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The BALTEUM™ and BALTEUM - ONE™ Lumbar Plate System are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The BALTEUM - ONE™ Lumbar Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the thoracolumbar spine (T1-L5) either through an antero-lateral, or lateral approach and to the lumbar/lumbosacral spine (L1-S1) through an anterior approach. The system includes instrumentation which assists in the surgical implantation of the device.

This document is a 510(k) summary for the BALTEUM - ONE™ Lumbar Plate System. It describes the device, its intended use, and the studies performed to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study results, or information typically found in a clinical study report for evaluating performance in terms of diagnostic accuracy or similar metrics.

It focuses on non-clinical (mechanical) testing to demonstrate substantial equivalence for a medical implant device, not a diagnostic AI device. Therefore, many of the requested categories are not applicable to the information provided.

Here's an breakdown of the available information based on your request:

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

The document does not specify "acceptance criteria" in terms of statistical thresholds for diagnostic accuracy, sensitivity, specificity, etc. for a AI device. Instead, it states that "Non-clinical testing was performed to demonstrate that the subject BALTEUM - ONE™ Lumbar Plate System is substantially equivalent to the predicate device."

The reported performance is that the device "demonstrates that the BALTEUM - ONE™ Lumbar Plate System is substantially equivalent to the legally marketed predicate devices" based on the following tests conducted in accordance with ASTM F1717:

• Static compression
• Dynamic compression
• Static Torsion

A detailed table of acceptance criteria and specific numerical results for these mechanical tests is not provided in this summary. It only states that the device was found substantially equivalent based on these tests.

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 and not provided. The testing described is non-clinical (mechanical) on the device itself, not on patient 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 information is not applicable and not provided, as the study is not related to diagnostic accuracy or interpretation by experts.

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

This information is not applicable and not provided.

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 and not provided. This is a mechanical device, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided.

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

For mechanical testing, the "ground truth" would be established by the physical properties and performance characteristics of the predicate devices under standardized testing conditions (ASTM F1717).

8. The sample size for the training set

This information is not applicable and not provided, as this is not an AI/machine learning study.

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

This information is not applicable and not provided, as this is not an AI/machine learning study.

In summary: This document is a regulatory submission for a physical medical device (spinal implant), not a diagnostic device or an AI product. Therefore, the details requested about acceptance criteria, study design for diagnostic accuracy, expert involvement, and ground truth for AI models are not present. The studies performed were non-clinical mechanical tests to demonstrate that the new device is "substantially equivalent" in its physical performance to already-approved predicate devices.

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The ELLIPSE® Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.

The ELLIPSE® Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.2mm to 6.5mm, including the PROTEX® CT or PROTEX®, REVERE®, or BEACON® Stabilization Systems, using corresponding connectors.

The ELLIPSE® Occipito-Cervico-Thoracic Spinal System consists of 3.5mm jointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, in-line connectors, rodto-rod connectors, rod extension clamps and occipital plates. CAPITOL ™ screws and rods are also available as components of the ELLIPSE® system. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), stainless steel (per ASTM F138) or cobalt chromium molybdenum allov (CoCr) (per ASTM F1537). Due to the risk of galvanic corrosion following implantation. titanium alloy or CoCr implants should not be connected to stainless steel implants.

The provided text describes a 510(k) submission for the ELLIPSE® Occipito-Cervico-Thoracic Spinal System, specifically for additional implants. This document details the device, its intended use, and the performance data that demonstrates its substantial equivalence to predicate devices, rather than a clinical study evaluating the device against specific acceptance criteria for a diagnostic or AI-driven system.

Therefore, many of the requested categories in your prompt are not applicable to this type of medical device submission (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size).

However, I can extract the information relevant to the performance data provided:

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

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

• Sample Size: Not specified in the document. Mechanical testing typically uses predefined samples for each test type, but the exact numbers are not reported here.
• Data Provenance: Not applicable in the context of mechanical testing. The "data" are the results of physical tests conducted on 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 "ground truth" for mechanical performance is established by standardized test methods and physical measurements, not by expert consensus on clinical data.

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

• Not applicable as this is not a diagnostic device relying on expert 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

• Not applicable. This is a spinal implant system, not a diagnostic imaging or AI system intended to assist human readers.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used

• The "ground truth" for mechanical testing is defined by the objective physical measurements obtained from tests conducted according to recognized industry standards (ASTM F1717, ASTM F1798) and FDA guidance for spinal systems.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as Mechanical testing.

