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The TIGER® Spine System is intended to provide immobilization 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 thoracic, lumbar, and sacral/iliac spine (TT Sifleum): degenerative discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective widence of neurological impairment, frecture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).

The TIGER® Spine System is composed of rods, connectors, and pedicle screws. It can be used for single or multiple level fixations.

The provided text describes a Special 510(k) Summary for the TIGER® Spine System. It focuses on the substantial equivalence of the device to existing predicate devices based on non-clinical testing. Crucially, the document explicitly states that no clinical studies were performed. Therefore, this device submission does not contain information regarding acceptance criteria for a device's performance based on clinical data, nor does it describe a study that proves the device meets such criteria through clinical outcomes.

Instead, the document details non-clinical testing performed to demonstrate mechanical safety and performance in comparison to predicate devices.

Here's a breakdown of the requested information based only on the provided text, acknowledging the absence of clinical performance data:

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

Since this is a non-clinical submission based on substantial equivalence to predicate devices, the "acceptance criteria" are implicitly meeting or exceeding the performance of the predicate device(s) in specified mechanical tests. The "reported device performance" is the conclusion that the TIGER® Spine System is equivalent.

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

The document does not specify the sample size (number of devices or test repetitions) used for the non-clinical mechanical tests. It also does not discuss data provenance as it pertains to patient data, as no clinical studies were performed. The tests are laboratory-based mechanical tests.

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. No ground truth based on expert clinical assessment (e.g., radiologists) was established because no clinical studies were performed. The "ground truth" for the non-clinical tests is based on established ASTM standards and comparative analysis to predicate devices.

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

This question is not applicable. No clinical test set requiring adjudication of expert opinions was created.

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. No MRMC study was performed, as no clinical studies involving human readers or AI assistance were conducted.

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

This question is not applicable. No algorithm or standalone software performance was evaluated, as this submission is for a physical spinal implant system.

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

For the non-clinical tests, the "ground truth" is based on established engineering standards (ASTM F1717, ASTM F1798) and the performance characteristics of legally marketed predicate devices. This is a technical, rather than clinical, ground truth.

8. The sample size for the training set

This question is not applicable. There was no training set, as no algorithms requiring training were involved in this submission.

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

This question is not applicable. There was no training set.

Summary of Study (Based on Provided Document):

The submission describes a non-clinical study involving mechanical and dimensional testing of the TIGER® Spine System. The study's purpose was to demonstrate substantial equivalence to existing predicate devices (e.g., Expedium™/Viper™ Spine System, Scient'x Polyaxial LP) for the addition of new components. The study involved:

• Tests performed: Static and dynamic compression (ASTM F1717), static torsion (ASTM F1717), static axial and torsional grip (ASTM F1798), and dimensional comparison.
• Conclusion: The results indicated that the TIGER® Spine System is equivalent to the predicate device(s) in terms of principles of operation, technology, materials, and indications of use.
• Sample Size and Ground Truth: Not explicitly detailed for the specific tests, but generally refers to standard testing protocols. The "ground truth" for this equivalence claim is the established performance and safety profile of the predicate devices.
• Clinical Studies: Explicitly stated as not performed. Therefore, no clinical acceptance criteria or performance studies were conducted or reported in this submission.

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The DePuy Pulse Thoracolumbar 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 acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The DePuy Pulse Thoracolumbar Screw System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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 in skeletally mature patients.

The DePuy Pulse Thoracolumbar Screw System consists of a variety of rods, pedicle screws, connectors, set screws and other connection components used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being made for the individual case.
The DePuy Pulse Thoracolumbar Screw System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DePuy Pulse Thoracolumbar Screw System:

This device is not an AI/ML device, but a physical medical device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a physical medical device, and the testing involved mechanical performance on device components, not a test set of data.

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 physical medical device, and the "ground truth" for mechanical testing is defined by the ASTM F-1717 standard's specifications.

4. Adjudication method for the test set

Not applicable. This is a physical medical device, and mechanical test results are typically objective measurements against a standard, not subject to 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

No. This is a physical medical device, not an AI/ML diagnostic or assistive tool, so an MRMC study is not relevant.

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

No. This is a physical medical device, not an algorithm, so standalone performance is not relevant.

7. The type of ground truth used

The "ground truth" for this device's performance is established by the specified mechanical testing standards (ASTM F-1717) for spinal implant constructs. These standards define the acceptable mechanical properties and behaviors under various loads.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.

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

Not applicable. This is a physical medical device, not an AI/ML device requiring a training set with established ground truth.

