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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 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.

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 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 18mm in width and come as 1- to 4-segmental implants with lengths ranging from 21 up to 94mm. The plates are precontoured to better fit patient anatomy. The screw holes in the plates are conical and threaded. The icotec ACP self-tapping screws are available in diameters of 4.0 and 4.25mm with lengths of 13 and 15mm. 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 is a 510(k) premarket notification for a medical device, the icotec Anterior Cervical Plate System. It focuses on demonstrating substantial equivalence to predicate devices, rather than proving that the device meets specific performance criteria for an AI/ML product. Therefore, the requested information regarding acceptance criteria for AI/ML device performance, ground truth establishment, training sets, and MRMC studies is not present in this document.

The document details the device's indications for use, its description, and the predicate devices used for comparison. It also lists performance testing that was conducted, which primarily involves mechanical biocompatibility and structural integrity tests relevant to a spinal implant, not an AI/ML algorithm.

Here's a breakdown of the information that is available, and why the requested AI/ML specific information is absent:

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

• Acceptance Criteria (Mechanical/Biocompatibility): The document states that "The nonclinical tests performed by the company, including static compression, static torsion and dynamic compression per ASTM F1717, met the pre-defined acceptance criteria." However, the specific numerical acceptance criteria (e.g., minimum load bearing capacity, maximum displacement) are not provided in this summary.
• Reported Device Performance (Mechanical/Biocompatibility): Similarly, the actual numerical results of these tests are not reported in this summary, only the qualitative statement that they "met the pre-defined acceptance criteria."

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

• Not Applicable for this type of device: This information typically pertains to clinical studies for AI/ML devices or drugs. For this mechanical implant, "sample size" would refer to the number of devices tested for mechanical properties, which is not detailed in this summary. There is no "data provenance" in the sense of patient data for an AI/ML algorithm.

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: Ground truth establishment by experts is a concept for AI/ML model validation, not for the mechanical testing of a spinal plate.

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

• Not Applicable: Adjudication methods are used in clinical trials or AI/ML evaluations to resolve disagreements among readers/experts. This is not relevant to mechanical testing.

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

• Not Applicable: MRMC studies are used to evaluate diagnostic performance, especially for AI/ML algorithms assisting human readers. This device is a mechanical implant, not a diagnostic AI/ML tool.

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

• Not Applicable: This refers to the performance of an AI/ML algorithm in isolation. This device is a physical implant.

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

• Not Applicable (for AI/ML context): For mechanical testing, the "ground truth" would be engineering specifications and ASTM standards.

8. The sample size for the training set

• Not Applicable: There is no AI/ML model being trained for this device.

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

• Not Applicable: There is no AI/ML model being trained for this device.

In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) demonstrating substantial equivalence based on mechanical and biocompatibility testing, not an AI/ML diagnostic or therapeutic device. Therefore, the questions related to AI/ML specific acceptance criteria, study methodologies, and ground truth establishment are not addressed in this document.

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