• Tests Conducted: Static and dynamic compression bending (in accordance with ASTM F1717), static torsion (in accordance with ASTM F1798), and axial gripping capacity (in accordance with the "Guidance for Industry and FDA Staff. Guidance for Spinal System 510(k)s," May 3, 2004).
• Conclusion: "Performance data demonstrate substantial equivalence to the predicate devices." The document states that the ELLIPSE® Additional Implants "are as safe, as effective, and perform as well as or better than the predicate devices."
• Predicate Devices: ELLIPSE® Occipito-Cervico-Thoracic Spinal System (K090565 & K110963), PROTEX® CT Cervicothoracic Spinal System (K050391 & K081906), REVERE® Stabilization System (K061202 & K122226), Blackstone™ Ascent® Posterior Occipital Cervico-Thoracic System (K080394).

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The Medyssey Co. Ltd. Zenius, Iliad and Kora Spinal Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograff and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Medyssey Co. Ltd., Cannulated Pedicle Screws are intended to be used with their respective (e.g. Zenius) top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Medyssey Co. Ltd., Cannulated Pedicle Screw implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. The Medyssey Co. Ltd., Cannulated Pedicle Screws can be used in the posterior plane providing unilateral and bilateral modes of fixation. The Medyssey Co. Ltd., Cannulated Pedicle Screw Spinal design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a mobile and non-mobile housing component which houses the screw and the rod which accepts a setscrew which tightens against the rod which tightens head of the pedicle screw upon secure tightening interface of the set screw assembly with the rod. The Cobalt Chrome Rods are for use with the Zenius or Iliad System. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Medyssey Co. Ltd. Cannulated Pedicle Screw implants.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medyssey Cannulated Pedicle Screws and Cobalt Chrome Rods:

1. Acceptance Criteria and Reported Device Performance

The provided document describes non-clinical (bench) testing for the Medyssey Cannulated Pedicle Screws and Co-Cr-Mo rods. The acceptance criteria are implicitly defined by the chosen ASTM standard and the comparison to predicate devices, which means the new device must perform at least as well as the legally marketed predicates.

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

• Test Set Sample Size: The document does not specify the exact number of devices (screws/rods) tested for each non-clinical test (static compression, torsion, tension, dynamic compression). Standard test methodologies for medical devices like ASTM F1717-04 typically require a minimum number of samples for statistically valid results, but these specific numbers are not detailed in this summary.
• Data Provenance: The data is from non-clinical (bench) testing performed by Medyssey Co. Ltd. The country of origin of the testing data is not explicitly stated, but Medyssey is a Korean company with a US-based contact for regulatory purposes.

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

This information is not applicable as the study described is non-clinical (bench testing) of physical device properties, not a clinical study involving human patients or expert interpretation of medical data. The "ground truth" here is the measured mechanical performance of the device against established engineering standards and predicate device performance.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is non-clinical (bench testing). Adjudication methods are typically employed in clinical studies or studies involving expert review of medical images/data to resolve discrepancies in interpretation.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (spinal pedicle screws and rods), not an AI/software device. Therefore, there is no mention of human readers or AI assistance.

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

This information is not applicable. The device is a physical implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" used for this non-clinical study is:

• Engineering Standards and Specifications: Adherence to ASTM F1717-04.
• Predicate Device Performance: The mechanical performance of the new device was compared to that of legally marketed predicate devices. The implicit ground truth is that the predicate devices are safe and effective, and therefore, a device demonstrating equivalent or superior mechanical properties would also be considered safe and effective for the stated indications.

8. The Sample Size for the Training Set

This information is not applicable as the study described is non-clinical (bench testing) of a physical device. There is no concept of a "training set" for this type of evaluation.

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

This information is not applicable as there is no training set for this non-clinical study.

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The REVERE® or BEACON™ Stabilization System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the REVERE® or BEACON™ Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as a posterior non-pedicle screw fixation system, the REVERE® or BEACON™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the REVERE® or BEACON™ Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

CoCr Rods consist of 5.5mm and 6.35mm rods manufactured from cobalt chromium molybdenum alloy. REVERE® and BEACON™ Stabilization System implants mate with these 5.5mm and 6.35mm diameter rods. The REVERE® and BEACON™ implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. CoCr Rods are composed of cobalt chromium-molybdenum alloy as specified in F1537.

