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The Invictus™ OCT Spinal Fixation System is intended to provide immobilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniccervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g.,pseudoarthrosis); 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 Invictus OCT Spinal 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 advance 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 Invictus OCT Spinal Fixation System may be connected to the components in the Arsenal® Spinal Fixation System or the Invictus™ System offered by Alphates Spine using various rod-to-rod connectors and/or transitional rods.

The purpose of this submission is to add occipital components to the previously cleared Invictus™ CT Spinal Fixation System (K200936). The Invictus™ OCT Spinal Fixation System is a posterior approach system designed to stabilize the cervico-thoracic spine and/or occiput with or without fusion. The Invictus OCT system is intended to be compatible with Arsenal® Spinal Fixation System or the Invictus™ Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods.

The Invictus OCT implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus OCT System consists of a variety of shapes and sizes of plates, screws, rods, cross connectors, rod-to-rod connectors and general surgical instruments that provide internal fixation and stabilization during bone graft healing and/or fusion mass development.

The Invictus OCT implants are provided non-sterile to be steam sterilized by the end user. The instruments are made of stainless steel and other materials, and are provided nonsterile to be cleaned and sterilized by the end user.

This is not a medical device that uses AI. This is a spinal fixation system. As such, information regarding acceptance criteria, study details, and AI-specific performance metrics (like sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for AI) are not applicable or found in the provided document.

The document discusses the regulatory review of a physical medical device. It confirms the device, the Invictus™ OCT Spinal Fixation System, is substantially equivalent to legally marketed predicate devices based on its intended use, indications for use, design, technology, and nonclinical performance data.

Here's the relevant information that is provided:

1. Acceptance Criteria and Reported Device Performance (Nonclinical Testing):

2. Sample size used for the test set and the data provenance: Not applicable for this type of nonclinical, physical device testing. The "test set" would refer to the physical devices themselves and the conditions under which they were tested according to ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device mechanical testing is based on established engineering standards and measurements, not expert consensus on diagnostic images.

4. Adjudication method for the test set: Not applicable for this type of nonclinical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This device is not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical spinal fixation system, not an algorithm.

7. The type of ground truth used: For the nonclinical performance data, the "ground truth" is defined by the objective physical measurements and engineering criteria outlined in the ASTM standards (F2706 and F1798).

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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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.

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The BRIDALVEIL Occipital Cervical Thoracic 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 (Cl to C7) and the thoracic spine from TI-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 BRIDALVEIL Occipital Cervical Thoracic 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 BRIDALVEIL Occipital Thoracic System may be connected to the OLYMPIC Posterior Spinal Fixation System rods and connectors. Transition rods with differing diameters may also be used to connect the BRIDALVEIL Occipital Cervical Thoracic System to the OLYMPIC Posterior Spinal Fixation System. Refer to the OLYMPIC Posterior Spinal Fixation System package insert for instructions for use and indications for use.

The BRIDALVEIL Occipital Cervical Thoracic System is a spinal fixation system intended to stabilize the uppermost portion of the spine during the fusion process. The system contains a wide variety of implants and instruments which allows for the transition across multiple spinal segments: Occipital Plate with Screws, Cervical Polyaxial Screws, Laminar Hooks, Cross Connectors, Rod Connectors, and Rods manufactured from Ti6Al4V ELI (ASTM F136) and cobalt chrome alloy (ASTM F1537).

The provided text describes the regulatory clearance for the BRIDALVEIL Occipital Cervical Thoracic System, a spinal fixation system. It does not detail acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML device.

This document is a 510(k) premarket notification for a traditional medical device (spinal fixation system), not an AI/ML device. Therefore, the details requested in the prompt, such as reported device performance, sample size for test sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set, are not applicable in the context of this submission.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Intended Use: Providing immobilization and stabilization of spinal segments as an adjunct to fusion for various conditions (traumatic fractures/dislocations, instability, tumors, degenerative disease, etc.) in the craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3). It also mentions restoring spinal column integrity for a limited time in advanced stage tumor patients.
• Design: The system includes occipital plates with screws, cervical polyaxial screws, laminar hooks, cross connectors, rod connectors, and rods.
• Materials: Ti6Al4V ELI (ASTM F136), cobalt chrome alloy (ASTM F1537), Elgiloy CoCrNi alloy (ASTM F1058), and Nitinol #1 (ASTM E2063).
• Mechanical Safety and Performance: Evaluated through non-clinical bench testing.

Here's the information extracted from the document, framed in the context of a traditional medical device submission, rather than an AI/ML one:

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

For this traditional medical device (BRIDALVEIL Occipital Cervical Thoracic System), "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices through conformity to recognized standards for mechanical performance and material properties. "Reported device performance" is derived from the results of these non-clinical tests meeting the requirements of those standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable in the context of human data. The "test set" here refers to physical specimens of the device components tested in a laboratory setting. No human patients or retrospective/prospective data were used for performance evaluation.
• Data Provenance: The data provenance is from non-clinical bench testing conducted in a laboratory. The specific country of origin of the lab is not stated in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. "Ground truth" in this context refers to the defined parameters and performance standards derived from the ASTM standards for mechanical testing. These standards are established by expert committees in engineering and materials science, but individual experts are not "adjudicating" a test set as they would for clinical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There's no human adjudication process described for the mechanical test results; rather, the results are compared against predefined criteria within the ASTM standards.

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 is not an AI/ML device, and no MRMC studies or human reader performance evaluations were conducted.

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

• Not applicable. This is not an AI/ML device. The "standalone performance" is the mechanical testing of the device itself against engineering standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For this device, the "ground truth" (or reference for evaluation) is established through recognized industry standards for mechanical testing of spinal implants (e.g., ASTM F1717, ASTM F2706, ASTM F1798). The device's performance is compared against the requirements and typical performance of predicate devices as measured under these standardized conditions.

8. The sample size for the training set

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

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

• Not applicable. This is not an AI/ML device.

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