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The Lineum OCT Spine 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 (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 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 Lineum OCT Spine 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 Lineum OCT Spine System can also be connected to the Biomet Polaris System via transitional rods or using the 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 Lineum OCT Spine System consists of various screws, hooks, plates, rods, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusions. The system can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient. The implants are designed for the occiput, cervical, and/or upper thoracic spine (Occiput – T3) and consist of medical grade titanium alloy and CoCrMo alloy, similar to the predicate device.

The provided document is a 510(k) premarket notification summary for a medical device called the "Lineum OCT Spine System." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data focusing on mechanical and material properties, rather than clinical efficacy studies often seen with AI/ML devices. As such, the information required for a detailed AI/ML device study description (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document.

The document discusses mechanical performance data, not AI/ML algorithm performance. Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, the study proving it meets them, sample sizes for AI/ML tests, ground truth details, expert qualifications, or MRMC studies, as these concepts are not applicable to the content of this regulatory submission.

Here's what the document does provide regarding performance data:

Performance Data (Mechanical)

Study Details (Mechanical Testing):

• Study Type: Non-clinical mechanical construct and component testing.
• Standards Used: Based on ASTM F2706 (Standard Test Method for Static and Fatigue Testing of a Spinal Orthosis for the Occiput-Cervical-Thoracic Spine) and ASTM F1798 (Standard Guide for Evaluation of Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Anterolateral Cervical Spine Fusion Constructs).
• Purpose: To support the substantial equivalence of the modified Lineum OCT Spine System to its predicate device.
• Conclusion: The mechanical testing provided demonstrates the substantial equivalence of the subject Lineum OCT Spine System.

Missing Information (Not applicable to this type of device submission):

• Sample size used for the test set and data provenance (e.g., country of origin, retrospective or prospective) for an AI/ML algorithm.
• Number of experts used to establish ground truth for a test set and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human readers with/without AI assistance.
• Standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML algorithm.
• Sample size for the training set (for an AI/ML algorithm).
• How the ground truth for the training set was established (for an AI/ML algorithm).

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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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The VuePoint® OCT System is intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), and is indicated for: (1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) Degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) Fracture/Dislocation, (4) Spinal Stenosis, (5) Atlantoaxial fracture with instability, (6) Occipitocervical dislocation, (7) Spinal tumor and/or (8) Revision of previous cervical spine surgery.

The occipital bone screws are limited to occipital fixation only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The VuePoint OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors or transition rods.

The NuVasive VuePoint OCT System consists of a variety of shapes and sizes of screws, rods, offset connectors, set screws, and cross connectors which can be rigidly locked in a variety of configurations to accommodate patient anatomy.

Here's a breakdown of the acceptance criteria and study information for the NuVasive® VuePoint® OCT System based on the provided 510(k) summary:

This device did not involve AI or algorithms; it is a spinal fixation system. Therefore, many of the requested categories related to AI performance, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to predicate devices through biomechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (number of constructs or test specimens) used for each biomechanical test.
• Data Provenance: Not applicable in the context of clinical data. The tests are nonclinical (laboratory-based biomechanical tests) performed to demonstrate mechanical equivalence. Country of origin for data is not specified, but the submission is to the U.S. FDA, implying adherence to U.S. recognized standards. The study is nonclinical (in-vitro testing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. This device is a spinal fixation appliance, and the "ground truth" for its performance is established by standardized biomechanical tests demonstrating its physical and mechanical properties, not by human expert opinion or clinical outcomes in the traditional sense. The "ground truth" is adherence to established engineering standards for strength and durability.

4. Adjudication Method for the Test Set

• Not applicable. There was no human adjudication of "cases" or "ground truth" as this was a nonclinical biomechanical study. The adjudication is against the performance of predicate devices and relevant ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This is not an AI-powered device. It is a physical spinal implant system. Therefore, MRMC studies and AI assistance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Nonclinical Biomechanical Performance. The "ground truth" for this device's performance is its ability to meet or exceed the biomechanical performance (static and dynamic torsion, compression, interconnection strength) of legally marketed predicate devices, as measured by established ASTM (American Society for Testing and Materials) standards.

8. The Sample Size for the Training Set

• Not applicable. This non-AI device does not have a "training set" in the context of machine learning.

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

• Not applicable. This non-AI device does not have a "training set" or "ground truth" established for training in the context of machine learning.

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The GSO PCT Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO PCT Spinal System should be removed after fusion.

The GSO PCT Spinal System is intended to promote fusion of the cervical spine and cervico-thoracic junction (C1-T3), and is indicated for the following:

1. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Spondylolisthesis
3. Spinal stenosis
4. Fracture or dislocation
5. Revision of previous cervical or cervico-throracic spine surgery
6. Tumors

The use of multi-axial pedicle screws is limited to placement in the upper thoracic spine (T1-T3) for the purpose of anchoring the construct. The multi-axial pedicle screws are not intended to be placed in the cervical spine.

The GSO PCT Spinal System consists of rods, screws, hooks, and connecting components that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are attached to the spine posteriorly by means of screws and/or hooks joined with rods. Cross connector components are used to attach two rods in parallel. The GSO PCT Spinal System can be installed with any suitable instrumentation.

The GSO PCT Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136. Devices are available in various diameters, lengths and sizes.

This appears to be a 510(k) premarket notification document for a spinal implant system, not an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device performance and testing (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

However, I can extract information related to the acceptance criteria and the study performed to demonstrate "device meets acceptance criteria" in the context of a traditional medical device (spinal implant).

Acceptance Criteria and Reported Device Performance for GSO PCT Spinal System

Study Details (Non-AI/ML Medical Device)

• Sample sized used for the test set and the data provenance: Not applicable. For this type of device, mechanical testing is done on device samples, not patient data sets.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert clinician consensus.
• Adjudication method for the test set: Not applicable.
• 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.
• 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 type of ground truth used:
  • For mechanical strength: Engineering standards (ASTM F1717) and physical measurements.
  • For substantial equivalence: Comparison against legally marketed predicate devices based on indications, design, and materials.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary of the Study:

The primary study conducted for the GSO PCT Spinal System was non-clinical mechanical testing.

• Study Type: Mechanical performance testing.
• Methodology: The testing was conducted according to ASTM F1717. ASTM F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model," typically evaluates the static and fatigue strength of spinal implant constructs under various loading conditions (e.g., compression, torsion, bending) to ensure they can withstand the anticipated physiological stresses without failure.
• Results: The mechanical testing demonstrated that the GSO PCT Spinal System possesses "sufficient strength for its intended use."

Additionally, the submission relies on demonstrating substantial equivalence to existing legally marketed devices (Mountaineer OCT Spinal System, Altius OCT System, and OASYS System). This comparison serves as a form of "study" to support the safety and effectiveness by showing similarity in:

• Indications for Use
• Design
• Materials of construction (CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136).

Clinical Testing: The document explicitly states: "Clinical testing was not necessary to demonstrate the substantial equivalence of the GSO PCT Spinal System to the predicate devices." This is common for 510(k) submissions where substantial equivalence can be established through non-clinical data and direct comparison to predicates.

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