Search Results

The Kestrel Posterior Cervical Fixation System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation 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
• Failed previous fusion

Occipital bone screws are limited to occipital fixation only. Pedicle bone screws are limited to placement in the upper thoracic spine (TI, T3) when anchoring the OCT construct only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fusion for the occipital/cervical loop

The proposed SPINE360 Kestrel system consists of screws, locking caps, rods, cross links, hooks, and instruments.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (Kestrel Posterior Cervical Fixation System), which focuses on demonstrating substantial equivalence to a predicate device rather than outright proving clinical efficacy or specific performance metrics against pre-defined acceptance criteria in the way a clinical trial might. Therefore, many of the requested fields related to clinical study design (sample size of test set, number of experts, adjudication, MRMC studies, standalone performance, training set details) are not applicable (N/A) in this context as this document describes a mechanical testing study.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study referenced is Mechanical Testing performed in accordance with ASTM F2706-08 "Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided text. Mechanical testing standards typically require a certain number of samples for each test type, but the exact count is not given here.
• Data Provenance: N/A for this type of mechanical testing. It's a laboratory study of physical device properties, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• N/A. This was a mechanical engineering study comparing the physical properties of the device to a standard and a predicate device, not a study requiring expert clinical opinion for ground truth.

4. Adjudication Method for the Test Set

• N/A. As above, no clinical adjudication was involved. The performance was measured against established ASTM standards and compared to a predicate device's performance.

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

• N/A. This is not an AI-enabled diagnostic device, but a surgical implant. No MRMC study was conducted.

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

• N/A. This is a surgical implant, not an algorithm.

7. The Type of Ground Truth Used

• For mechanical testing: ASTM F2706-08 Standard. The "ground truth" is defined by the rigorous methodologies and performance benchmarks specified in this industry standard for spinal implant constructs, and comparison against the predicate device.
• For material composition and design features: Regulatory standards (ISO, ASTM) and direct comparison to the predicate device.

8. The Sample Size for the Training Set

• N/A. There is no "training set" in the context of mechanical testing for a spinal implant. This is not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

• N/A. No training set was used.

Ask a specific question about this device