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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.

This document describes the AVAflex Vertebral Balloon System, specifically detailing its performance testing for substantial equivalence to a predicate device.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the "Constrained burst test," "Unconstrained burst test," or "Calibrated measurement."

For the "Cadaveric simulated use testing":

• Sample Size: Not explicitly stated (e.g., number of cadavers or balloons tested).
• Data Provenance: The cadaveric simulated use suggests human cadaver data, which is a form of ex vivo or in vitro testing that simulates a clinical environment. No country of origin is specified, but it's presumed to be associated with the manufacturer's testing facilities. The data is prospective in the sense that the tests were conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

It's important to note that for these types of mechanical performance tests, "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, rather than expert clinical consensus in the same way it would be for diagnostic AI. The results are objective measurements against defined criteria.

4. Adjudication Method for the Test Set

Not applicable. The performance tests are objective measurements against defined criteria, not subjective assessments requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "N/A - No clinical tests were conducted for this submission." This indicates no MRMC study or any clinical study was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical device (vertebral balloon system), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply. The performance described is the standalone performance of the device itself.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by:

• Pre-defined engineering specifications and design requirements (for burst pressure, volume, and dimensions).
• Industry standards for medical device testing.
• The performance of the predicate device (for substantial equivalence claims).
• Observed outcomes in simulated use (cadaveric testing).

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm 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 a physical medical device.

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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.

Unfortunately, the provided text does not contain information about acceptance criteria or specific studies proving the device meets those criteria. The document is a 510(k) summary for a medical device (AVAflex Vertebral Balloon System, an Inflatable Bone Tamp) and it focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data.

Here's a breakdown of what is available in the provided text, and what is not in relation to your request:

What is present:

• Device Description and Intended Use: The AVAflex Vertebral Balloon System is an Inflatable Bone Tamp for balloon kyphoplasty, intended for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine.
• Predicate Device: CareFusion Inflatable Bone Tamps (K103064, K093463, K090211) and Radiopaque Bone Cement (K043518).
• Technological Characteristics Comparison to Predicate:
  • Balloon inflation medium: 60% contrast recommended (New Device) vs. 60% contrast recommended (Predicate)
  • Balloon and catheter materials: Polyurethane (New Device) vs. Polyurethane (Predicate)
  • Wire mandrel material: Stainless steel (New Device) vs. Stainless steel (Predicate)
  • Balloon shape: Cylindrical (New Device) vs. Cylindrical (Predicate)
  • Maximum recommended inflation pressure: 400 psi (27 ATM) (New Device) vs. 400 psi (27 ATM) (Predicate)
  • Maximum recommended inflation volume: 4 mL - 8 mL (New Device) vs. 4 mL - 6mL (Predicate)
• Performance Data (Non-Clinical Tests):
  • Inflation pressure: Constrained burst test. Results Summary: The balloon catheters exceeded the requirements for the minimum burst pressure in a constrained environment.
  • Inflation volume: Unconstrained burst test. Results Summary: The balloon catheters exceeded the requirements for the minimum burst volume in an unconstrained environment.
  • Balloon double wall thickness: Calibrated measurement. Results Summary: The double wall thickness of the balloons was substantially equivalent to that of the predicate device.
• Conclusion from Non-Clinical Data: The new device meets performance requirements and is substantially equivalent to the predicate device.
• Clinical Tests: N/A - No clinical tests were conducted for this submission.

What is explicitly not present (and therefore cannot be provided from this text):

• A table of specific acceptance criteria and reported device performance against those criteria. The results summary states "exceeded the requirements" or "substantially equivalent," but does not define what those specific requirements (acceptance criteria) were in measurable terms (e.g., "minimum burst pressure must be X psi, device achieved Y psi").
• Sample sized used for the test set and the data provenance. While a burst test implies a sample, the specific number is not given and its origin (country, retrospective/prospective) is not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts. This information is typically relevant for studies involving human interpretation (e.g., image analysis), which are not present here.
• Adjudication method for the test set. Again, this is for studies involving human interpretation.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with/without AI assistance. This device is a physical medical device, not an AI/software device, so MRMC studies are not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. Not an AI/software device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.). For the non-clinical tests, the "ground truth" would be the established engineering/performance standards or the performance of the predicate device, but this is not explicitly detailed.
• The sample size for the training set. There isn't a "training set" in the context of this device's non-clinical testing.
• How the ground truth for the training set was established. Not applicable.

In summary, this 510(k) emphasizes that the new device is substantially equivalent to a previously approved predicate device based on non-clinical engineering performance benchmarks rather than a detailed study with explicit acceptance criteria and corresponding performance metrics. The specific numeric acceptance criteria for "minimum burst pressure" or "minimum burst volume" are not defined in the provided summary.

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