(106 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 provided document describes the acceptance criteria and study for the CareFusion AVAmax Vertebral Balloon.
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 devices. |
Study Details
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Sample size used for the test set and the data provenance: Not applicable. This submission relies on non-clinical performance testing of the device itself, rather than clinical data from a "test set" of patients.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for the performance tests was based on engineering measurements and established test standards, not expert consensus.
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Adjudication method for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was conducted. This device is a medical instrument, not an AI or imaging diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical instrument.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the non-clinical performance tests was based on quantitative measurements against predefined engineering standards and requirements.
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The sample size for the training set: Not applicable. No training set was used as this involved non-clinical performance testing of a physical device.
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How the ground truth for the training set was established: Not applicable.
§ 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.