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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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