(62 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: 1.
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities 2. 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 cobaltchromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.
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 screw; and stainless steel malleable strip and buckle.
The provided document is a 510(k) premarket notification for the JAZZ System, a bone fixation cerclage device. It primarily focuses on demonstrating substantial equivalence to predicate devices for a modification in indications for use. Crucially, the document explicitly states: "No new performance data was needed to support the change in indications."
Therefore, the comprehensive study information you requested (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not available within this specific FDA submission. This submission relies on the previously established performance of the JAZZ System and its predicate devices.
Here's what can be extracted and inferred from the document regarding "acceptance criteria" in the context of this 510(k):
1. Table of Acceptance Criteria and Reported Device Performance:
Since no new performance data was generated for this specific 510(k), there isn't a table of new acceptance criteria and device performance results. The core acceptance criterion for this submission was demonstrating substantial equivalence to predicate devices by ensuring the modified indications did not alter the fundamental safety and effectiveness already established.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (Inferred / Stated) |
|---|---|
| Same intended use as predicate devices | Stated as having the "same intended use" as the previous JAZZ System and predicate. |
| Same technological characteristics as predicate devices | Stated as having the "same technological characteristics" as the previous JAZZ System. |
| Same principles of operation as predicate devices | Stated as having the "same principles of operation" as the previous JAZZ System. |
| Modified indications are identical to other legally marketed bone fixation cerclage devices | Stated that the "minor changes to the indications for use allow the JAZZ System to be marketed for indications identical of other legally marketed bone fixation cerclage devices." |
| No alteration to safety and effectiveness despite modified indications | Stated that "The minor changes to its indications do not alter its intended use" and implies no change to safety/effectiveness. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided as no new performance data was generated for this 510(k).
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided as no new performance data was generated for this 510(k).
4. Adjudication method for the test set:
- Not applicable/Not provided as no new performance data was generated for this 510(k).
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 a bone fixation cerclage device, not an AI-driven diagnostic or interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical implant device, not an algorithm.
7. The type of ground truth used:
- Not applicable/Not provided as no new performance data was generated for this 510(k). For a physical device, ground truth would typically refer to established biomechanical testing standards, clinical outcomes, or material property verification.
8. The sample size for the training set:
- Not applicable/Not provided as no new performance data was generated for this 510(k).
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
In summary, this 510(k) submission for the JAZZ System focuses on regulatory demonstration of substantial equivalence based on previous testing and predicate device comparisons, not on presenting new performance study data.
§ 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.