Here's an analysis of the provided 510(k) summary for the CoCr Rods, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes mechanical testing of the CoCr Rods. For such testing, the "sample size" refers to the number of physical rods and corresponding components subjected to the mechanical tests.

• Sample Size: The document does not explicitly state the number of rods or components used in the compression-bending and torsion tests.
• Data Provenance: The data provenance is pre-clinical mechanical testing, conducted by the manufacturer, Globus Medical Inc. There is no information suggesting external lab testing or geographical origin of the samples beyond the manufacturer's location in Audubon, PA. This is not clinical data from patients.

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

This question is not applicable to this submission. The "ground truth" in this context is established by engineering standards and physical measurements from mechanical stress tests, not by expert clinical consensus. There are no experts involved in establishing a "ground truth" for clinical outcomes in this 510(k) submission.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods are used in clinical studies or expert reviews to resolve discrepancies in observations or diagnoses. Mechanical testing results are objective measurements against predefined engineering 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

This question is not applicable. This 510(k) submission is for a medical device (spinal rods) and not for an AI/CAD (Computer-Aided Detection) system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

This question is not applicable, as this is not an AI/CAD device.

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

The "ground truth" for this device's performance is based on established engineering standards and material specifications.

• For mechanical testing (compression-bending, torsion), the ground truth is defined by the failure criteria outlined in the referenced FDA Guidance document ("Guidance for Spinal System 510(k)s", May 3, 2004), as well as the inherent mechanical properties of the material.
• For material composition, the ground truth is adherence to ASTM F1537 (Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloys for Surgical Implants).

8. The sample size for the training set

This question is not applicable. There is no AI algorithm being trained, so there is no training set.

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

This question is not applicable, as there is no training set.

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The REVERE® Stabilization System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the REVERE® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or illum with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as a posterior non-pedicle screw fixation system, the REVERE® Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the REVERE® Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

The REVERE® Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking caps, t-connectors, offset housing clamps, REVERE® head offset connectors, trans iliac connectors, staples, and associated manual surgical instruments. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. REVERE® implants mate with 5.5mm diameter rods; REVERE® 6.35 implants mate with 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod.and trans iliac connectors.

The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.

The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.

Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae, pedicles, or transverse process of the posterior spine.

T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the t-connectors to the rods. Additional set screws secure the adjustable cross members at the desired length. T-connectors from the PROTEX® system may be used with 6.5mm, 6.0mm or 5.5mm rod systems. REVERE® tconnectors may only be used with 5.5mm rods; REVERE® 6.35 t-connectors may only be used with 6.35mm rods. Additional connectors may be used to connect two rods, and are also secured using set screws.

REVERE® rods are composed of titanium alloy, commercially pure titanium, or stainless steel, as specified in ASTM F136, F1472, F1295, F67, and F138. All other REVERE® implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1472, F1295, and F138. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium or titanium allov implants.

Here's a breakdown of the requested information based on the provided text for the K093294 510(k) summary for REVERE® Additional Implants.

Important Note: This 510(k) summary (K093294) primarily focuses on establishing substantial equivalence to existing predicate devices through mechanical testing. It does not describe a clinical study in the typical sense of evaluating AI performance or human reader effectiveness. Therefore, many of the requested fields related to clinical studies, AI performance, ground truth, and expert evaluation will be marked as "Not Applicable" or "Not Provided" because this type of submission doesn't involve those elements for this device.

Acceptance Criteria and Device Performance

Study Details (as applicable to a 510(k) for a medical device without AI)

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

   • Sample Size for Test Set: Not applicable in the context of a clinical test set for AI. The "test set" here refers to the mechanical testing performed on the device components. The specific number of devices or configurations tested is not provided in this summary but would be detailed in the full 510(k) submission as per the referenced guidance document.
   • Data Provenance: Not applicable in terms of country of origin or retrospective/prospective for a mechanical testing study. The testing would have been conducted by Globus Medical Inc. or a contracted lab.

2. 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):

   • Not applicable. This submission relies on mechanical and material standards, not expert-derived ground truth for clinical outcomes or image interpretation.

