(84 days)
Intended for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).
The Inflatable Bone Tamp (IBT) was designed for use in Balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture and preventing cement leakage, 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. The wire stiffener provides stiffness to the balloon catheter to facilitate insertion through the access cannula
The provided document describes the safety and effectiveness information for the CareFusion AVAmax Vertebral Balloon (Inflatable Bone Tamp). Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds against specific metrics for clinical performance. Instead, it presents summaries of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices. The performance data is framed as meeting or exceeding requirements based on these tests.
| Characteristic | Standard/Test/FDA Guidance | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Inflation pressure | Constrained burst test | Exceed minimum burst pressure in a constrained environment | Exceeded the requirements for minimum burst pressure |
| Inflation volume | Unconstrained burst test | Exceed minimum burst volume in an unconstrained environment | Exceeded the requirements for minimum burst volume |
| Balloon double wall | |||
| thickness | Calibrated measurement | Substantially equivalent to predicate device thickness | Substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and the Data Provenance
The document states, "N/A - No clinical tests were conducted for this submission." Therefore, there is no test set in the context of clinical data, no sample size, and no data provenance (country of origin, retrospective/prospective). The "test set" in this case refers to the physical devices subjected to non-clinical laboratory testing. The sample sizes for these engineering tests are not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical tests were conducted, no experts were used to establish ground truth for a clinical test set. The evaluation was based on engineering performance tests against established standards or internal requirements.
4. Adjudication Method for the Test Set
Not applicable, as no clinical tests were performed, and thus no expert adjudication was needed for clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states, "N/A - No clinical tests were conducted for this submission."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this device is a physical medical device (Inflatable Bone Tamp), not a software algorithm or AI-driven system.
7. The Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" was implicitly defined by engineering specifications, accepted standards for burst pressure/volume, and comparative measurements against predicate devices. There was no clinical ground truth (e.g., pathology, outcomes data).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or software system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set for an AI/software system.
§ 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.”