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The Medyssey Co, Ltd. Zenius™ Spinal System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft 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 Zenius™ System, Internal Fixation Device for Spinal Surgery is comprised of: rods, pedicle screw assemblies, compression retaining assemblies, set screws 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. Subject screws are manufactured from Ti6Al4V ELI per ASTM F136.

This document is a 510(k) premarket notification for a medical device called the "Zenius™ Spinal System." It is not a study of an AI/ML powered device. Instead, it details the substantial equivalence of an updated version of a pedicle screw system to existing predicate devices.

Therefore, the requested information about acceptance criteria, study design, expert involvement, ground truth, and AI/ML specific performance metrics cannot be extracted from this document. The document focuses on demonstrating that the modified hardware (the pedicle screw with fenestration) performs at least as well as its predicate devices through mechanical testing.

Here's why the specific questions can't be answered for this document:

• No AI/ML Component: The "Zenius™ Spinal System" is a physical implant (pedicle screws, rods). There is no mention or implication of any artificial intelligence or machine learning component in its design, function, or evaluation.
• Mechanical Testing, Not Clinical or Diagnostic Study: The "study" mentioned is "Mechanical Testing" (per ASTM F1717) to evaluate "static compression bending, static torsion, static tension, and dynamic compression bending." This is a laboratory test of the device's physical properties, not a clinical trial or a diagnostic performance study.
• Substantial Equivalence, Not Performance Acceptance Criteria for an AI: The FDA 510(k) process for this type of device focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This involves showing that the new device is as safe and effective as the predicate. It does not involve establishing clinical performance acceptance criteria for an AI algorithm.

In summary, this document is irrelevant to the prompt. The prompt asks for details about the acceptance criteria and the study proving an AI/ML device meets those criteria, which is not what this document describes.

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The Medyssey Co, Ltd. Zenius Spinal System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft 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 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 take into account the unique pathology of individual patients.

All implantable components are manufactured from Ti6Al4V ELI per ASTM F136 and wrought Co-Cr-Mo alloy per ASTM F1537. The subject of this submission is the addition of variable rods to the Zenius™ System.

This document is a 510(k) premarket notification clearance letter from the FDA for the Zenius Spinal System. It does not contain information about the performance of a device based on a study with acceptance criteria, human readers, or ground truth.

Specifically, there is no information in the provided text to address the following points in your request:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers' improvement with AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document discusses the substantial equivalence of modifications (addition of variable rods) to an existing device (Zenius Spinal System) to its predicate device based on performance testing related to ASTM F1717. This likely refers to mechanical and fatigue testing of the device components, not a study involving human readers or AI performance on patient data.

To clarify, the document states: "A rationale related to ASTM F1717 testing is provided showing the subject variable rod to be substantially equivalent to the predicate rods cleared in K131878." ASTM F1717 is a standard test method for both static and fatigue evaluation of pedicle screw systems. This indicates benchmark engineering performance, not clinical performance or AI algorithm performance.

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The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Zenius 146 Spinal System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Zenius ™ Spinal System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Zenius "" Spinal System implants.

The provided text describes a 510(k) summary for a spinal system and its modification, focusing on substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical or even extensive non-clinical testing beyond basic mechanical and sterilization validation.

This document specifically states: "Clinical tests: No clinical tests conducted on either the subject system nor the predicate system." The purpose of this submission was for the clearance of the redesign of the custom sterilization trays, not for assessing the clinical performance or efficacy of the spinal system itself beyond its substantial equivalence to the previously cleared predicate.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the text, with clear limitations:

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

Important Note: The document focuses on demonstrating substantial equivalence to a previously cleared device, particularly for a modification to sterilization trays. It does not present new performance data for the implant itself beyond the scope of that modification.

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

• Mechanical Testing: Not specified for this submission, as the mechanical tests (ASTM F 1717-04) were already performed for the predicate device, and the current submission primarily concerned sterilization trays. For the sterilization validation, the sample size and provenance are not detailed in this summary; it just states it was "satisfactorily performed."
• Clinical Data: No clinical tests were conducted for either the subject system or the predicate system (as stated in the document).

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

• Not applicable as no clinical tests were performed, and thus no expert ground truth was established from clinical data for this submission. The "ground truth" for mechanical testing would be the ASTM standards, and for sterilization, the AAMI guidelines.

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

• Not applicable as no clinical tests were performed and no human adjudication of results is mentioned for the non-clinical tests.

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 comparative effectiveness study was done. This device is a mechanical spinal implant, not an AI-assisted diagnostic or therapeutic system.

