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The Proximity Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative 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 (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

The Segmental Plating System (SPS) is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative 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 (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

The subject Alphatec Plating Systems consists of two anterior cervical plate subsystems, Proximity Anterior Cervical Plate System and Segmental Plating System, intended for anterior fixation to the cervical spine. The Alphatec Plating Systems consist of a variety of sizes of plates and screws that are manufactured from titanium alloy conforming to ASTM F136. The systems offer instrumentation for the delivery of the plate and screw constructs. The instruments in this system are intended for use in surgical procedures. The Alphatec Plating Systems implants are provided either terminally sterile or non-sterile to be steam sterilized by the end user.

I apologize, but the provided text from the FDA 510(k) clearance letter for the Alphatec Spine Proximity™ Anterior Cervical Plate System does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria for software-based AI/ML devices.

The document details:

• Device Type: Spinal Intervertebral Body Fixation Orthosis (a physical implantable device, not a software/AI device).
• Regulations: Primarily related to medical devices, specifically orthopedic implants.
• Performance Data: Lists non-clinical (mechanical) testing based on ASTM standards (e.g., Static and Dynamic Compression Bending, Static Screw Push-out) and sterilization/packaging validations.
• Substantial Equivalence: Compares the mechanical design and indications for use of the Proximity™ system to predicate physical spinal fixation devices.

Therefore, I cannot extract the information required by your prompts (acceptance criteria table, sample sizes for AI test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) because these concepts are not applicable to the type of device described in this 510(k) clearance letter. The letter pertains to a traditional, physical Class II medical device, not a software-based or AI/ML-driven diagnostic or therapeutic tool.

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The Resolve Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in 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, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

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

The provided FDA document, K251436, describes the Resolve Anterior Cervical Plate System, a medical device. The document states that the substantial equivalence of the device was demonstrated through performance criteria identified in the FDA guidance document "Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway".

While the document confirms that non-clinical mechanical tests were performed and met acceptance criteria, it does not provide the specific numerical acceptance criteria or the reported device performance in a table format. Nor does it detail a clinical study with human readers or specific ground truth methodologies. The information focuses on non-clinical mechanical testing for spinal plating systems.

Therefore, the following information is extracted and inferred based only on the provided document:

Acceptance Criteria and Device Performance Study (as per provided document)

1. Table of Acceptance Criteria and Reported Device Performance

The FDA document states that the device "meets or exceeds the acceptance criteria stated in the 'Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway' guidance document." However, the specific numerical acceptance criteria from this guidance document and the precise numerical results of the Resolve Anterior Cervical Plate System are not provided in this submission.

2. Sample Size for the Test Set and Data Provenance

The document describes non-clinical mechanical testing, not a clinical study involving a test set of human subjects or patient data.

• Sample Size: Not applicable in the context of human data. For mechanical testing, the "worst-case configuration" was tested. The specific number of mechanical test samples is not detailed.
• Data Provenance: Not applicable as it refers to non-clinical, laboratory-based mechanical testing.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "ground truth" here is adherence to mechanical performance standards, not expert clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader agreement. This describes non-clinical mechanical testing.

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

• Was an MRMC study done? No. The document describes non-clinical mechanical tests for a spinal implant, not an AI/imaging device requiring human-in-the-loop evaluation.
• Effect size of human readers with AI vs without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical spinal implant, not an algorithm or AI software. Therefore, there is no standalone algorithm performance.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established by meeting predetermined mechanical performance specifications outlined in the FDA guidance document "Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway" and relevant ASTM standards (ASTM F1717 for mechanical tests; ASTM F2052, ASTM F2213, ASTM F2182 for MR safety).

8. Sample Size for the Training Set

Not applicable. This refers to non-clinical mechanical testing of a physical device, not an AI model requiring a training set.

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

Not applicable. No training set for an algorithm was involved.

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The Frida™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine in skeletally mature patients, serving as an adjunct to fusion of the cervical spine (C2 - T1). The system is intended for the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: 1) degenerative disc disease (as defined as neck pain of discogenic origin and confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) spinal stenosis, 4) trauma, 5) failed previous fusions, 6) tumors, 7) curvature deformities (kyphosis, lordosis, or scoliosis), and/or 8) pseudoarthrosis.

