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510(k) Data Aggregation
(30 days)
The Osseoflex® SB 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. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.
The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture 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. After the bone is disrupted, PMMA is injected through an Osseoflex® needle to fill the previously created void(s).
An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device.
This document describes the performance testing for the Osseoflex SB, 10 Gauge Straight Balloon.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Bench Tests Performed | Acceptance Criteria | Reported Device Performance (Implied from Conclusion) |
|---|---|---|
| Balloon Profile and Tamp (Catheter) Working Length (TM-003) | • Balloon profile ≤ 2.79 mm (0.109 in) • Balloon catheter working length > 16.5 cm | Met or exceeded requirements |
| Balloon Compliance (TM-004) | • Balloon working length (L) ≤ 24 mm • Balloon diameter (D) ≤ 19 mm | Met or exceeded requirements |
| Maximum Pressure (TM-006) | The inflatable bone tamp exceeds the maximum inflation pressure, 27 atm (~400 psi) without failure. | Met or exceeded requirements (device withstood pressure without failure) |
| Bond Tensile Strengths (TM-007) | Bond tensile strength ≥ 15 N (3.37 lbf). The tensile force specification was adopted directly from ISO 10555 (Single Use Intravascular Catheters). This tensile force may be applied to the device during use when the balloon is deflated and retracted back through the access cannula. | Met or exceeded requirements |
| Balloon Maximum Volume (TM-008) | Maximum inflation volume to be greater than the maximum recommended volume with 95% confidence and 90% reliability. | Met or exceeded requirements |
| Balloon Fatigue, Unconstrained (TM-009) | Inflate to maximum recommended volume of, hold for 30 seconds / deflate; without leaks for 20 cycles. | Met or exceeded requirements (device performed without leaks for 20 cycles) |
| Balloon Inflation, Deflation Time (TM-010) | Deflation times to be < 5 seconds with 90/90% confidence/ reliability. | Met or exceeded requirements (device deflated in under 5 seconds with specified confidence/reliability) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test (TM-003, TM-004, etc.) within the "PERFORMANCE DATA" section. It broadly states that "The results of the non-clinical tests show that the Osseoflex SB, 10 Gauge Straight Balloon meets or exceed all performance requirements."
The data provenance is for non-clinical bench tests. These are laboratory tests and do not involve human or animal subjects, so country of origin or retrospective/prospective does not apply in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. These are non-clinical bench tests, and the "ground truth" is established by the predefined engineering and performance specifications and international standards (like ISO 10555 mentioned for tensile strength). No human experts are used to establish ground truth for this type of testing.
4. Adjudication Method for the Test Set
Not applicable. As these are bench tests with objective measurements against predefined criteria, an adjudication method for conflicting expert opinions is not relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This document describes non-clinical bench testing of a device (inflatable bone tamp) and not an AI or diagnostic imaging system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance data presented is for standalone device performance (algorithm only, if one considers the device's mechanical function as an "algorithm") without human interaction during the test execution itself, beyond operating the testing equipment.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on engineering specifications, design requirements, and relevant international standards (e.g., ISO 10555 for bond tensile strength). These criteria define what constitutes acceptable performance for the device.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a training set as this document describes non-clinical performance testing for a medical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set mentioned, the establishment of its ground truth is irrelevant to this document.
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