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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 Posterior Cervical Screws System Extension is a Medacta M.U.S.T. MINI Posterior Cervical Screws System line extension. Specifically, the current submission includes the following implants:

• M.U.S.T. MINI Polyaxial screw dual lead solid and cannulated with diameters ranging from 4 to . 6mm and lengths from 20 to 50mm;
• M.U.S.T. MINI cross connector top load, four sizes. ●

The subject devices are made of Ti6A14V ELI according to ISO 5832-3 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy and ASTM F136-13 Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The provided text is a 510(k) Summary for the Medacta M.U.S.T. MINI Posterior Cervical Screws System Extension. This document describes a medical device (surgical implants) and its substantial equivalence to previously cleared devices. It does not contain information about an AI/ML powered medical device, therefore, the requested information cannot be extracted.

The request asks for specific details related to an AI/ML powered medical device, such as acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, and results of comparative effectiveness studies (MRMC) or standalone performance studies. These are all concepts relevant to the evaluation of AI/ML software.

Since the provided text concerns mechanical surgical implants, these categories do not apply. The "Performance Data" section in the document refers to non-clinical studies (design validation, geometric comparison, dynamic biomechanical testing, pyrogenicity, biocompatibility, shelf-life) and explicitly states "No clinical studies were conducted." The non-clinical studies support the substantial equivalence of the new implants to previously cleared mechanical implants, not the performance of an AI/ML algorithm.

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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.

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 - 73) in treatment of the instabilities mentioned above, including occipitocervical dislocation.

The M.U.S.T. MINI poly-axial screws and lateral connectors are a line extension to the previously cleared Medacta M.U.S.T. MINI Posterior Cervical Screws System (K171369).

The poly-axial screws included in the line-extension are equivalent to the ones legally marketed, with the exception of individual length. For the Ø4.5mm poly screws, the length is extended from "26 to 50mm" to "14 to 50mm" (adding the 14 to 24 mm sizes).

The range of Ø4mm and Ø4.5mm partial thread screws design is extended from "26 to 42mm" to "26 to 50mm" (adding the 44 to 50mm sizes) with 2 mm of increments. For the Ø3.5mm partial thread screws, the lengths of 26 to 40mm are added, 2 mm increments.

The range of full thread screw design Ø4.5mm is extended from 26-50mm to 14-50mm with 2 mm increments.

All the poly-axial screws features are the same: intended use, diameters, pitch, threading pitch, length increment, range of motion, driving interface, material, surface finishing, manufacturing process, washing, packaging and final storing condition.

The lateral connectors introduced as line-extension are equivalent to the ones legally marketed, with the exception of the length: same intended use, diameter of the shaft, fixing interfaces, material, surface finishing, machining, washing, packaging and final storing condition.

The Lateral connector included in this line extension are aimed the product range from 10-15mm to 10-30mm, in steps of 5mm.

The M.U.S.T. MINI poly-axial screws and lateral connectors are manufactured from Ti-6Al-4V ELI (ISO 5832-3 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4vanadium alloy + 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 M.U.S.T. MINI Posterior Cervical Screws System (K171369).

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (M.U.S.T. MINI Posterior Cervical Screws System). This document is focused on demonstrating substantial equivalence to predicate devices and discusses the device's mechanical properties, indications for use, and a comparison of technological characteristics.

It does not contain information about an AI/ML-based device, nor does it discuss acceptance criteria, device performance, ground truth establishment, or clinical study designs relevant to AI/ML product validation (e.g., MRMC studies, standalone performance).

Therefore, I cannot extract the information required to answer your request about acceptance criteria and the study that proves the device meets them in the context of an AI/ML product.

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 M.U.S.T. MINI Posterior Cervical Screws System straight rods (Ø3.5) are a line extension to the previously cleared Medacta M.U.S.T. MINI Posterior Cervical Screws System (K171369) and are provided in multiple lengths (30 - 115 mm in 5 mm increments). The M.U.S.T. MINI Posterior Cervical Screws System straight rods are manufactured from Ti-6A1-4V ELI (ISO 5832-3 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4vanadium alloy+ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)) and CoCrMo (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)).

The provided text describes the 510(k) submission for the M.U.S.T. MINI Posterior Cervical Screws System, specifically a line extension involving straight rods. However, it does not include any information about an AI/ML-based device validation study, acceptance criteria, or performance data related to AI assistance for human readers.

