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The Momentum Posterior Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

When used in conjunction with G21 V-Steady Bone Cement, the Momentum Posterior Spinal Fixation 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum™ Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.

In order to achieve additional levels of fixation, the Momentum Posterior Spinal Fixation System can also be connected to the Cortium® Universal OCT Spinal Fixation System or neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the Cortium or neon3 Instructions for Use for a list of indications for use.

The Momentum® Posterior Spinal Fixation System is a standard pedicle screw and rod systems designed for fixation and correction in the thoracolumbar and sacroiliac spine. This 510(k) submission adds hooks, various connectors, and monoaxial screws to the previously cleared system from K231809 and K191932.

The subject hooks are intended to provide deformity correction according to patient anatomical needs. The subject connectors are intended to provide additional options to improve stability. The subject monoaxial fenestrated screws are identical below the tulip to the previously cleared fenestrated screws with the addition of the option to use G21 V-Steady bone cement. The Momentum® Posterior Spinal Fixation System is manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3 and cobalt chromium Co-Cr-28Mo per ASTM F1537 and ISO 5832-12.

This document is a 510(k) premarket notification decision letter for a medical device called the "Momentum® Posterior Spinal Fixation System." It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The letter simply states that the FDA has reviewed the submission and determined the device to be "substantially equivalent" to legally marketed predicate devices. This determination is based on a comparison of the device's indications for use, technological characteristics, and performance data (mechanical strength testing results) to existing predicate devices.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study data for an AI/ML powered device based solely on the provided text. The document concerns a traditional implantable medical device, not an AI/ML product.

To reiterate, the provided text does not contain any of the following information:

1. A table of acceptance criteria and the reported device performance: Not applicable, as this is not an AI/ML device with performance metrics like sensitivity, specificity, etc.
2. Sample sizes used for the test set and the data provenance: Not applicable for an AI/ML model. The "test set" here refers to mechanical testing of physical components, not a data-driven model.
3. Number of experts used to establish the ground truth...: Not applicable, as ground truth is not established in the context of an AI/ML model for this device.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The performance data mentioned (ASTM F1717 Dynamic Compression Bending) refers to mechanical testing of the spinal fixation system components to ensure their structural integrity and durability, not the performance of an AI/ML algorithm.

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The uCerv Flux ™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion. The hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are additively manufactured interbody fusion devices for cervical implantation. The implants are designed having porous surfaces to provide surgical stabilization of the spine. Each interbody has a central cavity that can be packed with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material and lateral windows for radiographic visualization. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.

The provided FDA document is a 510(k) clearance letter for a medical device, not a study evaluating an AI algorithm's performance. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI algorithms is not present in this document.

The document describes the uCerv Flux™-C 3D Porous Titanium Cervical Interbody, an intervertebral body fusion device. The acceptance criteria and "study" described relate to the mechanical performance of this physical device, not a digital diagnostic or AI-driven system.

Here's the relevant information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Explanation: The document states that "Mechanical testing of the worst case Flux-C devices was relied upon in support of the original uCerv Flux™-C 3D Porous Titanium Cervical Interbody clearance. The testing included static and dynamic axial compression and static torsion according to ASTM F2077 and subsidence according to ASTM F2267. An engineering rationale was used to demonstrate that the additional cervical interbody sizes did not introduce a new worst case." It further mentions, "Mechanical testing of the worst case subject uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants included dynamic torsion according to ASTM F2077 and expulsion tests. The mechanical test results demonstrate that the uCerv Flux™-C 3D Porous Titanium Cervical Interbody performance is substantially equivalent to the predicate devices." The acceptance criteria are implicit in meeting the standards (ASTM F2077, ASTM F2267) and demonstrating substantial equivalence to predicate devices. Specific numerical thresholds for acceptance are not provided in this summary.

Regarding the remaining points (2-9), the provided document does not contain information about an AI algorithm or a study involving human readers, so these points cannot be addressed. The document is for a physical orthopedic implant.

Here's why the other points are not applicable:

• 2. Sample size used for the test set and the data provenance: Not applicable. This document is about a physical device's mechanical performance, not an AI test set with data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI test set is mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for an AI algorithm is mentioned.
• 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. No AI assistance or human reader study is discussed.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for the device is its mechanical integrity and performance as per ASTM standards, compared to predicate devices.
• 8. The sample size for the training set: Not applicable. No AI training set is mentioned.
• 9. How the ground truth for the training set was established: Not applicable. No AI training set is mentioned.

