Search Results

The Sovereign Posterior Cervical System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of 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; and 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 Sovereign Posterior Cervical 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 Sovereign Posterior Cervical System may be connected to the Xultan 5.5 system using rod-to-rod connectors or transition rods. Please refer to the individual system's Instructions for Use for a list of indications for use for each system.

The Met One Technologies Sovereign Posterior Cervical System is an implant device designed for the posterior stabilization of the cervical and upper thoracic spine. The system includes implants such as polyaxial screws, blocker screws, rods, crosslinks, lateral connectors, and rod to rod connectors to form a unique construct to match patient anatomy.

Polyaxial screws are offered in a range of sizes in both standard and reduction tulips for ease of use. All screws are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

Straight, pre-bent, and transition rods are offered in 3.5mm and 4.0mm diameters and in two different materials, titanium alloy (Ti-6Al-4V ELI per ASTM F136) and cobalt chrome (Co-Cr28-Mo6 per ASTM F1537). Transition rods are fully compatible with Met One Technologies Xultan 5.5 Pedicle Screw System line of implants.

A variety of connectors and crosslinks are offered for surgeons to create the desired construction. Rod to rod crosslinks improve the torsional stability of the construct. Lateral connectors are provided in open and closed configurations, 3.5mm and 4.0mm diameters, and in long and short lengths. Rod to rod connectors are offered in several configurations to join rods together. All connectors are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

I am sorry, but the provided text is an FDA 510(k) clearance letter for a Sovereign Posterior Cervical System, which is a physical medical device (spinal implant system), not an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain any information about:

• Acceptance criteria for an AI/SaMD's performance.
• A study proving the device meets AI/SaMD acceptance criteria.
• A test set (sample size, provenance).
• Experts establishing ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth.
• Training set details.

The non-clinical testing described (ASTM F1717 and ASTM F1798) refers to mechanical testing of the physical implant's strength and durability, not software performance.

As such, I cannot fulfill your request for information related to AI/SaMD acceptance criteria and study details based on the provided input.

Ask a specific question about this device

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.

Ask a specific question about this device

The M.U.S.T. MINI Posterior Cervical Screw System is intended to provide immobilization of spinal segments as an adjunct to fusion, in skeletally mature patient, for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fraumatic dislocations; instability or deformity; failed previous (e.g., pseudarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The M.U.S.T. MINI Posterior Cervical Screw 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 M.U.S.T. MINI Posterior Cervical Screw System may be connected to the M.U.S.T. System rods with the M.U.S.T. MINI rod connectors. Transition rods with differing diameters may also be used to connect the M.U.S.T. MINI Posterior Cervical Screw System to the M.U.S.T. System. Refer to the M.U.S.T. System package insert for a list of the M.U.S.T. Indications of Use.

When used with the Occipital Plate, the M.U.S.T MINI Posterior Cervical Screw System is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic junction (occiput - T3) in treatment of the instabilities mentioned above, including occipitocervical dislocation.

The subject M.U.S.T. MINI Extension implants are line extension to the previously cleared Medacta M.U.S.T. MINI Posterior Cervical Screws System (K171369).

The new subject Posterior Occipital-Cervical Screw System is a multi-component device, manufactured from Titanium-based and CoCr materials, consisting of occipital screws and straight and pre-bent rods that longitudinally connect the occiput with the posterior cervical spine. The system is intended to stabilize and fuse the spine in degenerative disc disease, spinal fusion, cervical fractures and in surgically repaired spinal pseudoarthrosis. In addition, it is used in deformity correction e.g. scoliosis to correct and stabilize the spine.

The M.U.S.T. MINI Extension implants have been designed with the same or similar shape, dimensions and materials as the previously cleared Medacta M.U.S.T. MINI Posterior Cervical Screws System (K171369), Synthes Synapse OCT System (K070573 and K142838), DePuy Mountaineer OCT Spinal System (K042508 and K110353) and Alphatec Solanas Avalon Posterior Fixation System (K111076).

The M.U.S.T. MINI Extension implants are manufactured with the same materials of the Medacta predicate device M.U.S.T. MINI Posterior Cervical Screws System (K171369): Ti-6Al-4V ELI (ISO 5832-3 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium allov + ASTM F136 Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)) and CoCtMo (ISO 5832-12 Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy + ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)).

Additionally, the new 4x and 6x package for the already cleared (K171369) M.U.S.T. MINI set screw implant have been introduced.

This document describes the M.U.S.T. MINI Extension, a spinal fixation system, and its substantial equivalence to predicate devices, rather than a diagnostic AI device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and AI-specific performance metrics is not applicable in the context of this 510(k) submission.

The provided text does not contain information about an AI device or a study assessing its performance against acceptance criteria using a test set, ground truth, or human readers.