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

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

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

• For mechanical properties: ASTM F 1717-04 standards.
• For material properties: ASTM F 136 standard for titanium alloy.
• For sterility: AAMI ST77 and AAMI ST79 guidelines.
• No clinical ground truth (expert consensus, pathology, outcomes data) was used or generated for this specific submission because no clinical studies were performed.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not a machine learning algorithm.

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

• Not applicable. This is a mechanical device, not a machine learning algorithm.

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The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Zenius "M Spinal System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Zenius ™ Spinal System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Zenius™ Spinal System implants.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zenius™ Spinal System.

It's important to note that this document is a 510(k) Special Premarket Notification for a modification to an existing device. This type of submission often relies heavily on proving substantial equivalence to the predicate device, rather than entirely new, extensive studies.

Acceptance Criteria and Device Performance for Zenius™ Spinal System (K103272)

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the Absence of Specific Information for AI-Related Questions:

It is crucial to understand that the provided text is for a spinal fixation system (a physical medical device), not an AI/software-as-a-medical-device (SaMD). Therefore, many of the questions related to AI performance, sample sizes for test/training sets, experts for ground truth, adjudication methods, and MRMC studies are not applicable to this type of device submission. The study is mechanical/physical testing, not an algorithmic performance evaluation.

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size in the context of device testing. Mechanical tests specified by ASTM F 1717-04 would involve a certain number of test units, but this detail is not provided.
• Data Provenance: The mechanical testing was performed by Medyssey Co., Ltd., which is a Korean company (Gyeonggi-do, Korea). The ASTM standards are international standards. This is lab-based physical testing, not a clinical data set.
• Retrospective/Prospective: Neither. This refers to laboratory mechanical testing, not clinical studies.

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

• Not Applicable. For a mechanical spinal implant, "ground truth" is established through engineering specifications, material properties, and adherence to validated testing standards (like ASTM F 1717-04). It does not involve expert consensus in the way an AI diagnostic tool would.

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

• Not Applicable. Since there's no diagnostic or interpretative output from the device being evaluated by human experts, there's no adjudication method in play.

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 a hardware device; AI assistance for human readers is irrelevant.

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

• Not Applicable. This is a physical implant, not an algorithm.

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

• Engineering Specifications and Standardized Mechanical Test Results: The "ground truth" for this device revolves around its ability to meet the defined mechanical performance thresholds and material specifications outlined in standards like ASTM F 1717-04 and ASTM F 136. The predicate device's existing clearance (K093104) serves as the basis for substantial equivalence for similar material and design modifications.

8. The sample size for the training set:

• Not Applicable. This is not an AI device that requires a training set. The "training" for a physical device involves its design, manufacturing processes, and material selection, all adhering to established quality systems.

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

• Not Applicable. No training set in the AI sense. The "ground truth" for the device's design and manufacturing is established through adherence to engineering principles, material science, and quality management systems (21 CFR part 820, ISO 9001, ISO 13485).

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The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Medyssey Co. Ltd., Zenius ™ Spinal System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Medyssey Co. Ltd., Zenius ™ Spinal System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Medyssey Co. Ltd., Zenius ™ Spinal System implants.

This document describes a 510(k) premarket notification for a spinal fixation system, not an AI/ML powered medical device. Therefore much of the requested information, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, and MRMC studies, is not applicable to this submission type.

Here’s an analysis based on the provided text, focusing on the available information:

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)

This information is not applicable. The device is a physical medical implant (spinal fixation system), and its performance was evaluated through mechanical testing, not clinical data or a test set in the context of AI/ML. The provenance of the data is the mechanical testing conducted according to ASTM standards.

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. Ground truth, in the AI/ML sense, is not relevant for this type of device submission. Performance was established through standardized mechanical tests.

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

This information is not applicable, as there was no test set requiring human adjudication for ground truth.

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, nor would it be relevant for this type of physical implant device. The submission explicitly states: "Clinical tests: No clinical tests conducted on either the subject system nor the predicate systems."

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

This is not applicable. This is a mechanical device, not an algorithm.

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

For this device, the "ground truth" for proving performance was based on:

• Adherence to Material Standards: Conformance to ASTM F 136 for titanium alloy.
• Mechanical Testing Standards: Performance against established benchmarks and predicate devices in static and fatigue testing protocols as defined by ASTM F 1717-04.
• Predicated Device Equivalence: The performance of existing, legally marketed devices (U&I Corporation OPTIMA™ Spinal System and Medyssey's Co. Ltd., NOVEL™ Spinal System) served as the benchmark for "substantial equivalence."

8. The sample size for the training set

This information is not applicable, as there was no training set for an AI/ML algorithm.

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

This information is not applicable, as there was no training set for an AI/ML algorithm.

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