(92 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 alloy or cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.
The JAZZ Systems consists of the following components: JAZZ Connector, JAZZ Claw Connector, JAZZ Claw hooks, JAZZ Lock Connector, various rods, and JAZZ Braid (a.k.a. Band) with buckle. The JAZZ Band is inserted into various JAZZ connectors and is used to attach them to the spine.
The provided document is a 510(k) summary for a medical device (JAZZ System, including JAZZ Band) and does not contain the level of detail required to answer all parts of your request regarding acceptance criteria and a detailed study proving device performance in the context of an Artificial Intelligence (AI) or machine learning device. This document describes a traditional medical device (a temporary implant for orthopedic surgery) and its regulatory clearance process, not an AI/ML powered medical device.
Therefore, for aspects related to AI/ML device evaluation (like sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance of an algorithm, and training set details), the information is not applicable as the JAZZ System is a physical implant, not a software-based diagnostic or predictive tool.
However, I can extract the relevant information regarding the performance data provided for this specific device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Equivalent to predicate (assessed per ISO 10993) |
| Mechanical Performance | Equivalent to predicate (assessed via static tensile testing) |
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical implant, and the performance assessment described is based on testing the physical properties of the device, not a classification or prediction task on a "test set" of data in the AI/ML sense. Data for biocompatibility and mechanical testing would involve a certain number of test samples of the device and testing materials, but these are not disclosed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/ML devices is not relevant here. Biocompatibility and mechanical performance are assessed through laboratory testing against established standards and engineering principles.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
For biocompatibility, the ground truth would be adherence to the ISO 10993 standard. For mechanical performance, the ground truth would be demonstrating equivalent or superior strength and integrity compared to the previously cleared predicate device, based on established engineering specifications and static tensile testing protocols.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Additional Information from the Document:
- Device Name: JAZZ System, including JAZZ Band
- Purpose of 510(k): To modify the JAZZ Band component. Minor changes were made to the ultrasonic welding of the braid and the design of the metal buckle.
- Predicate Devices: Implanet's JAZZ System (K151740), Implanet's JAZZ Systems (K162764), Implanet's JAZZ Lock (K153348).
- Conclusion: The modified JAZZ Band is as safe and effective as the predicate JAZZ Braid. The JAZZ Band has the same intended uses and indications, and similar technological characteristics and principles of operation as its predicate device. Performance data (biocompatibility and mechanical performance) demonstrate that the modified JAZZ Band is substantially equivalent.
§ 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.