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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 SUMMIT® SI OCT Spinal Fixation System and MOUNTAINEER® OCT Spinal System are intended to provide immobilization and stabilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, 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. pseudarthrosis);
• · tumors involving the cervical/thoracic spine;

• and degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and

· degenerative disease of the facets with instability.

The SUMMIT and MOUNTAINEER Systems are 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 SONGER® Wire/Cable System to be used with the SUMMIT and MOUNTAINEER Systems allows for wire/cable attachment to the posterior cervical spine.

The SUMMIT and MOUNTAINEER Systems can also be linked to the ISOLA®, MONARCH®, MOSS® MIAMI, VIPER® and EXPEDIUM® Spine Systems using the dual wedding band and axial connectors, and via dual diameter rods.

The SUMMIT and MOUNTAINEER Systems are posterior spinal fixation systems intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3). The systems are composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The systems consist of bone anchors including hooks, SONGER® cables and screws, longitudinal members including rods and occipital plates, transverse connectors including cross connectors and interconnection mechanisms including lateral offset connectors, cable connectors, set screws, nuts, axial and wedding band connectors. The system components are implanted using class I exempt manual surgical instruments. This premarket notification expands the indications for use of the SUMMIT and MOUNTAINEER Systems to include posterior cervical screw fixation.

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML device performance. This document is a 510(k) premarket notification for a spinal fixation system, focusing on its substantial equivalence to predicate devices based on technological characteristics and mechanical performance testing, rather than an AI/ML driven device and its performance metrics.

Therefore, I cannot extract the requested information from the provided text.

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When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for:

• Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
• Spondylolisthesis
• Spinal Stenosis
• Trauma (i.e. Fracture or Dislocation)
• Atlanto/axial fracture with instability
• Revision of previous cervical spine surgery
• Tumors
  Occipital Plates / Occipital Bone Screws / Hooks:
  The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only.
  The use of the occipital plate requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
  Hooks and rods:
  The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
  Polyaxial screws/Connectors:
  The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine.
  The PASS OCT Spinal System can also be linked to the PASS LP® Spinal System using the dual diameter rod.

The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.
The implants are manufactured from titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications and in PEEK OPTIMA LT1 conforming to ASTM E2026 specifications.

The PASS OCT Spinal System is a spinal fixation device. No AI/ML components are mentioned in the provided text. The device's substantial equivalence to predicate devices was determined through non-clinical testing.

Here's the information based on the provided text, focusing on the mechanical performance of the device rather than AI/ML related criteria:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: The document does not specify a "test set" in the context of AI/ML. The performance data presented is for non-clinical (mechanical) tests. The sample sizes for these mechanical tests are not explicitly stated. Data provenance is not applicable in the context of device mechanical testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's performance is established by mechanical testing standards, not expert clinical interpretation.
3. Adjudication method for the test set: Not applicable. Mechanical testing is typically evaluated against defined scientific standards and acceptable ranges, not human adjudication.
4. 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 physical spinal fixation system, not an AI/ML diagnostic or assistive tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical spinal fixation system and does not contain an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established by mechanical testing standards (e.g., ASTM F2706-08) and FDA guidance for spinal systems, which define acceptable physical properties and performance under various loading conditions.
7. The sample size for the training set: Not applicable. This device is a physical spinal fixation system; there is no training set as would be used for an AI/ML algorithm.
8. How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.

Conclusion from non-clinical data: MEDICREA® INTERNATIONAL PASS OCT Spinal system is substantially equivalent to several predicate devices (SUMMIT System, Mountaineer OCT Spinal System, Vertex Reconstruction System, and PASS 2 Spinal System) in terms of intended use, materials, design, mechanical safety, and performance. The device is considered safe and effective.

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When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervicothoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

The occipital bone screws are limited to occipital fixation only.

The use of pedicle screws, is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.

The Nextgen Altius OCT System is an occipito-cervico-thoracic spinal fixation system. This submission is a line extension to Altius OCT System to add CoCr rods and alternate styles of rods, and screws, as well as other system components to the system and to update the indications for use for the system as a whole.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

This 510(k) summary is for a spinal fixation system, which falls under the category of a medical device and not an AI/ML algorithm. Therefore, many of the requested points related to AI/ML studies (like MRMC, standalone algorithm performance, AI improvement over human readers, training set details) are not applicable to this document. The study described is a series of mechanical tests to demonstrate substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: This information is not explicitly stated in the summary. For mechanical tests, the "sample size" would refer to the number of constructs tested for each configuration.
• Data Provenance: The data is generated from mechanical laboratory testing of the device components, not from patient data. Therefore, concepts like "country of origin" or "retrospective/prospective" studies are not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. As this is a mechanical testing study for a physical device, expert-established ground truth (in the clinical sense, e.g., for image interpretation) is not relevant. The "ground truth" here is adherence to established mechanical testing standards (ASTM standards) and the comparison of performance metrics against predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert clinical assessments or diagnostic interpretations. This study involves objective mechanical performance measurements, not subjective expert reviews.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for evaluating the impact of an AI/ML system on human reader performance. This document describes mechanical testing of a spinal fixation device, which does not involve human readers for diagnostic interpretation.

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

• No. This is not an AI/ML algorithm. It is a physical medical device.

7. The Type of Ground Truth Used

• The "ground truth" in this context is based on established mechanical testing standards (ASTM F2706, F1717, F1798) and performance characteristics of legally marketed predicate devices. The goal is to demonstrate that the new device's components meet these engineering and regulatory benchmarks, indicating that they are at least as safe and effective as existing devices.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of mechanical testing for a spinal fixation system. This concept applies to the development of AI/ML algorithms.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. As there is no training set, there is no ground truth established for one.

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