(87 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 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.
Here's a breakdown of the acceptance criteria and the study details for the JAZZ System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Static perforation testing | Met necessary specifications and functioned as intended. |
| Static tear testing (using two different instruments) | Met necessary specifications and functioned as intended. |
| Manual perforation testing | Met necessary specifications and functioned as intended. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, but the document mentions "Four custom tests were performed to assess the minor manufacturing modification to the polyester braid distal tip." This implies a limited number of test units were used for each of the four tests.
- Data Provenance: Not specified, but the testing was conducted for Implanet S.A., a French company. The document does not indicate if the testing was retrospective or prospective. Given it was for a modification, it was likely conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable as the study described is a bench test, not one involving human interpretation or clinical data. Therefore, there's no "ground truth" in the sense of expert consensus on medical findings.
4. Adjudication Method for the Test Set
- None applicable. This was a bench test on a device component, not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC comparative effectiveness study was not done. The submission focuses on bench testing a minor design modification to an existing device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical medical implant, not an AI/software algorithm.
7. The Type of Ground Truth Used
- For the bench testing, the "ground truth" was essentially the pre-defined engineering specifications and functional requirements for the polyester braid distal tip. The tests confirmed that the manufacturing process change met these required performance criteria.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical implant, not an AI/software algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
§ 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.