The Frida™ Anterior Cervical Plate System is an anterior cervical plating system that consists of single-use plates and screws, along with manual instruments for implant insertion. The plates are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136 and come in a variety of lengths to accommodate individual pathology and anatomical conditions of the patient. Plates incorporate a graft window for intraoperative visualization. Screws are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136 and are available in self-tapping and self-drilling options. Screws are available in a fixed or variable configuration, with a range of sizes to accommodate individual pathology. Plates and screws are available in single-use sterile packaging.

The provided FDA 510(k) clearance letter for the Frida™ Anterior Cervical Plate System does not contain the detailed information typically found in an AI/Software as a Medical Device (SaMD) submission regarding acceptance criteria and study results.

This document is for a traditional medical device (a mechanical implant), not a software-based device. Therefore, the "acceptance criteria" and "study proving the device meets the acceptance criteria" are related to mechanical performance and biocompatibility, not algorithmic performance or clinical effectiveness in a human-computer interaction context.

Here's how to interpret the available information based on your request, and what information is missing due to the nature of this particular device:

Device Type: This is a physical, implantable medical device (Anterior Cervical Plate System), not an AI/SaMD. The "studies" described are primarily mechanical performance tests.

Acceptance Criteria & Device Performance (as much as can be inferred for a mechanical device):

Missing Information (Crucial for an AI/SaMD, but not applicable/provided for this physical device):

The following points are specifically geared towards AI/SaMD and are not found in the provided document because it pertains to a physical, mechanical medical device:

1. Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to physical samples of the device undergoing mechanical testing, not a dataset of patient information.
2. Number of experts used to establish ground truth: Not applicable. Ground truth for a spinal plate is its mechanical performance and material properties.
3. Adjudication method: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating AI-assisted human performance, not relevant for a physical implant.
5. Standalone (algorithm only) performance: Not applicable.
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/SaMD sense. The ground truth here is the objective measurement of mechanical properties compared to established standards and predicate devices.
7. Sample size for the training set: Not applicable. This device does not have a "training set" in the machine learning sense. Its design and manufacturing are based on engineering principles and material science.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):

• Study Type: Non-clinical mechanical performance testing.
• Tests Performed:
  • Static compression testing
  • Dynamic compression testing
  • Static torsion testing
• Standards Used: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model)
• Comparison Basis: The device's performance was compared to "legally marketed predicate devices."
• Conclusion: The tests demonstrated that the "worst-case constructs were substantially equivalent to legally marketed devices." This implies that the Frida™ Anterior Cervical Plate System's mechanical characteristics, such as strength and durability, are comparable to or better than existing devices on the market, thereby demonstrating its safety and effectiveness for its intended use.

In essence, while the prompt asks for information typically found in AI/SaMD submissions, the provided document details the regulatory clearance for a traditional orthopedic implant, focusing on mechanical and material equivalence rather than data-driven algorithmic performance.

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The Skyway Anterior 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, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The 4-Hole 1-Level Plates are limited to use at one contiguous level.

The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.

The Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System consists of anterior cervical plates, bone screws, and a locking screw. The implant components are composed of titanium alloy Ti-6Al-4V ELI per ASTM F136. The Skyway Anterior Cervical Plate System is offered in various sizes to accommodate patient anatomical needs. The subject 1-Level plates are compatible with and may be permanently attached to the Tesera-k SC System interbody spacers.

The purpose of this Special 510(k) is to introduce non-sterile plate options to the sterile packaged plates which were previously cleared and to modify the geometry of the plate's screw holes and the screw heads with minor dimensional changes.

This document is an FDA 510(k) clearance letter for a medical device called the Skyway Anterior Cervical Plate System. It is focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing the kind of performance data (e.g., AI model performance metrics, clinical study outcomes) typically associated with acceptance criteria for novel software-based devices, especially those using artificial intelligence.

