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The SLIM LOC Anterior Cervical Plate System and SKYLINE Anterior Cervical Plate System are 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 metastatic 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 EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.

Indications include symptomatic cervical spondylosis, traumatic kyphosis or lordosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.

The UNIPLATE and UNIPLATE 2 Anterior Cervical Plate Systems and the EAGLE Plus Micro Anterior Cervical Plate System are also indicated for treatment of spinal stenosis.

The PULSE Anterior Cervical Plate System is indication of the cervical spine from C2 to T1 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 deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic 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 SWIFT™ Plus Anterior Cervical Plate System is manufactured from titanium alloy and consists of segmented plates that allow up to 2mm of controlled graft settling between each of the segments. The plates are available with two to six screw hole pairs, in various lengths and two configurations, discectomy and corpectomy. The screws are available in various sizes and screw-tip geometries. A graft screw is available for use in the corpectomy plates and can be used in the SWIFT Plus system.

The EAGLE™ Plus Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates are available with two to six screw hole pairs in various lengths. The screws are available in various sizes and screw-tip geometries.

The EAGLE Plus Micro Anterior Cervical Plate System is designed for use alone or adjacent to a previously implanted anterior cervical plate. The EAGLE Plus Micro Anterior Cervical Plate System consists of an assortment of titanium alloy single-level plates and uses EAGLE Plus screws. The anterior cervical plates are available in various lengths to accommodate varying patient anatomy.

The DePuy PULSE™ Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to four screw-hole pairs in various lengths. The screws are available in various sizes and screw-tip geometries, including self drilling and blunt tip to create a semi-constrained construct.

The SKYLINE" Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to six screw hole pairs in various lengths. The screws are available in various sizes and screwtip geometries. Both constrained and variable screws are available to create a constrained, variable or hybrid configuration.

The SLIM LOC® Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates are available in lengths ranging from 22-111mm in configurations with 2, 3, 4, 5 or 6 pairs of screw holes. The SLIMLOC screws are available in 4.5mm in diameter and are available as self-drilling in even length sizes ranging from 10-18mm or self-tapping in even length sizes ranging from 10-26mm. Larger diameter screws (4.8mm) are available in 12, 14, and 16mm lengths.

The UNIPLATE® and UNIPLATE® 2 Anterior Cervical Plate Systems consist of an assortment of titanium alloy plates and screws. The anterior cervical plates are available in various lengths to accommodate one to two segments of fixation. The screws are available in various sizes and tip geometries.

Here's an analysis of the provided text regarding the acceptance criteria and study for the medical devices, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details for Device Acceptance:

This submission is for MR Conditional Labeling for existing devices. The primary purpose is to demonstrate that the devices are safe for use in an MRI environment under specific conditions.

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

• Sample Size: The document does not specify the exact number of devices or components tested. It generally refers to "tests and analyses were conducted."
• Data Provenance: The data is from non-clinical testing (bench testing) performed by the manufacturer (Medos International, SARL). The location of the testing is not explicitly stated, but the manufacturer is based in Switzerland. This is prospective testing, specifically conducted to support the MR conditional claim.

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

• Number of Experts: Not applicable. The ground truth for MR compatibility is established by adherence to recognized international standards (ASTM).
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The assessment relies on objective measurements against the criteria defined by the ASTM standards, rather than expert adjudication.

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

• MRMC Study: No. This submission does not involve a multi-reader multi-case comparative effectiveness study. It is focused on the inherent MR compatibility properties of the devices.

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

• Standalone Performance Study: Yes, in a sense. The "performance" being evaluated is the physical interaction of the medical device with an MRI system. This is an objective measurement of the device's physical properties in an MRI environment, without human interpretation or intervention in the measurement process. The results directly reflect the device's inherent characteristics.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth is based on objective physical measurements and adherence to established international standards (ASTM) for MRI safety and compatibility. The FDA Guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, December 11, 2014" also serves as a guiding framework.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. These are physical medical devices, not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable.

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The SKYLINE 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: instabliity 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 metastatic 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 UNIPLATE Anterior Cervical Plate System and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kvphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.

The UNIPLATE and UNIPLATE 2 Anterior Cervical Plate Systems are also indicated for treatment of spinal stenosis.

The UNIPLATE® and UNIPLATE® 2 Anterior Cervical Plate Systems consist of an assortment of titanium alloy plates and screws. The anterior cervical plates are available in various lengths to accommodate one to three segments of fixation. The screws are available in various sizes and tip geometries.

The SKYLINE® Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to six screw hole pairs in various lengths: The screws are available in various sizes and screw-tip geometries. Both constrained and variable screws are available to create a constrained, variable or hybrid configuration.

The provided text is a 510(k) summary for anterior cervical plate systems, focusing on demonstrating substantial equivalence to predicate devices, primarily due to a change in sterilization method. It explicitly states that "Performance data is not provided in this submission." Therefore, the document does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or results of MRMC or standalone studies.

This document is a regulatory submission for a medical device that has undergone a change in manufacturing process (sterilization method). The manufacturer is asserting that this change does not alter the fundamental safety or effectiveness of the device, and therefore, extensive new performance studies are not required. Instead, they are relying on the established performance and safety of the previously cleared predicate devices.

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The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

The UNIPLATE Anterior Cervical Plate System consists of an assortment of plates and screws. The UNIPLATE Anterior Cervical Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification. Manufactured from ASTM F 136 implant grade titanium alloy.

