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V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine from T9 to L5. It is intended to be used in combination with Teknimed F20® bone cement.

V-STRUT© Vertebral Implant is part of V-STRUT© Transpedicular Vertebral System. V-STRUT© Transpedicular Vertebral System is composed of :

• V-STRUT© Vertebral Implant,
• -V-STRUT© Guide Wire,
• -V-STRUT© Instrumentation Kit.
  V-STRUT© Vertebral Implant is a medical device to be placed in the vertebrae through a minimally invasive procedure. Two devices are implanted in each vertebra to be treated. Each implant is introduced posteriorly through the pedicle up to the anterior vertebral body wall.
  The implant is made of radio transparent polymer, PEEK (Polyetheretherketone as per ASTM F2026) and includes two visualizing markers made of tantalum (as per ASTM F560).
  V-STRUT© Vertebral Implant exists in 2 different diameters and 5 different lengths to accommodate individual patient's anatomy of thoracic and/or lumbar vertebrae from T9 to L5.
  V-STRUT© Vertebral Implant is provided sterile and is not reusable.
  V-STRUT© Vertebral Implanted using specific instrumentation provided with the implant and is combined in situ with a Polymethylmethacrylate (PMMA) bone cement, F20® manufactured by Teknimed SA (K103433).

This document is a 510(k) summary for the V-STRUT© Vertebral Implant, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a complex clinical trial with specific acceptance criteria for AI performance as would be seen for an AI/ML medical device.

Therefore, the requested information about acceptance criteria and the study proving the device meets them, particularly in the context of an AI/ML device (e.g., sample size, expert ground truth, MRMC studies, standalone performance), is not applicable to this 510(k) submission.

This document describes a traditional medical device (an implant) and its substantial equivalence is demonstrated through:

• Biomechanical Performance Testing: Static and dynamic mechanical testing.
• Biocompatibility Testing: According to ISO 10993-1, 10993-5, and USP 42-NF 37.
• Sterility Testing: According to ISO 11137-1 and 11137-2.
• Shelf-Life Testing: According to ASTM F1980.
• Clinical Evaluation: Stating that "V-STRUT© Vertebral Implant has demonstrated to be substantially equivalent to its predicate device KIVA® VCF Treatment System. No additional safety or effectiveness issues as the ones expected and documented in the literature for predicates and references devices have been raised." This is not a prospective clinical trial with specific performance metrics designed to prove the device meets acceptance criteria related to a specific diagnosis or outcome as would be expected for an AI device.

To directly answer your numbered questions based on the provided document:

1. A table of acceptance criteria and the reported device performance: This document does not contain such a table because it's for a physical implant, not an AI/ML diagnostic device with performance metrics like sensitivity, specificity, etc. The performance is assessed through the non-clinical tests listed above, demonstrating it functions as intended and is safe.
2. Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" in the context of an AI/ML algorithm. The "testing" refers to lab-based biomechanical, biocompatibility, and sterility tests of the physical implant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood for AI/ML diagnostic interpretation (e.g., radiologist reads) is not relevant to this device.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for tasks like image interpretation, which is not the function of this implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used: For the physical device, "ground truth" relates to standardized testing conditions and material properties (e.g., biomechanical strength, non-cytotoxicity), rather than a clinical diagnosis adjudication.
8. The sample size for the training set: Not applicable. There is no training set for a physical implant.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a 510(k) submission for a vertebral implant, focusing on its substantial equivalence to a predicate device through non-clinical performance testing and a literature-based clinical evaluation, as opposed to the clinical trial and AI/ML specific performance metrics you've inquired about.

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The AV Amax Vertebral Balloon System (system) is intended for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements and Cortoss® Bone Augmentation Material indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

The AVAflex Vertebral Balloon System) is intended for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

The Stryker AVAmax and AVAflex Vertebral Balloon Systems are designed for use in percutaneous vertebral augmentation procedures. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter.

Radiopaque markers provide for fluoroscopic visualization of the vertebral balloon prior to filling it with contrast media. The radiopaque balloon markers are located within the balloon.

The AVAflex includes a curved needle or a curved wire assembly. The introducer is a flexible radiopaque tube that retains its shape within the vertebral body when used in conjunction with the curved vertebral augmentation needle or wire assembly.

This 510(k) is being submitted for a labeling modification to the AVAmax and AVAflex devices as cleared in K150523 and K151125. Specifically, the purpose of this 510(k) is to modify the indications for use of the devices to include their use with all FDA cleared spinal Polymethylmethacrylate (PMMA) bone cements. Additionally, the AVAmax indication for use is being modified to include its use with Cortoss® Bone Augmentation Material, which was cleared in K080108.

The subject devices were both recently cleared in K150523 (AVAmax) and K151125 (AVAflex). Since those clearances there have been no changes to the device design that effect its performance. There have been no changes to the materials, manufacturing or processing of the subject devices their previous clearances in K150523 (AVAmax) and K151125 (AVAflex).

This document is a 510(k) premarket notification for the Stryker AVAmax Vertebral Balloon System and AVAflex Vertebral Balloon System. It is an application to modify the indications for use of devices previously cleared (K150523 and K151125), specifically to include their use with all FDA-cleared spinal Polymethylmethacrylate (PMMA) bone cements, and for the AVAmax, to also include Cortoss® Bone Augmentation Material.

Since this 510(k) is for a labeling modification only, and explicitly states "no changes to the device that effect its performance specifications, no new performance testing is required to establish substantial equivalence," the document does not contain information about acceptance criteria or a study proving the device meets said criteria for performance.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance: Not provided in this document, as no new performance testing was conducted for this specific 510(k). The basis for substantial equivalence is that the device design, materials, manufacturing, processing, sterilization, packaging, shelf life, and biocompatibility have not changed since their previous clearances (K150523 and K151125).

2. Sample size used for the test set and the data provenance: Not applicable. No new performance study on a test set was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new performance study on a test set was conducted.

4. Adjudication method for the test set: Not applicable. No new performance study on a test set was conducted.

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 a medical instrument (vertebral balloon system), not an AI diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical instrument.

7. The type of ground truth used: Not applicable for this 510(k) submission, as no new performance data or ground truth establishment was required.

8. The sample size for the training set: Not applicable. This device is a medical instrument.

9. How the ground truth for the training set was established: Not applicable. This device is a medical instrument.

The document's central message for this 510(k) is that because there are "no changes to the device that effect its performance specifications, no new performance testing is required to establish substantial equivalence." The previous clearances (K150523 and K151125) are referenced, which would contain the performance data that established initial substantial equivalence.

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