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The Intelligent Implant Systems Mediant™ Anterior Cervical Plating System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Intelligent Implant Systems' Mediant™ Anterior Cervical Plating System consists of bone screws (4.0 and 4.5 mm diameter) of various lengths and a series of plates for fusion of 1-. 2-. or 3- levels of the cervical spine (C2-T1). The device functions as follows: An appropriately sized plate is placed on the anterior aspect of the vertebral body of the cervical spine by inserting either a 4.0 mm or a 4.5 mm diameter bone screw through the cephalad and caudad holes and into the vertebral body. The device improves stability of the spine while supporting fusion. The Mediant™ cervical plates are provided in multiple lengths from 19 mm (one-level) through 78 mm (three-level) for one-, two- and three-level fusions. The thickness of all plates is 2.2 mm and the width is 19.0 mm. All plates interface with the same cervical bone screws. which are either 4.0 mm diameter or 4.5 mm diameter. The bone screws can best be described as semi-constrained, but can be inserted at any angle (within a ±18° angular variation) to the plate. A slider mechanism then locks the bone screws to the plate at the angle of insertion using the supplied locking pliers. The bone screw will remain fixed at the angle of insertion unless bone resorption results in high loading levels on the bone screws. If this occurs, due to the polyaxiality of the screw, the screw will re-position itself and re-lock at the new angle. All implant components of the Mediant™ Anterior Cervical Plating system are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

This document is a 510(k) summary for the Mediant™ Anterior Cervical Plating System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing. It does not describe the acceptance criteria for a device, nor does it detail a study proving a device meets specific acceptance criteria in the way you've outlined for diagnostic AI/medical imaging systems.

Here's why the requested information cannot be extracted from this document:

• Device Type: This is a physical orthopedic implant (spinal plating system), not a diagnostic device or software (like an AI algorithm for medical imaging). The regulatory pathway and substantiation methods differ significantly.
• Performance Metrics: The performance data provided is mechanical testing (Static Compression Bending, Static Torsional Bending, Dynamic Compression Bending) to assess the strength and safety of the implant, not diagnostic accuracy metrics (sensitivity, specificity, AUC) or human reader performance.
• Clinical Study Absence: There is no mention of a human clinical study in the context you described (e.g., test set, ground truth, experts, MRMC studies) because it's not relevant to demonstrating substantial equivalence for this type of device based on mechanical properties.

Therefore, I cannot populate the table or answer the specific questions because the provided text pertains to a different type of medical device and a different kind of performance evaluation.

If you have a document related to a diagnostic AI or medical imaging device, I would be happy to analyze it according to your requested format.

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The Quintex Cervical Plating System is intended for the immobilization and stabilization of the spine as an adjunct to fusion in patients with:

• . Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
• Spondylolisthesis,
• Trauma (i.e. fracture or dislocation), ●
• Spinal Stenosis,
• . Deformity (i.e., scoliosis, kyphosis, and/or lordosis),
• . Tumors.
• Pseudoarthrosis as a result of failed spine surgery,
• Failed previous fusions, .
• Symptomatic cervical spondylosis
• . Instability following surgery for the above indications.
  Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
  Warning: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Aesculap Implant Systems (AIS) Quintex Cervical Plating System consists of dynamic and semi-constrained plate, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The AIS 3G Cervical Plating System is manufactured from Titanium/ Titanium Alloy and will be provided non-sterile.

The provided text describes the Quintex Cervical Plating System, its indications for use, and its substantial equivalence to predicate devices based on biomechanical testing. However, it does not contain the specific information required to complete the table and answer the questions related to acceptance criteria and a study proving a device meets those criteria, particularly in the context of AI/software performance or detailed clinical trials.

The document discusses performance data in a general sense, stating: "Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications. 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 'Spinal System 510(k)s' was completed where relevant. Testing results demonstrate the AIS Quintex Cervical Plating System is safe and effective comparable to other predicate systems currently on the market."

This indicates that mechanical and possibly other non-clinical performance benchmarks were met, but it lacks the detail to fulfill the prompt's request for specific acceptance criteria and study designs relevant to clinical performance, expert adjudication, or AI performance.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not specified in the document. The testing mentioned appears to be mechanical/biomechanical, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified, as the "ground truth" seems to relate to engineering and biomechanical properties rather than clinical diagnoses.

4. Adjudication method for the test set: Not applicable and not specified.

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 device is a mechanical implant, not an AI or imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used: For biomechanical testing, the "ground truth" would likely be established mechanical properties, failure limits, and performance under various loads, as defined by engineering standards and predicate device performance. Specifics are not provided.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

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