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510(k) Data Aggregation
(36 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. The articulating or steering feature of the device assists the clinician in directing the device to the pre-existing channel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.
The provided text describes the acceptance criteria and the results of a study for the Osseoflex SB device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Balloon Profile and Tamp (Catheter) Working Length (TM-003) | Balloon profile ≤ 2.79 mm (0.109 in) Balloon catheter working length > 16.5 cm | The device meets or exceeds all performance requirements (implying the reported performance met these criteria, though specific values are not provided). |
| Balloon Compliance (TM-004) | Balloon working length (L) ≤ 24 mm Balloon diameter (D) ≤ 19 mm | The device meets or exceeds all performance requirements. |
| Maximum Pressure (TM-006) | The inflatable bone tamp exceeds the maximum inflation pressure, 27 atm (~400 psi) without failure. | The device meets or exceeds all performance requirements. |
| 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) requirements. This tensile force may be applied to the device during use when the balloon is deflated and retracted back through the access cannula. | The device meets or exceeds all performance requirements. |
| Balloon Maximum Volume (TM-008) | Maximum inflation volume to be greater than the maximum recommended volume with 95% confidence and 90% reliability. | The device meets or exceeds all performance requirements. |
| Balloon Fatigue, Unconstrained (TM-009) | Inflate to maximum recommended volume of, hold for 30 seconds / deflate; without leaks for 20 cycles. | The device meets or exceeds all performance requirements. |
| Balloon Inflation, Deflation Time (TM-010) | Deflation times to be < 5 seconds with 90/90% confidence/reliability. | The device meets or exceeds all performance requirements. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes for each non-clinical test. The tests are non-clinical, implying they were conducted in a laboratory setting, not on human subjects. Therefore, there is no country of origin or retrospective/prospective data as it relates to patient data. The provenance is internal laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The tests are non-clinical engineering and performance characteristic tests of a medical device, not clinical studies requiring expert ground truth establishment for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable, as no expert adjudication was involved in these non-clinical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. The studies described are non-clinical performance evaluations of a medical device, not AI-assisted diagnostic studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical medical instrument (inflatable bone tamp), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these non-clinical tests is based on established engineering and material science principles, international standards (e.g., ISO 10555 for bond tensile strength), and device design specifications. The acceptance criteria themselves serve as the 'ground truth' for performance evaluation.
8. The Sample Size for the Training Set
Not applicable. This is a non-clinical device performance study, not an AI model training study.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model. For the non-clinical tests, the "ground truth" (acceptance criteria) was established based on engineering requirements and relevant industry standards.
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