The information provided explicitly states: "No performance testing was required for this 510(k)." This is because the submission is a "Special 510(k)" to introduce minor changes (non-sterile plate options and minor geometric modifications) to an already cleared device. Therefore, the questions related to AI model performance, sample size for test/training sets, expert adjudication, MRMC studies, ground truth establishment, etc., are not applicable to this specific 510(k) submission.

Based on the provided text, here's an attempt to answer the questions within the scope of what is stated:

Acceptance Criteria and Device Performance for the Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System (K250486)

As this is a Special 510(k) for minor modifications to an already cleared device, the "acceptance criteria" primarily revolve around demonstrating that the changes do not adversely affect the foundational safety and efficacy already established for the predicate device. The "study" described is a regulatory review process to confirm this, rather than a de novo clinical or performance study of the device's functional performance in a use-case scenario.

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

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

• Sample Size for Test Set: Not applicable for this type of submission. No performance testing on a "test set" of clinical data or patient outcomes was conducted or required. The review focused on engineering changes and regulatory compliance.
• Data Provenance: Not applicable. The "study" was a regulatory review of engineering specifications and manufacturing process changes (sterilization adoption), not a data-driven performance study.

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)

• Number of Experts & Qualifications: Not applicable. Given "No performance testing was required," there was no "test set" requiring ground truth establishment by clinical experts in the context of device performance. The experts involved would be FDA reviewers (e.g., Engineer & Regulatory Specialist Nathan Wright from KMTI, and the FDA's Division of Spinal Devices staff like Colin O'Neill and Maziar Shah Mohammadi), who assess regulatory compliance and engineering specifications against predicate devices.

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

• Adjudication Method: Not applicable. There was no "test set" of performance data requiring adjudication. The FDA's review process serves as the "adjudication" against regulatory standards and comparison to predicate devices.

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

• MRMC Study: No. This device is not an AI-powered diagnostic tool. It is a physical implant (spinal plate system). Therefore, an MRMC study and AI assistance effect size are not applicable.

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

• Standalone Performance: No. This device is a physical implant, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable.

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

• Type of Ground Truth: Not applicable in the context of clinical performance data. The "ground truth" for this 510(k) submission relates to established engineering principles, material science standards (e.g., ASTM F136 for titanium alloy), and regulatory requirements (e.g., ISO 17665-1 for sterilization). The substantial equivalence claim is the ultimate "ground truth" sought.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. No AI model training was involved for this physical medical device.

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

• Ground Truth for Training Set Establishment: Not applicable. No AI model training was involved.

Summary of this Specific 510(k):

This 510(k) clearance (K250486) is a "Special 510(k)" for minor modifications to an existing, already-cleared device. Its purpose is to assure the FDA that changes (adding non-sterile options, minor geometric changes) do not alter the previously established safety and efficacy profiles. Therefore, it does not involve the kind of performance studies, particularly those related to AI model validation, that the questions typically imply. The core "study" is the demonstration of substantial equivalence through regulatory and engineering assessment, not a clinical trial or AI performance evaluation.

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The Skyway Anterior 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 disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The 4-Hole 1-Level Plates are limited to use at one contiguous level.

The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.

The KMTI Skyway Anterior Cervical Plate System is an anterior cervical plating fixation system consisting of implants and associated instrumentations to provide supplemental fixation between two adjacent cervical vertebral bodies as an adjunct to fusion or for spinal correction. The Skyway Anterior Cervical Plate System is implanted via an anterior surgical approach.

The subject devices proposed in this submission are a line extension of the Skyway Anterior Cervical Plate System (K231766) with the introduction of additional length and configuration options for the 1-Level Plates and 2-hole and 3-hole 1-Level Plates. This subject line extension also includes non-sterile bone screw and locking screw options. The Skyway Anterior Cervical Plate System plates, bone screws, and locking screws are manufactured from Ti-6Al-4V per ASTM F136.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (Skyway Anterior Cervical Plate System) and does not contain information related to software, imaging, or AI studies. Therefore, I cannot extract the acceptance criteria for a device from this text, nor can I describe any study proving that the device meets such criteria because the information is not present.

