(64 days)
JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ System may also be used in conjunction with other medical implants made of titanium allov whenever "wiring" may help secure the attachment of other implants.
The JAZZ System is intended to be used with the Implanet Spine System.
The Implanet JAZZ System is part of a spinal posterior fixation system that is designed to provide a stable interface between spinal constructs and the rod used in spinal surgery. The device is secured around vertebral structures such as the lamina, facet, or transverse processes from T1 to L5.
The JAZZ System consists of the following components and accessories: polyester (polyethylene-terephthalate) braid; titanium alloy connector and stainless steel malleable strip and buckle.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Implanet S.A.'s JAZZ System, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes the JAZZ System as a bone fixation cerclage used in spinal surgery. The performance data focuses on mechanical and biocompatibility testing. The acceptance criteria generally state that the product met "necessary specifications" and "functioned as intended." Specific quantitative acceptance criteria are not detailed in the document, nor are specific quantitative performance results for each test.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Product "met the necessary specifications and functioned as intended" for various bench tests. | Confirmed for Static Tensile Test (braid), Viscoelastic Characteristics (braid), Static Tensile Testing, Static Axial Compression Corpectomy Construct Testing, Dynamic Tension Testing, and Dynamic Axial Compression Corpectory Construct Testing. |
| Sterilization and shelf life validation in accordance with recognized industry standards. | Validated. |
| Biocompatibility confirmed in accordance with ISO-10993. | Confirmed. |
| Modified JAZZ System satisfied acceptance criteria for dynamic axial compression corpectory construct. | Satisfied. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the individual bench tests. It also does not explicitly state the provenance of the data (e.g., country of origin) or whether the tests were retrospective or prospective, although bench testing would inherently be prospective in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the provided document. The "ground truth" in this context refers to the results of engineering and biocompatibility tests, not clinical evaluations by human experts.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or assessment, not for direct engineering bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The document focuses on the mechanical and biocompatibility performance of the device itself, rather than its impact on human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to an orthopedic implant like the JAZZ System. The device is a physical implant, not an algorithm. Therefore, "standalone performance" refers to its mechanical and biological characteristics, which were assessed through the described bench testing.
7. Type of Ground Truth Used
The ground truth used for performance evaluation was based on engineering specifications and established test methodologies for mechanical performance (e.g., tensile strength, compression resistance, viscoelastic characteristics, dynamic loading) and recognized industry standards (ISO-10993) for biocompatibility.
8. Sample Size for the Training Set
This information is not applicable. The JAZZ System is a physical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set mentioned for this medical device.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.