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The uNion MAX Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

uNion MAX is an anterior cervical plate and screw system used to provide mechanical support across implanted level(s) in the cervical spine until fusion is achieved. The components include Ø4.0mm and Ø4.5mm fixed and variable screws having self-tapping, self-drilling or self-drilling/self-tapping tips and one- through four-level plates having lengths from 8mm to 84mm. The plates incorporate a pivoting locking mechanism which functions to block screw backout. The devices are sold non-sterile.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the uNion® MAX Cervical Plate System. It describes the device and its intended use, and importantly, declares that the device is "substantially equivalent" to legally marketed predicate devices based on performance data.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance. This document pertains to the regulatory clearance of a physical medical implant, not a software or AI-driven diagnostic or treatment device.

Therefore, I cannot provide the requested information. The concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "experts to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set" as typically applied to AI/ML devices, are not applicable to this document.

The "Performance Data" section in the 510(k) summary refers to "ASTM F1717 mechanical testing of the worst case uNion MAX constructs included static and dynamic compression bending and static torsion." This testing is for the mechanical properties of the cervical plate system itself, ensuring its structural integrity and safety. It tests the physical attributes of the device, not its analytical or interpretive capabilities.

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The Momentum® Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

When used in conjunction with G21 V-Steady Bone Cement, the Momentum Posterior Spinal Fixation 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.

In order to achieve additional levels of fixation the Momentum Posterior System can also be connected to the neon38 universal OCT spinal stabilization system via transition rods or connectors. Please refer to the neon3 Instructions for Use for a list of indications for use.

The Momentum® MIS Posterior System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum MS is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

When used in conjunction with G21 V-Steady Bone Cement, the Momentum MIS Posterior 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum MIS Posterior System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.

The Momentum® Posterior Spinal Fixation System, and Momentum® MIS Posterior Spinal Fixation System are standard pedicle screw and rod systems designed for fixation in the thoracolumbar and sacroiliac spine. There have been no major changes to the device since K191932, and K223274, respectively. The subject devices are identical to the previously cleared versions with the addition of the option to use bone cement (G21 V-Steady) with the fenestrated screws.

G21 V-Steady Bone Cement consists of a liquid and powder component. The powder component is constituted of PMMA beads shaped particles containing the initiator benzoy1 peroxide required for starting to initiate the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization). The liquid component comprises the monomer, methylmemethylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage. V-STEADY bone cement has an immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time.

While the provided text describes the regulatory clearance of a medical device (Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement), it does not contain any information regarding acceptance criteria, performance studies (other than "bone cement usability testing and screw removal testing"), or detailed clinical data typically associated with AI/ML device evaluations.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and non-clinical performance (material composition, manufacturing, basic mechanical testing). It is not a clinical study report for an AI/ML diagnostic or prognostic tool.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, specifically regarding:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document states "bone cement usability testing and screw removal testing was conducted to validate the use," but no specific metrics or acceptance criteria are given.
2. Sample sized used for the test set and the data provenance: Not applicable to the type of testing described (usability and screw removal, likely biomechanical or benchtop).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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, as this is a physical medical device, not an AI/ML-driven diagnostic tool.
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 concensus, pathology, outcomes data, etc): Not clearly defined for the "usability" and "screw removal" tests, but would likely refer to engineering specifications or validated test methods.
8. The sample size for the training set: Not applicable (no AI/ML training set).
9. How the ground truth for the training set was established: Not applicable (no AI/ML training set).

In summary, the provided document is a regulatory submission for a physical medical device (spinal fixation system with bone cement) and does not contain the characteristics of an AI/ML device study that your questions refer to.

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Cortium is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fraumatic 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.

Cortium 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, Cortium can also be connected to Momentum via transition rods or connectors. Please refer to the Momentum Instructions for Use for a list of indications for use.

The Cortium system is a posterior occipital-cervical-thoracic (OCT) spinal fixation system. The system components include longitudinal rods, screw anchors, and interconnecting devices such as anchor-to-rod and rod-to-rod connectors, rod-to-rod crosslinks and screw-to-screw crosslinks.

I am sorry, but based on the provided text, there is no information about an AI/ML-driven device, its acceptance criteria, or a study proving that it meets those criteria.

The document is a 510(k) premarket notification for a medical device called "Cortium™," which is a Posterior Cervical Screw System (an orthopedic implant). The performance data section refers to mechanical testing of the implant's constructs, not a study of an AI/ML algorithm.

