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The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograff or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation)
4. Spinal Stenosis.
5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor.
7. Pseudoarthrosis, and
8. Failed previous fusion

The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This submission includes modified polyaxial screws, additional multiaxial-cross-connectors, offset connectors and additional components in sterile version. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system are shaped intraoperatively to correct or maintain proper spinal curvature.

This document is a 510(k) premarket notification for a medical device (ENNOVATE® Spinal System) and as such, it describes the equivalence of the device to existing predicate devices, rather than establishing acceptance criteria and proving the device meets them through a performance study against a defined ground truth.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert consensus, adjudication methods, MRMC studies, and standalone algorithm performance, is not present in this document.

The document focuses on demonstrating substantial equivalence through:

• Indications for Use: Listing the conditions the device is intended to treat, which are the same as the predicate devices.
• Technological Characteristics: Stating that the components, materials (titanium alloy, medical grade silicone, stainless steel, titanium alloy, PEEK), and configurations are similar to predicate and reference devices.
• Performance Data: Citing various ASTM standards (F1717-15, F2193-14, F1798-13, F543-13/17) for mechanical testing (dynamic/static compression, torsion, flexion bending, pull-out strength, driving torque). These tests confirm the physical properties and mechanical performance are comparable to the predicate, not that the device meets clinical acceptance criteria.

In summary, this document does not contain the information required to populate the requested table or answer the specific questions about clinical performance studies, AI algorithms, or human-in-the-loop improvements, because it is a 510(k) submission focused on substantial equivalence, not a clinical trial report proving a device meets specific clinical performance acceptance criteria.

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The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation)
4. Spinal Stenosis.
5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor.
7. Pseudoarthrosis, and
8. Failed previous fusion

The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This system includes polyaxial screws of varying diameters and lengths, rod-to-rod and cross connectors of various styles and lengths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be rigidly locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature.

This document describes a spinal system, not a device that would typically have acceptance criteria and performance metrics in the way an AI/ML or diagnostic device would. This is a 510(k) premarket notification for a medical device called the "ENNOVATE Spinal System," which is a metallic implant system for spinal fusion.

The document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing novelty or specific performance criteria like sensitivity, specificity, or accuracy for a diagnostic tool.

Therefore, many of the requested categories are not applicable to this type of device and regulatory submission. I will explain why each category is not applicable and what information is provided in the document.

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

• Not Applicable. For a spinal implant system like the ENNOVATE Spinal System, "acceptance criteria" are typically related to mechanical and material performance standards, not diagnostic accuracy or clinical outcomes in the same way as an AI/ML device. The "performance" reported is compliance with these standards through mechanical testing.

Note: The document states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the guidance 'Spinal System 510(k)s May 3, 2004' was completed where applicable." This indicates that the device met the performance requirements outlined in these guidance documents, primarily through mechanical testing to demonstrate substantial equivalence.

The following sections are NOT APPLICABLE because this document describes a physical spinal implant system, not a diagnostic AI/ML device requiring clinical performance evaluation with ground truth.

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

• Not Applicable. This is a mechanical device, not an AI/ML diagnostic. No 'test set' of clinical data for diagnostic performance is described. The 'test set' here refers to physical devices tested in a lab.

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, in the context of expert review, is for diagnostic devices or AI, not for mechanical spinal implants.

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

• Not Applicable. Adjudication methods are relevant for clinical endpoints or diagnostic interpretations, not for mechanical testing of an implant.

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 specific to AI/ML diagnostic tools, not an orthopedic implant.

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

• Not Applicable. This is specific to AI/ML diagnostic tools.

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

• Not Applicable. Ground truth refers to the definitive determination of a condition for diagnostic purposes. For a spinal implant, the "truth" is whether it meets engineering specifications and functions mechanically as intended.

8. The sample size for the training set

• Not Applicable. This is for AI/ML models. No training set is involved for this mechanical device.

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

• Not Applicable. As above, no training set or ground truth in this context.

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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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