(210 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.
This document describes the AVAflex Vertebral Balloon System, specifically detailing its performance testing for substantial equivalence to a predicate device.
Here's an analysis of the provided text based on your request:
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 catheters exceeded the requirements for the minimum burst pressure in a constrained environment. |
| Inflation volume | Unconstrained burst test | The balloon catheters exceeded the requirements for the minimum burst volume in an unconstrained environment. |
| Balloon double wall thickness | Calibrated measurement | The double wall thickness of the balloons was substantially equivalent to that of the predicate device. |
| Simulated use | Cadaver | Cadaveric simulated use testing demonstrated substantial equivalence in performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the "Constrained burst test," "Unconstrained burst test," or "Calibrated measurement."
For the "Cadaveric simulated use testing":
- Sample Size: Not explicitly stated (e.g., number of cadavers or balloons tested).
- Data Provenance: The cadaveric simulated use suggests human cadaver data, which is a form of ex vivo or in vitro testing that simulates a clinical environment. No country of origin is specified, but it's presumed to be associated with the manufacturer's testing facilities. The data is prospective in the sense that the tests were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
It's important to note that for these types of mechanical performance tests, "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, rather than expert clinical consensus in the same way it would be for diagnostic AI. The results are objective measurements against defined criteria.
4. Adjudication Method for the Test Set
Not applicable. The performance tests are objective measurements against defined criteria, not subjective assessments requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "N/A - No clinical tests were conducted for this submission." This indicates no MRMC study or any clinical study was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical device (vertebral balloon system), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply. The performance described is the standalone performance of the device itself.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests is established by:
- Pre-defined engineering specifications and design requirements (for burst pressure, volume, and dimensions).
- Industry standards for medical device testing.
- The performance of the predicate device (for substantial equivalence claims).
- Observed outcomes in simulated use (cadaveric testing).
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.