(118 days)
The Synflate Vertebral 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 Synflate Vertebral Balloon System is a comprehensive array of instrumentation (Vertebral Access Kit as well as a Biopsy Kit), vertebral augmentation balloons (inclusive of balloon-catheter, stiffening wire, and syringe with luer lock), and Inflation System (previously cleared via K110604). All instruments and implants are provided sterile and packaged separately.
The Synflate balloon catheter includes a stiffening wire and syringe with luer lock. The balloon is inflated within the vertebral body via the Inflation System.
The Synflate balloon catheter 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.
Here's a breakdown of the acceptance criteria and study information for the Synthes Synflate Vertebral Balloon System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific, quantifiable acceptance criteria or detailed reported device performance in a table format. It broadly mentions:
| Acceptance Criteria Category | Reported Device Performance (Summary from text) |
|---|---|
| Mechanical Properties | Not explicitly defined with specific numerical targets. The aim was to "characterize the properties and functionality" and allow "comparison with established acceptance criteria." This implies internal manufacturer-defined criteria. |
| Balloon Pressure Limits | The device was tested to assess "balloon pressure and volume limitations." No specific values are provided. |
| Volume Limitations | The device was tested to assess "balloon pressure and volume limitations." No specific values are provided. |
| Burst Characteristics | The device was tested to assess "burst characteristics." No specific values or thresholds are provided. |
| Functionality (Fracture Reduction/Void Creation) | The device's "ability...to be used for the reduction of fractures and/or creation of a void in cancellous bone" was assessed. The conclusion stated it is "as safe and effective as the predicate devices identified." This suggests a qualitative assessment of functionality against a benchmark. |
| Safety and Effectiveness | The overall conclusion of the non-clinical testing was that the Synflate System is "as safe and effective as the predicate devices identified." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Mechanical and biomechanical testing was performed" but does not give specific numbers of units or tests performed.
- Data Provenance: The tests were "performed in order to provide data to support a substantial equivalence determination." This implies the tests were conducted by the manufacturer, Depuy Synthes Spine, as part of their 510(k) submission. It is a non-clinical (benchtop) study, not involving human subjects. Therefore, country of origin related to patient data or retrospective/prospective classification is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this submission. The "test set" in this context refers to the physical devices undergoing mechanical and biomechanical testing, not a dataset requiring expert interpretation for ground truth. The "ground truth" for these tests would be the measured physical properties and performance characteristics against engineering specifications.
4. Adjudication Method for the Test Set
This question is not applicable. Since the "test set" consists of physical devices undergoing objective mechanical measurements, there is no need for expert adjudication of results in the way commonly seen in clinical image-based studies. The "adjudication" would be based on comparison of measured values against predefined engineering acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed to demonstrate the safety and effectiveness of this system." The submission relies solely on non-clinical (mechanical and biomechanical) testing to demonstrate substantial equivalence to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as this device is a medical instrument (vertebral balloon system), not an algorithm or AI-powered device.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests would be engineering specifications and established mechanical testing standards/methods. The device's performance was compared against these predefined physical and functional requirements, and against the established performance characteristics of the predicate devices.
8. The Sample Size for the Training Set
This question is not applicable. Since this is a physical medical device and not an AI/machine learning algorithm, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as point 8.
§ 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.”