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The Trivergent Spinal Fixation System is intended to provide immobilization of a single spinal segment in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of lumbar and sacral spine from L2-S1: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; and failed previous fusion.

The Trivergent Spinal Fixation System is a pedicle screw system intended to stabilize and immobilize the L2-S1 spinal segments as an adjunct to fusion. The system includes a variety of screws and plates along with guides, guidewires, drills, drivers, handles, and tans.

The Trivergent Spinal Fixation System plates and screws are available in a variety of geometries to accommodate various patient anatomies. The Trivergent screws come in lengths from 45mm to 60mm, and the Trivergent plates come in angles from 60° to 75°.

The Trivergent Spinal Fixation System implants and instruments are provided non-sterile and are to be sterilized by the end user.

The Trivergent Spinal Fixation System implants are machined from Ti-6A1-4V ELI per ASTM F136.

This document describes the Trivergent Spinal Fixation System, a medical device. Based on the provided text, it's a 510(k) Premarket Notification for a Class II medical device, specifically a pedicle screw system. These submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results for novel AI-powered diagnostics.

Therefore, the information typically found in an AI/ML medical device submission (such as acceptance criteria for AI performance, clinical study design for AI efficacy, expert adjudication, etc.) is not present in this document. The "Performance Testing Summary" section focuses on bench testing of the physical device (e.g., static compression, fatigue testing) and a cadaver usability study, which are standard for orthopedic implants, not AI/ML algorithms.

Based on the provided text, I cannot answer the questions directly as they pertain to an AI/ML device's acceptance criteria and proving its performance.

Here's why and what information is available:

• Device Type: This is a physical orthopedic implant (spinal fixation system), not an AI/ML diagnostic or therapeutic device.
• Regulatory Pathway: 510(k) demonstrates substantial equivalence, primarily through non-clinical (bench) testing and comparison to predicates, not typically extensive human clinical trials to establish efficacy akin to AI-driven diagnostics.
• Lack of AI/ML Specifics: There is no mention of algorithms, machine learning, image analysis, or any other AI-related components.

Therefore, the questions regarding acceptance criteria for AI performance, sample sizes for AI test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance simply do not apply to the content of this particular document.

If this document were for an AI/ML device, the required information would be detailed under sections like "Clinical Performance Data," "Software Validation," or "Algorithm Performance Benchmarks." This document is focused on the mechanical and material properties of a physical implant.

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The Luna XD Ti Interbody Fusion System consists of the Luna XD Ti Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna XD Ti Interbody Fusion is to be used with autogenous bone graft and/or allogence bone graft composed of cancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna XD Ti Implant. The Luna XD Ti Interbody Fusion System is to be used with supplemental fixation.

The Benvenue Luna XD Ti Interbody Fusion System consists of the Luna XD Ti Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna XD Ti Interbody Fusion System are identical to the primary predicate device. The Luna XD Ti Implant is provided pre-loaded and sterile within a single-use Insertion Tool.

The Luna XD Ti Implant is an assembly of three (3) PEEK components referred to as the Top, Middle and Bottom, similar to the Luna 3D Gen2. Additionally, a Nitinol Spine is inserted into the middle component to retain its normally closed shape configuration. And finally, the outer top and bottom surfaces of the implant XD Ti have a commercially pure (Cp) Ti metallic powder. The final components have radiopaque tantalum markers for fluoroscopic visibility.

The outer surfaces of the Top and Bottom components have teeth in addition to the already rough surface created by the Ti coating, which are designed to enhance the implant's resistance to expulsion. Upon insertion of the outer components, the middle component is inserted to expanded into its ultimate height. The central cavity of the implant accommodates placement of autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft through a graft window.

The Luna XD Ti Implant is manufactured from polyetheretherketone (Evonik VESTAKEEP i4R; ASTM F2026), Nitinol (nickel titanium alloy; ASTM F2063), tantalum (ASTM F560) and commercially pure (Cp) Ti metallic powder coating layer (ASTM F 1580).

The Luna XD Ti Implant is available in heights ranging from 10mm to 14mm with 2mm increments and a 6° lordotic angle and from 12mm with 2mm increments and a 12° lordotic angle. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates. In addition, the outer top and bottom surfaces of the implant XD Ti have a commercially pure (Cp) Ti metallic powder conforming to ASTM F1580 with a specified grain size and morphology. This additional titanium coating offers initial stability due to increased surface roughness and possibly also long-term stability due to bony ingrowth created from osteoconductive microenvironment on the device surface.