The provided text is a 510(k) summary for the UNIPLATE Anterior Cervical Plate System. It describes the device, its intended use, and indicates that performance data were submitted to characterize the device. However, it does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria in the way typically expected for an AI/ML device.

This document is for a medical implant (spinal fixation system), not a diagnostic AI/ML device. Therefore, the questions regarding AI/ML performance metrics like sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies are not applicable to this submission.

Here's a breakdown of what can be extracted from the provided text, and where it falls short for an AI/ML device context:

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

The document states: "Performance data were submitted to characterize the subject UNIPLATE Anterior Cervical Plate System components addressed in this notification."

However, it does not provide a table of acceptance criteria or reported device performance in the typical sense of accuracy, sensitivity, specificity, etc., that would be applicable to an AI/ML diagnostic or measurement device. For an implantable device like this, "performance data" likely refers to biomechanical testing (e.g., fatigue, static strength, subsidence testing) to ensure it can withstand the forces in the spine and maintain stability. These specific results and their acceptance criteria are not detailed in this summary.

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

This information is not applicable and not present as this is a medical implant, not a diagnostic AI/ML device. There is no "test set" in the context of image analysis data.

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)

This information is not applicable and not present as this is a medical implant, not a diagnostic AI/ML device. Ground truth as typically defined for AI/ML (e.g., expert consensus on images) is not relevant here.

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

This information is not applicable and not present as this is a medical implant, not a diagnostic AI/ML device.

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 and not present as this is a medical implant, not a diagnostic AI/ML device. MRMC studies are used for evaluating diagnostic performance of human readers with and without AI assistance.

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

This information is not applicable and not present as this is a medical implant, not an algorithm.

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

This information is not applicable and not present directly in the provided text. For an implant, "ground truth" might pertain to established biomechanical standards or clinical outcomes from prior similar devices (often addressed through substantial equivalence).

8. The sample size for the training set

This information is not applicable and not present as this is a medical implant, not a machine learning algorithm.

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

This information is not applicable and not present as this is a medical implant, not a machine learning algorithm.

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The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1.

Indications include symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, turnor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

The UNIPLATE Anterior Cervical Plate System consists of an assortment of plates and screws. The UNIPLATE Anterior Cervical Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification. Manufactured from ASTM F 136 implant grade titanium Materials: alloy.

The provided text describes a 510(k) submission for a medical device and does not contain information about a study proving the device meets acceptance criteria or details about AI/algorithm performance. It is a regulatory submission for a spinal implant, which typically relies on mechanical testing and comparison to predicate devices, rather than AI performance studies or human reader studies.

Therefore, I cannot fulfill the request as it asks for information not present in the provided context. The document focuses on regulatory approval based on substantial equivalence and mechanical performance data, not a study evaluating algorithm performance or human reader improvement with AI.

To directly answer the prompt based on the absence of information:

1. Table of acceptance criteria and reported device performance: Not applicable. The document refers to "Performance data per ASTM F 1717" being submitted to characterize the device but does not provide specific acceptance criteria or detailed results of those tests.
2. Sample size used for the test set and the data provenance: Not applicable. This document is for a spinal implant, not an AI/algorithm-based device. "Test set" in this context would refer to mechanical testing of the implant, not a data set for an algorithm. Data provenance is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/algorithm studies (e.g., expert consensus on medical images) is not relevant to the regulatory submission for this physical medical device.
4. Adjudication method: Not applicable.
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, an MRMC study was not done, as this is a physical medical device (spinal plate) and not an AI or imaging diagnosis device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, a standalone algorithm performance study was not done, as this is a physical medical device.
7. The type of ground truth used: Not applicable in the context of AI/algorithm ground truth. The "ground truth" for this device would be its mechanical properties, established through standardized ASTM testing.
8. The sample size for the training set: Not applicable, as this is not an AI/algorithm device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/algorithm device.

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The Uniplate Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.

Indication includes symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

Uniplate Anterior Cervical Plate System consists of an assortment of plates and screws.

The Uniplate Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

This 510(k) summary describes a spinal implant device, not a device that measures or reports performance metrics like accuracy, sensitivity, or specificity. Therefore, the information requested in the prompt (acceptance criteria, study details, human reader improvement, etc.) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than on performance metrics obtained from human subject studies or algorithmic evaluations.

Here's why the specific questions cannot be answered from the provided text:

• No reported performance data: The "PERFORMANCE DATA:" section states "Performance data were submitted to characterize the Uniplate Anterior Cervical Plate System" but does not provide any specific metrics or results. This is common for mechanical devices where testing often involves benchtop mechanical evaluations rather than clinical performance metrics.
• No AI/Algorithm component: The device is a physical spinal implant (plates and screws). It does not involve any artificial intelligence, algorithms, or image interpretation components that would require a test set, ground truth, expert consensus, or MRMC studies.
• Nature of the device: This is a Class II medical device, specifically a "Spinal Intervertebral Body Fixation Orthosis." The regulatory pathway for such devices often involves demonstrating mechanical performance and biocompatibility, along with substantial equivalence to a legally marketed predicate device, rather than diagnostic accuracy.

Therefore, a table of acceptance criteria and reported device performance with the requested details cannot be generated from the given text.

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