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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 Facet-Link Stabilization Platform is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The system is indicated for use with bone graft, at single or multiple levels, from C2 to S1 (inclusive) for the Facet Screws and L3 to S1 (inclusive) for MINI and HEMI devices. The Platform is indicated for the treatment of any or all of the following:

1. Spondylolisthesis.
2. Degenerative disc disease (DDD) as defined as back pain of discogenic origin as confirmed by radiographic studies.
3. Degeneration of the facets with instability.

The Facet-Link Facet Screw System is indicated for treatment of any or all of the following:

1. Pseudoarthrosis and failed previous fusion;
2. Spondylolisthesis; and
3. Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.

The Facet-Link Stabilization Platform consists of a series of devices designed to stabilize the spine. The Platform includes the MINI and HEMI devices. The devices are secured to the bone using Facet-Link trans-articular (facet) screws. The MINI device utilizes an adjustable monorail to crossconnect the Facet Screws, while the HEMI device uses a small, fixed plate as a cross-connector. The implants are fabricated from anodized titanium alloy (Ti-6AI-4V) and are supplied in various sizes. The devices are provided non-sterile and for single patient use.

The Facet-Link Stabilization Platform requires several purpose manual orthopedic instruments for implantation, including a variety of k-wires, gauges, inserters, drills, and drivers.

The provided text describes the Facet-Link Stabilization Platform, a medical device intended to stabilize the spine. However, the document does not contain the specific information required to complete the table and answer all questions regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop system. The document focuses on regulatory approval (510(k)) based on substantial equivalence to predicate devices, and the performance data presented is for mechanical and biocompatibility testing, not clinical performance or AI diagnostic accuracy.

Here's a breakdown of what can and cannot be answered based on the provided text:

Information Available:

• Acceptance Criteria (Implicit - based on predicate device testing): The document states that the device was evaluated to demonstrate substantial equivalence to predicate devices through various bench tests and functional cadaver tests. These tests are primarily focused on mechanical performance and biocompatibility.
  • Static Axial Compression Bending
  • Static Torsion
  • Dynamic Axial Compression Bending
  • Biocompatibility (ISO 10993)
  • MR Conditional (ASTM F2052-06)
• Reported Device Performance:
  • "Performance of the subject constructs was substantially equivalent to that of legally marketed screw constructs."
  • "Results demonstrated that repeatable and proper seating of the devices was achieved."
  • "The materials of the Stabilization Platform are biocompatible for the indicated use in accordance with ISO 10993."
  • "Testing demonstrated that the Stabilization Platform is MR Conditional, in accordance with ASTM F2052-06."

Information NOT Available (and thus cannot be filled in for your request):

• Specific numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy).
• Detailed quantitative results of the bench tests (e.g., actual force values, displacement).
• Any information regarding an AI component, human-in-the-loop performance, diagnostic accuracy, or clinical outcomes that would typically be evaluated with a test set of patient data, experts, and ground truth.
• Sample sizes for test sets related to human or AI performance.
• Data provenance for clinical studies (country, retrospective/prospective).
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• MRMC study details or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used for clinical validation (pathology, outcomes data, etc.).
• Sample size for training sets.
• How ground truth for training sets was established.

Based on the provided document, here's how the information would be organized, with unknowns explicitly stated:

Acceptance Criteria and Study Proving Device Meets Criteria

The Facet-Link Stabilization Platform underwent a series of bench tests and functional cadaver tests to demonstrate substantial equivalence to its predicate devices, as required for 510(k) clearance. The performance data primarily focused on mechanical stability, material biocompatibility, and MR compatibility. There is no information in the provided document about an AI component, clinical diagnostic performance metrics, or a study involving human readers or a test set with established ground truth related to diagnostic outcomes.

1. Table of Acceptance Criteria and 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)

• Sample Size for Test Set: Not applicable. The document describes bench tests and functional cadaver tests. No "test set" of patient data for diagnostic evaluation is mentioned.
• Data Provenance: Not applicable. The tests involved cadaveric specimens and laboratory equipment.

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. There is no mention of experts establishing ground truth for a diagnostic test set. The cadaver implantation testing assessed the ability of "users" to perform surgical techniques, but no specific number or qualifications are provided, and this is not establishing ground truth for a diagnostic outcome.

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

• Not applicable. No diagnostic test set or adjudication method is described.

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 comparative effectiveness study was not done, and this device is not presented as an AI-assisted diagnostic tool.

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

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

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

• Not applicable. The "ground truth" for the performance described is based on established engineering standards (ASTM, ISO) for mechanical stability, biocompatibility, and MR compatibility, and the observable success of surgical implantation in cadavers, rather than clinical diagnostic outcomes.

8. The sample size for the training set

• Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

• Not applicable.

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