(127 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:
- 1 Spinal trauma surgery, used in sublaminar or facet wiring techniques;
- 2 Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
- 3 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 alloy 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 modified JAZZ System is designed to function in the same manner as the cleared predicate device. The JAZZ System is intended to be used with the Implanet Spine System (K143731).
This document describes the Implanet S.A.'s JAZZ System, a temporary implant for orthopedic surgery, and its 510(k) premarket notification. The submission is for a modification to an already cleared device, primarily involving an expansion of connector sizes and minor instrument modifications.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | ASTM F1717 | Not explicitly stated (implied to meet "necessary specifications and functioned as intended" for spinal constructs) | Confirmed that the product met the necessary specifications and functioned as intended. |
| Static Tensile Testing | Not explicitly stated | Confirmed that the product met the necessary specifications and functioned as intended. | |
| Dynamic Tensile Testing | Not explicitly stated | Confirmed that the product met the necessary specifications and functioned as intended. | |
| Biocompatibility | ISO-10993 | Compliance with ISO-10993 requirements | Biocompatibility of the device was confirmed. |
| Sterilization & Shelf Life | Recognized industry standards | Compliance with recognized industry standards | Sterilization and shelf life validation testing conducted successfully. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of clinical data or patient samples. The performance data section refers to mechanical testing, sterilization and shelf life validation, and biocompatibility testing. For these types of tests, individual components or prototypes are typically tested, not patient samples.
- Sample Size: Not explicitly stated for each test, but typically refers to a number of manufactured components/assemblies required by the test standard.
- Data Provenance: Not applicable in the context of patient data for this submission. The tests are laboratory-based and conducted by the manufacturer, Implanet S.A.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The reported performance data (mechanical, biocompatibility, sterilization, shelf life) refers to engineering and laboratory tests, not clinical studies involving human patients or interpretations by medical experts. Ground truth in this context is established by meeting predefined engineering specifications and international standards.
4. Adjudication Method for the Test Set:
Not applicable, as the performance data refers to objective engineering and lab tests, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not reported. This submission focuses on the substantial equivalence of a modified medical device to a predicate device, based on mechanical, biocompatibility, and sterilization testing, rather than a clinical effectiveness study involving human readers and AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The JAZZ System is a physical medical implant (bone fixation cerclage), not an AI algorithm or a software device. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used:
The "ground truth" for the reported performance data is based on:
- Engineering Specifications: The device's design specifications for mechanical strength and function.
- International Standards: Compliance with recognized international standards such as ASTM F1717 (for spinal constructs) and ISO-10993 (for biocompatibility).
- Industry Standards: Compliance with recognized industry standards for sterilization and shelf life validation.
8. Sample Size for the Training Set:
Not applicable. The JAZZ System is a physical medical implant, not a machine learning model or 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 this 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.