The Luna XD Ti Implant that is the subject of this 510(k) is manufactured from polyetheretherketone (Evonik VESTAKEEP i4R; ASTM F2026), Nitinol (nickel titanium alloy; ASTM F2063), tantalum (ASTM F560) and commercially pure (Cp) Ti metallic powder coating layer (ASTM F 1580). This 510(k) is submitted in support of the additional surface coating to an existing Device cleared under K183560.

The extract provided describes the Luna XD Ti Interbody Fusion System, which is an intervertebral body fusion device. The document is an FDA 510(k) premarket notification summary.

Based on the provided text, the device is not an AI/ML powered device. The information focuses on mechanical testing, material properties, and sterilization, comparing the device to a predicate device. Therefore, several of the requested categories related to AI/ML device performance, such as 'number of experts used to establish ground truth', 'adjudication method', 'MRMC study' and 'standalone algorithm performance' are not applicable to this submission.

Here is the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document primarily describes mechanical and material testing based on ASTM standards. It does not mention human subject studies or a "test set" in the context of clinical data for AI/ML performance. The "testing" refers to bench testing of the device and its materials.
• No information on "data provenance" (country of origin, retrospective/prospective) is provided as it's not a clinical study.

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

• Not Applicable. This is a medical device (interbody fusion system) of the mechanical type, not an AI/ML diagnostic or prognostic tool. Therefore, "ground truth" as related to expert interpretation of data is not relevant here.

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

• Not Applicable. See point 3.

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 not an AI-assisted device.

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.):

• For mechanical and material performance, the "ground truth" is established by adherence to recognized ASTM and other relevant standards for material properties, mechanical integrity, and biocompatibility, as well as comparison to the performance of a legally marketed predicate device. The ultimate "ground truth" for substantial equivalence lies in demonstrating that the modified device performs similarly or better than the predicate device in relevant bench tests.

8. The sample size for the training set:

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

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

• Not Applicable. See point 8.

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The Luna 3D GEN2 Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D GEN2 Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D GEN2 Implant. The Luna 3D GEN2 Interbody Fusion System is to be used with supplemental fixation.

The Benvenue Luna 3D GEN2 Interbody Fusion System consists of the Luna 3D GEN2 Implant and associated accessories set of disposable and re-usable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 3D GEN2 Interbody Fusion System are identical to the primary predicate device. The Luna 3D GEN2 Implant is provided pre-loaded and sterile within a single-use Insertion Tool.

The Luna 3D GEN2 Implant is available in heights ranging from 10mm to 14mm with 2mm increments and a 6° lordotic angle and from 12mm with 2mm increments and a 12° lordotic angle. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space. Once the implant is in the desired position, the device is expanded into its ultimate height and forming a bone graft pocket. Teeth on the outer surfaces of the top and bottom components engage the implant into the adjacent endplates.

The Luna 3D GEN2Implant that is the subject of this 510(k) is manufactured from polyetheretherketone (VESTAKEEP i4R, conforming to ASTM F2026), nitinol wire (superelastic alloy SE508, conforming to ASTM F2063) and tantalum rod conforming to ASTM F560. This 510(k) was submitted in support of the Generation 2 device.

This FDA 510(k) summary does not describe an AI medical device. It pertains to the Luna 3D GEN2 Interbody Fusion System, which is a physical intervertebral body fusion device used in spinal fusion procedures. The document focuses on mechanical and material testing to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI algorithm based on data.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI device is not applicable and cannot be extracted from this document.

The "Performance Testing" section (page 5) describes the mechanical testing performed on the device:

• Acceptance Criteria & Reported Performance: Not explicitly stated as acceptance criteria with numerical targets. However, the document states, "The results demonstrate that the Luna 3D GEN2 Interbody Fusion System device is substantially equivalent to the predicate devices." This implies that the performance in these tests met a level comparable to the predicate devices.

  • Tests performed:
    • Static compression
    • Static compression-shear
    • Static torsion
    • Static modified compression-shear
    • Dynamic compression
    • Dynamic compression-shear
    • Dynamic torsion
    • Expulsion
    • Subsidence
    • Corrosion testing (ASTM F2129)
    • Nickel leaching quantitative ICP/MS analysis
    • Surgical technique validation in cadaver specimens

• Sample size for the test set: Not specified in the provided text. The document mentions "worst-case devices" were subjected to mechanical testing, but the number of devices is not given.

