ANAX™ OCT Spinal 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; 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. ANAX™ 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, ANAX™ OCT Spinal System may be connected to Perfix™ Spinal System and ANAX™ 5.5 Spinal System rods with the rod connectors. Transition rods with differing diameters may also be used to connect ANAX™ OCT Spinal System to Perfix™ Spinal System and ANAX™ 5.5 Spinal System.

The ANAX™ OCT Spinal System is for fixation the cervicocranium (Occiput/C2), the true subaxial region (C3/C6), and the cervicothoracic junction (C7 to T2) by one system. The ANAX™ OCT Spinal System consists of polyaxial screws, polyaxial shank screws, hooks, rods, set screws, transverse (cross) links and occipital plate. Connectors are also provided for surgical convenience. The ANAX™ OCT Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The single-use ANAX™ OCT Spinal System components are supplied as non-sterile and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). All polyaxial screws have self-tapping functions in the ANAX™ OCT Spinal System.

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the ANAX™ OCT Spinal System implants.

The provided FDA 510(k) Clearance Letter for the ANAX™ OCT Spinal System does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. This is a common pathway for medical device clearance, where the new device is shown to be as safe and effective as a legally marketed device that does not require Pre-Market Approval (PMA).

Here's an analysis based on the information provided, highlighting why certain questions cannot be answered from this document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are implicitly related to demonstrating that the new CoCr rods perform at least as well as, or better than, the existing titanium rods in terms of mechanical properties and do not alter the overall system's safety or intended function. The FDA's acceptance of the 510(k) implies that these criteria were met.

Regarding the specific study details for AI/software-based devices, the following cannot be answered from this document because the ANAX™ OCT Spinal System is a physical implantable medical device, not an AI or software device.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical components is typically derived from engineering specifications and material science, not expert consensus in the diagnostic sense.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, "ground truth" relates to material properties (e.g., tensile strength, yield strength), dimensional accuracy, and mechanical performance under simulated physiological loads, established by engineering standards (e.g., ASTM F136, F1537, F1717, F1798).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: Physical implantable spinal fixation system (ANAX™ OCT Spinal System).
• Modification: Addition of cobalt-chromium-molybdenum (CoCr) rods.
• Mechanism of Proof: Substantial equivalence to predicate devices.
• Key Evidence for Substantial Equivalence:
  • Indications for Use: Identical to predicate devices.
  • Design & Components: Equivalent overall construct, dimensions, and components, with the only change being rod material.
  • Material Properties: CoCr rods demonstrate higher tensile and yield strength than the previously cleared titanium (Ti) rods.
  • Manufacturing: CoCr rods are manufactured and processed using the same methods and surface treatments as the Ti rods.
  • Performance Testing: Comprehensive mechanical testing (e.g., ASTM F1717, F1798) was conducted, including a worst-case configuration.
  • Failure Analysis: All observed failure modes occurred at the screw-housing interface, not within the rod itself, suggesting the rods are sufficiently strong.
• Conclusion of Study: The mechanical integrity of the CoCr rods was confirmed, and the comparative material analysis showed comparable or superior performance, leading to the conclusion that the addition of CoCr rods does not raise new questions of safety or effectiveness.

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The Sovereign Posterior Cervical 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 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. pseudoarthrosis); 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 Sovereign Posterior Cervical 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 Sovereign Posterior Cervical System may be connected to the Xultan 5.5 system using rod-to-rod connectors or transition rods. Please refer to the individual system's Instructions for Use for a list of indications for use for each system.

The Met One Technologies Sovereign Posterior Cervical System is an implant device designed for the posterior stabilization of the cervical and upper thoracic spine. The system includes implants such as polyaxial screws, blocker screws, rods, crosslinks, lateral connectors, and rod to rod connectors to form a unique construct to match patient anatomy.

Polyaxial screws are offered in a range of sizes in both standard and reduction tulips for ease of use. All screws are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

Straight, pre-bent, and transition rods are offered in 3.5mm and 4.0mm diameters and in two different materials, titanium alloy (Ti-6Al-4V ELI per ASTM F136) and cobalt chrome (Co-Cr28-Mo6 per ASTM F1537). Transition rods are fully compatible with Met One Technologies Xultan 5.5 Pedicle Screw System line of implants.

