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The Medyssey Co, Ltd. Zenius™, Iliad™ and Kora™ Spinal Fixation Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Zenius™ Spinal System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to account for the unique pathology of individual patients.

The liad™ Spinal Fixation and Adjustable Bridge System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients.

The Kora™ Spinal Fixation and Adjustable Bridge System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients.

Subject screws are manufactured from Ti6Al4V ELI per ASTM F136. The subject of this submission is the addition of smaller diameter cannulated screws to the spinal systems.

This is a tough one! The provided text is a 510(k) premarket notification for spinal fixation systems (Zenius™, Iliad™, and Kora™). It describes the devices and their indications for use, and makes a claim of "substantial equivalence" to previously cleared predicate devices.

However, a 510(k) submission primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not typically involve a clinical study as would be described for an AI/ML device.

The "Performance Testing" section states: "Mechanical testing was performed per ASTM F1717 (Static and Dynamic Compression Bending, Tensile Bending, Static Torsion) to establish that the mechanical properties of the subject devices are equivalent to the predicate devices."

This is bench testing for mechanical properties, not a study involving patient data, ground truth establishment, or expert readers, which are the typical elements requested in your prompt for AI/ML device performance.

Therefore, many of the requested items (sample sizes, data provenance, ground truth, expert qualifications, MRMC studies, standalone studies, training set details) are not applicable to this type of device submission and the performance testing described.

Here's how I can address your request based on the provided text, highlighting the differences:

The provided document describes the Medyssey USA, Inc.'s Zenius™, Iliad™, and Kora™ Spinal Fixation Systems. This is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to already marketed predicate devices, rather than proving efficacy through a de novo clinical study with patient data, ground truth, or human reader performance, as would be the case for an AI/ML device.

The performance testing described is mechanical (bench) testing, not a clinical study involving patient data. Therefore, many of the requested elements are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria and performance are for mechanical properties tested against an industry standard, not diagnostic or clinical accuracy. The document states the goal was to "establish that the mechanical properties of the subject devices are equivalent to the predicate devices." It does not explicitly list numerical acceptance criteria or detailed results in the provided excerpt, but refers to ASTM F1717.

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

• Sample Size: Not specified in terms of patient data. The "test set" here refers to physical mechanical samples of the spinal fixation system components (rods, screws, etc.). The exact number of physical samples tested is not stated, but would typically follow ASTM F1717 guidelines.
• Data Provenance: Not applicable in the context of patient data. The "data" comes from physical laboratory testing of manufactured devices.

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

• Not Applicable. This is mechanical testing of physical devices, not a study evaluating human interpretation or diagnostic accuracy where expert ground truth would be established.

4. Adjudication Method for the Test Set

• Not Applicable. No human interpretation or clinical judgment requiring adjudication was involved in this mechanical testing.

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

• No. An MRMC study is relevant for evaluating the impact of an AI/ML device on human reader performance in diagnostic tasks. This submission is for a physical spinal implant device and relies on mechanical bench testing.

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 algorithm.

7. The Type of Ground Truth Used

• Not Applicable in the clinical/diagnostic sense. For mechanical testing, the "ground truth" is established by the standardized measurement methods and specifications outlined in ASTM F1717, which define how the mechanical properties (e.g., strength, endurance) are to be determined and compared.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to establish for it.

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The Medyssey Co. Ltd. Zenius, Iliad and Kora Spinal Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograff and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Medyssey Co. Ltd., Cannulated Pedicle Screws are intended to be used with their respective (e.g. Zenius) top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Medyssey Co. Ltd., Cannulated Pedicle Screw implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. The Medyssey Co. Ltd., Cannulated Pedicle Screws can be used in the posterior plane providing unilateral and bilateral modes of fixation. The Medyssey Co. Ltd., Cannulated Pedicle Screw Spinal design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a mobile and non-mobile housing component which houses the screw and the rod which accepts a setscrew which tightens against the rod which tightens head of the pedicle screw upon secure tightening interface of the set screw assembly with the rod. The Cobalt Chrome Rods are for use with the Zenius or Iliad System. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Medyssey Co. Ltd. Cannulated Pedicle Screw implants.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medyssey Cannulated Pedicle Screws and Cobalt Chrome Rods:

1. Acceptance Criteria and Reported Device Performance

The provided document describes non-clinical (bench) testing for the Medyssey Cannulated Pedicle Screws and Co-Cr-Mo rods. The acceptance criteria are implicitly defined by the chosen ASTM standard and the comparison to predicate devices, which means the new device must perform at least as well as the legally marketed predicates.

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

• Test Set Sample Size: The document does not specify the exact number of devices (screws/rods) tested for each non-clinical test (static compression, torsion, tension, dynamic compression). Standard test methodologies for medical devices like ASTM F1717-04 typically require a minimum number of samples for statistically valid results, but these specific numbers are not detailed in this summary.
• Data Provenance: The data is from non-clinical (bench) testing performed by Medyssey Co. Ltd. The country of origin of the testing data is not explicitly stated, but Medyssey is a Korean company with a US-based contact for regulatory purposes.

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

This information is not applicable as the study described is non-clinical (bench testing) of physical device properties, not a clinical study involving human patients or expert interpretation of medical data. The "ground truth" here is the measured mechanical performance of the device against established engineering standards and predicate device performance.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is non-clinical (bench testing). Adjudication methods are typically employed in clinical studies or studies involving expert review of medical images/data to resolve discrepancies in interpretation.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (spinal pedicle screws and rods), not an AI/software device. Therefore, there is no mention of human readers or AI assistance.

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

This information is not applicable. The device is a physical implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" used for this non-clinical study is:

• Engineering Standards and Specifications: Adherence to ASTM F1717-04.
• Predicate Device Performance: The mechanical performance of the new device was compared to that of legally marketed predicate devices. The implicit ground truth is that the predicate devices are safe and effective, and therefore, a device demonstrating equivalent or superior mechanical properties would also be considered safe and effective for the stated indications.

8. The Sample Size for the Training Set

This information is not applicable as the study described is non-clinical (bench testing) of a physical device. There is no concept of a "training set" for this type of evaluation.

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

This information is not applicable as there is no training set for this non-clinical study.

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