The document discusses the regulatory approval of a physical medical implant (a cervical plate system) and its mechanical testing, not software performance. As such, sections related to sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, ground truth, and training set information are not applicable to the content of this document.

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The FlexWing Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine(C2-T1) for the following indications: degenerative 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 (kyphosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The FlexWing Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The FlexWing Anterior Cervical Plate System is made of Titanium Alloy (Ti-6AL-4V) and Nickel-Titanium Alloy, which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI(Extra Low Interstitial) Alloy for Surgical Implant Applications, and ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. The Anterior Cervical Plates consist of 1 to 3 levels which have different lengths. The bone screws are 3.5 and 4.0mm in diameter with self-tapping and selfdrilling threads and provided in lengths from 10.0 to 26.0mm.

The provided text is a 510(k) summary for the Jeil Medical Corporation's FlexWing Anterior Cervical Plate System. It describes the device, its indications for use, technological characteristics, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance or AI model evaluation.

The document states: "No clinical studies were considered necessary and performed." This indicates that the regulatory clearance was based on non-clinical testing (mechanical and material tests) and substantial equivalence to existing predicate devices, rather than a study evaluating diagnostic performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving the device meets them because such information is not present in the provided text. The device described is a physical implant (Anterior Cervical Plate System), not a diagnostic or AI-powered medical device.

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The Wolff's Law Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:

• Degenerative Disc Disease (DDD) – as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;

• · Spondylolisthesis;
• Spinal Stenosis:
• · Trauma (including fractures);
• · Tumor;
• · Deformity (i.e., scoliosis, kyphosis, and/or lordosis);
• · Pseudoarthrosis; and
• · Failed previous fusions

The Spinal Simplicity Wolff's Law Anterior Cervical Plate System is a dynamic cervical plate designed for the anterior cervical spine (C2-C7). The Wolff's Law Plate System consists of one-level plates in multiple lengths with both fixed- and variable-angle screws. The plates are translatable and use a nitinol Compression Element to provide continuous compression at each level. The Wolff's Law Cervical Plate consists of components made from titanium alloy Ti6Al4V ELI per ASTM F136 and superelastic nitinol per ASTM F2063. The fixed and variable screws are made from Titanium alloy Ti6Al4V ELI per ASTM F136. The Anterior Cervical Plate System is provided to the end-user sterile and is single use.

The FDA 510(k) summary for the "Wolff's Law Anterior Cervical Plate System" describes non-clinical performance testing rather than a study involving an AI/CAD software device with specific acceptance criteria and human readers.

Therefore, I cannot provide information on the following as it is not present in the provided document:

• A table of acceptance criteria and the reported device performance for an AI/CAD device.
• Sample size used for the test set and data provenance.
• Number of experts used to establish the ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone performance (algorithm only) of an AI/CAD device.
• Type of ground truth used for an AI/CAD device.
• Sample size for the training set.
• How the ground truth for the training set was established.

However, based on the provided document, I can extract information related to the performance study of the Wolff's Law Anterior Cervical Plate System (a medical device, not an AI/CAD software):

1. Type of Study:
Non-clinical mechanical tests were performed to establish substantial equivalence for the Wolff's Law Anterior Cervical Plate System. Clinical performance testing was explicitly not performed for this submission.

2. Tests Performed and Guidance:
The study utilized FDA Guidance Document "Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff" and the following ASTM tests:

• ASTM F1717 Static Compression Bending
• ASTM F1717 Static Torsion
• ASTM F1717 Static Tension Bending
• ASTM F1717 Dynamic Compression Bending
• ASTM F543 Axial Screw Pullout/Pushout
• ASTM F2129 & ASTM F3044 Corrosion Testing
• ASTM F1877 Particulate Analysis
• ASTM F2004 Transformational Temperature

3. Purpose of the Study:
The purpose of these non-clinical tests was to demonstrate that the Wolff's Law Anterior Cervical Plate System is capable of performing as intended and is substantially equivalent to the legally marketed predicate device. The document explicitly states: "Performance testing device has mechanical performance substantially equivalent to that of the predicate."

