(285 days)
The Vertebral Body Balloon 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 indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
The VBB System consists of a Vertebral Body Balloon Catheter, Inflation System, and Vertebral Augmentation Access Kit. The Vertebral Body Balloon Catheter is a bone tamp with an inflatable component (balloon) at the distal end. A stainless steel radiographic marker (ISO 5832-1) is located at the distal tip of the balloon. The balloon is inflated by the Inflation System within the vertebral body. The Vertebral Body Balloon 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 indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
The provided text is a 510(k) Summary for the Synthes VBB System, which is a medical device for vertebral augmentation. It describes the device, its intended use, and states that mechanical and biomechanical testing was performed to support its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or detailed study results in a format that allows for a direct comparison table as requested.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document states, "Mechanical and biomechanical testing was performed in order to provide data to support a substantial equivalence determination. These tests were performed to characterize the properties and functionality of the VBB System, as well as to allow comparison with established acceptance criteria." However, the document does not explicitly list the "established acceptance criteria" themselves.
- Reported Device Performance: Similarly, it only provides a general statement: "The conclusions drawn from testing demonstrate that the VBB System is as safe and effective as the predicate devices identified." It does not provide specific performance metrics or values for the device.
Therefore, a table cannot be populated from the given text as the specific criteria and performance metrics are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Mechanical and biomechanical testing" but does not provide any information regarding the sample size for these tests (e.g., number of balloons tested, number of vertebral models used). It also does not specify the data provenance (e.g., retrospective or prospective, country of origin). The testing would likely have been conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. The study described is mechanical and biomechanical testing of a medical device's physical properties and functionality. It does not involve human interpretation of images or clinical data that would require experts to establish a "ground truth" in the diagnostic context.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, the study focuses on mechanical testing, not diagnostic performance requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed for this device." The study focused on mechanical and biomechanical properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical medical instrument (Vertebral Body Balloon System), not an algorithm or a software-based diagnostic tool. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical and biomechanical testing would have been based on engineering specifications, material science standards, and established physical and mechanical testing protocols for similar devices, ensuring characteristics like burst pressure, volume limitations, and ability to create a void in cancellous bone meet target values or compare favorably to predicate devices. It is not dependent on expert consensus, pathology, or outcomes data in the diagnostic sense.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for a physical device.
In summary:
The provided document describes physical device testing for regulatory clearance. It does not involve diagnostic performance evaluation, AI/ML, or the types of studies and ground truth establishment typically associated with those fields. The document primarily attests that mechanical and biomechanical tests were performed against "established acceptance criteria" to demonstrate substantial equivalence to predicate devices, without detailing those criteria or the specific results.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”