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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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Intended for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).

The Inflatable Bone Tamp (IBT) was designed for use in balloon kyphoplasty. 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.

The provided document is a 510(k) summary for the CareFusion AVAmax Vertebral Balloon. It describes the device, its intended use, comparison to a predicate device, and performance data from non-clinical tests.

Here's an analysis of the document to address your request:

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

The document provides "Performance Test Summary - New Device" which lists the characteristic and results summary. It doesn't explicitly state "acceptance criteria" with numerical targets, but rather describes the performance in relation to requirements. I will interpret "acceptance criteria" as the implied requirements based on the "Results Summary."

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

The document primarily describes non-clinical performance and does not detail specific sample sizes for tests beyond implying multiple "balloon catheters" were tested for inflation pressure and volume. For the "Simulated Use" test, it mentions "Cadaveric simulated use testing," but does not specify the number of cadavers.

• Test Set Sample Size: Not explicitly stated, beyond implying multiple "balloon catheters" and "cadaveric" in the simulated use.
• Data Provenance: Not specified, but given it's a 510(k) by CareFusion (a US-based company), it's likely conducted in the US. The testing is prospective in nature as it's part of premarket notification for a new/modified device.

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 document. The tests described are primarily engineering/performance tests (inflation pressure, volume, thickness) and a simulated use on cadavers. These types of tests do not typically involve human "experts" establishing a diagnostic ground truth in the way a clinical study would (e.g., radiologists reviewing images). The assessment of performance would be based on objective measurements and observations by the test engineers/personnel.

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

Not applicable. This document describes non-clinical performance testing, not a study involving human readers or subjective assessments that would require an adjudication method.

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, a multi-reader, multi-case comparative effectiveness study was not done. The document explicitly states "N/A - No clinical tests were conducted for this submission." This device is a medical device (vertebral balloon), not an AI diagnostic tool, so such a study is irrelevant here.

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

Not applicable. This device is a physical medical device (vertebral balloon), not an algorithm or AI.

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

For the non-clinical tests described:

• Inflation Pressure & Volume: The "ground truth" is based on objective physical measurements against predefined engineering requirements or industry standards.
• Balloon double wall thickness: Objective physical measurement.
• Simulated Use (Cadaver): "Ground truth" would be the observed mechanical performance and ability to perform the intended function (create a cavity, reduce fracture, prevent cement leakage simulation) in the cadaveric model, assessed against the performance of the predicate device. This is a functional assessment rather than a diagnostic one.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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