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The ISOBAR Closed Pedicle Screw is to be used in conjunction with the ISOBAR Spinal System, 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, 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 and crosslink members. It can be used for single or multiple level fixation. The U-line pedicle screws, rods, nuts and crosslink members were cleared on Single of manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The additional component that is the subject of this Special 510(k) submission is a pedicle screw with a closed set-screw. It has a U shaped head to accept a rod in the same manner as the U-line screw. The difference is the set-screw used to secure the rod into place. As the set-screw is tightened the rod is secured in the U slot of the screw and is fixed in position.

The provided 510(k) summary for the ISOBAR Closed Pedicle Screw does not contain information typically found in acceptance criteria and study reports for software-driven medical devices or AI algorithms. This submission is for a physical medical device (a pedicle screw spinal system), not a software or AI product.

Therefore, many of the requested categories are not applicable to this submission. I will address the applicable points based on the provided text.

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)

This information is not applicable and not provided. The "test set" in this context would refer to the physical screws or components tested according to ASTM F1717-96. The document does not specify the number of screws tested or the origin of the data beyond the standards applied.

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 is not applicable. For a physical device like a pedicle screw, "ground truth" is established through physical and mechanical testing against recognized engineering standards (like ASTM F1717-96), not by expert consensus or interpretations of data.

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

This is not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading), not for objective mechanical performance 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

This is not applicable. MRMC studies are used for evaluating diagnostic software (often AI-driven) where human readers interpret medical images. This submission is for a physical orthopedic implant.

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

This is not applicable as this is a physical device, not an algorithm.

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

The "ground truth" for this device's performance would be the objective measurements obtained from mechanical testing (static and fatigue compression) against the specified ASTM F1717-96 standard. The standard itself defines the acceptable parameters for these measurements.

8. The sample size for the training set

This is not applicable as there is no "training set" for a physical medical device in the context of an algorithm.

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

This is not applicable, as there is no training set mentioned or implied for this physical device.

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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 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies (DDD), trauma (i.e. fractures), tumors, deformities (i.e. kyphosis, lordosis, and scoliosis), pseudoarthrosis, spinal stenosis, and failed previous fusions.

WARNING: These devices are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Anterior Cervical Plate System consists of multiple sized plates and screws. All components are manufactured from titanium alloy (Ti-6A1-4V) that conform to ASTM F136.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

This device (Anterior Cervical Plate System) is a Class II medical device, and the submission is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel clinical effectiveness. Therefore, the study details provided will be different from those typically found for AI/software-as-a-medical-device (SaMD) products.

Acceptance Criteria and Reported Device Performance

Note: The document states that "The Food and Drug Administration have established no performance standards applicable to anterior cervical plating systems." However, it explicitly mentions that testing was performed according to ASTM F1717-96. This implies that compliance with the methods and expected outcomes of this standard would serve as the de facto acceptance criteria for the mechanical performance of the device. The summary doesn't provide specific numerical results of these tests, only that they were performed.

Study Details

This 510(k) submission primarily relies on mechanical performance testing and substantial equivalence arguments rather than a clinical study evaluating diagnostic accuracy or reader performance typically seen with AI/SaMD.

1. 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 in the context of clinical patient data. The "test set" here refers to the actual physical devices (plates and screws) that underwent mechanical testing. The exact number of units tested is not specified in the summary but would be dictated by the ASTM F1717-96 standard.
   • Data Provenance: Not applicable for mechanical testing. The testing would have been conducted in a laboratory setting.

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

   • Not applicable. Mechanical testing outcomes (e.g., force at failure, cycles to failure) are objectively measured by testing equipment, not established by human experts. The "ground truth" is determined by physical properties and engineering principles.

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

   • Not applicable. As noted above, the results are objective measurements from mechanical testing, not subjective human interpretations requiring adjudication.

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

   • No MRMC clinical study was performed or is mentioned. This device is an implantable medical device (anterior cervical plate system), not an AI/SaMD product that assists human readers.

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

   • Not applicable. This is not an algorithm or software. The "standalone performance" is the mechanical performance of the device itself.

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

   • For the mechanical testing, the "ground truth" is the physical measurement of material and structural properties under various stress conditions, as defined and measured according to the ASTM F1717-96 standard.

