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The PSG 5.5mm Cannulated Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments 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), spondylolisthesis, trauma (i.e., fracture or dislocation), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion.

The PSG 5.5mm Cannulated Pedicle Screw System is a non-cervical spinal fixation system. Pedicle screw fixation is limited to skeletally mature patients.

The PSG 5.5mm Cannulated Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.

The provided document is a 510(k) premarket notification for a medical device called the "PSG 5.5mm Cannulated Pedicle Screw System." This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance rather than clinical efficacy studies in the context of AI/software-as-a-medical-device (SaMD). Therefore, many of the requested details about acceptance criteria, clinical study design, and AI performance metrics are not applicable or available in this submission.

However, I can extract the information relevant to the device's mechanical performance and what the submission provides in place of clinical study details.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices such as pedicle screw systems, "acceptance criteria" and "reported device performance" are typically defined by engineering standards to ensure mechanical integrity and safety. In this context, the device's performance is compared against these standards and to predicate devices.

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

The document does not specify the exact sample sizes (number of devices or test repetitions) used for the mechanical tests. It only states that the device "has been tested" according to the ASTM standards.

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 device is a mechanical implant, not an AI/SaMD that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for mechanical testing is adherence to established engineering standards (ASTM F1717-13).

4. Adjudication method for the test set

Not applicable. Mechanical testing is objective and relies on measurements and adherence to specified test protocols, not human adjudication of results.

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

Not applicable. This device is a pedicle screw system, not an AI/SaMD for diagnostic imaging or decision support. No MRMC study was performed.

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

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

7. The type of ground truth used

The "ground truth" for this type of device is defined by engineering standards and established mechanical performance characteristics relevant to spinal implants. Specifically, the ASTM F1717-13 standard dictates the methodologies and expected performance metrics for static and dynamic mechanical integrity. Comparison to legally marketed predicate devices also serves as a benchmark for "ground truth" in terms of acceptable clinical performance and safety.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a mechanical device, not a machine learning algorithm.

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

Not applicable.

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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 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 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM and VIPER Spine System components consist of screws and are available in various geometries and sizes.

The provided document is a 510(k) Summary for the DePuy Spine EXPEDIUM® and VIPER® Systems, which are spinal fixation devices. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials and detailed acceptance criteria for an AI/algorithm.

Therefore, the specific information requested about acceptance criteria, study design for proving device performance against those criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies for AI/software-as-a-medical-device (SaMD) are not applicable to this submission.

Here's an explanation based on the provided document:

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

• Not Applicable. This submission is for mechanical spinal implants, not an AI/software device. The "performance" is assessed through a comparison to predicate devices and mechanical testing, not against specific diagnostic or treatment accuracy acceptance criteria as would be expected for a SaMD.

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

• Not Applicable. There is no "test set" in the context of an AI/software device. The performance was evaluated via non-clinical mechanical testing of the physical implants. The document does not specify the number of units tested, but mechanical tests typically involve a pre-determined number of samples to ensure statistical validity for the specific test (e.g., fatigue or static load).

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, in the context of AI/SaMD, refers to the verified correct output (e.g., diagnosis, measurement) for comparison with the algorithm's output. For mechanical implants, "ground truth" is typically defined by engineering specifications and material properties, verified through testing procedures against established standards (e.g., ASTM F1798). Experts involved would be engineers and material scientists.

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

• Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert opinions when establishing ground truth for AI/SaMD. This is not pertinent to the mechanical testing of spinal implants.

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. MRMC studies are designed to evaluate the impact of an AI algorithm on human reader performance (e.g., radiologists, pathologists). This device is a physical implant, not an AI system.

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

• Not Applicable. This concept applies to AI algorithms and not to physical medical devices like spinal implants.

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

• For mechanical testing: The "ground truth" (or reference standard) for the nonclinical tests would be the established scientific and engineering principles outlined in the cited ASTM standards (F1798). Performance is measured against physical properties and failure points defined by these standards, not against biological or clinical outcomes or expert consensus on images.

