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The VERTICALE Cervical 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 (occiput-C2), the cervical spine (C1 to C7) and the thoracic spine (T1-T3):

• traumatic spinal fractures and /or traumatic dislocations
• instability or deformity
• failed previous fusions (e.g. pseudoarthrosis)
• tumors involving the cervical/thoracic spine
• degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and
• degenerative disease of the facets with instability

The VERTICALE Cervical System is a posterior double rod fixation system for immobilization and stabilization of the spinal seqments of the craniocervical junction (occiput-C2), cervical spine (C1-C7), and thoracic spine (T1-T3).
The system may only be used in the field of human medicine and consists of polyaxial screws, favored anqle polyaxial (FA) screws, rods, occiput plates, connectors and the related instrumentation.
The VERTICALE Cervical System will be used in patients with occiput cervical and upper cervical spine instabilities.
The implants of the VERTICALE Cervical System are manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3. They are delivered in a sterile condition and can be used without any further preparations. The implants are packaged in accordance with EN ISO 11607 Part 1+2 and sterilized with gamma irradiation at a minimum dose of 25 kGy.
Implants delivered by the manufacturer in a sterile condition may not be sterilized. They are intended for single use.

I am sorry, but based on the provided text, I cannot find the specific information regarding the acceptance criteria, reported device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC study, standalone performance, or ground truth details for a device that relies on AI.

The document you provided is an FDA 510(k) clearance letter for the VERTICALE® Cervical System, which is a posterior double rod fixation system for spinal immobilization. This device is a traditional medical implant, not an AI/ML-driven device. The document primarily discusses:

• Substantial Equivalence: Comparing the device to a predicate device (Mountaineer OCT Spinal System) based on indications for use, principles of operation, technological characteristics, materials, and performance testing.
• Non-Clinical Performance Data: It lists mechanical performance tests (e.g., ASTM F1717-18, ASTM F2706-18, ASTM F1798-13), biocompatibility (ISO 10993-1), cleaning and sterilization (ISO 11137), and shelf-life testing. These are standard tests for medical implants.
• Clinical Performance Data: States explicitly, "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

Therefore, the requested information about acceptance criteria, study details, expert qualifications, and ground truth for an AI/ML device is not present in this document.

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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 Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion when using autograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/ or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.

The Streamline OCT System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, occipital plates, occipital screws, and connecting components used to build an occipito-cervico-thoracic spinal construct. System components are manufactured from ASTM F136 medical grade titanium alloy and ASTM F1537 medical grade cobalt chromium molybdenum alloy. Medical grade titanium alloy and medical grade cobalt chromium molybdenum alloy may be used together. The system should be implanted using only the surgical instruments designed for the system.

The purpose of this submission is to: expand the use of the system to include the use of screws in the posterior cervical spine, add line extension components and modify an existing component.

This document is a 510(k) premarket notification for a medical device called the "Streamline OCT Occipito-Cervico-Thoracic System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices. The information provided is about the device itself and its regulatory clearance process, rather than a study proving performance against specific acceptance criteria for AI or diagnostic performance metrics.

Therefore, many of the requested sections about acceptance criteria and study details for an AI-powered diagnostic device cannot be extracted from this document.

However, I can extract information related to the non-clinical testing performed for this physical medical device.

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of precise acceptance criteria with numerical thresholds for performance (e.g., tensile strength > X, fatigue life > Y), nor does it report specific measured values for device performance against such criteria. Instead, it generally states that engineering analysis and re-creation testing demonstrated improvements and confirmed that the physical components met regulatory expectations.

2. Sample size used for the test set and the data provenance

For the non-clinical mechanical testing, the document does not specify the sample size used for each test (e.g., number of constructs tested for fatigue or static loading). It simply refers to "engineering analysis" and "re-creation testing."

The term "data provenance" (e.g., country of origin, retrospective/prospective) is not applicable here as the testing is physical mechanical testing on device components, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to the non-clinical mechanical testing of this physical medical device. "Ground truth" in this context would typically refer to clinical diagnoses or outcomes, which are not part of the described engineering or mechanical testing.

4. Adjudication method for the test set

This question is not applicable to the non-clinical mechanical testing of this physical medical device. Adjudication methods like "2+1" or "3+1" are used in clinical studies to resolve discrepancies in expert interpretations of medical data, which is not what was performed for this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data, often with AI assistance, to assess improvements in reader performance. This document is about a spinal implant system.

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

No, a standalone (algorithm only) performance study was not done. This is also not applicable to a physical spinal implant system.

7. The type of ground truth used

For the non-clinical mechanical testing described, the "ground truth" would be established by the physical properties and behavior of the materials and constructs under specific, controlled loading conditions, as defined by engineering standards (e.g., ASTM F1717, ASTM F2706). It is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set

This concept is not applicable as this document is not describing an AI/machine learning device that requires a training set. The "training set" refers to data used to train an algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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