Instead, the document focuses on demonstrating that the M.U.S.T. MINI Extension is substantially equivalent to existing, legally marketed spinal fixation devices through a comparison of:

• Intended use: The conditions for which the device is designed to be used.
• Design and technological characteristics: Materials, dimensions, and overall structure.
• Performance evaluations: Mechanical tests to ensure the device meets safety and efficacy standards for spinal implants.

Here's a breakdown of the relevant information provided in the document:

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

The document mentions that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." However, it does not provide a specific table of acceptance criteria and reported numerical performance results for the new device compared to those criteria. It lists the types of mechanical tests performed, which inherently have acceptance criteria defined by the cited ASTM standards, but the specific Pass/Fail outcomes or quantitative measurements are not detailed in this summary.

Examples of tests performed (implying acceptance criteria based on standards):

• Static Compression Bending Test (ASTM F2706-08 (Reapproved 2014))
• Static Torsion Test (ASTM F2706-08 (Reapproved 2014))
• Dynamic Axial Compression Test (ASTM F2706-08 (Reapproved 2014))
• Dynamic Torsion Test (ASTM F2706-08 (Reapproved 2014))
• Axial Gripping Test (ASTM F1798-13)
• Plate Torque to Failure Test
• Screw Torque to Failure Test
• Pyrogenicity (Bacterial Endotoxin Test (LAL test) according to European Pharmacopoeia §2.6.14/USP chapter , and pyrogen test according to USP chapter )

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

• Sample size: Not explicitly stated for each mechanical test. Mechanical tests typically use a specific number of samples of the device components.
• Data provenance: Not applicable in the context of a clinical patient dataset. The "data" here refers to the results of mechanical testing on the device itself (implants, rods, screws). These tests are performed in a lab setting, not on patient data.

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

• This is not applicable as there is no "ground truth" related to expert assessment of AI output. The "truth" for this device's performance is determined by adherence to engineering standards and mechanical properties.
• There was a "Design Validation Workshop" mentioned, which implies expert review during the design process, but not for establishing ground truth in a diagnostic context.

4. Adjudication method for the test set:

• Not applicable, as there are no expert adjudications in the context of mechanical testing of a spinal implant.

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:

• No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI, where human readers evaluate cases with and without AI assistance. This document is for a physical surgical implant.

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

• Not applicable. This device is a physical implant, not a standalone algorithm.

7. The type of ground truth used:

• For the mechanical tests, the "ground truth" is defined by the objective physical and mechanical properties required by the cited ASTM standards. It's not expert consensus, pathology, or outcomes data in the typical sense of AI/diagnostic studies, but rather engineering specifications.

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

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

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

In summary: The provided document is a 510(k) summary for a physical medical device (spinal implant) and demonstrates its substantial equivalence primarily through comparisons with predicate devices and mechanical performance testing against established engineering standards. It does not involve AI, diagnostic performance, patient data, or expert interpretations in the way the requested questions imply.

Ask a specific question about this device

The CENTINEL SPINE PCT SYSTEM is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and 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 CENTINEL SPINE PCT 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.

The Centinel Spine PCT System consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, and connecting components (e.g., variable and fixed cross connectors). The hooks and polyaxial screws are intended to be attached to the posterior elements of the cervical and/or upper thoracic spine and serve as bone anchors. The rods are longitudinally secured to the bone anchors with the set screw. The various connecting components serve to both secure the construct and provide additional construct configuration options. All implants are manufactured from titanium alloy, Ti6A14V (ASTM F136 or ISO 5832-3)

This document is a 510(k) summary for the Centinel Spine PCT System, a device intended for spinal immobilization and stabilization. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific clinical acceptance criteria in terms of AI/algorithm efficacy. As such, many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable or available in this document.

However, I can extract information related to the device's mechanical performance testing:

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

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

• Test Set Sample Size: Not explicitly stated within this document. The testing refers to "performance testing" and indicates that "published literature" was also used, but does not detail the number of constructs or specimens tested for each mechanical test.
• Data Provenance: The document does not specify the country of origin of the data. The tests are described as "Performance Testing" conducted according to modified versions of ASTM standards (ASTM F1717 and ASTM F1798), implying laboratory-based mechanical testing rather than clinical data from human subjects. It would be considered an in-vitro study.

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

This information is not applicable. The "ground truth" here is mechanical performance measured against engineering standards, not clinical diagnoses or outcomes requiring expert interpretation.

4. Adjudication method for the test set:

Not applicable. Mechanical tests for physical devices typically involve direct measurement against specified engineering limits, not human adjudication.

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 spinal implant, not an AI diagnostic tool that assists human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth used for performance assessment was based on mechanical engineering standards and the performance of predicate devices. Specifically, the "acceptance criteria were defined by predicate device performance."

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that would have a training set.

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

Not applicable.

Ask a specific question about this device