7. The sample size for the training set:

   • Not applicable. There is no AI/machine learning model involved; therefore, no "training set" in the computational sense. The design and manufacturing process for the device would have been developed based on general engineering principles and material science.

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

   • Not applicable, as there is no training set for an AI model. For the mechanical device, its design and expected performance are based on established engineering principles, material specifications (titanium alloy (Ti-6A1-4V) conforming to ASTM F136), and prior knowledge of predicate devices.

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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

• Must meet fatigue test requirements as per ASTM F1717-96. | Fatigue Tensile Testing:
• Performed according to ASTM F1717-96.
• Specific performance values (e.g., cycles to failure, stress levels) are not provided in this summary. |
  | Material Composition:
• Manufactured from titanium alloy (Ti-6AI-4V) conforming to ASTM F136. | Material Composition:
• All components manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136. |
  | Indications for Use:
• Must be for immobilization and stabilization of spinal segments as an adjunct to fusion for specified acute and chronic instabilities/deformities (pedicle screw and non-pedicle screw indications). | Indications for Use:
• Stated as intended for 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, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis), and severe spondylolisthesis (Grade 3 and 4) of L5-S1. Also for hook fixation (non-pedicle screw) for spondylolisthesis, degenerative disc disease, deformities, tumor, pseudoarthrosis, trauma, and/or previous failed fusion surgery. |
  | Substantial Equivalence:
• Must be substantially equivalent in design, materials, and indications to predicate devices (TSRH™ Spinal Implant System and ISOLA® Spinal System). | Basis for Equivalence:
• The ISOBAR Spinal System hook components are similar in design, materials, and indications to the TSRH™ Spinal Implant System (K982990) and the ISOLA® Spinal System (K980485). |

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.

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The ISOBAR Semi-rigid 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, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Semi-rigid 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 Semi-rigid 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 allov (Ti-6Al-4V) that conforms to ASTM F136.

This system consists of pedicle screws that require 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 Semi-rigid Spinal System. It details the device's description, intended use, and states its substantial equivalence to a previously cleared device (ISOBAR Spinal System K990118).

However, the summary does not contain the information requested regarding specific acceptance criteria, a detailed study proving device performance against those criteria, sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods for ground truth establishment.

Instead, it explicitly states:
"The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. However, static and fatigue compression testing of the U-Line Screws was performed according to ASTM F1717-96."

This indicates that while some testing was conducted to a recognized standard (ASTM F1717-96), it was not against FDA-established performance standards or specific acceptance criteria provided within this document. The primary basis for clearance is substantial equivalence to an existing device, not a new comparative effectiveness study or standalone performance evaluation against predefined criteria as would be typical for an AI/CADe device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided document does not contain this information in the level of detail requested for a typical AI/CADe device submission.

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The ISOLOCK 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 ISOLOCK 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 ISOLOCK Spinal System consists of pedicle screws, rods, nuts, crosslink members and plates. 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.

This system consists of pedicle screws that require plate assembly directly over the top of the screw and a combination of screws and clamps that allow the rod to be offset from the screw.

This document describes the ISOLOCK Spinal System, a pedicle screw system. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. The testing appears to be mechanical (static and fatigue compression) on device components, not on patient data.
• Data Provenance: The document does not mention data provenance in terms of country of origin or retrospective/prospective for patient data, as the performance data is related to component testing.

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

• This information is not applicable as the performance data described relates to mechanical testing (static and fatigue compression) of the device components according to an ASTM standard, not clinical expert review of human data.

4. Adjudication Method for the Test Set

• This information is not applicable as the performance data described relates to mechanical testing, not clinical data requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The study described is mechanical testing of physical device components.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, this is not applicable. The device is a physical pedicle screw spinal system, not an algorithm or AI.

7. Type of Ground Truth Used

• The "ground truth" for the mechanical testing would be the specifications and requirements set forth in the ASTM F1717-96 standard. The device's components were tested to ensure they performed within the acceptable parameters defined by this engineering standard for static and fatigue compression.

8. Sample Size for the Training Set

• This information is not applicable as the device is a physical medical implant, not an AI or algorithm that requires a training set.

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

• This information is not applicable for the same reason as above (physical implant, not an AI/algorithm).

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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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