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

   • Not applicable. This type of adjudication is for clinical or image interpretation studies, not mechanical testing.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a spinal implant, not an AI-powered diagnostic device.

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

   • No, a standalone algorithm performance study was not done. This is a medical device, not an algorithm.

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

   • For mechanical testing, the "ground truth" is adherence to established engineering standards (e.g., ASTM standards) and meeting predetermined pass/fail criteria derived from these standards and the predicate device's performance. There is no biological "ground truth" involved in the summary provided.

7. The sample size for the training set:

   • Not applicable. There is no AI training set for this device.

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

   • Not applicable. There is no AI training set for this device.

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The TRUSS™ Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or failed previous spine surgery.

The TRUSS™ Thoracolumbar Plate System consists of rigid and compression plates of various lengths that are used with variable or fixed angle bone screws. These plates attach to the anterolateral or lateral portion of the vertebral bodies of the thoracolumbar spine (T1-L5). Implants are composed of titanium allov, as specified in ASTM F136. F1295 and F1472.

The provided text describes a 510(k) summary for the TRUSS™ Thoracolumbar Plate System. It focuses on establishing substantial equivalence to predicate devices through mechanical testing. The document highlights the device's indications for use and its regulatory classification.

However, the provided text does not contain any information regarding clinical studies, acceptance criteria for device performance in a clinical context, or details about the methodological aspects requested such as sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for AI/device performance evaluation.

The "Basis of Substantial Equivalence" section explicitly states: "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." This indicates that the evaluation for this device was primarily based on benchtop mechanical testing to demonstrate performance similar to predicate devices, rather than a clinical study evaluating its performance against specific clinical acceptance criteria.

Therefore, I cannot provide the requested information in the format of the table and detailed points, as the input document does not contain this type of data.

To provide the requested details, a document describing a clinical study or performance evaluation with specific acceptance criteria, test sets, expert reviews, and ground truth methodologies would be necessary.

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The H-LINK™ Integrated Rod, when used with a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the H-LINK™ Integrated Rod is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

The H-LINK™ Integrated Rod is a unitary implant that combines a t-connector with two rods. The rod diameter is 5.5mm or 6.35mm and the t-connector feature adjusts laterally. The 5.5mm H-LINK™ Integrated Rod can be used with a 5.5mm rod titanium posterior pedicle screw system, such as the REVERE™ Stabilization System. The 6.35mm H-LINK™ Integrated Rod can be used with a 6.35mm rod titanium posterior pedicle screw system, or with the PROTEX Stabilization System, which utilizes 6.0mm or 6.5mm rods. These implants are available in a variety of sizes to accommodate individual patient anatomy. H-LINK™ is intended for posterior use only and is positioned and secured into bilateral pedicle screws.

H-LINK™ is composed of titanium alloy as specified in ASTM F136 and F1295. Due to the risk of galvanic corrosion following implantation, titanium alloy implants should not be connected to stainless steel implants.

The provided text is a 510(k) summary for the H-LINK™ Integrated Rod, a medical device. This document focuses on establishing substantial equivalence to existing predicate devices through technical characteristics and performance, specifically mechanical testing. It is not a study report for a diagnostic AI device, and therefore, much of the requested information (like acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) is not applicable to this type of regulatory submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical testing performed to demonstrate that the H-LINK™ Integrated Rod is substantially equivalent to predicate devices based on established FDA guidance for spinal systems.

Here's a breakdown of the available information and why other points are not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented."

While specific numerical acceptance criteria (e.g., specific load endurance, displacement limits) and the detailed results of the mechanical tests are not explicitly tabulated within this summary document, the statement implies that:

• Acceptance Criteria: These would be derived from the "Guidance for Spinal System 510(k)s, May 3, 2004," which typically specifies various mechanical tests (e.g., static and dynamic axial compression, torsion, bending, fatigue testing) and performance requirements that the device must meet to be considered safe and effective, often by demonstrating equivalence or superiority to predicate devices under those conditions. The predicate devices themselves would have previously demonstrated acceptable performance under similar testing.
• Reported Device Performance: The document only states that the testing was "presented," indicating that the H-LINK™ Integrated Rod did meet the criteria outlined in the guidance and demonstrated performance substantially equivalent to the predicate devices (Globus Medical REVERE™ Stabilization System and PROTEX® Stabilization System). No specific performance values are given in this summary.