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The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (defined as back pain of discogenic origin with degencration 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 fision.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The provided document is a 510(k) premarket notification for the Range Spinal System: Mesa Modifications. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. Therefore, the information typically requested regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment for AI/diagnostic devices will not be present in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and 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):

• Test Set Sample Size: Not applicable. The submission relies on mechanical testing of components, not human test subjects or clinical data in the context of diagnostic performance. The sample size for the mechanical tests (e.g., number of screws or rods tested) is not specified in this summary.
• Data Provenance: Not applicable in the context of clinical data. The data provenance is from laboratory mechanical testing.

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 as typically understood for diagnostic or AI devices (e.g., expert consensus on medical images) is not relevant for this type of mechanical device submission and testing. The "ground truth" here is compliance with ASTM standards and comparison to a predicate device's mechanical properties.

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

• Not applicable. This is not a clinical study involving human readers or interpretation of results that would require an adjudication method.

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 fixation system, not an AI or diagnostic device designed to assist human readers.

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

• Not applicable. This refers to an AI/algorithm's performance, which is not relevant to this device.

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

• The "ground truth" in this context is the established performance characteristics and mechanical properties of the legally marketed predicate devices, and the compliance with established ASTM standards (like F1717) for mechanical testing.

8. The sample size for the training set:

• Not applicable. This submission does not involve machine learning or AI models with training sets.

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

• Not applicable. There is no training set mentioned in this submission.

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The EXPEDIUM and VIPER Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM and VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The proposed cortical fix polyaxial screws for EXPEDIUM and VIPER System are available in various geometries and sizes.

The provided 510(k) summary (K110216) describes the DePuy Spine EXPEDIUM® and VIPER® Systems. This device is a spinal fixation system, and the submission focuses on new cortical fix polyaxial screws for these systems.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "No clinical tests were performed." Therefore, there is no information regarding a test set sample size or data provenance from a human study. The testing performed was mechanical.

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

Not applicable, as no clinical tests were performed. The "ground truth" for the mechanical tests would be the established engineering standards (ASTM F 1798-97) and the physical measurements against those standards. These would be assessed by engineers/technicians performing the tests.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical tests were performed involving human readers or interpretation.

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

No, an MRMC comparative effectiveness study was not done. The submission states, "No clinical tests were performed."

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

Not applicable, as this device is a physical medical implant (spinal fixation system), not a software algorithm.

7. The Type of Ground Truth Used:

For the mechanical tests performed, the "ground truth" is defined by the ASTM F 1798-97 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. The device's performance was compared against the requirements and specifications outlined in this standard.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical implant, not a machine learning or AI algorithm, so there is no training set in the conventional sense. The "development" or "design" process for such a device involves engineering principles, material science, and manufacturing processes, rather than data-driven algorithm training.

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

Not applicable, as there is no training set for this type of device.

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The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; pseudarthrosis; and failed previous fusion in skeletally mature patients.

The EXPEDIUM Spine System is a 5.5mm rod-based and platebased system offered in both titanium and stainless steel. The system consists of monoaxial screws, polyaxial screws, uni-planar screws, reduction screws, reduction hooks, hooks, extended tab implants, sacral extenders, lateral connectors, washers, fixed bolts, polyaxial bolts, closed screws, slotted connectors, plates, nuts, washers, drop-entry connectors, modular cross connectors, transverse rod connectors, and wires.

The proposed addition to the EXPEDIUM 5.5mm Spine System is an increased favored angle polyaxial screw. The polyaxial screw head opens posteriorly for placement of a rod which is secured to a screw by either a dual inner or unitized set screw. This additional component is available in various geometries and sizes to accommodate patient anatomy. It will be provided non-sterile.

Here's a breakdown of the acceptance criteria and study information for the K102249 submission, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a Special 510(k) submission for an addition to an existing spinal system, the EXPEDIUM® Spine System. The acceptance criteria and "device performance" (in this context, demonstrating that the new component meets the same performance standards as the predicate device) are based on mechanical non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size (number of devices/components tested) for each mechanical test. It only states that the tests were conducted in accordance with ASTM F1798-97.
• Data Provenance: The data is from non-clinical mechanical testing performed by the manufacturer, DePuy Spine, Inc., presumably in their labs. This is not patient-derived data, so terms like "country of origin" or "retrospective/prospective" are not applicable.

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

This question is not applicable to this submission. The "ground truth" for mechanical testing is established by the specified ASTM standard (F1798-97), which outlines the methodology and performance metrics. There are no "experts establishing ground truth" in the sense of clinical interpretation or diagnosis for this type of non-clinical mechanical evaluation.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication typically refers to the process of resolving discrepancies in expert opinions, often in clinical studies. For mechanical testing against an ASTM standard, the results are objectively measured and compared to the predefined criteria of the standard.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were performed."

