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The MESA and DENALI Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications:

Posterior non-cervical fixation as an adjunct to fusion 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; pseudoarthosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.

Except for the ARI staples, the MESA. DENALI and EVEREST Spinal Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis when used for posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Range (Denali and Mesa) Spinal Systems are top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation systems consisting of pedicle screws, rods, hooks and rod connectors. The purpose of this 510(k) is to add revision connectors and rods to the system.

Function: The systems function as spinal fixation devices to provide support and stabilization of the posterior thoracic and lumbar spine.

This FDA 510(k) summary describes the Range (Denali and Mesa) Spinal Systems. However, it does not contain the kind of detailed information about acceptance criteria and a study that proves the device meets those criteria, as typically found in submissions for AI/ML-driven medical devices.

The document pertains to a traditional medical device (spinal fixation system) and thus the "acceptance criteria" and "study" refer to mechanical performance evaluations, not AI/ML performance.

Based on the provided text, the answer is that the document does not contain the requested information regarding acceptance criteria and a study proving an AI/ML device meets them.

Here's a breakdown of why the requested information cannot be extracted from this document, and what is present:

• 1. A table of acceptance criteria and the reported device performance: This document reports that "Mechanical testing in accordance with ASTM F1717 (including static torsion, static compression and dynamic compression bending) was conducted on constructs representing the worst case components." It states, "The test results revealed that the proposed implants were substantially the same as the predicate devices."
  • Missing: Specific numerical acceptance criteria (e.g., minimum torque, maximum displacement) and the corresponding numerical results from the K2M device. The report only states "substantially the same."
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
  • Missing: This information is not relevant to a mechanical test of a spinal implant and is therefore not provided.
• 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):
  • Missing: This information is not relevant to mechanical testing, which relies on physical measurements and established ASTM standards, not expert interpretation.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
  • Missing: Not applicable for a mechanical performance study.
• 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:
  • Missing: This is relevant for AI/ML diagnostic or assistive devices, not for a spinal fixation system.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  • Missing: Not applicable for a traditional medical device.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
  • Existing (for mechanical testing): The "ground truth" would be the established acceptable ranges or performance levels defined by the ASTM F1717 standard for spinal implant mechanical properties and comparison to predicate devices' performance.
• 8. The sample size for the training set:
  • Missing: No training set is involved for a mechanical implant.
• 9. How the ground truth for the training set was established:
  • Missing: No training set or ground truth in the AI/ML sense is established for this device.

In summary, the provided document is for a traditional spinal implant and reports mechanical testing for substantial equivalence, not performance criteria or studies related to AI/ML algorithms, expert review, or clinical data interpretation.

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RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to 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): curvatures (i.e. scoliosis, kyphosis and/or lordosis): tumor: pseudarthrosis: and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system the RANGE Spinal System may also be used for the same indications as an adjunct to fusion.

Except for the ARI staples, the RANGE Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatic patients. The RANGE Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

The Range/Denali/Mesa Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system consisting of pedicle screws, rods, hooks and rod connectors. The purpose of this 510(k) is to add Mesa Hook-Claws to the system.

Function: The system functions as a spinal fixation device to provide support and stabilization of the posterior thoracic and lumbar spine.

This document is a 510(k) premarket notification for the K2M Range/Denali/Mesa Spinal System. It does not describe a study involving a device that uses artificial intelligence or machine learning, therefore, the requested information for acceptance criteria and study details cannot be extracted from the provided text.

The document discusses a spinal fixation system, its indications for use, comparison to predicate devices, and non-clinical mechanical performance evaluation. It confirms the mechanical testing was performed according to ASTM F1717 standards, which are physical tests, not AI model evaluations.

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RANGE/DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications:

Non-cervical fixation as an adjunct to 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; pseudoarthosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral the Range Spinal System may also be used for the same indications as an adjunct to fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Range/Denali/Mesa Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The subject 510(k) adds additional screws and rods to the system.

Function: The system functions as a spinal fixation device to provide support and stabilization of the posterior thoracic and lumbar spine.

This document is a 510(k) premarket notification for a medical device called the RANGE/DENALI/MESA Spinal System. It's a regulatory submission to the FDA, not a clinical study report. Therefore, much of the requested information regarding acceptance criteria and clinical study details is not present in this type of document.

However, I can extract what is available and clarify what is not.