A variety of connectors and crosslinks are offered for surgeons to create the desired construction. Rod to rod crosslinks improve the torsional stability of the construct. Lateral connectors are provided in open and closed configurations, 3.5mm and 4.0mm diameters, and in long and short lengths. Rod to rod connectors are offered in several configurations to join rods together. All connectors are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

I am sorry, but the provided text is an FDA 510(k) clearance letter for a Sovereign Posterior Cervical System, which is a physical medical device (spinal implant system), not an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain any information about:

• Acceptance criteria for an AI/SaMD's performance.
• A study proving the device meets AI/SaMD acceptance criteria.
• A test set (sample size, provenance).
• Experts establishing ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth.
• Training set details.

The non-clinical testing described (ASTM F1717 and ASTM F1798) refers to mechanical testing of the physical implant's strength and durability, not software performance.

As such, I cannot fulfill your request for information related to AI/SaMD acceptance criteria and study details based on the provided input.

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The Signature Orthopaedics Freedom Cervical Screw and Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (C1 to C7) as an adjunct to fusion in the treatment of the following acute and chronic instabilities and deformities of the cervical spine:

• traumatic spinal fractures and/or traumatic dislocations
• instability or deformity; failed previous fusions (e.g. pseudarthrosis)
• degenerative disease, including neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability, and
• short term stabilization 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 expectancy is of insufficient duration to permit achievement of fusion.

The Freedom™ Posterior Cervical Screw System consists of screws, longitudinal rods and cross connectors in a variety of sizes to accommodate differing anatomic requirements. The cervical screws are inserted into adjacent vertebrae, then rods are clamped into the tulip of the pedicle screw using the cap screw, thus immobilising the instrumented vertebrae. The cross-connector may then be attached between rods to improve stability. The system components are made of Ti6Al4V alloy and are supplied sterile.

The provided FDA 510(k) clearance letter pertains to the Freedom Posterior Cervical Screws, which is a medical device and not an AI/ML-driven software system. As such, the information you've requested regarding acceptance criteria, study details, sample sizes, ground truth, and human reader performance is not applicable to this type of device submission.

The FDA clearance for this device is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing and engineering evaluations. These tests focus on the physical and mechanical properties of the screws to ensure they are safe and effective for their intended use as a spinal implant.

Here's a breakdown of the relevant information provided in the document concerning the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states that "worst-case sizes of the subject cervical screws" were tested.
• Sample size: Not explicitly quantified with a specific number of units, but implied it was a representative selection of "worst-case sizes."
• Data provenance: The tests were "non-clinical testing and engineering evaluations" conducted by the manufacturer, Signature Orthopaedics Pty Ltd, in Australia. This is a form of prospective testing done specifically for regulatory submission.

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

• Not applicable. This is a hardware device where "ground truth" is established through engineering principles and physical testing against established ASTM standards, not through expert human interpretation or diagnosis.

4. Adjudication method for the test set:

• Not applicable. This involves objective mechanical testing, where results are measured directly against predefined acceptance criteria from engineering standards. There is no subjective adjudication process for establishing a "ground truth" as would be the case for image interpretation or diagnostic performance.

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 device is a surgical implant, not an AI-assisted diagnostic tool. Therefore, no MRMC studies or human reader performance evaluations were conducted or are relevant.

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

• Not applicable. This is a physical product, not a software algorithm.

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

• The "ground truth" for this device's performance is derived from established mechanical and material engineering standards (ASTM standards). The device's components must meet or exceed the performance specifications (e.g., strength, fatigue resistance) outlined in these standards to be deemed safe and effective for their intended surgical purpose.

8. The sample size for the training set:

• Not applicable. This refers to a dataset used to train an AI model. This device is hardware and does not involve a training set.

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

• Not applicable. As above, there is no training set for this type of medical device submission.

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The Virage® OCT Spinal Fixation 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-C7) and the thoracic spine from T1-T3; traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); 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 Virage® OCT Spinal Fixation 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 advance 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 Virage® OCT Spinal Fixation System may be connected to the Vital Spinal Fixation System offered by Highridge Medical, using rod connectors and transition rods. Refer to the Vital Spinal Fixation System package insert for a list of the system specific indications of use. The Vital/Vitality Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).

The Virage® OCT Spinal Fixation System is a posterior fixation system intended to provide immobilization and stabilization of the Occipital-Cervical-Thoracic spine (Occiput-T3). The system consists of a variety of rods, anchors, connectors, screws, and polyaxial screws to achieve an implant construct as necessary for the individual case. The system also includes the instruments necessary for inserting and securing the implants. The implant system is intended to be removed after solid fusion has occurred.

The Virage® System implants are fabricated from medical grade titanium alloy and medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together.

The provided FDA 510(k) clearance letter for the Virage® OCT Spinal Fixation System focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an Artificial Intelligence (AI)/Machine Learning (ML) device.