4. Acceptance Criteria (Implied):
While not explicitly presented in a table in the provided text, the acceptance criteria for these mechanical tests are implicitly that the Wolff's Law Anterior Cervical Plate System must have mechanical performance substantially equivalent to the predicate device(s). This substantial equivalence is assessed against the standards outlined in the FDA Guidance Document and the specific ASTM standards listed. The document does not provide specific numerical thresholds or target values that define "substantial equivalence" in this summary.

5. Predicate Devices:
The predicate devices used for comparison are:

• K083020 DynaTran™ Anterior Cervical Plating (ACP) System
• K143626 SC-AcuFix® Ant-Cer Dynamic Cervical Plating System
• K051665 Synthes Vectra-T System

In summary, the provided document details non-clinical mechanical testing for a spinal implant, not an AI/CAD system. Therefore, most of the requested information regarding AI/CAD specific acceptance criteria and study details are not applicable or available in this text.

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The ARENAL Anterior Cervical Plate System is intended for fixation and temporary stabilization of the anterior cervical spine (C2-T1) during the development of cervical spine fusions with the following indications:

• Degenerative 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
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
• Pseudarthrosis
• Spondylolisthesis
• Spinal stenosis

The ARENAL Anterior Cervical Plate System is interior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral spine with self-tapping or self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths, addressing multiple levels of fixation.

The provided text describes a 510(k) premarket notification for the Arenal Anterior Cervical Plate System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. It does not contain information about a study proving device performance against acceptance criteria in the context of AI/software or human readers, as the device is a spinal implant.

Therefore, many of the requested categories are not applicable to the information provided.

However, I can extract information related to the performance of the device based on mechanical testing.

Here's the relevant information derived from the provided text for the mechanical testing of the device:

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

Study that proves the device meets the acceptance criteria:

The study referenced is a series of non-clinical mechanical tests performed according to ASTM standards for spinal implant constructs. These tests are:

• Static compression per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• Dynamic compression per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• Static torsion per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

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

• Sample Size: The document does not specify the sample size (number of devices tested) for each test.
• Data Provenance: The tests were performed as part of the 510(k) submission process for a medical device (Arenal Anterior Cervical Plate System). The origin is not specified but is implicitly from testing conducted to support a US FDA submission. It is prospective testing, specifically designed to demonstrate safety and effectiveness for regulatory clearance.

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 applicable. The ground truth for mechanical testing is based on physical measurements and engineering principles, not expert interpretation.

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

• Not applicable. Mechanical test results are quantitative and do not require adjudication.

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 device is a physical spinal implant, not an AI or software-based diagnostic tool that would involve human readers.

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

• Not applicable. This device is a physical spinal implant, not an AI algorithm.

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

• The "ground truth" for these tests are the defined physical properties and performance characteristics as outlined in the ASTM F1717 standard and the FDA Spinal Plating Systems guidance document. This is based on engineering standards and regulatory requirements for spinal implants.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device.

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The icotec Anterior Cervical Plate System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine (C2-T1) in whom life expectancy is of insufficient duration to permit achievement of fusion.

When used with the icotec Cervical Cage or the KONG®-C VBR System, the icotec Anterior Cervical Plate System is intended to stabilize the cervical (from C2 to T1) spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

The icotec Anterior Cervical Plate System consists of plates and screws intended for use in anterior cervical fixation from C2 to T1. The system is developed to allow for conventional ventral approaches to the cervical spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate tantalum markers per ASTM F560.

The icotec Anterior Cervical Plate System is available in various plate lengths and with selftapping screws for the specific adaption to the patient's anatomy. The icotec Anterior Cervical Plates are 18 mm in width and come as 1- to 4-segmental implants with lengths ranging from 21 up to 94 mm. The plates are precontoured to fit patient anatomy. The screw holes in the plates are conical and threaded.