• Data provenance: Not applicable in the context of an AI device. The tests are laboratory-based mechanical and material performance tests.

• Number of experts and qualifications for ground truth: Not applicable. The "ground truth" here is the physical performance of the device under specific mechanical loads and conditions, measured objectively according to ASTM standards.

• Adjudication method: Not applicable.

• MRMC comparative effectiveness study: Not applicable. This is a physical device, not an AI algorithm for diagnostic or prognostic purposes.

• Standalone (algorithm only) performance: Not applicable. This is a physical device.

• Type of ground truth used: Material and mechanical engineering standards (ASTM F2077-14, F2267-04, F2129, F2063, F560) and cadaveric testing for surgical technique validation.

• Sample size for the training set: Not applicable. There is no training set for a physical device.

• How the ground truth for the training set was established: Not applicable.

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The Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D Implant. The Luna 3D Interbody Fusion System is to be used with supplemental fixation.

The Benvenue Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 3D Interbody Fusion System are identical to predicate interbody lumbar cages. The Luna 3D Implant is provided pre-loaded and sterile within a single-use Insertion Tool.

The Luna 3D Implant is available in heights ranging from 8mm to 15mm in 1mm increments. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates.

The Luna 3D Implant is manufactured from polyetheretherketone (PEEK Optima LT-1 or Evonik VESTAKEEP i4R), stainless steel, tantalum, and silicone lubricant (NuSil MED-360).

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a diagnostic algorithm or AI product would be evaluated (e.g., sensitivity, specificity, or reader studies). This document is a 510(k) premarket notification for a medical device called the "Luna 3D Interbody Fusion System," which is an implant for spinal fusion procedures.

The "Performance Testing" section describes bench testing conducted to evaluate the impact of design changes on product performance. This is typical for mechanical devices and focuses on physical and mechanical properties, not diagnostic accuracy or human-AI comparative effectiveness.

Here's an analysis of the information that is available in relation to your request, and where the requested information is missing:

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

• Missing. The document describes a medical implant, not an AI or diagnostic device that would have performance criteria like sensitivity or specificity. The "performance testing" referred to are mechanical bench tests.

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

• Missing. The "performance testing" involved mechanical bench tests (static/dynamic compression, shear-compression, torsion, and subsidence testing). These do not involve "test sets" in the context of patient data or AI evaluation.

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 concept is not applicable to the type of device and testing described.

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

• Missing. This concept is not applicable to the type of device and 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

• Missing. This is not an AI or diagnostic imaging device.

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

• Missing. This is not an AI or algorithm-based device.

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

• Missing. For mechanical testing, the "ground truth" would be the engineering specifications and established mechanical testing standards (e.g., ASTM F2077, ASTM F2267). The document states the results "confirmed that this design is substantially equivalent to legally marketed predicate devices," implying successful adherence to these standards and equivalence criteria.

8. The sample size for the training set

• Missing. This concept is not applicable to the type of device and testing described.

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

• Missing. This concept is not applicable to the type of device and testing described.

Summary of available information related to performance:

The document describes performance testing for the Luna 3D Interbody Fusion System, which is a physical implant. This testing was primarily bench testing (mechanical tests) to confirm the new design's equivalence to predicate devices and ensure its structural integrity and performance under various loads.

• Tests Conducted:
  • Static/dynamic compression
  • Static/dynamic shear-compression
  • Static/dynamic torsion tests (per ASTM F2077)
  • Subsidence testing (per ASTM F2267)
• Purpose: To evaluate the impact of minor design changes (e.g., addition of an 8-degree lordotic version, expansion of implant height, use of alternative PEEK material, alternative trial instrument) on product performance.
• Conclusion of Testing: The results "confirmed that this design is substantially equivalent to legally marketed predicate devices."

In essence, for this medical implant, the "acceptance criteria" were implied to be meeting the mechanical performance characteristics demonstrated by predicate devices, as assessed through standardized bench tests. This is a very different type of evaluation compared to the performance assessment of AI/diagnostic software.