Therefore, I cannot fulfill your request for information regarding AI acceptance criteria and a corresponding study from this text.

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The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are additively manufactured interbody fusion devices for cervical implantation. The implants are designed having porous surfaces to provide surgical stabilization of the spine. Each interbody has a central cavity that can be packed with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material and lateral windows for radiographic visualization. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.

The given text describes a medical device, the uCerv Flux™-C 3D Porous Titanium Cervical Interbody, and its 510(k) premarket notification to the FDA. The document focuses on establishing substantial equivalence to a predicate device through performance testing. However, it does not contain information related to acceptance criteria or studies involving AI or human-in-the-loop performance.

Therefore, for the information requested regarding acceptance criteria, AI studies, human experts, and ground truth for AI model development, I must state that this information is not present in the provided document.

The document details mechanical testing for the interbody device to demonstrate substantial equivalence to predicate devices, but this is a different type of evaluation than what is asked for in the prompt.

Here's a breakdown of what is available in the document related to performance, even though it's not about AI:

1. A table of acceptance criteria and the reported device performance

The document states that the performance data for the uCerv Flux™-C 3D Porous Titanium Cervical Interbody included:

• Static and dynamic axial compression according to ASTM F2077.
• Static and dynamic torsion according to ASTM F2077.
• Subsidence according to ASTM F2267.
• Expulsion tests.

The reported performance is that "The mechanical test results demonstrate that the uCerv Flux™-C 3D Porous Titanium Cervical Interbody performance is substantially equivalent to the predicate devices."

However, specific numerical acceptance criteria (e.g., "must withstand X N of force") and detailed numerical results are NOT provided in the text. It only states the tests performed and the conclusion of substantial equivalence.

2. Sample sized used for the test set and the data provenance

Not applicable, as the evaluation is mechanical testing of physical device units, not a dataset for an AI model. The document does not specify the number of devices tested in the mechanical studies.

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

Not applicable, as the evaluation is mechanical testing, not expert-based assessment.

4. Adjudication method for the test set

Not applicable, as the evaluation is mechanical testing, not a read study requiring adjudication.

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, this type of study was not done or mentioned. The device is a cervical interbody fusion device, not an AI diagnostic tool.

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

No, this is not an AI algorithm.

7. The type of ground truth used

For the mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices. The document implies compliance with ASTM standards, which provide established methodologies and expected performance ranges for such devices.

8. The sample size for the training set

Not applicable, as there is no mention of an AI training set.

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

Not applicable, as there is no mention of an AI training set.

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The Navigation Module of the Momentum System is intended to be used during the preparation and placement of Momentum Posterior Spinal Fixation System screws during spinal surgery, to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigation Module of the Momentum System is designed for use with the Medtronic SteathStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Navigation Module of the Momentum System contains non-sterile, reusable manual instruments including taps and screwdrivers. The instruments are designed for use with the Medtronic StealthStation System for implantation of the Momentum Posterior Spinal Fixation System components.

Here's a breakdown of the acceptance criteria and study information for the "Navigation Module of the Momentum System" as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document states that the device performance was "substantially equivalent" to predicate devices, but it does not provide specific numerical acceptance criteria or performance metrics for navigation accuracy, registration, rigidity, or simulated surgery. It only confirms that these validations were performed and met the equivalency standard.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It refers to "side-by-side testing" but gives no further details on the methodology or data characteristics.

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

The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method

The document does not specify an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that an MRMC comparative effectiveness study was done, nor does it mention any effect size for human reader improvement with or without AI assistance. The device in question is a navigation system accessory, not an AI-based diagnostic tool for interpretation.

6. Standalone (Algorithm Only) Performance Study

The document does not discuss standalone performance of an algorithm. The device is a "Navigation Module" and instruments designed for use with an existing navigation system (Medtronic StealthStation System), implying it's an integrated component rather than a standalone algorithm.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, given it's a navigation system for spinal surgery, the typical ground truth in such studies would involve highly accurate measurements (e.g., using a coordinate measuring machine or high-resolution imaging) to verify the accuracy of instrument tip localization.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. This type of medical device (navigation instrument) typically undergoes engineering verification and validation rather than machine learning model training.

9. How Ground Truth for the Training Set Was Established

The document does not describe how ground truth for a training set was established, as it pertains to a hardware device validation rather than a machine learning application that would require a training set.