The icotec Anterior Cervical Plate System self-tapping screws are available in diameters of 4.0 and 4.25 mm with lengths of 13 and 15 mm. The fully threaded bone screws have threaded conical heads to firmly lock into the plate. The conical threaded screw heads are designed to block pullout while screw angulation in the cranial direction prevents screws from penetrating through the lower end plate of the vertebral body.

This document describes the regulatory clearance (K233215) for the icotec Anterior Cervical Plate System. The information provided focuses on the device's technical specifications and the basis for its substantial equivalence to a predicate device, rather than detailed performance study results against specific, quantifiable acceptance criteria.

The provided text does not contain a detailed study with specific acceptance criteria and reported device performance in the format of a table as requested. Instead, it presents a summary of non-clinical and clinical data supporting substantial equivalence.

Based on the provided text, here's an attempt to extract and infer the requested information, noting limitations due to the nature of the available document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter for a 510(k) submission typically does not present performance data in a detailed table against pre-defined acceptance criteria, especially for a device seeking substantial equivalence based on prior clinical data without a de novo clinical trial. Instead, it refers to a summary of performance testing and clinical data that broadly supported substantial equivalence.

The document explicitly states: "However, the provided clinical data did not support that the specific material or unique technological characteristics of the subject device components provides additional benefit relative to other anterior cervical plate devices for the indications for use related to infection." This suggests that while equivalence was shown, superiority or additional benefit for specific aspects (like infection) was not demonstrated. |
| Substantial Equivalence | The device was demonstrated to be substantially equivalent to the predicate device (K201587) with respect to indications for use, intended use, design, and performance, based on non-clinical testing data and clinical data. The subject and predicate devices are stated to have similar technological characteristics, be made of similar materials, and are packaged/sterilized by identical methods. The conclusion is that the device is substantially equivalent. |

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

• Sample Size for Test Set: Not specified in the provided text. The document refers to "clinical data provided" but does not detail the size or nature of this dataset in terms of individual patients or cases used for the "test set" (if a distinct test set was even explicitly defined in the context of this 510(k) submission).
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

• This information is not available in the provided document. The clearance letter mentions "clinical data" but does not detail how ground truth was established for any specific test set, or the number and qualifications of experts involved in such a process.

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

• This information is not available in the provided 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:

• This document describes a spinal implant device (Anterior Cervical Plate System), not an AI/software device that would involve human readers or AI assistance in interpretation. Therefore, an MRMC study related to AI assistance would not be applicable in this context.

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

• This document concerns a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

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

• For a spinal implant device seeking 510(k) clearance based on substantial equivalence, the "ground truth" would typically refer to established clinical safety and effectiveness from the predicate device and the clinical data supporting the subject device's performance. This would involve "outcomes data" and potentially clinical assessments, but the specific methodology (e.g., expert consensus on outcomes) is not detailed here. The document states "clinical data provided supports a substantially equivalent safety and effectiveness profile."

8. The sample size for the training set:

• This concept of "training set" is relevant for AI or machine learning models. This document is about a physical medical device. Therefore, a "training set" in that context is not applicable.

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

• As above, the concept of a "training set" for ground truth establishment is not applicable to this type of device.

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The TDM Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to C7). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment ve 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, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The TDM Anterior Cervical Plate System consists of cervical plates, screws and the instruments necessary to implant this specific system. All implant components are made from a titanium alloy (Ti-6AL-4V). The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and self-drilling bone screws using an anterior approach. Cervical Plate System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

I am sorry, but the provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria.

The document is a 510(k) premarket notification clearance letter from the FDA for the "TDM Anterior Cervical Plate System." It confirms that the device is substantially equivalent to a legally marketed predicate device.

The section titled "Performance Data" mentions:

• Non-clinical testing: static compression, dynamic compression, and static torsion.
• Standard: ASTM F1717.
• Purpose: to demonstrate substantial equivalence to the predicate device.

However, it does not provide specific acceptance criteria values for these tests, nor does it list detailed results or a study report with sample sizes, data provenance, ground truth establishment, or any of the other specific information requested in your prompt regarding acceptance criteria and a study proving their fulfillment. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with explicit acceptance criteria.

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