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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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