8. The sample size for the training set

• Not Applicable. There is no training set as this is not an AI/machine learning device.

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

• Not Applicable. Since there is no training set, this question is not relevant.

Summary of what the document does provide regarding device performance:

The document states that "No clinical tests were performed."
Instead, the device's performance and safety were established through "Nonclinical Test Summary:"

• Static Cantilever Beam in accordance with ASTM F1798
• Dynamic Cantilever Beam in accordance with ASTM F1798
• Axial Slip in accordance with ASTM F1798

These tests are designed to evaluate the mechanical properties and stability of the spinal implants and their interconnection mechanisms, ensuring they meet the requirements for their intended use and are comparable to predicate devices. The "acceptance criteria" here are implied to be the successful completion of these tests in accordance with the ASTM standards, demonstrating structural integrity and mechanical equivalence to the already cleared predicate devices. The specific results of these tests (e.g., actual load values, cycles to failure) are not detailed in this 510(k) summary but would have been submitted to the FDA in a more comprehensive report.

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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 4.5mm and 6.35mm rods and are available in various geometries and sizes.

The provided text describes the EXPEDIUM Spine System, a medical device intended for spinal immobilization and stabilization. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics in a way that would allow for a complete answer to your request regarding acceptance criteria and a study proving the device meets them.

The document is a 510(k) summary and FDA clearance letter, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study against pre-defined acceptance criteria.

Here's a breakdown of what can be gleaned and what is missing, structured as requested:

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

Explanation: The document states that "Performance data per ASTM F 1717 were submitted." ASTM F 1717 is a standard specification for spinal implant constructs in vitro, likely involving mechanical testing (e.g., fatigue, static strength). However, the specific acceptance criteria (e.g., "must withstand X cycles at Y load," or "static strength must exceed Z N-m") and the device's measured performance against those criteria are not provided in this summary. The summary confirms that data was submitted to characterize the device, implying that a study was conducted, but it does not present the results or the pass/fail thresholds.

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

• Sample Size: Not specified for any test set. The ASTM F 1717 standard would typically define the number of constructs to be tested, but this detail is not present in the summary.
• Data Provenance: Not specified. It's an in-vitro mechanical test, so "country of origin of data" is less relevant than for clinical data, but the location of the testing facility is not provided. Retrospective or prospective classification is not applicable to an in-vitro mechanical test.

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 to the device and performance data described. The device is a spinal implant system, and the performance data cited (ASTM F 1717) refers to mechanical properties, not diagnostic performance or clinical outcomes requiring expert interpretation to establish ground truth.

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

• Not applicable. As the performance data pertains to mechanical testing (ASTM F 1717), there is no need for expert adjudication. Mechanical tests follow standardized protocols.

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

• Not applicable. This device is a spinal implant system, not a diagnostic imaging or AI-assisted device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

• Not applicable. This device is a physical spinal implant system, not a software algorithm.

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

• Not applicable in the typical sense of ground truth for diagnostic devices. For mechanical testing (ASTM F 1717), the "ground truth" is established by the physical properties and behavior of the device components under controlled test conditions, measured against the specifications of the standard. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" for this type of performance assessment.

8. The sample size for the training set

• Not applicable. There is no "training set" for a physical medical device undergoing mechanical performance testing. This concept applies to machine learning algorithms.

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

• Not applicable. (See point 8).

Summary of available information:

The 510(k) summary indicates that the EXPEDIUM Spine System is a Class III medical device intended for spinal immobilization and stabilization. It states that "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components." This implies that a study was conducted to evaluate the mechanical properties of the device according to the ASTM F 1717 standard. However, the specific details of this study, including the acceptance criteria, the actual performance results, sample sizes, or any form of "ground truth" that would be applicable to diagnostic or AI devices, are not present in the provided document. The document primarily serves to demonstrate substantial equivalence to previously cleared predicate devices, allowing it to proceed to market without a full PMA.

