Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 describes the acceptance criteria and study for the CareFusion AVAmax Vertebral Balloon.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. This submission relies on non-clinical performance testing of the device itself, rather than clinical data from a "test set" of patients.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for the performance tests was based on engineering measurements and established test standards, not expert consensus.

3. Adjudication method for the test set: Not applicable.

4. 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 MRMC study was conducted. This device is a medical instrument, not an AI or imaging diagnostic tool.

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

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the non-clinical performance tests was based on quantitative measurements against predefined engineering standards and requirements.

7. The sample size for the training set: Not applicable. No training set was used as this involved non-clinical performance testing of a physical device.

8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

Intended for the reduction and fixation of fractures 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 text is a 510(k) summary for the CareFusion Inflatable Bone Tamp. It describes the device, its intended use, and states that performance testing demonstrated substantial equivalence to predicate devices. However, the document does not contain the detailed information necessary to answer the specific questions about acceptance criteria, a comprehensive study design, or specific performance metrics.

Here's what can be extracted and what is missing based on your template:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly states that the device was evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 and in accordance with industry-recognized test methods, and "were found to be acceptable for the intended use." Performance testing "demonstrated that the proposed device is substantially equivalent to the currently marketed predicate devices with regard to functional characteristics."
• Reported Device Performance: No specific performance metrics (e.g., success rates, precision, accuracy, sensitivity, specificity, etc.) are provided. The only "performance" reported is meeting the safety standards and achieving substantial equivalence to predicates.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified.

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)

• Not applicable as no human-expert-reviewed test sets are mentioned. The testing described focuses on material and functional characteristics, not diagnostic or interpretive tasks.

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

• Not applicable.

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 is a medical device for a surgical procedure (Inflatable Bone Tamp), not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is a physical medical device.

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

• For the biological and functional testing, the "ground truth" would be established by the ISO standards and industry-recognized test methods themselves (e.g., material property specifications, inflation/pressure limits, leakage tests against defined benchmarks).

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable.

Summary of Study Information Available in the Document:

The study described in this 510(k) pertains to the non-clinical testing of the Inflatable Bone Tamp.

• Type of Study: Non-clinical (bench testing) to assess material safety and functional characteristics.
• Objective: To demonstrate substantial equivalence of the proposed device to predicate devices.
• Methods:
  • Biological Qualification Safety Tests: As outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices."
  • Other Performance Testing: Evaluated in accordance with industry-recognized test methods. These tests focused on ensuring the device shares similar design, materials, and manufacturing characteristics, and functional performance, with legally marketed predicate devices.
• Results: All materials and performance testing were found to be acceptable for the intended use and demonstrated substantial equivalence to the predicate devices.
• Predicates: Cardinal Health Inflatable Bone Tamp (K090211), Kyphx Inflatable Bone Tamp (K041454, K981251), and Radiopaque Bone Cement (K043518).

In conclusion, this document primarily serves as a regulatory submission demonstrating substantial equivalence for a physical medical device, not an AI/software device. Therefore, many of the requested details related to clinical studies, AI performance metrics, and human reader-contributed data are not present nor relevant to this type of device submission.

Ask a specific question about this device