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The INFINITY™ OCT System is intended to provide immobilization and stabilization 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 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, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The INFINITY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

To achieve additional levels of fixation, the INFINITY OCT System may be connected to the CD HORIZON® Spinal System and VERTEX® Reconstruction System rods with the INFINITY OCT System rod connectors. Transition rods with differing diameters may also be used to connect the INFINITY OCT System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert and VERTEX® Reconstruction System package insert for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK® at each level in which the 3.0mm screw is intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

The INFINITY™ OCT System is a posterior occipitocervical-upper thoracic system. The system consists of a variety of shapes and sizes of plates, rods, hooks, set screws, multiaxial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Per this 510(k) submission, Medtronic is seeking the clearance of new non-sterile multiaxial screws (MAS), axial dominos, and MAS extension connector that will be part of the INFINITY TM OCT System. These devices are identical in design and material to those cleared in K163375 (S.E. 08/21/2017) and there is only a change in sterility.

The provided text from the FDA 510(k) K223764 does not describe an AI/ML-driven medical device, nor does it detail acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML algorithm's performance.

Instead, the document pertains to a Class II medical device, the Medtronic INFINITY™ OCT System, which is a posterior occipitocervical-upper thoracic system used for spinal immobilization and stabilization. The 510(k) submission is for the clearance of new non-sterile multiaxial screws (MAS), axial dominos, and MAS extension connector that are part of this system. The key aspect of this submission is that these new components are identical in design and material to previously cleared components (K163375) and the only change is sterility.

Therefore, the document explicitly states:

• "These devices are identical in design and material to those cleared in K163375 (S.E. 08/21/2017) and there is only a change in sterility." (Page 4)
• "The subject devices do not represent a new worst-case and the testing for the predicate devices is deemed applicable for the subject devices. The sterilization justification for the predicate devices adopts the subject devices into existing steam validation documents. The subject devices and the predicate devices have identical designs, materials, and manufacturing processes. Therefore, no additional bench performance testing is needed." (Page 6)

Given this, the document does not contain the information required to answer the prompt's specific questions regarding acceptance criteria and a study proving device performance in the context of AI/ML (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance). The "study" described (or rather, the justification for no new study) is simply the assertion of substantial equivalence based on identical design, material, and manufacturing process with the predicate device, with only a change in sterilization.

Thus, I cannot populate the requested table or answer the specific questions about AI/ML study methodologies based on the provided text. The document clearly indicates that no new performance data was required because the new components are essentially the same as previously cleared ones, differing only in sterilization.

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The Infinity™ OCT 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 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, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT Rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and VertexTM Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert and Vertex™ Reconstruction System package insert for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) reguires the use of MAS Crosslink™ at each level in which the 3.0mm screw is intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offiset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

The PASS OCT spinal 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 from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical 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 PASS OCT spinal 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 PASS OCT spinal system may be connected to the PASS LP spinal system with the dual diameter rods. Refer to the PASS LP spinal system package insert for a list of the PASS LP spinal system indications of use.

The Infinity™ OCT System and PASS OCT Spinal System (including UNID™ OCT Patient-Specific Rods) are posterior systems, which consist of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations.

The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, Cobalt-chromium molybdenum alloy Co-Cr28Mo6 according to ISO 5832-12 and ASTM F1537.

The purpose of this submission is to add titanium alloy and cobalt chrome 3.5/4.75 mm transition rods to the line of UNID™ OCT Patient-Specific Rods. The subject rods are designed and manufactured for one specific patient and are compatible with Infinity™ OCT System and PASS OCT Spinal Systems (cranially) and the CD Horizon Spinal System (caudally). The UNID™ OCT Patient-Specific Rods must be used during surgery for this patient only and must not be reused (single use only).

This document describes a spinal system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for AI/ML models is not applicable and cannot be extracted from the provided text.

The document pertains to the 510(k) premarket notification for the "Infinity™ OCT System and PASS OCT Spinal System," which are posterior cervical screw systems intended to provide immobilization of spinal segments. The purpose of the specific submission is to add titanium alloy and cobalt chrome 3.5/4.75 mm transition rods to the line of UNiD™ OCT Patient-Specific Rods.

The "Performance Data (Non-Clinical Test Summary)" section mentions that "Medicrea has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices." The tests performed were "static and dynamic compression bending, and static torsion" per ASTM F1717, to confirm the compatibility of the caudal 4.75 mm portion of the subject rods with the CD Horizon Spinal System. This describes mechanical testing of a medical device, not a study of an AI/ML algorithm.

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The Infinity™ OCT 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 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, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
  The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
  The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and Vertex™ Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert, Vertex™ Reconstruction System and PASS OCT Spinal System package insert for a list of the indications of use.
  Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is intended to be used.
  The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.
  Note: Segmental fixation is recommended for these constructs.

The PASS OCT® Spinal 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 from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical 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 PASS OCT® Spinal 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 PASS OCT® Spinal System may be linked to the PASS LP® Spinal System using the dual diameter rods or specific connecting components.
The PASS OCT® Patient Specific Rod is to be implanted either with PASS OCT® Spinal System or with Infinity (1) OCT Spinal System.

