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The Nutech Spine and Biologics Anterior Cervical Plate System is interior 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 Anterior Cervical Plate System consists of single level titanium bone plates of various sizes and titanium bone screws in various diameters and lengths to allow for patient specific configurations. The triangular shape of the plate allows for adjacent level fusion without removal of prior Nutech Cervical Plates. Implants are made from Ti 6AI4V ELI, per ATSM F136. The instrumentation allows for simple preparation and placement of the implant construct.

The provided FDA document describes the Nutech Spine and Biologics Anterior Cervical Plate System, which is an implantable medical device, not an AI/ML powered device. Therefore, the information regarding AI/ML device specific acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable.

The document generally outlines the regulatory process for this type of device and refers to performance testing that confirms its structural integrity and mechanical properties.

Here's an interpretation of the available information regarding acceptance criteria and the study that proves the device meets them, tailored to the context of a non-AI medical device:

Acceptance Criteria and Reported Device Performance

Study Details (as inferable for a non-AI implantable device)

1. Sample size used for the test set and the data provenance: Not applicable in the context of clinical data for an AI/ML device. For this implantable device, "test set" refers to the physical devices manufactured and tested for mechanical properties. The document doesn't specify the exact number of physical devices tested but states that testing was performed per ASTM F1717-18 standards. The "provenance" would be the manufacturing lot and controlled laboratory conditions where the mechanical tests were conducted.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing of an implantable device, "ground truth" is established by engineering specifications and industry standards (like ASTM F1717-18). The "experts" would be engineering and quality control professionals overseeing the testing, but their specific number and qualifications are not typically detailed in a 510(k) summary.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials for diagnostic devices or AI systems where human interpretation is involved. For mechanical testing, the results are quantitative measurements against predetermined pass/fail criteria according to ASTM standards.

4. 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 non-AI implantable device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a non-AI implantable device.

6. The type of ground truth used: For this device, the "ground truth" for performance is based on engineering specifications and established mechanical test standards (ASTM F1717-18) to ensure the device can withstand the forces it will encounter in the body. For safety and substantial equivalence, the primary ground truth is comparison to the legally marketed predicate device.

7. The sample size for the training set: Not applicable. This is a non-AI implantable device, so there is no training set as understood in AI/ML.

8. How the ground truth for the training set was established: Not applicable.

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The Anterior Cervical Plate System is indicated 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 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 Anterior Cervical Plate System consists of self-tapping screws and plates. Screws are available in a variety of diameter-length combination. Plates are available in a variety of lengths.

This document is a 510(k) premarket notification for a medical device called the Anterior Cervical Plate System. It is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding AI/algorithm performance, detailed study design, and expert review is not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This was a bench testing study, not a clinical study with patient data. The "sample size" would refer to the number of physical constructs tested, but this specific number is not provided, only that the "worst case" construct was tested.
• Data Provenance: Not applicable. This refers to bench test results in a lab environment.

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

• Not applicable. This was a mechanical bench test against a standard, not a study requiring expert clinical ground truth.

4. Adjudication method for the test set

• Not applicable. No clinical test set to adjudicate.

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 not an AI/algorithm-driven device. It is a physical implant.

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

• Not applicable. This is not an AI/algorithm-driven device.

7. The type of ground truth used

• Mechanical Performance Standards: The ground truth for performance was established by recognized mechanical testing standards (ASTM F1717) and comparison to the predicate device's established performance.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-driven device. There is no "training set."

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

• Not applicable.

Summary of the Study:

The study proving the device meets the acceptance criteria was a bench testing study. The purpose of this study was to demonstrate substantial equivalence of the Anterior Cervical Plate System to a legally marketed predicate device (Synthes Anterior CSLP System, K030866).

• Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion was that the mechanical performance of the subject device, when tested according to ASTM F1717 (covering static compression bending, torsion, and dynamic compression bending), would be comparable or equivalent to the predicate device.
• Device Performance: The study reported that "The mechanical test results demonstrated that the Subject device is substantially equivalent to the predicate devices."
• Test Conduct: The testing was performed on the "worst case Anterior Cervical Plate construct."
• Ground Truth: The "ground truth" for the mechanical performance comparison was the established performance characteristics of the predicate device and the requirements of the ASTM F1717 standard.
• Purpose: The overall conclusion was that the Anterior Cervical Plate System has the same intended use, identical indications for use, similar technological characteristics and materials as its predicate(s), and minor differences do not raise new safety or efficacy concerns after bench testing.

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The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis,
trauma (i.e. fractures or dislocations),
tumors.
deformity (defined as kyphosis, lordosis, or scoliosis),
pseudarthrosis.
failed previous fusion,
spinal stenosis

The Osteomed Implantes Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (22 mm - 110mm), addressing multiple levels of fixation (one to six). The Osteomed plate incorporates holes or vision ports on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Bone screws are available in two diameters (Ø3.85 mm and Ø4.25 mm) and a variety of lengths (8mm - 20mm).

The provided document describes the Osteomed Implantes Anterior Cervical Plate System and its 510(k) submission to the FDA. This document does not contain information about a study proving the device meets specific acceptance criteria related to software algorithm performance, human-in-the-loop studies, multi-reader multi-case studies, or the use of experts for ground truth establishment.

Instead, this document details regulatory information for a medical device (an Anterior Cervical Plate System) and its non-clinical testing for substantial equivalence to predicate devices. The "acceptance criteria" referred to in the document are primarily related to mechanical performance standards for spinal implants, not algorithmic performance.

Here's an analysis based on the available information, addressing what can be answered and clearly stating what is not present:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not specified for the mechanical tests. Typically, these are engineering bench tests, not clinical human-based studies.
• Data Provenance: The tests are non-clinical (bench tests) performed to ASTM F1717 standards. The country of origin of this specific test data is not detailed, but the manufacturer is Osteomed Implantes, LTDA from Brazil.

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

• This information is not applicable and not provided. The "ground truth" for mechanical testing is adherence to engineering standards and comparative performance against predicate devices, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

• This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for clinical or imaging studies where expert consensus is needed.

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 MRMC study was done. The document explicitly states: "No clinical studies were performed." This device is a physical implant, not an AI or imaging diagnostic tool.

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

• No standalone algorithm performance study was done. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" is adherence to the mechanical performance requirements and benchmarks set by the ASTM F1717 standard and the performance of the legally marketed predicate devices. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable and not provided. This is not an AI/ML device requiring a training set.

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

• Not applicable and not provided. This is not an AI/ML device.

Conclusion based on the provided document:

The Osteomed Implantes Anterior Cervical Plate System underwent non-clinical mechanical testing (static and dynamic compression, static torsion per ASTM F1717) to demonstrate substantial equivalence to predicate devices. The study concluded that the device is equivalent based on similarities in principles of operation, technology, materials, and indications for use, and the results of these non-clinical evaluations. No clinical studies were performed, and no information regarding algorithmic performance, human reader studies, or expert-derived ground truth for such studies is present because the device is a physical implant, not a software or AI-based diagnostic tool.

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The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metatstatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metatstatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

The plates with lowest profile are available several configurations, including different levels and lengths. It accommodates both semi-constrained constructs in which the variable screws are used for fixation, and constrained applications in which the fixed screws are rigidly locked to the plate attach to the anterior cervical spine with a minimum of four screws per plate.

The screws are also available in several configurations, including types (screw and self-tapping screw), locking methods (fixed locking and variable locking), diameters and various lengths.

All implants of Anterior Cervical Plate System are manufactured from Titanium alloy that meets the requirements of ASTM F136-11, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The materials are wildly used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.

This system is provided non-sterile.

The provided text describes a medical device submission (K123578) for an Anterior Cervical Plate System. The document focuses on establishing the substantial equivalence of the proposed device to a predicate device based on non-clinical bench tests. It does not contain information about studies involving human subjects, AI algorithms, or detailed performance metrics that would typically address the requested criteria.

