(264 days)
The Joline Kyphoplasty System Allevo is intended to be used for the reduction of fixation of fractures and or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacy late (PMMA) bone cements).
The Joline® Kyphoplasty System Allevo is a sterile, single-use system of instruments that facilitates balloon kyphoplasty. The subject device includes both single and double balloon catheter options that allows the introduction of one, or two balloons, into each pedicle at a time, for a total of two or four balloons per vertebrae. The balloons can be expanded or deflated separately using contrast medium, a balloon adapter, and an inflation device. The Joline® Kyphoplasty System Allevo includes instruments and accessories that facilitate the kyphoplasty procedure, including devices and curettes for creation of access channels within the bone. Subsequent to creating the cavities within the vertebral bone, the vertebral body is stabilized with an FDA cleared PMMA bone cement that cures within a few minutes. The Joline Kyphoplasty System Allevo is offered in kits that are comprised of various combinations of instruments that address surgeon preference and specific clinical condition of the patient.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Performed) | Requirement | Reported Device Performance (Test Result and Conclusion) |
|---|---|---|
| Balloon Burst Pressure | $\ge$ 27 bar ($\approx$ 400 psi) | Passed all conditions; Equivalent to predicate |
| Balloon Burst Volume | $\ge$ 3 ml | Passed all conditions; Equivalent to predicate |
| Balloon Inflation Behavior (Average Diameter at 6ml inflation) | Average diameter = 16 mm (at 6ml inflation) | Passed all conditions; Equivalent to predicate |
| Balloon Inflation Behavior (Diameter constraint) | Balloon Diameter $\le$ 19 mm | Passed all conditions; Equivalent to predicate |
| Balloon Inflation Behavior (Length Change) | Least possible length change | Passed all conditions; Equivalent to predicate |
| Tensile Force Balloon-Shaft | $\ge$ 15 N | Passed all conditions; Equivalent to predicate |
| Tensile Force Hub-Shaft | $\ge$ 15 N | Passed all conditions; Equivalent to predicate |
| Tensile Force Luer Lock | $\ge$ 15 N | Passed all conditions; Equivalent to predicate |
| Balloon Repeated Inflation | Must not burst within 3 inflation/deflation cycles | Not explicitly reported in the "Test Result and Conclusion" column in the smaller table, but the general statement "The results of the non-clinical tests show that the inflatable bone tamp of the Joline Kyphoplasty System Allevo meets or exceeded all performance requirements" implies it passed. |
| Balloon Deflation Time | $\le$ 3 s | Not explicitly reported in the "Test Result and Conclusion" column in the smaller table, but the general statement "The results of the non-clinical tests show that the inflatable bone tamp of the Joline Kyphoplasty System Allevo meets or exceeded all performance requirements" implies it passed. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the tests. It refers to "non-clinical tests," which are typically laboratory bench tests rather than tests performed on human subjects. Therefore, provenance regarding country of origin or retrospective/prospective data is not applicable in the human subject sense. These are engineering design verification tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The tests performed are non-clinical, evaluating the physical and mechanical properties of the device against predefined engineering specifications. Ground truth in the context of expert consensus or medical diagnosis is not relevant here.
4. Adjudication method for the test set
This information is not applicable as the tests are non-clinical engineering tests, not involving human interpretation or adjudication.
5. 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
There is no mention of an MRMC study or any AI assistance. This document describes a medical device (a kyphoplasty system) that is a physical instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical kyphoplasty system, not an algorithm.
7. The type of ground truth used
The "ground truth" for these tests is the established engineering specifications and performance requirements for a kyphoplasty balloon system, derived from industry standards, predicate device characteristics, and safety considerations. These are objective measurements of physical properties.
8. The sample size for the training set
This is not applicable. There is no concept of a "training set" as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 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.”