Therefore, many of the requested criteria, such as those pertaining to AI model performance (sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance), are not applicable to this submission. This document describes a traditional 510(k) for a spinal fixation system, not an AI/ML diagnostic or therapeutic device.

However, I can extract the information that is relevant and state where the requested information is not applicable based on the provided document.

Analysis of Acceptance Criteria and Device Performance (Based on Provided Document)

The Virage® OCT Spinal Fixation System is a physical medical device (spinal fixation system), not an AI/ML software device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to mechanical testing and usability assessments to demonstrate substantial equivalence to a predicate device, not evaluation of an AI model's diagnostic or predictive performance.

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: Not applicable in the context of an AI/ML test set. The document refers to "worst-case subject connectors" for mechanical testing, implying specific samples of the device components were tested, but not a "test set" of patient data or images.
• Data Provenance: Not applicable. The "data" are mechanical test results, not patient data.

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

• Not Applicable. This is a physical device, not an AI/ML diagnostic tool that requires expert-established ground truth from images or patient data. Ground truth for mechanical testing would be defined by engineering specifications and standard test methods.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are for human expert consensus on medical images or patient outcomes, which is not relevant for mechanical testing of a spinal implant.

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

• No. An MRMC study is used to evaluate the impact of an AI/ML system on human reader performance for tasks like diagnosis or detection. This is a mechanical device, so an MRMC study is not relevant.

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

• Not Applicable. This is a physical spinal implant, not a standalone algorithm.

7. The type of Ground Truth Used

• Mechanical Test Standards and Engineering Specifications: The "ground truth" for this device's performance evaluation is adherence to standardized mechanical testing protocols (ASTM F1717, ASTM F1798) and internal engineering specifications for safety and performance, demonstrating equivalence to the predicate device.
• MRI Compatibility Standards: Compliance with relevant ASTM standards for MRI compatibility (F2052, F2182, F2213, F2119) serves as the ground truth for this aspect.

8. The Sample Size for the Training Set

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

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

• Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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The EUROPA™ Posterior Cervical Fusion 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 cervical spine (C1 to C7) and the upper thoracic spine (T1 to T3):

• · Traumatic spinal fractures and/or traumatic dislocations
• · Instability or deformity
• · Failed previous fusions (e.g. pseudarthrosis)
• · Tumors involving the cervical/thoracic spine
• · Degenerative disease, including intractable radiculopathy and/or myelopathy
• · Neck and/or arm pain of discogenic origin as confirmed by radiographic studies
• · Degenerative disease of the facets with instability

The EUROPA™ Posterior Cervical Fusion System is also intended to restore the intearity 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 EUROPA™ Posterior Cervical Fusion System may be connected to the EUROPA™ Pedicle Screw System via the rod to rod connectors.

The EUROPA™ Posterior Cervical Fusion System is a posterior cervical screw system intended to provide structural stability and mechanical support to the cervical spine following posterior cervical fusion.
The EUROPA™ Posterior Cervical Fusion System consists of rods manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, pedicle screws and connectors manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The EUROPA™ Posterior Cervical Fusion System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements.
The rods are provided sterile packed and are intended for single use only. The pedicle screws and connectors must be steam sterilized prior to use.

The provided text is related to the FDA 510(k) clearance for the EUROPA™ Posterior Cervical Fusion System. It details the device's intended use, indications, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices.

However, the request asks for information about the acceptance criteria and the study that proves an AI/software device meets the acceptance criteria, including details like sample size, ground truth establishment, expert qualifications, and MRMC studies.

The EUROPA™ Posterior Cervical Fusion System is a physical medical device (a posterior cervical screw system), not an AI or software device. The provided document does not contain any information about AI/software performance, nor does it describe studies with human readers, radiologists, or ground truth established by experts for an AI system.

Therefore, I cannot extract the requested information regarding AI/software device acceptance criteria and study details from the provided text. The document focuses on demonstrating the mechanical performance and material equivalence of a physical implant system.

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The CarboClear® Posterior Cervical Screw System is 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 CarboClear® Posterior Cervical Screw System ("CarboClear® System") is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The CarboClear® System is a posterior, cervical screw fixation system, intended to provide immobilization and stabilization of cervical spinal segments in oncological patients.

The CarboClear® System implants include posterior screws, rods and locking elements (set screw). The implants are made mainly of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion and the spherical head of the screw are encased within a thin titanium shell, and may include a tantalum marker.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets acceptance criteria in the context of an AI/ML-driven medical device. The document is a 510(k) clearance letter from the FDA for a CarboClear® Posterior Cervical Screw System, which is a physical implant, not a software or AI/ML device.