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

This document does not provide explicit acceptance criteria or reported device performance in the context of a clinical study. Instead, it describes a "Technological Comparison to Predicate(s)" and "Non-clinical Performance Evaluation."

• Acceptance Criteria (Implicit from Non-clinical Testing): The implicit acceptance criterion for the non-clinical performance evaluation is that the proposed implants (new screws and rods) are "substantially the same as the predicate devices" in terms of design features, materials, and sizes, and perform comparably in "worst case components" testing.
• Reported Device Performance (Non-clinical):
  • Performance evaluations were previously conducted on constructs representing the worst-case components.
  • Tests included: static torsion, static compression, and dynamic compression bending.
  • These tests were performed in accordance with ASTM F1717.
  • "Engineering rationales determined that the proposed implants were substantially the same as the predicate devices."

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

This document describes non-clinical performance evaluations (mechanical testing), not a clinical test set involving human subjects. Therefore, information about human sample size, data provenance (country, retrospective/prospective) is not applicable or provided.

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 as there is no clinical test set or ground truth established by medical experts for device performance in this document. The "ground truth" for the non-clinical testing is compliance with ASTM F1717 and comparability to predicate devices.

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

This is not applicable as there is no clinical test set or adjudication process 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, an MRMC comparative effectiveness study was not done. This device is a spinal fixation system (physical implant), not an AI diagnostic tool.

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

No, this is not an algorithm or AI device.

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

For the non-clinical performance evaluation, the "ground truth" is adherence to ASTM F1717 standards and demonstrating substantial equivalence in mechanical properties to previously cleared predicate devices. There is no clinical ground truth established or used in this submission.

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device that requires a training set.

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

This is not applicable for the same reason as above.

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RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondy lolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis: and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is linited to a posterior approach.

The Range/Mesa/Denali Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors The subject 510(k) adds additional screws and connectors to the system.

Function: The system functions as a spinal fixation device to provide support and stabilization of the posterior thoracic and lumbar spine.

The provided text is a 510(k) premarket notification from the FDA for a medical device called the "Range/Denali/Mesa Spinal System." This type of document focuses on establishing substantial equivalence to previously cleared devices rather than presenting new clinical study data with specific acceptance criteria and performance metrics for a novel device.

Therefore, the document does not contain the information requested in your prompt regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set.
3. Data provenance (country of origin, retrospective/prospective).
4. Number of experts used to establish ground truth.
5. Qualifications of experts.
6. Adjudication method.
7. MRMC comparative effectiveness study.
8. Standalone (algorithm only) performance.
9. Type of ground truth used (pathology, outcomes data, etc.)
10. Sample size for the training set.
11. How ground truth for the training set was established.

Instead, the document states:

• Non-clinical Performance Evaluation: "Performance evaluations were previously conducted on constructs representing the worst case components (including static torsion, static compression and dynamic compression bending in accordance with ASTM F1717). Engineering rationales determined that the proposed implants were substantially the same as the predicate devices." (Page 4)

This indicates that the evaluation was based on non-clinical mechanical testing of the device's components against recognized standards (ASTM F1717) and engineering rationales to demonstrate substantial equivalence to predicate devices, not on human clinical data or the performance of an AI algorithm evaluated against ground truth established by experts.

The core of a 510(k) submission is to show that a new device is "substantially equivalent" to an already legally marketed device (predicate device), meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that the new characteristics do not raise different questions of safety and effectiveness. This typically relies on testing against standards and comparison to predicates, not de novo clinical studies with acceptance criteria as one might see for AI/ML devices or novel therapies.

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RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to 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); turnor: pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Range/Mesa/Denali Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors The subject 510(k) adds Mesa 2 implants and connectors to the system.

Function: The system functions as a spinal fixation device to provide support and stabilization of the posterior thoracic and lumbar spine.

The provided text is related to a 510(k) premarket notification for a spinal fixation system, not a device that would typically have acceptance criteria and performance evaluated through clinical studies with ground truth. This document is a regulatory clearance from the FDA for a medical device (Range/Denali/Mesa Spinal System) based on its substantial equivalence to previously marketed predicate devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training and test sets cannot be extracted from this document. The document describes a "non-clinical performance evaluation" based on mechanical testing, not a study involving human data or AI algorithms.