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

This question is not applicable. This submission is for a physical medical device (spinal implant components), not a software algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device meets acceptance criteria is adherence to established mechanical testing standards (ASTM F1798-97). The performance of the new components was compared to these standards to ensure they are equivalent to the predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. This submission is for a physical medical device, not a machine learning model. Therefore, 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 for a machine learning model, there is no ground truth for a training set to be established.

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The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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 in skeletally mature patients.

The subject EXPEDIUM Spine System components consist of designs that interface to 5.5mm and 6.35mm rods and are available in various geometries and sizes.

This document describes a 510(k) premarket notification for the EXPEDIUM Spine System, a medical device for spinal fixation. It is not a traditional AI/ML device approval, therefore much of the requested information about AI model performance, training sets, and ground truth establishment is not applicable.

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

1. Acceptance Criteria and Reported Device Performance

The document states that "Performance data per ASTM F 1798 were submitted to characterize the subject EXPEDIUM Spine System components addressed in this notification." This implies that the acceptance criteria are tied to the standards outlined in ASTM F 1798. However, the specific quantitative acceptance criteria (e.g., maximum deflection, fatigue life, strength) and the reported performance values are not provided in the summary. The document only confirms that data was submitted, not the results themselves.

Note: For medical devices like spinal fixation systems, acceptance criteria typically involve detailed mechanical testing (e.g., static and dynamic compression, bending, torsion), biocompatibility, and material characterization to ensure safety and effectiveness. The ASTM F 1798 standard specifically deals with the fatigue testing of intervertebral body fusion devices.

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

The document describes mechanical performance testing, not data analysis or human subject testing in the traditional sense of a "test set" for an AI model. Therefore, the concept of sample size for a "test set" and "data provenance" (country of origin, retrospective/prospective) as it applies to an AI/ML device is not applicable here. The "test set" for this device would refer to the physical components subjected to mechanical tests. The specific number of components tested is not provided in the summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as this is a physical medical device (spinal fixation system) and not an AI/ML product. The "ground truth" for such a device is established through adherence to engineering specifications, material science principles, and mechanical testing standards (like ASTM F 1798). Experts involved would be engineers, material scientists, and potentially surgeons for clinical relevance, but their role is not in establishing a data "ground truth" as it would be for an AI model.

4. Adjudication Method for the Test Set

This concept is also not applicable as this is a physical medical device. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert labeling or diagnoses for AI/ML training or evaluation datasets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-analysis AI/ML systems where human readers interpret cases with and without AI assistance to measure improved performance. This device is a physical implant.

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

This question is not applicable as the device is a physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering standards and mechanical test results. Specifically, the summary states "Performance data per ASTM F 1798 were submitted." ASTM F 1798 is a standard specification for fatigue test performance of spinal artificial disc prostheses and components. Therefore, the ground truth is derived from objective mechanical testing outcomes compared against established engineering standards.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI/ML product. There is no "training set" in the context of machine learning. The design and manufacturing process would involve iterative engineering and testing, but not in the sense of an AI training set.

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

This information is not applicable for the same reasons as #8.

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The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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 in skeletally mature patients.

The subject EXPEDIUM™ Spine System rods are designed to work in conjunction with the components of the following DePuy Spine spine systems: EXPEDIUM™ 6.35mm Spine System (Ti + SS), EXPEDIUM™ 5.5mm Spine System (Ti + SS), ISOLA® 4.75mm Spine System (Ti + SS), ISOLA® 6.35mm Spine System (Ti + SS), MONARCH™ 5.5mm Spine System (Ti), MONARCH™ 6.35mm Spine System (Ti), MOSS MIAMI™ 5.0mm Spine System (SS), MOSS MIAMITM 5.5mm Spine System (Ti), MOSS MIAMI™ 6.35mm Spine System (SS), VIPERTM 5.5mm Spine System (Ti). Manufactured from ASTM F 138 implant grade stainless steel and ASTM F 136 implant grade titanium alloy.

The provided document is a 510(k) summary for the EXPEDIUM™ Spine System, a medical device for spinal fixation. It describes the device, its intended use, materials, and a declaration of substantial equivalence to predicate devices, noting performance data per ASTM F 1717.

However, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, specifically for diagnostic or AI-assisted devices.

The product is a physical orthotic system, not a diagnostic device or an AI/software product that would typically have acceptance criteria related to performance metrics like sensitivity, specificity, or reader improvement. The "performance data" mentioned refers to mechanical testing (ASTM F 1717) for the physical components of the spinal system, not clinical or diagnostic performance criteria.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance using the provided text, as this information is not present. The questions about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information are all pertinent to the evaluation of AI or diagnostic devices, which this product is not.

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