The document discusses:

• Device Name: CarboClear® Posterior Cervical Screw System
• Regulation Number: 21 CFR 888.3075 (Posterior Cervical Screw System)
• Regulatory Class: Class II
• Product Code: NKG
• Indications for Use: Restoring spinal column integrity in patients with advanced stage tumors involving the cervical spine for a limited time.
• Device Description: Implants (screws, rods, locking elements) made of carbon fiber-reinforced PEEK, with titanium shells and tantalum markers, and associated instruments.
• Substantial Equivalence: Comparison to predicate devices (Synapse OCT System, Mesa Mini Spinal System, CarboClear® X Pedicle Screw System) based on indications for use, design, materials, technological characteristics, principles of operation, and performance characteristics (static and dynamic tests according to ASTM standards).

There is no mention of an AI/ML component, algorithm performance, ground truth establishment, expert review, or any of the specific criteria related to an AI/ML performance study as requested in your prompt.

Therefore, I cannot extract the information required to populate the table or answer the questions related to acceptance criteria and study proving device meets acceptance criteria for an AI/ML device from this document.

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The QUARTEX® Occipito-Cervico-Thoracic Spinal System implants are 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 (CI-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and 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. These implants 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. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers.

The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

QUARTEX® additional implants include monoaxial, polyaxial, and dual lead polyaxial screws manufactured from titanium alloy; MIS rods manufactured from titanium alloy, stainless steel, and/or cobalt chromium molybdenum; and, associated manual and navigated surgical instruments.

ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be used with ExcelsiusGPS® or ExcelsiusHub® and may be used for a navigated surgical procedure. No changes were made to the ExcelsiusGPS® or ExcelsiusHub® systems with the addition of the subject ExcelsiusGPS® instruments.

The provided text is a US FDA 510(k) K231850 clearance letter for the QUARTEX® Occipito-Cervico-Thoracic Spinal System and ExcelsiusGPS® Instruments. This document primarily focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving performance against acceptance criteria in the context of an AI/medical device standalone or comparative effectiveness study.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not available within the provided text.

The document mentions "Verification and validation testing were conducted to confirm implant placement accuracy with ExcelsiusGPS®" under the "Performance Data" section. However, it does not provide any specifics about these tests, methodologies, acceptance criteria, or the results of these tests.

In summary, the provided document does not contain the information needed to fill out the requested table or answer the detailed questions about the study proving the device meets acceptance criteria.

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MySpine Cervical is intended to be used with any 510(k) cleared, legally marketed, posterior cervical screw system (for its cleared indications for use) and its respective compatible components for cervical posterior spinal fixation procedures intended for fusion. MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating quides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7.

For pedicle diameters equal or less than ø4mm. Medacta provides for the pilot hole preparation into the lateral mass without penetrating the pedicle.

The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical placement of the implants based upon the radiological images of the patients' anatomical landmarks and the selected surgical equipment. These components include patientspecific guides fabricated based on the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Cervical guides are intended for single use only.

MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating guides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7.

The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent the template used to generate the corresponding MySpine Cervical Guide fitting the patient's vertebral anatomy.

The MySpine Cervical Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.

The provided text is a 510(k) summary for the MySpine Cervical Guides. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing an acceptance criteria study. Therefore, much of the requested information about device performance against acceptance criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not present in this document.

However, based on the Performance Data section, we can infer some information about validation and the type of studies conducted.

Here's a breakdown of the available and missing information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The document states that "Design Validation workshops... were conducted... to validate the design and the overall functionality of the subject device as well as to evaluate their accuracy." It also mentions "MySpine Cervical stability assessment to evaluate the stability of the subject lateral mass guides." However, specific numerical acceptance criteria and the corresponding reported performance values from these validation activities are not detailed.

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

This information is not explicitly provided. The document states that "Two validation workshops, one for the unilateral and the other for the mass lateral guides, have been performed." It does not specify the number of cases or subjects included in these workshops, nor the country of origin or whether the data was retrospective or prospective.

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

This information is not explicitly provided. While "Design Validation workshops" imply expert involvement, the number of experts and their qualifications are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This type of study was not explicitly conducted or reported. The document focuses on design validation and stability assessment, not a comparative effectiveness study with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device described is a physical surgical guide generated by software (MySpine software platform). The validation activities mentioned ("Design Validation workshops" and "stability assessment") seem to relate to the physical guides and their interaction (functionality, accuracy, stability), rather than a standalone assessment of the software algorithm's performance independent of the physical guide or human surgeon. So, a standalone algorithm-only performance study in the typical sense of AI algorithms detecting pathologies is not applicable/not reported for this type of device. The accuracy evaluation would likely be for the guide's ability to direct screw placement as planned.

