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The Struxxure® System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

Struxxure consists of plates and screws in a variety of sizes. Plates from 1- to 5-levels are offered. Fixed and variable angle screws are available in two diameters in both self-tapping and self-drilling versions.

This 510(k) summary describes a spinal fixation device, not an AI/ML device, and therefore the requested information fields (2-9) about AI/ML studies are not applicable. The device's substantial equivalence is based on mechanical performance testing against predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device. The "test set" in this context refers to the physical samples of the Struxxure® components subjected to mechanical testing. The provenance is the manufacturer (Nexxt Spine).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F1717) and direct measurement of physical properties, not expert consensus.

4. Adjudication method for the test set: Not applicable. Mechanical testing involves direct measurement and comparison to established standards, not adjudication of interpretations.

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 not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: For the mechanical performance, the ground truth is the measured physical properties (e.g., strength, stiffness, fatigue life) according to the specified ASTM F1717 standard. For the technological characteristics and intended use, the ground truth is the direct comparison to the characteristics of the predicate devices.

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

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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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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