Here's why and what information is available:

• Device Type: The device is a "Spinal Fixation System" (pedicle screws, rods, hooks, connectors) which is an implantable medical device used in orthopedic surgery. These devices are typically cleared based on mechanical performance, material compatibility, and substantial equivalence to existing devices, rather than human clinical studies with "ground truth" as you'd find for diagnostic AI algorithms.
• Regulatory Pathway: This is a 510(k) submission, which means the manufacturer is demonstrating that their new device is substantially equivalent to a legally marketed predicate device. This often relies on comparative analysis of design, materials, and mechanical testing, rather than extensive human clinical trials to establish efficacy or diagnostic performance.
• "Performance Evaluation" mentioned: The document states: "Performance evaluations were conducted on constructs representing the worst case components (including static torsion, static compression and dynamic compression bending in accordance with ASTM F1717) and the proposed implants were found to be substantially the same as predicate devices." This refers to mechanical testing in a lab setting, not a clinical study involving patients or AI.

In summary, there is no information in the provided text to fulfill your request for acceptance criteria and study details related to device performance in a clinical setting, as this document pertains to the regulatory clearance of a physical implantable device based on substantial equivalence and mechanical testing.

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

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Mesa Spinal System is a top-loading, multiple component, spinal fixation system. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from titanium and cobalt chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to provide immobilization and stabilization of spinal segments of the thoracic, lumbar and / or sacral spine.

The provided text pertains to a 510(k) summary for the "Mesa Spinal System" and its substantial equivalence to predicate devices. It describes the device, its intended use, and a comparison to other legally marketed systems, primarily focusing on mechanical testing against ASTM F1717 standards.

However, the document does not contain information about acceptance criteria, a specific study used to prove the device meets those criteria, or details regarding ground truth, expert consensus, or clinical performance data that would typically be found in a study demonstrating effectiveness for a diagnostic or AI-driven device.

This document is for a spinal fixation system, which is a mechanical implant, not a diagnostic or AI device. Therefore, the questions posed (related to AI performance, expert ground truth, multi-reader studies, etc.) are not applicable to this type of medical device submission.

The "study" referenced in the document is mechanical testing to ASTM F1717.

Here's how to address the prompt based on the provided text, while acknowledging the limitations:

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

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

• Test Set Sample Size: Not specified in terms of patient data. The "test set" here refers to the components of the Mesa Spinal System subjected to mechanical testing. The number of components tested for ASTM F1717 is not detailed.
• Data Provenance: Not applicable in the context of patient data for a mechanical fixation device. The testing is performance-based for the device itself.

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. This document describes a mechanical device, not a diagnostic or AI system requiring expert-established ground truth from medical images or clinical outcomes. The "ground truth" for the mechanical testing is defined by the ASTM F1717 standard itself.

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

• Not applicable. Adjudication methods are typically used for clinical studies involving human interpretation or uncertain outcomes. This document details mechanical testing against a standard.

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 spinal fixation system, not a diagnostic or AI device. An MRMC study is not relevant to this type of device.

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

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

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

• The "ground truth" in this context is the ASTM F1717 standard for mechanical testing of spinal implant constructs. The device's performance is compared against the requirements and performance characteristics of legally marketed predicate devices as measured under this standard.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI system that requires a "training set."

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

• Not applicable. As a mechanical device, a training set and its associated ground truth are not relevant concepts for this submission.

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Non-cervical spinal fixation devices intended for posterior, non-pedicle fixation for the following indications: degenerative disc disease ( DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.

The Mesa Spinal System is a top-loading, multiple component, posterior system which consists of pedicle screws, rods, hooks, and transverse connectors. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of spinal segments of the thoracic, lumbar and / or sacral spine.

This request is about a medical device, the Mesa Spinal System, specifically the 4.0mm Screw component, and not about an AI/ML powered device. Therefore, many of the typical acceptance criteria and study design elements expected for an AI/ML device (like sample size for test/training sets, ground truth methodology, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable here.

The provided text describes a 510(k) submission for the Mesa Spinal System, which is a spinal fixation device. For such devices, the "acceptance criteria" and "study" typically revolve around demonstrating substantial equivalence to a legally marketed predicate device through engineering and biocompatibility testing, material characterization, and comparison of design features and intended use.