7. The Type of Ground Truth Used

The document mentions that the surgical planning software uses "radiological images of the patients' anatomical landmarks" to create a "3D model of the vertebrae." The guides are "patient-specific guides fabricated based on the surgical plan." The "accuracy" of the guides was evaluated. It is highly probable that the ground truth for evaluating the accuracy of the guides would involve comparing the intended screw placement (from the surgical plan) with the actual placement achieved using the guide, potentially through post-operative imaging or cadaveric studies. However, the exact type of ground truth (e.g., expert consensus on optimal placement, direct measurement from a phantom/cadaver after guide use, pathology) is not explicitly stated.

8. The Sample Size for the Training Set

The document describes the device as a "patient-specific device" generated from a patient's CT scans. It does not mention a "training set" in the context of machine learning or AI models learning from a dataset. The MySpine software platform "allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans." This implies a custom generation for each patient rather than a model trained on a large dataset. Therefore, the concept of a "training set" as typically understood for AI algorithms is not applicable here.

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

As the concept of a "training set" is not applicable, this information is not provided.

Summary of Available Information from the Document:

• Acceptance Criteria & Performance: Not explicitly stated, but "design validation workshops" focused on "overall functionality" and "accuracy," and a "stability assessment" were performed.
• Study Type: Non-clinical studies (design validation workshops, stability assessment). No clinical studies were conducted.
• Sample Size (Test Set): Not specified beyond "Two validation workshops."
• Data Provenance (Test Set): Not specified.
• Experts for Ground Truth: Implied by "validation workshops," but number and qualifications not specified.
• Adjudication Method: Not specified.
• MRMC Study: Not conducted.
• Standalone Performance: Not applicable/not reported in the AI sense; validation likely involved the physical guides' performance.
• Type of Ground Truth: Not explicitly stated, but likely related to comparing planned vs. actual screw placement using the guides.
• Training Set Size: Not applicable.
• Training Set Ground Truth: Not applicable.

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The Statera-C™ Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); 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. It 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 Statera-C™ Spinal System may be connected to the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System using corresponding connectors and/or transition rods.

The Statera-C™ Spinal System is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and upper thoracic spine. The Statera-C™ Spinal System contains rods, polyaxial screws, hooks, set screws, connectors and cross connectors that are made from Titanium alloy and Cobalt Chrome alloy and are available in multiple shapes and sizes. Connecting components can be locked to the rod in various configurations to accommodate individual patient anatomy.

The provided text is related to an FDA 510(k) clearance for a spinal system and does not contain any information about an AI/ML-driven medical device. Therefore, I cannot extract the requested details about acceptance criteria, study performance, sample sizes, ground truth establishment, or expert involvement for an AI medical device from this document.

The document describes the Statera-C™ Spinal System as a physical medical device (rods, screws, hooks, etc.) used for spinal stabilization and fusion, with its performance demonstrated through non-clinical testing according to ASTM F1717 standards (static compression bending, dynamic compression bending, static torsion).

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The Posterior Cervical 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 from T1-T2:

(1)Traumatic spinal fractures and/or traumatic dislocations.

(2)Instability or deformity.

(3)Failed previous fusions (e.g. pseudarthrosis).

(4)Tumors involving the cervical spine.

(5)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 Posterior Cervical Spine System consists of pedicle screws, nut, rods, connectors, hook, transconnectors, laminar hooks, occipital plates and occipital screw.

The implants in Posterior Spine Cervical System is made from Ti-6A1-4V ELI following ASTM F136 or Ti-6Al-4V following ASTM F1472.

The implants are provided as sterile or non-sterile, while the instruments are provided as non-sterile.

The implants are intended for single-use only, while the instruments are reusable.

The provided text is a 510(k) summary for a medical device (Posterior Cervical Spine System) and does not describe acceptance criteria, device performance, or details of a study involving AI or human readers. The document explicitly states:

"No clinical performance data was provided to demonstrate substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample size for testing/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the given input.

The document focuses on demonstrating substantial equivalence through:

• Comparison of Technological Characteristics: Stating similarity in regulatory classification, indications for use, materials, and design features to predicate devices.
• Non-Clinical Performance Data: Referring to biocompatibility testing (in accordance with FDA Guidance "Use of International Standard ISO 10993-1") and mechanical testing (per ASTM F2706-08, ASTM F543-17, and ASTM F1798-13) to ensure the device's physical properties are safe and effective.

No AI-related information or clinical study details are present in this document.

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