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The ISOBAR Spinal System is a pedicle screw system 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The ISOBAR Spinal System consists of pedicle screws, rods, nuts, crosslink members and hooks. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The provided text describes a 510(k) summary for the "ISOBAR Spinal System Additional Components." This document focuses on the mechanical performance and substantial equivalence of the device to existing predicate devices, rather than a clinical study evaluating diagnostic accuracy or a human-AI interaction.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of submission. This 510(k) is for a medical device (spinal implant components), not an AI algorithm or a diagnostic tool.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable/Not provided. This submission is for mechanical device components, not a dataset for an AI algorithm. The performance data refers to material and mechanical testing, not analysis of patient data.

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

• Not applicable/Not provided. Ground truth, in the context of an AI algorithm, typically refers to expert labels on a dataset. For this medical device, "ground truth" would relate to engineering standards and material properties, not clinical expert consensus on an image or patient outcome.

4. Adjudication method for the test set

• Not applicable/Not provided. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple expert annotators in AI algorithm studies. This is not relevant to the mechanical testing described.

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 mechanical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study and human-AI improvement metrics are not relevant.

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

• Not applicable. This device is hardware; there is no "algorithm only" performance.

7. The type of ground truth used

• Engineering Standards / Material Specifications. For this device, the "ground truth" for acceptance criteria revolves around established ASTM (American Society for Testing and Materials) standards for materials and mechanical performance (e.g., ASTM F136 for titanium alloy, ASTM F1717-96 for static and fatigue compression testing of spinal implant constructs).

8. The sample size for the training set

• Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning product.

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

• Not applicable/Not provided.

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The ISOBAR Spinal System is a pedicle screw system 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The ISOBAR Spinal System consists of pedicle screws, rods, nuts, crosslink members and hooks. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136.

Here's an analysis of the provided text regarding the ISOBAR Spinal System, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) summary for a medical device submitted to the FDA in 2001. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical efficacy studies as would be required for a Class III device or for certain novel technologies today. Therefore, many of the typical elements you'd find in a modern AI/software as a medical device (SaMD) study are not present in this document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not discuss a "test set" in the context of performance data from patient outcomes or clinical trials. The "test set" mentioned in the modern context of AI/SaMD studies (i.e., a dataset used to evaluate an algorithm's performance) is not applicable here.

The performance data mentioned relates to mechanical testing (fatigue tensile testing) of the device components. The sample size for this mechanical testing is not specified in the summary. Data provenance is also not applicable as it's a lab-based mechanical test, not clinical data.

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

This information is not applicable to the provided document. The device is a physical implant, not a diagnostic algorithm that requires expert-established ground truth from clinical images or data.

4. Adjudication Method for the Test Set

This information is not applicable to the provided document, for the same reasons as point 3.

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 evaluating the impact of AI on human reader performance for diagnostic tasks. The ISOBAR Spinal System is a surgical implant, not a diagnostic tool, and the submission predates widespread AI in medical devices requiring such studies.

6. 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 concept is completely irrelevant to a physical spinal implant device.

7. The Type of Ground Truth Used

For the mechanical performance data (fatigue tensile testing), the "ground truth" is defined by the acceptance criteria established by the ASTM F1717-96 standard. This standard specifies how the test should be conducted and what constitutes a passing performance. It's an engineering ground truth, not a clinical one.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an algorithm that undergoes "training" on a dataset. The design and manufacturing processes are informed by engineering principles and existing medical knowledge, not a training set in the AI sense.

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

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

Summary of Key Findings from the 510(k) for K013440:

• Device Type: Physical spinal implant system (pedicle screws, rods, nuts, crosslink members, hooks).
• Approval Basis: Substantial Equivalence to predicate devices (TSRH™ Spinal Implant System and ISOLA® Spinal System).
• Performance Data: Primarily focused on mechanical testing (fatigue tensile testing according to ASTM F1717-96) and demonstrated material conformity (Ti-6AI-4V to ASTM F136).
• Clinical Studies: No clinical studies with human subjects are described in this 510(k) summary. The FDA's review for substantial equivalence at the time did not require such studies for this type of device if mechanical performance and material equivalence were demonstrated to predicate devices.
• Absence of AI/SaMD Concepts: The concepts of "test set," "training set," "expert ground truth," "adjudication," and "MRMC studies" are entirely out of scope for this 2001 510(k) submission for a physical implant.

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The ISOBAR Spinal System is a pedicle screw system 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The ISOBAR Spinal System consists of pedicle screws, rods, nuts, crosslink members and hooks. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The provided document is a 510(k) summary for the ISOBAR Spinal System Additional Components. This document pertains to a medical device (pedicle screw spinal system) and its mechanical performance, not an AI/ML-based device. Therefore, many of the requested elements for AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or cannot be extracted from this type of documentation.

However, I can extract the acceptance criteria and the study performed based on the information provided, focusing on the mechanical aspects of the device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. Testing according to ASTM F1717-96 would involve a specific number of samples, but this summary does not provide that detail.
• Data Provenance: The testing was "performed according to ASTM F1717-96." This implies laboratory testing of the physical device components. Data provenance in terms of country of origin or retrospective/prospective is not applicable for this mechanical testing.

