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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.

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The Spine360 Stingray Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Spine 360 Cervical Interbody Fusion System implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to T1 disc levels using autograft bone. The Spine 360 Cervical Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Stingray Cervical Cage was developed as an intercorporal implant for anterior cervical spondylosis. Stingray is a system of wedge-shaped implants and instruments designed for anterior cervical interbody fusion (ACF). In the lateral view, the implant has a 3.5° lordotic form. The Stingray Cervical Cage has a flat top and bottom. Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) and tantalum according to ASTM F560.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Spine 360 Cervical Interbody Fusion System (K122085), framed according to your requested information.

Please note that this is a medical device submission, not an AI/software device. Therefore, many of the requested fields related to AI performance, human readers, training sets, and ground truth in the context of an algorithm will not be applicable or will need to be reinterpreted in the context of a physical device.

Acceptance Criteria and Study for Spine 360 Cervical Interbody Fusion System (K122085)

This device is a physical medical implant (interbody fusion system) and not an AI or software-based medical device. Therefore, the "acceptance criteria" and "device performance" are related to mechanical and material properties, not algorithmic accuracy or human reader improvement. The "study" refers to non-clinical (mechanical) testing based on ASTM standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on demonstrating mechanical equivalence or superiority to predicate devices and meeting established biomechanical tissue tolerances for the cervical spine. The performance is reported as meeting or exceeding these criteria.

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 tested for each mechanical test. However, standards like ASTM F2077-11 typically require a minimum number of samples for statistically valid testing (e.g., 5-6 samples per test group). The tests are conducted on manufactured devices, not human data.
• Data Provenance: The data is generated from non-clinical (laboratory) mechanical testing of the physical device. It is not patient data, nor does it have a country of origin in that sense. It's a prospective testing design to evaluate the device against established engineering standards.

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

• This question is not applicable to a physical medical device. "Ground truth" in this context refers to established engineering standards (ASTM standards) and biomechanical properties of the human spine. The "experts" would be the engineers and scientists who developed these standards and conducted the testing, not clinical experts establishing ground truth from patient data.

4. Adjudication Method for the Test Set

• This question is not applicable as there is no human interpretation or adjudication of test results in the clinical sense. The results of the mechanical tests are quantitative measurements against predefined criteria in the ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

• This device is a physical medical implant, not an AI or software device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

• This device is a physical medical implant, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance relies on established engineering standards (ASTM F2077-11, F2267-04) and recognized biomechanical properties and tolerances of the human cervical spine. The objective is to ensure the device's mechanical integrity and safety when implanted.

8. The Sample Size for the Training Set

• This device is a physical medical implant, not an AI with a training set. Therefore, this question is not applicable.

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

• This device is a physical medical implant, not an AI with a training set. Therefore, this question is not applicable.

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The Spine 360 Talon Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).

The Talon Spinal Fixation System was cleared for use via K071824, and is comprised of polyaxial screws, locking plugs, spinal rods and rod to rod connectors. The Talon System can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Spine 360 proposes to add new smaller diameter (4.5mm) screws in various lengths, cannulated screws in various diameters and lengths, pedicle screw spacers as well as the minimally invasive surgical technique for use with the Spine 360 Talon Spinal System. The new components are based upon the same fundamental scientific technology and do not alter the indications for use as compared to the existing system.

This excerpt focuses on the Spine 360 Talon Spinal System, a medical device, and the documentation provided does not include the detailed information about acceptance criteria and a study design that you are requesting for a typical AI/software-as-a-medical-device (SaMD) submission.

The provided document is a 510(k) Summary for a Premarket Notification (K102995) for a Spinal Fixation System. This is a physical medical device (implants for spinal fusion) and the regulatory submission heavily relies on non-clinical (mechanical) testing and demonstration of substantial equivalence to predicate devices, rather than clinical performance studies with acceptance criteria based on human or AI-assisted performance metrics.

Therefore, I cannot directly extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance: The acceptance criteria for this device are related to mechanical properties (e.g., strength, stiffness, fatigue) and functional equivalence to predicate devices, not diagnostic performance metrics like sensitivity, specificity, or AUC.
• Sample size used for the test set and the data provenance: Not applicable in the context of this device's testing. Mechanical tests involve test specimens, not patient data.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. Ground truth for mechanical testing would be direct measurements from the tests themselves.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is not a diagnostic device involving human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant.
• The type of ground truth used: For this device, the "ground truth" for non-clinical testing refers to the physical properties measured during mechanical tests against established ASTM standards and against predicate device performance.
• The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
• How the ground truth for the training set was established: Not applicable.

What is present in the document is:

1. Acceptance Criteria (implied through non-clinical test summary and substantial equivalence justification):

The acceptance criteria for this type of device are primarily based on:

• Meeting or exceeding the performance standards of recognized ASTM standards (e.g., ASTM F1717-09 for Static Compression Bending, Dynamic Compression Bending).
• Demonstrating equivalence or better performance (in terms of compression bending performance, stiffness, and dynamic compression bending fatigue strength) compared to the predicate devices.
• Providing stability greater than tolerated thresholds in range of motion and stiffness limits of the human lumbar spine, and adequately stabilizing a fusion site.

2. Reported Device Performance (Summary):

The document states:

• "The Spine 360 Spinal Fixation System proposed additional 4.5 screws, cannulated screws and spacers demonstrated equivalence or better in compression bending performance and stiffness to the predicate device listed."
• "The dynamic compression bending fatigue strength for the Spine 360 Spinal Fixation System had already demonstrated a greater endurance strength than predicates referenced."
• "The Spine 360 Spinal Fixation System including the smaller 4.5 screws, cannulated screws and spacers will provide stability greater than the tolerated thresholds in range of motion and stiffness limits of the human lumbar spine and will adequately stabilize a fusion site."

In summary, the provided document describes a medical device undergoing a 510(k) clearance process based on substantial equivalence and mechanical testing, not a software or AI device requiring the type of clinical validation study details you've requested.

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