(69 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 perculancous vertebral augmentation. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutancous 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.
Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
Device: Osseoflex® SB (2mL)
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Test (TM #) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Balloon Profile and Tamp (Catheter) Working Length (TM-003) | Balloon profile ≤ 3.48 mm (0.137 in) | |
| Balloon catheter working length > 16.5 cm (length of access cannula) | The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". Specific numerical results for this test are not provided. | |
| Balloon Compliance (TM-004) | Balloon working length (L) is 16 mm (reference) at the maximum recommended volume 2 mL. | |
| Balloon diameter (D) is 15 mm maximum at the maximum recommended volume 2 mL. | ||
| (15 mm diameter ensures balloon does not pass through vertebral end plates). | The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". Specific numerical results for this test are not provided. | |
| Maximum Pressure (TM-006) | The inflatable bone tamp exceeds the maximum inflation pressure, 27 atm (~400 psi) without failure. | The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". Specific numerical results for this test are not provided. |
| Bond Tensile Strengths (TM-007) | Bond tensile strength ≥ 15 N (3.37 lbf). (Adopted from ISO 10555 requirements). | The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". Specific numerical results for this test are not provided. |
| Balloon Maximum Volume (TM-008) | Maximum inflation volume 2 mL with 95% confidence and 90% reliability. | The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". T specific numerical result verifying the 95% confidence and 90% reliability is not provided. |
| Balloon Fatigue, Unconstrained (TM-009) | Inflate to maximum recommended volume of 2 mL, hold for 30 seconds / deflate; without leaks for 20 cycles. | The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". Specific numerical results confirming 20 cycles without leaks are not provided. |
| Balloon Inflation, Deflation Time (TM-010) | The Osseoflex SB 2ml samples deflation times to be clinically equivalent to other marketed inflatable bone tamps. | The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". While clinical equivalence is the criterion, specific data comparing deflation times is not presented. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each non-clinical performance test. It only summarizes that "non-clinical tests" were conducted. The data provenance is from non-clinical laboratory testing, performed by Osseon LLC, as indicated by the "Summary of Non-Clinical Tests Conducted." There is no indication of country of origin for the data (beyond the company being US-based) or whether it was retrospective or prospective in nature (as it's laboratory testing, it would inherently be prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The tests conducted were non-clinical performance tests for a medical device (inflatable bone tamp), not a diagnostic or AI-assisted system requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set:
Not applicable, as this was non-clinical laboratory testing against pre-defined engineering specifications, not a study requiring human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "N/A – No clinical test were conducted for this submission."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This is a medical device (inflatable bone tamp), not an algorithm or AI system. The performance tests are for the physical properties and functionality of the device itself.
7. The Type of Ground Truth Used:
The "ground truth" for these tests consisted of pre-defined engineering specifications and performance requirements (acceptance criteria) based on device design and relevant standards (e.g., ISO 10555 for bond tensile strength).
8. The Sample Size for the Training Set:
Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
§ 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.”