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

• Not applicable. This is mechanical performance testing against an engineering standard, not clinical data requiring expert human review or ground truth establishment.

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

• Not applicable. This refers to consensus methods for clinical assessment, which is not relevant 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 medical device for spinal fixation, not an AI-based diagnostic or assistive technology.

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

• Not applicable. This is not an algorithm.

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

• The "ground truth" for this device's performance is compliance with the ASTM F1717-96 standard for static and fatigue compression testing, and the ASTM F136 standard for material composition. These are engineering standards, not clinical ground truths.

8. The sample size for the training set:

• Not applicable. This is mechanical performance testing, not an AI/ML model that requires a training set.

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

• Not applicable. There is no training set for this type of device and study.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study performed to demonstrate the device meets acceptance criteria involved mechanical testing of the ISOBAR Spinal System Additional Components. The specific standard cited for this testing is ASTM F1717-96, which covers static and fatigue compression testing of metallic spinal implant ensembles. Additionally, the material used, titanium alloy (Ti-6Al-4V), was confirmed to conform to ASTM F136, a standard specification for wrought titanium-6aluminum-4vanadium alloy for surgical implant applications.

The 510(k) submission states that these tests were "performed according to" the specified standards. This implies that the device and its components successfully met the performance requirements and material specifications outlined in those ASTM standards, thus establishing its substantial equivalence to predicate devices (Moss Miami Polyaxial Screw and ISOBAR U-Line Spinal System) that also rely on compliance with such standards for their mechanical integrity. The document does not provide a detailed report of the exact numerical results or the pass/fail thresholds for these tests, as is typical for a 510(k) summary which focuses on demonstrating substantial equivalence rather than a full engineering report.

Ask a specific question about this device

Ask a specific question about this device

The ISOBAR Spinal System is a pedicle screw system 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The ISOBAR Spinal System consists of pedicle screws, rods, nuts, crosslink members and hooks. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F136.

The provided text describes the ISOBAR Spinal System and its substantial equivalence to predicate devices, but it does not contain information related to software or AI-based device performance, acceptance criteria, or a study to prove acceptance criteria.

The device in question is a physical pedicle screw spinal system, and its performance data is limited to "static and fatigue compression testing... according to ASTM F1717-96." This is a standard for mechanical testing of metallic spinal implant constructs, not for evaluating algorithm performance or clinical accuracy.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/software device, as these aspects are not applicable to the presented documentation for the ISOBAR Spinal System.

Ask a specific question about this device

The ISOBAR Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.

The ISOBAR Spinal System consists of pedicle screws. rods, nuts and crosslink members. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F136.

This system consists of pedicle screws that required rod attachment directly over the top of the screw (U-Line Screws) and a combination of screws and clamps that allow the rod to be offset from the screw (Hemispherical Headed Screws).

The provided text is a 510(k) summary for the ISOBAR Spinal System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a rigorous standalone study in the way an AI/software device would.

Therefore, many of the requested elements for an AI/software device's acceptance criteria and study design are not applicable to this spinal implant device. The "performance data" section in this document refers to mechanical testing to ensure the device meets engineering standards, not clinical performance or diagnostic accuracy.

Here's an attempt to answer the questions based only on the provided text, highlighting where the information is not applicable (N/A) for this type of medical device submission.

Acceptance Criteria and Study Information for ISOBAR Spinal System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA established no performance standards applicable to pedicle screw spinal systems at the time of this submission. The testing conducted was to an industry standard. The document states "was performed according to ASTM F1717-96," which implies the device met the requirements of this standard, but no specific numerical performance data (e.g., maximum load, cycles to failure) is provided in this summary.

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

N/A. This device is a physical pedicle screw system, not an AI/software device that would have a "test set" of data. The "testing" refers to mechanical integrity testing of the implants themselves. Data provenance (country of origin, retrospective/prospective) is not relevant to this type of mechanical testing.

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

N/A. Ground truth and expert adjudication are not applicable to the mechanical testing of a physical implant device for this type of submission.

4. Adjudication method for the test set

N/A. Adjudication method is not applicable to the mechanical testing of a physical implant device.

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

N/A. This is a physical spinal implant, not an AI or diagnostic imaging device. MRMC studies are not relevant.

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

N/A. This is a physical spinal implant, not an AI or diagnostic imaging device. Standalone algorithm performance is not relevant.

7. The type of ground truth used

N/A. This is a physical spinal implant. Mechanical testing relies on engineering specifications and measurements, not "ground truth" derived from clinical outcomes, pathology, or expert consensus in the diagnostic sense.

8. The sample size for the training set

N/A. This is a physical spinal implant. There is no "training set" in the context of AI/machine learning. If by "training set" it refers to the number of devices mechanically tested, that information is not provided in this summary.

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

N/A. Not applicable, as there is no "training set" or "ground truth" in the AI/ML context for this device.

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