The content focuses on the substantial equivalence of mechanical and material properties of the new rods compared to previously cleared devices. The "Performance Data" section explicitly states that "no additional mechanical testing were performed; no design validation was undertaken" because the new rods are equivalent to longer rods in terms of mechanical strength.

Therefore, I cannot fulfill your request for information about acceptance criteria, AI device performance, sample sizes, expert ground truth, MRMC studies, or training sets from the provided text. This document pertains to a traditional medical device (spinal implants), not an AI/ML diagnostic or assistive tool.

Ask a specific question about this device

The M.U.S.T. Mini posterior cervical screws system is intended to provide immobilization of spinal segments as an adjunct to 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; 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 M.U.S.T. Mini posterior cervical screws 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 screws 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 screws 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.

The M.U.S.T. MINI Posterior Cervical Screws System is a multi-component system constructed from titanium and CoCrMo materials, consisting of rods that are longitudinally interconnected and anchored to adjacent vertebrae using screws. Stability enhancement is possible by means of interconnection mechanisms and transverse connectors used as cross connectors.

The M.U.S.T. MINI Posterior Cervical Screws System is intended to stabilize and fuse the spine in degenerative disc disease, spinal fusion, cervical fractures, and in surgically repaired spinal pseudo-arthrosis. In addition, the M.U.S.T. MINI Posterior Cervical Screws System is used in deformity correction e.g. scoliosis to correct and stabilize the spine.

The M.U.S.T. MINI Posterior Cervical Screws System consists of polyaxial screws (full and partially threaded), cannulated polyaxial screws (full and partially threaded), hooks, cross connectors, connectors and rods (straight and transition) are manufactured of Titanium-6Aluminum-4Vanadium Extra Low Interstitial (Ti-6Al-4V ELI). The M.U.S.T. MINI Posterior Cervical Screws System rods (straight and transition) are manufactured of Cobalt-Chromium-Molybdenum Alloy.

The provided text describes the submission for a medical device called the "M.U.S.T. MINI Posterior Cervical Screws System" to the FDA for 510(k) clearance. This type of submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving efficacy through clinical studies for new uses.

Therefore, the document does not contain information about:

1. Acceptance criteria for an AI/algorithm-based device and reported device performance. The device is a physical surgical implant, not an AI or algorithm.
2. Sample size used for a test set or data provenance for an AI/algorithm.
3. Number of experts or their qualifications for establishing ground truth for an AI/algorithm test set.
4. Adjudication method for an AI/algorithm test set.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data) for an AI/algorithm.
8. Sample size for a training set (AI/algorithm).
9. How ground truth for a training set was established (AI/algorithm).

The document primarily focuses on demonstrating substantial equivalence of a physical medical device (spinal screws system) through:

• Comparison of Technological Characteristics: Detailed tables comparing the subject device's materials, dimensions (screw diameter, length, rod diameter, length), device usage, biocompatibility, and sterilization status to several predicate devices (e.g., Synthes Synapse Systems, Synthes Cervifix/Axon Systems, Medtronic Vertex Reconstruction System).
• Performance Data (Non-Clinical Studies): The document lists various mechanical tests conducted to support substantial equivalence. These tests include:
  • Static and dynamic compression (Per ASTM F1717-15)
  • Static and dynamic torsion (Per ASTM F1717-15)
  • Static axial and torsional grip (Per ASTM F1798-13)
  • A-P screw pull out (Per ASTM F1798-13)
  • Flexion-extension (Per ASTM F1798-13)
  • Torque to failure
  • Cadaver Testing (listed but no details provided)
  • Design Comparisons
  • Pyrogenicity (Bacterial Endotoxin Test and Pyrogen Test per European Pharmacopoeia and USP)
• Acceptance Criteria for the Mechanical Tests: The text states that "acceptance criteria that were based on standards and FDA guidance document 'FDA Guidance for Industry and FDA Staff, Spinal System 510(k)s'". However, the specific quantitative acceptance criteria values (e.g., minimum load to failure, maximum displacement) and the exact reported performance results of the subject device against these criteria are not explicitly provided in the excerpt. The document states that these tests "support a substantial equivalence determination," implying the device met these criteria.

In summary, the provided document is a 510(k) summary for a physical medical device and does not contain the information requested regarding acceptance criteria and studies for an AI/algorithm-based device.

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