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The Momentum™ Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

In order to achieve additional levels of fixation, the Momentum Posterior System can also be connected to the neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the neon3 Instructions for Use for a list of indications for use.

The Momentum™ Posterior Spinal Fixation System consists of longitudinal members (rods), anchors (screws), connectors (rod/rod and rod/anchor) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

This document is a 510(k) summary for the Momentum™ Posterior Spinal Fixation System. It describes the device, its intended use, and its substantial equivalence to predicate devices, primarily based on mechanical testing. It does not describe an AI/ML-based medical device. Therefore, the questions related to acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, ground truth, expert involvement, and sample sizes for AI model training/testing, are not applicable to the provided document.

The document focuses on the mechanical performance of a spinal fixation system. Below is the relevant information from the document related to its performance as a physical medical device, structured as closely as possible to the request, while noting the non-applicability of AI/ML specific criteria.

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document mentions "Mechanical testing of worst case Momentum™ System constructs." However, it does not specify the sample size (number of constructs tested) used for these mechanical tests.
• Data Provenance: Not specified, but generally, mechanical testing for medical devices is conducted in a laboratory setting, not typically described by country of origin or retrospective/prospective data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This question is not applicable as the device is a mechanical spinal fixation system, not an AI/ML diagnostic or prognostic tool. "Ground truth" in this context would refer to the physical and mechanical properties measured in a lab, not expert interpretations of medical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This question is not applicable. Mechanical testing typically involves predefined test methods and measurements, not adjudication by human experts.

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

• This question is not applicable as the device is a mechanical spinal fixation system and does not involve human readers or AI assistance.

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

• This question is not applicable as the device is a mechanical spinal fixation system and does not involve algorithms or AI.

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

• The "ground truth" for this device would be its measured mechanical properties (e.g., strength, stiffness, resistance to pull-off) determined experimentally and compared against established industry standards (ASTM F1717) and the performance of predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the medical sense.

8. The sample size for the training set

• This question is not applicable as the device is a mechanical spinal fixation system and does not involve AI/ML models with training sets.

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

• This question is not applicable for the same reason mentioned in point 8.

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The Solidity™ Vertebral Body Replacement is intended for use during open surgical procedures in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Solidity™ is intended to be used with supplemental spinal fixation. The use of bone grafting material with the Solidity™ is optional.

The Solidity™ Vertebral Body Replacement is a system of corpectomy devices used to provide mechanical support to the thoracolumbar spine. The Solidity™ Vertebral Body Replacement components include a cylindrical center piece and end caps. The center piece provides the capability for device expansion. End caps provide the anatomical footprint for the device. The components are offered in expansions, angle, footprint combinations to accommodate varying patient anatomy.

This document is a 510(k) summary for the Solidity™ Vertebral Body Replacement device, which is a medical device for spinal intervertebral body fixation. This type of device does not typically involve AI/ML components, and therefore the concepts of "acceptance criteria for device performance" in the context of AI models, "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set size," and "ground truth establishment for training set" are not applicable to the information provided in this document.

The document discusses the regulatory compliance and mechanical performance of the device, which are different types of acceptance criteria than those for AI/ML performance.

Here's an analysis of the provided text based on the request, reinterpreting "acceptance criteria" and "device performance" in the context of a non-AI medical device:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is not an AI/ML device study. The provided document details mechanical testing of physical devices. The "test set" here refers to the actual physical devices subjected to mechanical tests. The document does not specify a "sample size" in terms of number of devices tested, other than referring to "worst case Solidity™ devices." Data provenance (country of origin, retrospective/prospective) is also not applicable in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. For mechanical testing of a medical device, "ground truth" is established by physical measurement against engineering standards (like ASTM F2077), not by expert consensus on data interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are relevant for subjective data interpretation, which is not the case for mechanical testing of a physical device.

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

This information is not applicable. This is a physical medical device, not an AI/ML system. Therefore, no MRMC study involving human readers and AI assistance would have been conducted or reported here.

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

This information is not applicable. This describes a physical medical device, not an algorithm.

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

The "ground truth" for the device's mechanical performance is based on established engineering standards and material specifications (e.g., ASTM F2077 for mechanical properties, ASTM F136 for material composition). For substantial equivalence, the "ground truth" refers to the characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not an AI/ML system. There is no "training set."

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

This information is not applicable. There is no "training set" for this type of device.

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