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The Luna 360 Interbody Fusion System consists of the Luna 360 Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 360 System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 360 Implant. The Luna 360 System is to be used with supplemental fixation.

The Benvenue Luna 360 System consists of the Luna 360 Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 360 System are identical to predicate interbody lumbar cages. The Luna 360 Implant is provided pre-loaded and sterile within a single-use Insertion Tool.

The Luna 360 Implant is available in heights ranging from 8mm to 13mm in 1mm increments. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates.

The Luna 360 Implant is manufactured from polyetheretherketone (PEEK Optima LT-1), stainless steel, tantalum, and silicone lubricant (NuSil MED-360).

The provided text describes a 510(k) premarket notification for the "Luna 360 Interbody Fusion System." This document is primarily concerned with establishing substantial equivalence to legally marketed predicate devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically found in AI/ML medical device submissions.

Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, and adjudication methods is not available in the provided text, as this type of information is generally not required for this specific device type and approval pathway.

The device is an intervertebral body fusion device, not an AI/ML algorithm, and thus the concepts of "acceptance criteria" for algorithm performance, "test set," "training set," "ground truth," "MRMC studies," or "standalone performance" as they relate to AI/ML devices do not apply here.

However, the document does contain information about performance testing relevant to a medical device's physical and mechanical properties.

Here's a breakdown of the relevant information provided:

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

• Acceptance Criteria (Implicit): The implicit acceptance criterion is that the device demonstrates mechanical properties that are "substantially equivalent" to legally marketed predicate devices, particularly regarding static/dynamic compression, shear-compression, torsion, subsidence, and expulsion. The specific numerical thresholds for "acceptance" are not explicitly stated as they would be in an AI/ML performance summary, but rather implied by meeting the standards of similar devices.
• Reported Device Performance:
  • Mechanical Testing: The tests demonstrated that the Luna Interbody System is "substantially equivalent" to legally marketed predicate devices in static/dynamic compression, static/dynamic shear-compression, static/dynamic torsion testing (per ASTM F2077), static subsidence (ASTM F2267), and expulsion testing (ASTM Draft Standard F-04.25.02.02).
  • Cadaveric Testing: Performed to validate the surgical technique.
  • MR Compatibility Testing: Performed to demonstrate MR safety.

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

• Not applicable for this type of device and testing. The "test set" in this context refers to the physical devices undergoing mechanical and material testing, not a dataset of patient images or clinical outcomes.

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

• Not applicable. "Ground truth" in this context would likely refer to engineering specifications or validated test methods, rather than expert diagnostic opinions.

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

• Not applicable.

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

• Not applicable. This device is not an AI-assisted diagnostic tool.

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

• Not applicable.

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

• For the mechanical testing, the "ground truth" would be the established ASTM standards (F2077, F2267, and ASTM Draft Standard F-04.25.02.02) and engineering principles for mechanical performance. For MR compatibility, the "ground truth" would be established MR safety protocols.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device.

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

• Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device (intervertebral body fusion system) based on substantial equivalence to existing devices, supported by a series of mechanical and material performance tests. It does not involve a clinical study or AI/ML algorithm, and therefore the specific questions related to AI/ML validation are not addressed by the text.

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The Kiva VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

The Kiva® VCF Treatment System is provided as a sterile, single use, implantable device which may be used in percutaneous procedures for the reduction and treatment of spinal fractures. The device consists of an implant, a deployment system for the implant, and a set of accessory access instruments. The deployment system component is a single-use, non- implantable device that is used to properly position and deliver the implant. It consists of a nitinol Kiva Coil, which is guided through a deployment cannula into the bone via a hand- operated mechanism. The Kiva Implant, made from PEEK Optima with barium sulfate for radiopacity, is guided over the nitinol Kiva Coil. As the Kiva Implant is pushed over the Kiva Coil, it reduces the fracture via height distraction of the vertebral body. Up to 5 loops of implant may be deployed, corresponding with a maximum height of 15mm. Once the Implant is placed into the vertebral body, PMMA bone cement is deployed into the Kiva Implant. The Kiva Implant contains the PMMA bone cement and helps extravasation. A collection of manual surgical orthopedic instrumentation (Class I needles, stylets, cannulas) is used to gain access to the vertebral body at the start of the procedure, then again later for bone cement deployment. Other instruments are optional for the physician and not provided as part of the Kiva® VCF Treatment System including a Bone Drill, a Bone Biopsy Needle and Kiva Pilot.

