-A design and MR Conditional labeling.

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

• Sample Size for Mechanical Testing: The document states that the "worst-case construct for the predicate family of Fortilink devices" was assessed. It does not provide a specific numerical sample size (e.g., number of devices tested for each mechanical test).
• Data Provenance: The data is generated from non-clinical (bench) testing performed by the manufacturer, Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. The country of origin of the data is not explicitly stated beyond the manufacturer's location in Marquette, Michigan, USA. This is a prospective test in the sense that the testing was conducted specifically to support this 510(k) submission.

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

This information is not applicable to this type of submission. For mechanical and MR safety testing, "ground truth" is established by adherence to recognized ASTM standards and FDA guidance documents. The expertise lies in the engineers and technicians performing the tests and interpreting the results according to these standardized methodologies, rather than clinical experts establishing a ground truth based on patient data.

4. Adjudication Method for the Test Set

This information is not applicable to the non-clinical testing performed. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or image interpretation studies where multiple human readers assess a case.

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. This submission concerns an interbody fusion device, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported.

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

This information is not applicable. This device is an implanted medical device, not a software algorithm.

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

For the mechanical testing and MR Safety testing, the "ground truth" is defined by:

• Recognized consensus standards: Specifically, the ASTM standards (F2077-18, F2267-04 (2018), F2052-15, F2213-17, F2182-11a, F2119-07 (Reapproved 2013)) and the DRAFT Z8423Z standard for expulsion testing.
• FDA Guidance: "Guidance for Industry and Food and Drug Administration Staff, Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices."

The device's performance is compared against the requirements and specifications outlined in these documents to demonstrate compliance.

8. The Sample Size for the Training Set

This information is not applicable. This is a hardware medical device submission, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

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