Here's an analysis based on the provided text, addressing the relevant points where possible:

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)

• Sample Size for Test Set: This is not applicable in the context of this 510(k) submission. "Test set" typically refers to data used to evaluate an AI/ML model's performance on unseen data. For a spinal fixation device, performance is evaluated through material testing and biomechanical testing on representative samples of the device components, not a "test set" of patient data. The text indicates that the device was "biomechanically tested," which implies a certain number of physical samples were subjected to various tests, but the exact count is not provided.
• Data Provenance: Not applicable in the AI/ML sense. The "data" here would be the results of laboratory biomechanical and material tests. The document does not specify the location where these tests were performed or if they were retrospective or prospective, as these terms are generally used for clinical studies or data collection for AI.

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" and "experts" in this context are not relevant for demonstrating substantial equivalence for a spinal fixation device. Performance is determined by objective engineering and material standards (e.g., ASTM F1717).

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

• Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling or diagnoses, which is not part of a spinal fixation device's 510(k) submission.

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 for AI-assisted image interpretation or diagnostic tools. The Mesa Spinal System is a physical implant, not an AI diagnostic tool.

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

• Not applicable. This concept pertains to AI algorithms.

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

• Not applicable. "Ground truth" as an expert-derived label or outcome is not used here. Instead, the "truth" or standard for performance is defined by established engineering and material standards (e.g., ASTM F1717 for biomechanical testing) and comparison to the predicate device's characteristics.

8. The sample size for the training set

• Not applicable. There is no "training set" for physical medical devices in this context.

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

• Not applicable. As there's no training set, there's no ground truth to establish for it.

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The Mesa Spinal System is a non-cervical spinal fixation device intended for posterior, non-pedicle fixation for the following indications: degenerative disc disease ( DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Mesa Spinal System is also intended for non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe 'pondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by utogenous 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 Mesa Spine System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, hooks, and transverse connectors. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar and / or sacral spine.

The provided document is a 510(k) Summary for the Mesa Spinal System, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed device. It describes the device's intended use, materials, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of clinical or diagnostic efficacy.

Instead, the document primarily focuses on biomechanical testing to demonstrate equivalence to predicate devices, which is typical for spinal fixation systems. Here's a breakdown of why the requested information cannot be fully provided from the given text:

1. Acceptance criteria and reported device performance (Table 1): The document states: "The Mesa Spine System was biomechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717." This indicates a type of performance standard (ASTM F1717) was used, and the device met or exceeded it. However, specific numerical acceptance criteria (e.g., "must withstand X N of force," "fatigue life must exceed Y cycles") and the exact reported performance values are not detailed in this summary. The table below reflects the limited information available.

2. Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, and ground truth establishment for a clinical/diagnostic study: These questions are entirely not applicable to the type of information presented in this 510(k) summary. The document describes a biomechanical study, not a clinical study involving human patients, image analysis, or diagnostic accuracy where such details would be relevant.

Therefore, most of the requested fields cannot be filled based on the provided text.

Here's the closest possible answer based only on the provided text, with explanations where information is absent:

Acceptance Criteria and Device Performance

Explanation: The document explicitly states that the device was biomechanically tested against the ASTM F1717 standard and compared to predicate devices. The acceptance criterion was implicitly defined as performing "equal to or better than" these established systems. Specific numerical thresholds for this ASTM standard and the exact results are not provided in this 510(k) summary.

Details of the Study

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

   • Sample Size: Not specified. (This likely refers to the number of devices or components tested in the biomechanical study).
   • Data Provenance: Not applicable, as this was a biomechanical study, not a clinical data collection from patients or specific countries.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not Applicable. This was a biomechanical test of physical properties, not a study requiring expert clinical "ground truth" establishment.

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

   • Not Applicable. (Again, this pertains to clinical/diagnostic studies, not biomechanical tests).

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. An MRMC study was not done. This device is a spinal fixation system, not a diagnostic AI tool, so this type of study is irrelevant.

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

   • Not Applicable. This is a physical medical device, not an algorithm.

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

   • Not Applicable. The "ground truth" for a biomechanical study would typically be the physical properties and performance standards defined by the ASTM F1717 standard and the performance of the predicate devices.

7. The sample size for the training set:

   • Not Applicable. This device is hardware; there is no "training set" in the machine learning sense.

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

   • Not Applicable. As there is no training set for this type of device and study.

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