The provided text describes the Kiva® VCF Treatment System, a medical device for treating spinal fractures. However, it does not include information about a study proving the device meets acceptance criteria related to AI/algorithm performance, nor does it mention any AI components, human readers, or ground truth establishment in the context of an AI-powered diagnostic or treatment device.

The document is a 510(k) summary for a physical medical device that augments vertebral bodies with cement. The "acceptance criteria" and "study" described in the provided text relate to the mechanical and biomechanical performance of an implantable device, specifically comparing a 5-loop version to a 4-loop version.

Therefore, most of your requested information (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness, standalone performance, training set sample size, ground truth for training set) is not applicable or present in this document, as it pertains to AI/algorithm studies, not the mechanical testing of a physical implant.

I can, however, extract the acceptance criteria and performance data relevant to the physical device's mechanical integrity and deployment performance as described in the document.

Acceptance Criteria and Device Performance (for the physical Kiva® VCF Treatment System)

Study Information (related to the physical device's mechanical and deployment performance):

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

   • Biomechanics: Not explicitly stated as a "sample size" of devices evaluated, but indicates testing per ASTM F2077-11 and ASTM F1877-05 for both the 4-loop and 5-loop systems. These standards specify how many samples are typically tested.
   • Deployment Performance: "a total of 30 units" for the 5-loop system.
   • Data Provenance: The cadaveric spines and urethane foam analogs would be considered laboratory/bench testing data. The origin isn't specified (e.g., country), but it's a controlled test environment. This is prospective testing for the device modification.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is meeting engineering specifications (e.g., structural integrity, successful deployment), not expert clinical interpretation.

3. Adjudication method for the test set: Not applicable. This refers to mechanical testing against engineering standards.

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: Not applicable. This document does not describe a study involving human readers or AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about a physical medical device, not an algorithm.

6. The type of ground truth used:

   • Biomechanical Performance: Adherence to established ASTM standards (material and mechanical engineering specifications).
   • Deployment Performance: Successful completion of a predefined simulated clinical-use protocol (i.e., successful deployment of the implant within specified parameters).

7. The sample size for the training set: Not applicable. There is no algorithm or "training set" mentioned.

8. How the ground truth for the training set was established: Not applicable. There is no algorithm or "training set" mentioned.

Summary of the document's relevance:

This document is a regulatory submission demonstrating the substantial equivalence of a modified physical medical device (Kiva® VCF Treatment System with 5 loops) to a previously cleared version (4 loops). The "study" described is a series of non-clinical, benchtop, and simulated-use tests to ensure the modified device maintains the same safety and performance characteristics as its predicate. It is not related to software, AI, or diagnostic image analysis.

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The Kiva® VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

The Kiva® VCF Treatment System is provided as a sterile, single use, implantable device which may be used in percutaneous procedures for the reduction and treatment of spinal fractures. The device consists of an implant, a deployment system for the implant, and a set of accessory access instruments. The deployment system component is a single-use, nonimplantable device that is used to properly position and deliver the implant. It consists of a nitino! Kiva Coil, which is guided through a deployment cannula into the bone via a hand operated mechanism. The Kiva Implant, made from PEEK Optima with barium sulfate for radiopacity, is guided over the nitinol Kiva Coil. As the Kiva Implant is pushed over the Kiva Coil, it reduces the fracture via height distraction of the vertebral body. Once the Implant is placed into the vertebral body. PMMA bone cement is deployed into the Kiva Implant. The Kiva Implant contains the PMMA bone cement and helps minimize posterior extravasation. A collection of manual surgical orthopedic instrumentation (Class I needles, stylets, cannulas) is used to gain access to the vertebral body at the start of the procedure, then again later for bone cement deployment.

The provided text discusses the Kiva® VCF Treatment System, focusing on its substantial equivalence to predicate devices rather than defining specific acceptance criteria for a new device's performance against a numerical benchmark. The document describes a clinical trial (KAST trial) but uses its findings to support substantial equivalence, not to explicitly state and prove performance against pre-defined acceptance criteria with specific metrics.