Therefore, many of the requested items cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for the bench tests.
• Data Provenance: The tests are "bench tests," meaning they were conducted in a laboratory setting, not with patient data. The manufacturer is Weigao Orthopaedic Device Co., Ltd. in Weihai, Shandong, China.

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

• Not Applicable. This is a bench test study, not a clinical study involving experts establishing ground truth for patient outcomes or image interpretation.

4. Adjudication Method for the Test Set:

• Not Applicable. This is a bench test study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done (with or without AI assistance):

• No. This is a mechanical device, and the study described is a bench test, not an MRMC study. There is no mention of AI.

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

• No. This is a mechanical device, and there is no mention of an algorithm or AI.

7. The Type of Ground Truth Used:

• For the bench tests, the "ground truth" would be the specifications outlined in the ASTM F1717-04 standard and the material properties defined by ASTM F136-11. The device's performance was compared against these predefined physical and mechanical criteria.

8. The Sample Size for the Training Set:

• Not Applicable. This is a bench test for a physical medical device, not a machine learning model, so there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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The Anterior Cervical Plate System 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 during the development of a solid spinal fusion in patients with neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies (DDD), trauma (i.e. fractures), tumors, deformities (i.e. kyphosis, lordosis, and scoliosis), pseudoarthrosis, spinal stenosis, and failed previous fusions.

WARNING: These devices are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Anterior Cervical Plate System consists of multiple sized plates and screws. All components are manufactured from titanium alloy (Ti-6A1-4V) that conform to ASTM F136.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

This device (Anterior Cervical Plate System) is a Class II medical device, and the submission is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel clinical effectiveness. Therefore, the study details provided will be different from those typically found for AI/software-as-a-medical-device (SaMD) products.

Acceptance Criteria and Reported Device Performance

Note: The document states that "The Food and Drug Administration have established no performance standards applicable to anterior cervical plating systems." However, it explicitly mentions that testing was performed according to ASTM F1717-96. This implies that compliance with the methods and expected outcomes of this standard would serve as the de facto acceptance criteria for the mechanical performance of the device. The summary doesn't provide specific numerical results of these tests, only that they were performed.

Study Details

This 510(k) submission primarily relies on mechanical performance testing and substantial equivalence arguments rather than a clinical study evaluating diagnostic accuracy or reader performance typically seen with AI/SaMD.

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

   • Test Set Sample Size: Not applicable in the context of clinical patient data. The "test set" here refers to the actual physical devices (plates and screws) that underwent mechanical testing. The exact number of units tested is not specified in the summary but would be dictated by the ASTM F1717-96 standard.
   • Data Provenance: Not applicable for mechanical testing. The testing would have been conducted in a laboratory setting.

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

   • Not applicable. Mechanical testing outcomes (e.g., force at failure, cycles to failure) are objectively measured by testing equipment, not established by human experts. The "ground truth" is determined by physical properties and engineering principles.

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

   • Not applicable. As noted above, the results are objective measurements from mechanical testing, not subjective human interpretations requiring adjudication.

4. 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 MRMC clinical study was performed or is mentioned. This device is an implantable medical device (anterior cervical plate system), not an AI/SaMD product that assists human readers.

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

   • Not applicable. This is not an algorithm or software. The "standalone performance" is the mechanical performance of the device itself.

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

   • For the mechanical testing, the "ground truth" is the physical measurement of material and structural properties under various stress conditions, as defined and measured according to the ASTM F1717-96 standard.

7. The sample size for the training set:

   • Not applicable. There is no AI/machine learning model involved; therefore, no "training set" in the computational sense. The design and manufacturing process for the device would have been developed based on general engineering principles and material science.

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

   • Not applicable, as there is no training set for an AI model. For the mechanical device, its design and expected performance are based on established engineering principles, material specifications (titanium alloy (Ti-6A1-4V) conforming to ASTM F136), and prior knowledge of predicate devices.

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