(64 days)
The Osseoflex® SB is intended to be used for the reduction and fixation 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 Osseoflex® SB is an inflatable bone tamp designed for use in balloon kyphoplasty to create a cavity in the vertebral body for cement interdigitation, and to reduce fractures.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Results Summary) |
|---|---|---|
| Inflation Pressure | Constrained Burst Test | The balloon catheter exceeded the requirements for the minimum burst pressure in a constrained environment. |
| Inflation Volume | Unconstrained Burst Test | The balloon catheter exceeded the requirements for the minimum burst volume in an unconstrained environment. |
| Balloon Double Wall Thickness | Calibrated Measurement | The double wall thickness of the balloon was substantially equivalent to that of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention a test set with a specific sample size. The studies conducted were non-clinical performance tests rather than tests involving patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The reported studies are non-clinical performance tests (mechanical and material characteristic tests), not studies requiring expert review of data for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable, as no test set requiring expert adjudication was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "N/A – No clinical test were conducted for this submission." Therefore, an MRMC comparative effectiveness study was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical medical device (inflatable bone tamp), not an algorithm or AI software. Therefore, the concept of standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests was established by predefined engineering and material science requirements and standards for medical devices (e.g., minimum burst pressure, minimum burst volume, and material specifications). These are objective measurements rather than subjective expert interpretations.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI or software device that undergoes training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
§ 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.”