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The Stryker IVAS® Elite Inflatable Vertebral Augmentation System is intended to be used 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 Stryker iVAS ® Elite Balloon Catheter is a bone tamp with an inflatable component at the distal end. The balloon is inflated to create a void within the vertebral body. It is used with various accessories during vertebral augmentation.

When the balloon is inflated with radiopaque fluid, the balloon expands axially and radially. Two radiopaque markers are fixed near the distal end of the balloon to show the location of the balloon during placement. The balloon is coated with silicone to assist with insertion of the catheter into the access needle.

This looks like a 510(k) summary for a medical device that isn't an AI/ML device. Therefore, the questions about acceptance criteria for AI/ML performance metrics (like sensitivity, specificity, AUC, human reader improvement with AI assistance, sample sizes for training/test sets, expert ground truth establishment, etc.) are not applicable here.

This document describes a conventional medical device (an inflatable vertebral augmentation system) and focuses on engineering and biological performance rather than diagnostic or analytical accuracy.

However, I can extract the acceptance criteria and the study details for the conventional device as presented in the document:

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

2. Sample sized used for the test set and the data provenance

• Biocompatibility: No specific sample size is mentioned for biocompatibility testing in this summary, but it states "Biocompatibility testing... was performed following the recommendations of ISO 10993-1 and FDA Guidance."
• Bench Testing (Constrained Burst, Un-Constrained Burst, etc.): No specific sample sizes are mentioned, but it indicates "All bench testing pertaining to the subject device modifications met their respective acceptance criteria as specified per the individual test report." These tests are typically performed on a statistically relevant sample size of manufactured devices.
• Cadaveric Testing: "Cadaveric testing was completed to provide evidence..." The specific number of cadavers or test instances is not provided in this summary. The provenance is cadaveric (human anatomical specimens).

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

• Cadaveric testing: "This cadaveric testing was completed by a physician..." The exact number of physicians is not specified, nor are their specific qualifications beyond being a "physician."

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

• Cadaveric testing: "Following the inflation of the balloon, the physician evaluated nearby anatomical structures for adverse events related to the high-pressure balloon inflations." This implies a single physician assessment; no adjudication method (like 2+1) is 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

• This is not an AI/ML device. No MRMC comparative effectiveness study was conducted or is applicable.

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

• This is not an AI/ML device. No standalone algorithm performance was assessed.

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

• Biocompatibility: Ground truth is established by standardized biological assays and regulatory guidelines (ISO 10993-1, FDA Guidance).
• Bench Testing: Ground truth is established by engineering specifications, physical measurements, and industry-accepted standards (e.g., burst pressure, tensile strength).
• Cadaveric Testing: Ground truth is established by direct visual inspection and assessment by a physician for damage to anatomical structures.

8. The sample size for the training set

• This is not an AI/ML device. There is no concept of a "training set" in the context of this submission.
• However, the submission does mention that "Biocompatibility testing... adopted per K172116" and "Catheter Flexibility Testing and Cold Age testing have been adopted from K093429. Accelerated Age testing has been adopted from K172116." These refer to prior submissions that likely involved biocompatibility testing and accelerated aging on a set of devices, which could be considered an analogous "training" or foundational dataset for these aspects, but not in the AI/ML sense.

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

• Not applicable as this is not an AI/ML device. The "ground truth" for the various engineering and biocompatibility tests would have been established through the methods and standards relevant to those specific test types in the original K093429 and K172116 submissions.

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The Stryker® iVAS® Elite Inflatable Vertebral Augmentation System is intended to be used 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 Stryker iVAS ® Elite Balloon Catheter is a bone tamp with an inflatable component at the distal end. The balloon is inflated to create a void within the vertebral body. It is used with various accessories during vertebral augmentation.

When the balloon is inflated with radiopaque fluid, the balloon expands axially and radially. Two radiopaque markers are fixed near the distal end of the balloon to show the location of the balloon during placement. The balloon is coated with silicone to assist with insertion of the catheter into the access needle.

The patient contacting components of the device such as the balloon, catheter, catheter coating, lubricant and radiopaque material are externally communicating tissue/bone/dentin-limited contact ≤24 hrs.

Associated Accessories include:

• Access cannula/stylet
• Syringe
• Inflator
• Hand Drill
• Coaxial Cement Tube

The provided text describes the acceptance criteria and supporting studies for the Stryker iVAS® Elite Balloon Catheter. Here's a breakdown of the requested information:

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

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

The document does not explicitly state a sample size for test sets in the traditional sense of a clinical or human performance study. The studies primarily involve bench testing and cadaveric testing.

• Bench Testing: The sample sizes for each specific bench test (e.g., insertion force, tensile force, burst tests) are not provided.
• Cadaveric Testing: The sample size (number of cadavers or vertebral segments) for cadaveric testing is not specified.
• Data Provenance: This information is not directly applicable to the type of testing performed (bench and cadaveric, not human data).

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

This information is not applicable. The device is not an AI or diagnostic device requiring expert interpretation for ground truth establishment. The performance is assessed against engineering specifications, material properties, and physical capabilities.

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

This information is not applicable. There was no expert adjudication process as the testing involved physical and material properties rather than medical interpretations.

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 performed. This device is a medical instrument (balloon catheter), not an AI diagnostic or assistive technology.

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

No. This concept is not applicable as the device is a physical medical instrument, not an algorithm.

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

The "ground truth" for the device's performance is established by engineering specifications, material science standards, and mechanical testing results. For example, the "ground truth" for burst pressure is the specified pressure the balloon must withstand, and for biocompatibility, it's meeting the criteria of ISO 10993-1. Cadaveric testing provided practical validation of the device's ability to create a void in bone.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable as there is no training set for this type of device.

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