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

• Sample Size for Test Set: Not applicable in the context of mechanical testing. "Test set" for mechanical testing would refer to the number of physical device units subjected to the stress tests. This number is not specified in the summary.
• Data Provenance: The "data" refers to the results of mechanical tests performed on the physical device itself, not patient data. Therefore, country of origin or retrospective/prospective status is not relevant. These would be laboratory tests.

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

• Not applicable. This document is not about evaluating a diagnostic AI device or establishing ground truth from expert interpretation of data. The "ground truth" for mechanical testing is defined by engineering standards and test procedures specified in the FDA guidance and ASTM standards.

4. Adjudication Method for the Test Set

• Not applicable. This is not relevant for mechanical testing. Adjudication methods are typically for resolving discrepancies in expert interpretations of medical images or clinical outcomes, which is not the subject here.

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 is not a study of a diagnostic AI device. MRMC studies are for evaluating the performance of diagnostic aids, often AI.

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

• No. This is not a diagnostic AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For mechanical testing, the "ground truth" is adherence to established mechanical engineering standards (e.g., ASTM F136, F1295, and the "Guidance for Spinal System 510(k)s"). The "truth" is whether the device can withstand specified loads and cycles without failure, as per the predefined criteria for substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. There is no AI model being trained discussed in this document.

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

• Not applicable. There is no AI model being trained discussed in this document.

Summary of what is known from the 510(k) Summary:

The H-LINK™ Integrated Rod demonstrates substantial equivalence to predicate devices (Globus Medical REVERE™ Stabilization System and PROTEX® Stabilization System) through mechanical testing. The specific "acceptance criteria" and "study" are a conformance to the requirements outlined in the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004, and relevant ASTM standards (F136, F1295 for material composition). The summary indicates that these tests were performed and presented, implying that the device met the necessary mechanical performance benchmarks to achieve substantial equivalence.

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The CITADEL™ Anterior Lumbar Plate System is intended for use in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

The CITADEL™ Anterior Lumbar Plate System consists of plates of various lengths with variable or fixed bone screws for spinal fixation of the anterior or anterolateral vertebral bodies of the lumbar or lumbosacral spine (L1-S1). The implants are composed of titanium alloy, as specified in ASTM F136, F1295.

The provided text describes a medical device, the "CITADEL™ Anterior Lumbar Plate System," and its 510(k) submission to the FDA. The submission focuses on establishing substantial equivalence to predicate devices through mechanical testing. However, the document does not contain the specific information requested in the prompt regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device.

Here's an analysis based on the provided text:

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

• Not found: The document states that "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s', May 3, 2004 is presented." However, it does not provide a table of specific acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or the explicit performance results of the CITADEL™ device against these criteria. It only asserts that the device is "similar" to predicate devices in "technical characteristics, performance, and intended use."

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

• Not applicable/Not found: This device is a mechanical orthopedic implant, not an AI or algorithm-based diagnostic tool. Therefore, concepts like a "test set" with data provenance (country, retrospective/prospective) are not relevant in the context of the device described here. Mechanical testing typically uses physical samples of the device components. The document does not specify the number of samples used for the mechanical tests.

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)

• Not applicable: Ground truth using expert consensus is relevant for diagnostic performance studies, not for the mechanical testing of an implant.

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

• Not applicable: Adjudication methods are relevant for expert review in diagnostic studies, not for mechanical testing.

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 is a mechanical implant, not an AI-assisted diagnostic tool.

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

• Not applicable: This is a mechanical implant, not an algorithm.

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

• Not applicable: For mechanical devices, performance is typically measured against established engineering standards (e.g., ASTM standards) rather than clinical ground truth types like pathology or outcomes data in the context of an AI model's performance. The "ground truth" here would be the physical properties and mechanical behavior of the device under test, compared to relevant standards or predicate devices.

8. The sample size for the training set

• Not applicable: This device is a mechanical implant and does not involve a "training set" in the sense of machine learning.

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

• Not applicable: As above, this concept does not apply to a mechanical implant.

In summary, the provided document relates to a 510(k) submission for a mechanical spinal implant. It confirms that mechanical testing was performed according to a guidance document for spinal systems. However, it does not offer the detailed information requested about acceptance criteria and a study design that would be relevant for an AI/algorithm-based medical device.

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