Ask a specific question about this device

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 5.5mm rods and are available in various geometries and sizes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EXPEDIUM Spine System, structured to answer your questions:

The provided document is a 510(k) summary for the EXPEDIUM Spine System, specifically for additions to the existing system. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy or performance against specific clinical acceptance criteria in the same way a PMA would. Therefore, the study details you're asking for, particularly concerning AI/algorithm performance and human reader improvement, are not applicable to this type of medical device submission. This document describes a surgical implant, not an AI/imaging device.

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

For a spinal implant system like the EXPEDIUM Spine System, "acceptance criteria" are not reported in terms of diagnostic performance metrics (like sensitivity, specificity, etc.). Instead, they relate to mechanical and material performance standards to ensure the device is safe and effective when implanted.

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

The document does not detail a "test set" in the context of clinical data, as it's not a clinical study designed to test diagnostic accuracy. The performance data relates to mechanical testing of the implant components. Therefore, information about sample size, country of origin, and retrospective/prospective nature of a clinical test set is not applicable to this submission.

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

This is not applicable. The ground truth for mechanical testing is established by engineering standards and measurement techniques, not by expert clinician consensus on clinical cases.

4. Adjudication method for the test set

This is not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish a ground truth from ambiguous cases.

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 is not applicable. The EXPEDIUM Spine System is a physical surgical implant, not an AI or imaging device that would involve human readers or AI assistance.

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

This is not applicable. The EXPEDIUM Spine System is a physical surgical implant, not an algorithm or software.

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

For this device, the "ground truth" for its performance is based on engineering standards and material science properties (e.g., strength, fatigue resistance, biocompatibility) as defined by standards like ASTM F 1537 (for material) and ASTM F 1717 (for mechanical testing of spine fusion constructs). There are no clinical outcomes data, pathology, or expert consensus used as ground truth for this type of submission's performance data.

8. The sample size for the training set

This is not applicable. This is a physical implant, not an AI model, so there is no "training set."

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

This is not applicable.

Summary of what the document does provide:

• Device Type: Spinal implant system (rods, screws)
• Purpose of Submission: Special 510(k) for additions to an existing system, demonstrating substantial equivalence to predicate devices.
• Key Performance Data: Mechanical performance data per ASTM F 1717, and material characterization per ASTM F 1537. This data ensures the device meets established engineering standards for strength, durability, and biocompatibility suitable for its intended use.
• Intended Use: Immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Material: ASTM F 1537 implant grade cobalt-chromium-molybdenum alloy.

The document demonstrates that the new components for the EXPEDIUM Spine System are substantially equivalent to previously cleared devices based on their design, materials, and mechanical performance testing, not on clinical performance against diagnostic or AI-related metrics.

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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 are designed to accept a 5.5mm rod and are available in various geometries and sizes. The EXPEDIUM™ Spine System also contains Class I manual surgical instruments, trays and cases and are exempt from premarket notification. Manufactured from ASTM F 136 implant grade titanium alloy.

This is a 510(k) premarket notification for the EXPEDIUM™ Spine System, a medical device. The provided text is a summary of the application and the FDA's response, not a study report for an AI device. Therefore, I cannot extract the requested information concerning acceptance criteria and a study proving a device meets those criteria, especially details related to AI, ground truth, expert opinions, or sample sizes for testing and training sets.

The document describes a mechanical spine system and references characterization data per ASTM F 1798, which is a standard for fatigue testing of spinal implants. It does not involve AI or any form of image analysis.

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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; pseudarthrosis; 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.

The provided text describes a Special 510(k) Submission for additions to the EXPEDIUM Spine System. It focuses on the regulatory approval process and device description rather than performance studies or acceptance criteria for a system that uses AI.

Therefore, I cannot extract the requested information regarding:

• 1. A table of acceptance criteria and the reported device performance
• 2. Sample sized used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method for the test set
• 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
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

The document only mentions:

• Performance Data: "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification." This indicates that mechanical performance testing, likely related to strength and fatigue, was conducted according to a specific ASTM standard (ASTM F 1717 for Spinal Implant Constructs in a Corpectomy Model). However, it does not provide the acceptance criteria or results of these tests, nor does it relate to any AI/algorithm performance.

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