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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 fractures and/or traumatic 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 M.U.S.T. MINI Anodized Rods and the Rod to Rod Connectors (parallel and in-line) are a line extension to the previously cleared Medacta M.U.S.T. MINI Posterior Cervical Screws System (K171369), M.U.S.T. MINI Posterior Cervical Screws System extension (K182837) and M.U.S.T. MINI Posterior Cervical Screws System extension (K200130).

Rod to rod connectors are extended to additional design: the parallel and the In-line design, available in both open/closed design. Connectors are designed to accommodate both the rods in 03.5mm and Ø5.5mm. This solution allows to connect the cervical and upper thoracic spine with axial or parallel rods from equal diameter or different: 3.5mm versus 3.5mm versus 5.5mm.

Anodized rods (straight and pre-curved) are provided in straight and pre-curved designs and the diameters and lengths are within the range of existing M.U.S.T. MINI Posterior Cervical Screws System rods product range, with equivalent overall characteristics: same intended use, diameter 3.5mm, in the range 30-420mm, material, machining, washing, packaging and final storing condition.

The subject devices are manufactured from Ti-6A1-4V 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-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), the same material of the previous cleared M.U.S.T. MINI Posterior Cervical Screws System (K171369) and M.U.S.T. MINI Posterior Cervical Screws System Extension (K182837 and K200130).

Surface finishing of both subjects devices is further characterized by color anodization like for existing Polyaxial screws, hooks, lateral connector, rod to rod connector, cross connector clamp and spinous reconstruction cross connectors (all cleared under K171369), Occipital Plates (K182837) and are Type III color anodized.

This document describes the M.U.S.T. MINI Posterior Cervical Screws System, a medical device for spinal immobilization. The information provided is a 510(k) summary submitted to the FDA, which focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific, quantitative acceptance criteria through a rigorous clinical study involving human readers and ground truth for an AI-powered diagnostic device.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study design are not applicable or extractable from this document. This document details a mechanical device, not a diagnostic AI.

Here's an analysis based on the provided text, highlighting what's present and what's missing due to the nature of the device:

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

• Not Applicable / Not Provided in this format. For a mechanical spinal implant, acceptance criteria are typically related to biocompatibility, mechanical strength (fatigue, static compression), material properties, and manufacturing consistency, demonstrated through engineering tests rather than performance metrics like sensitivity/specificity for a diagnostic AI. The document states a "comparative analysis" and that "the line-extension can be considered within the scope of the design verification and validation testing previously completed for the initial MUST MINI implants product range." This implies that the new components meet the same (unspecified in detail here) acceptance criteria as the original system.

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

• Not Applicable / Not Provided. This document does not describe a "test set" in the context of data for an AI/ML model. The "testing" mentioned refers to engineering and mechanical tests of the physical device components.

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

• Not Applicable. Ground truth, in the context of diagnostic AI, involves expert annotation of medical images or other data. This is not relevant for a mechanical spinal implant.

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

• Not Applicable. See point 3.

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 a mechanical device, not an AI-assisted diagnostic tool. No human reader study would be performed.

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

• Not Applicable. This is not an algorithm.

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

• Not Applicable. For a mechanical device, "ground truth" would relate to verifiable material properties, mechanical performance under stress, and biocompatibility, typically established through standardized testing protocols (e.g., ISO, ASTM standards) rather than clinical ground truth methods.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device requiring a training set.

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

• Not Applicable.

Summary of Device Performance (Based on the document):

The document states that the M.U.S.T. MINI Posterior Cervical Screws System performs "as safe and effective as the predicate devices." The core argument for acceptance is substantial equivalence to previously cleared devices.

Key points from the document regarding performance/testing, though not in the form of AI acceptance criteria:

• Engineering Rationale: A comparative analysis was performed to determine if the line-extension (new rods and rod-to-rod connectors) created a new worst-case product size.
• Conclusion: It was determined that the subject devices are substantially equivalent to the previously cleared predicate device and that the line-extension can be considered within the scope of the design verification and validation testing previously completed for the initial M.U.S.T. MINI implants product range.
• Technological Characteristics Shared with Predicates: diameter, materials of construction, biocompatibility, device usage, sterility, shelf life, and packaging.
• Material: Manufactured from Ti-6A1-4V ELI (ISO 5832-3 and ASTM F136), the same material as previous cleared M.U.S.T. MINI systems.
• Surface Finishing: Type III color anodized, like existing components cleared under K171369 and K182837.
• Performance Claim: Minor differences (e.g., new designs for rod-to-rod connectors, extended rod lengths) do not raise new questions of safety or effectiveness.

In essence, the "study" proving the device meets its acceptance criteria (which are mechanical and material-based, not diagnostic AI performance) is a comparative analysis and reliance on prior design verification and validation testing of the predicate devices.

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