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The Posterior Cervical Spine System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T2:

(1)Traumatic spinal fractures and/or traumatic dislocations.

(2)Instability or deformity.

(3)Failed previous fusions (e.g. pseudarthrosis).

(4)Tumors involving the cervical spine.

(5)Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Posterior Cervical Spine System consists of pedicle screws, nut, rods, connectors, hook, transconnectors, laminar hooks, occipital plates and occipital screw.

The implants in Posterior Spine Cervical System is made from Ti-6A1-4V ELI following ASTM F136 or Ti-6Al-4V following ASTM F1472.

The implants are provided as sterile or non-sterile, while the instruments are provided as non-sterile.

The implants are intended for single-use only, while the instruments are reusable.

The provided text is a 510(k) summary for a medical device (Posterior Cervical Spine System) and does not describe acceptance criteria, device performance, or details of a study involving AI or human readers. The document explicitly states:

"No clinical performance data was provided to demonstrate substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample size for testing/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the given input.

The document focuses on demonstrating substantial equivalence through:

• Comparison of Technological Characteristics: Stating similarity in regulatory classification, indications for use, materials, and design features to predicate devices.
• Non-Clinical Performance Data: Referring to biocompatibility testing (in accordance with FDA Guidance "Use of International Standard ISO 10993-1") and mechanical testing (per ASTM F2706-08, ASTM F543-17, and ASTM F1798-13) to ensure the device's physical properties are safe and effective.

No AI-related information or clinical study details are present in this document.

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The Proficient® Posterior Cervical Spine System is intended to immobilize the spine as an adjunct to fusion for cervical (C1-C7) and thoracic (T1-T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies and degenerative disease of the facets with instability. The Proficient® Posterior Cervical Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient® Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient® transition rods.

The modified Proficient® Posterior Cervical Spine System consists of a selection of non-sterile, single-use polyaxial screws, locking screws, rods, and connectors manufactured from titanium per ASTM F136 and ASTM F67 and cobalt-chrome alloys per ASTM F1537 and ASTM F1058. The rods, screws, and connectors are attached to the cervicothoracic spine of skeletally mature patients to stabilize the spine during fusion of vertebral bodies.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Proficient® Posterior Cervical Spine System." This document primarily focuses on establishing substantial equivalence to a predicate device based on material composition, design, and mechanical performance testing.

Crucially, this document does NOT describe the acceptance criteria or a study that proves the device meets the acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device.

The questions you've asked (about sample size, expert ground truth, MRMC studies, standalone performance, etc.) are highly relevant to the validation of AI/ML-driven medical devices, especially for image analysis or diagnostic support. However, this FDA submission pertains to a physical orthopedic implant, specifically a spinal fixation system. Its "performance data" refers to mechanical testing (e.g., dynamic axial compression bend testing, dynamic torsional testing, and axial grip testing) to ensure the physical device can withstand anticipated forces in the human body, not to the performance of an algorithm or diagnostic accuracy.

Therefore, I cannot extract the information requested from the provided text as it does not contain the type of study design and performance metrics relevant to an AI/ML medical device.

To answer your request, if this were an AI/ML medical device submission, the provided information would be insufficient. Based on the document, here's what can be inferred:

• Type of Device: Physical spinal implant (Proficient® Posterior Cervical Spine System).
• Purpose of Submission: To gain clearance for the addition of new components and a modification to instrumentation for an already cleared device.
• Key Clearance Mechanism: Substantial Equivalence to a predicate device (K172594 - Proficient® Posterior Cervical Spine System by Spine Wave, Inc.).
• Performance Data Mentioned: Dynamic axial compression bend testing, dynamic torsional testing, and axial grip testing. These are mechanical tests for the implant's structural integrity.

Therefore, a direct answer to your specific questions, as if this were an AI/ML device, cannot be provided from this document.

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The Proficient® Posterior Cervical Spine System is intended to immobilize the spine as an adjunct to fusion for cervical (C1-C7) and thoracic (T1- T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radios and degenerative disease of the facets with instability. The Proficient® Posterior Cervical Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient® Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient® transition rods.

The subject Proficient® Posterior Cervical Spine System consists of a selection of non-sterile, single-use polyaxial screws, locking screws, rods, and connectors manufactured from titanium per ASTM F136 and ASTM F67 and cobalt-chrome allovs per ASTM F1537 and ASTM F1058. The rods, screws, and connectors are attached to the cervicothoracic spine of skeletally mature patients to stabilize the spine during fusion of vertebral bodies.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device (e.g., an AI-powered medical device) meets those criteria.

The document is a 510(k) premarket notification for a medical device called the "Proficient® Posterior Cervical Spine System," which is a spinal implant. It describes the device, its intended use, comparison to predicate devices, and mechanical performance testing to demonstrate substantial equivalence, such as:

• Dynamic axial compression bend testing
• Dynamic torsional testing
• Static and axial grip testing

This type of testing is to ensure the mechanical integrity and performance of the physical implant, not to validate criteria for an AI or software-based medical device as your request implies.

Therefore, I cannot extract the information required in your request, such as sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, or training set details, because this document is about a surgical implant and not a software/AI device.

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The Proficient™ Posterior Cervical Spine System is intended to immobilize and stabilize the spine as an adjunct to fusion for cervical (C2-C7) and thoracic (T1-T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies and degenerative disease of the facets with instability. The Proficient™ Posterior Cervical Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient™ Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient™ transition rods.

The Proficient™ Posterior Cervical Spine System consists of a selection of non-sterile, single use polyaxial screws, set screws, rods, and cross-connector components manufactured from titanium (ASTM F136 and ASTM F67) and cobalt chrome alloys (ASTM F1537 and ASTM F1058). The surgeon attaches the rod, screw, and cross connectors to the cervicothoracic region of the spine in order to stabilize the spine during fusion of vertebral bodies.

This document is a 510(k) premarket notification for the Proficient™ Posterior Cervical Spine System. It describes a medical device, not an AI/ML-driven device or study with acceptance criteria related to a diagnostic or predictive algorithm. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this document.

The performance data listed in Section 8 of the 510(k) summary are for mechanical testing of the spinal implant device, not for the performance of an AI system. These tests are:

• Static and dynamic compression bending (per ASTM F1717)
• Static and dynamic torsion (per ASTM F1717)
• Axial grip (per ASTM 1798)

These are standard engineering tests to evaluate the physical properties and durability of the spinal system and are used to demonstrate its substantial equivalence to predicate devices, rather than meeting acceptance criteria for an AI system's performance.

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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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