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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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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 wire stiffener provides stiffness to the balloon catheter to facilitate insertion through the access cannula

The provided document describes the safety and effectiveness information for the CareFusion AVAmax Vertebral Balloon (Inflatable Bone Tamp). Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds against specific metrics for clinical performance. Instead, it presents summaries of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices. The performance data is framed as meeting or exceeding requirements based on these tests.

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

The document states, "N/A - No clinical tests were conducted for this submission." Therefore, there is no test set in the context of clinical data, no sample size, and no data provenance (country of origin, retrospective/prospective). The "test set" in this case refers to the physical devices subjected to non-clinical laboratory testing. The sample sizes for these engineering tests are not specified.

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

Since no clinical tests were conducted, no experts were used to establish ground truth for a clinical test set. The evaluation was based on engineering performance tests against established standards or internal requirements.

4. Adjudication Method for the Test Set

Not applicable, as no clinical tests were performed, and thus no expert adjudication was needed for clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states, "N/A - No clinical tests were conducted for this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this device is a physical medical device (Inflatable Bone Tamp), not a software algorithm or AI-driven system.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" was implicitly defined by engineering specifications, accepted standards for burst pressure/volume, and comparative measurements against predicate devices. There was no clinical ground truth (e.g., pathology, outcomes data).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or software system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set for an AI/software system.

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Intended for the reduction and fixation of fractures in cancellous bone in the spine for kyphoplasty (for use with Cardinal Health 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 wire stiffener provides stiffness to the balloon catheter to facilitate insertion through the access cannula

This document, K090211, describes an Inflatable Bone Tamp (IBT) submitted for 510(k) clearance by Cardinal Health. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove a specific level of performance for the device. Here's a breakdown of the requested information based on the provided text:

Key Takeaway: The provided document is a 510(k) summary, which aims to demonstrate "substantial equivalence" of a new device to existing predicate devices. It does not outline specific acceptance criteria for a new performance benchmark for the device, nor does it detail a study that proves the device meets such criteria as one might find for a novel device with new claims. Instead, it relies on demonstrating that the new device shares similar technological characteristics and performs comparably to already cleared devices.

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

Based on the provided text, specific acceptance criteria in the sense of quantitative performance thresholds (e.g., "Must achieve XYZ accuracy" or "Tensile strength of X MPa") are not explicitly stated. The "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating "substantial equivalence" to the predicate devices. The performance reported is that the device is substantially equivalent to its predicates.

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

The document mentions "Performance testing" and "biological qualification safety tests" but does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full 510(k) submission, not necessarily in the public summary.

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

This type of information is not applicable or not mentioned in this 510(k) summary. The context is not one of diagnostic accuracy or expert consensus on findings, but rather physical and biological performance of a medical device. "Ground truth" in this context would likely refer to established engineering and material science standards for device components, not expert interpretation of medical data.

4. Adjudication method for the test set

Not applicable or not mentioned. Adjudication methods are typically used in studies involving human interpretation or subjective assessments. The tests described (material safety, functional characteristics) are objective engineering and biological tests that wouldn't require an adjudication method in the clinical sense.

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 an Inflatable Bone Tamp, a physical medical device used in surgery, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is entirely outside the scope of this device.

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

Not applicable. As stated above, this is a physical medical device, not an algorithm.

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

For the non-clinical testing described:

• Material safety: The "ground truth" would be established by validated ISO 10993 standards and other industry-recognized test methods for biocompatibility and material properties.
• Functional characteristics: The "ground truth" would be the established performance characteristics of the predicate devices as measured against engineering specifications and validated test methods.

8. The sample size for the training set

Not applicable. This is not a study involving machine learning or algorithms that require a training set. The term "training set" is not relevant to the evaluation of this physical medical device.

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

Not applicable. As there is no training set for this type of device evaluation, there is no ground truth to establish for it.

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