Therefore, many of the requested sections about acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics cannot be directly extracted from the provided text. The document focuses on regulatory approval through substantial equivalence, which often relies on demonstrating similar safety and effectiveness to existing devices, rather than achieving independent, predefined performance thresholds.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not provide explicit acceptance criteria in numerical or precise qualitative terms typical for device performance studies (e.g., sensitivity, specificity thresholds, or specific success rates). Instead, it states:

• "The results demonstrate the safety and effectiveness of the Kiva® VCF Treatment System and support substantial equivalence to predicate devices."
• "Results demonstrated that the Kiva® VCF Treatment System is biocompatible."
• "Results of the testing confirm that the Kiva® VCF Treatment System can reliably perform as intended."

2. Sample sized 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: 300 subjects
• Data Provenance: Prospective, multi-center, randomized, controlled study. Conducted at 21 sites in the US, Canada, and Europe.

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 information is not provided in the text. The KAST trial evaluated "safety and effectiveness," with "primary endpoint was a composite of reduction in pain or improvement in function in the absence of device related serious adverse events." This suggests patient-reported outcomes and adverse event monitoring, not necessarily expert adjudication for image-based ground truth.

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

This information is not provided in the text. Given the nature of the primary endpoint (pain/function, adverse events), it's unlikely a specific "adjudication method" in the context of image interpretation or diagnostic performance would apply directly.

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

• MRMC Study: No, this was not an MRMC study. It was a clinical trial comparing the Kiva® VCF Treatment System to balloon kyphoplasty (another treatment method).
• Effect Size of human readers with/without AI: This is not applicable as the device is a VCF treatment system, not an AI or diagnostic imaging device.

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

This is not applicable as the Kiva® VCF Treatment System is a medical device for treating spinal fractures, not a standalone algorithm. Its performance is intrinsically linked to its use in a human-led procedure.

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

The "ground truth" for the primary endpoint relates to:

• Patient-reported outcomes: reduction in pain or improvement in function
• Absence of device-related serious adverse events

Secondary endpoints included:

• Vertebral height restoration
• Cement volume
• Quality of life
• Ambulatory status
• Subject satisfaction
• Cement extravasation
• Device or cement migration
• Subsequent fracture

These would have been assessed through various clinical measures, imaging, and patient self-assessment – a combination of outcomes data and clinical/imaging assessments.

8. The sample size for the training set

This information is not provided as the Kiva system is a physical device, not an AI model that requires a "training set" in the computational sense. The "KAST trial" is a clinical evaluation, not a dataset for training.

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

This is not applicable for the same reason as point 8.

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The Benvenue VCF Osteo Coil System is indicated for the treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions, by creating channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA).

The Benvenue VCF Osteo Coil System is packaged as a single-use, sterile, non-implantable device. It is a surgical instrument designed to be used in percutaneous applications, for the creation of channels within the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA). The Benvenue VCF Osteo Coil System consists of three primary components: Nitinol Osteo Coil, Deployment Cannula with PEEK liner, and Handle. The nitinol Osteo Coil is pre-set into a loop shape and can be temporarily straightened into a cannula for deployment into cancellous bone. Once positioned in the cancellous bone, the Osteo Coil is advanced forward out of the cannula. The surgeon controls the amount of Osteo Coil deployment with the use of the handle, which allows for incremental deployment and directional control. Upon exiting the Osteo coil regains its loop shape as it channels through the cancellous bone. The device is available in two sizes. This system does not include the bone cement.

The provided text describes a 510(k) submission for the Benvenue VCF Osteo Coil System, a surgical instrument. It details the device, its intended use, and claims of substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets them.

The "Discussion of Nonclinical Tests" section states: "The safety and performance of the Benvenue VCF Osteo Coil System have been substantiated through extensive non-clinical testing. Results of testing show that the Benvenue VCF Osteo Coil System can reliably and safely perform as intended in the treatment of pathological compression fractures of the vertebral body, by creating channels within the existing spinal bone structure in preparation for the flow of polymethylmethacrylate bone cement (PMMA). No new questions of safety or effectiveness have been raised."

This statement is a high-level summary and does not provide the specific details required to answer the request, such as a table of acceptance criteria, reported performance, sample sizes, ground truth establishment, or details of any comparative effectiveness studies.

Therefore, I cannot provide the requested information from the given text. The text confirms that non-clinical tests were performed to substantiate safety and performance, but it does not describe these tests or their results in sufficient detail to fulfill your requirements.

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