The purpose of this submission is to expand the use of previously cleared Infinity™ OCT System with previously cleared PASS OCT® Patient Specific UNiD OCT Rods.
The Infinity™ OCT System is a posterior occipitocervical-upper thoracic system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case.
The Infinity™ OCT System is fabricated from medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together.
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 connection components, which can be rigidly locked to the rod in a variety of configurations.
The implants are manufactured in titanium alloy Ti-6A1-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, Grade Titanium conforming to ASTM F67 and ISO 5832-2, Cobalt-chromium molybdenum alloy Co-Cr28Mo6 according to ISO 5832-12 and ASTM F1537 and in PEEK OPTIMA LT1 conforming to ASTM F2026 specifications.
The PASS OCT® Patient Specific Rod has been designed and manufactured for one specific patient. The PASS OCT® Patient Specific Rod should be used during surgery for this patient only and should not be reused (single use only).

The provided text describes a 510(k) submission for the Medtronic Infinity™ OCT System and PASS OCT® Spinal System, specifically for an expansion of use involving Patient Specific UNiD OCT Rods. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria for performance in terms of diagnostic accuracy or a similar measure, as would be the case for an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training and test sets), is not applicable to this type of regulatory submission (a 510(k) for a spinal implant system).

A 510(k) submission for a traditional medical device like a spinal implant typically relies on:

1. Bench Testing: Mechanical and material testing to ensure the device meets predefined mechanical properties and safety standards (e.g., strength, fatigue, corrosion resistance).
2. Biocompatibility Testing: To ensure the materials are safe for human implantation.
3. Comparison to Predicate Devices: Demonstrating that the new device has similar technological characteristics and performs as safely and effectively as a legally marketed predicate device.

In this specific case, the "performance data" section (VI) states:

• "Rationales were provided confirming that the use of the PASS OCT® System Patient Specific UNiD OCT Rods did not introduce a new worst case when used with the Infinity™ OCT System."
• "However, confirmatory testing (static and dynamic compression bending and static and dynamic torsion per ASTM F1717) performed met the pre-determined acceptance criteria."

This indicates that the "acceptance criteria" here refer to the mechanical performance standards for spinal implants, as defined by industry standards like ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model). The study conducted was a bench test to confirm that the mechanical properties of the combined system (Infinity™ OCT System with Patient Specific UNiD OCT Rods) meet these engineering standards.

Therefore, I cannot extract the information asked for in the prompt (related to AI/ML device performance study) from this document. The document does not describe an AI/ML device or a study involving human readers, expert consensus for imaging interpretation, or similar elements.

If you would like me to discuss the "acceptance criteria" and "study" in the context of a traditional medical device 510(k) submission based on mechanical testing, please let me know.

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The INFINITY™ OCT 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 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, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The INFINITY™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time 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 INFINITY™ OCT System may be connected to the CD HORIZON® Spinal System and VERTEX Reconstruction System rods with the INFINITY™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the INFINITY™ OCT System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert and VERTEX Reconstruction System package insert for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK® at each level in which the 3.0mm screw is intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

The INFINITY™ OCT System is a posterior occipitocervical-upper thoracic system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case.

The INFINITY™ OCT System is fabricated from medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together.

The sole purpose for this traditional 510(k) is to seek clearance for the INFINTIY OCT System.

This document is a 510(k) Pre-market Notification for the INFINITY™ OCT System. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical context with performance metrics like accuracy, sensitivity, or specificity.

Therefore, much of the requested information about acceptance criteria for device performance in terms of diagnostic effectiveness or AI model performance, and the details of such a study, cannot be extracted from this document, as it describes a mechanical spinal implant system, not a diagnostic or AI-driven device.

However, I can extract information related to the non-clinical (mechanical) testing performed to demonstrate substantial equivalence.

Here's the information that can be extracted from the provided text, primarily related to the mechanical performance of the INFINITY™ OCT System:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Mechanical Testing: Not explicitly stated beyond "worst case construct testing." The number of constructs tested or the specific types of components within those constructs are not detailed.
• Non-Pyrogenicity Endotoxin Testing: "utilizing worst case subject implants." The specific number is not provided.
• Data Provenance: The tests were conducted internally by Medtronic, likely in a laboratory setting, to evaluate the mechanical properties and biocompatibility of the device components.

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 the studies described are non-clinical mechanical and biological compatibility tests, not studies requiring expert interpretation of clinical data or imaging.

4. Adjudication method for the test set:

• Not applicable for mechanical and biological compatibility tests. Results are quantitative measurements against established standards.

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 document pertains to a mechanical spinal implant system, not an AI-assisted diagnostic or imaging interpretation device.

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

• Not applicable. This is not an algorithmic device.

7. The type of ground truth used:

• Mechanical Testing: The "ground truth" is defined by the performance requirements and methodologies outlined in accepted ASTM standards (ASTM F1717 and ASTM F2706) for spinal implant constructs. The device's performance is compared against these engineering specifications and the performance of predicate devices.
• Non-Pyrogenicity Endotoxin Testing: The "ground truth" is the established limit of 20 EU/device for bacterial endotoxins in medical devices, as specified by ANSI/AAMI ST72 and USP .

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable. This is not a machine learning or AI device.

Summary of what the document does provide regarding "proof":

The document, a 510(k) summary, demonstrates substantial equivalence to existing legally marketed spinal systems. The "study" described is a series of non-clinical, laboratory-based mechanical and biocompatibility tests. These tests were conducted to show that the INFINITY™ OCT System performs comparably to its predicate devices and meets established industry standards for safety and mechanical integrity. The "acceptance criteria" here are compliance with these standards (ASTM and ANSI/AAMI/USP for pyrogenicity).

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