(112 days)
The Jazz System is a temporary implant for use in orthopedic surgery. The 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:
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- Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of 2. spinal deformities such as scoliosis, kyphosis, spondylolisthesis;
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- 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 CALYPSO pedicle screw system.
The device consists of the following components and accessories: polyester (polyethyleneterephthalate) braid; titanium alloy connector and screw; and stainless steel malleable strip and buckle.
The K121541 filing for Implanet S.A.'s Jazz System focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility assessments, rather than clinical studies or reader performance evaluations. Therefore, many of the requested categories related to clinical study design, expert ground truth, and reader performance cannot be populated from the provided text.
Here's a breakdown of the information that can be extracted:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Jazz System were based on meeting the "necessary specifications" through bench testing. The specific quantitative acceptance criteria are not detailed in the provided document, but the general requirement was to confirm "adequate mechanical strength for its intended use."
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Adequate for intended use, met necessary specifications | "All bench testing confirmed that the product met the necessary specifications." |
| Biocompatibility | In accordance with ISO-10993 | "The biocompatibility of the device has been confirmed in accordance with ISO-10993, through performance of the following tests: Cytotoxicity, Intracutaneous irritation, Systemic toxicity (acute, sub-acute, sub-chronic, pyrogenicity), Sensitization, Genotoxicity, Implantation." |
| Sterilization and Shelf Life Validation | In accordance with recognized industry standards | "The company has conducted sterilization and shelf life validation in accordance with recognized industry standards." |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The testing described is bench testing, not human or image data.
- Data Provenance: The document does not specify country of origin for any data beyond the manufacturer being located in Martillac, France. The studies are described as "bench testing," meaning they were conducted in a laboratory setting. This is a form of prospective testing of the device hardware.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a bench testing study, not one requiring expert human interpretation or ground truth establishment in a clinical context.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This was a bench testing study, not one requiring adjudication of human interpretations.
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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:
- No MRMC study was done. This filing is for a surgical implant (bone fixation cerclage) and relies on mechanical and biocompatibility testing, not AI or reader performance studies.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the bench testing was established through engineering specifications and industry standards for mechanical strength and biocompatibility (e.g., ISO-10993). There is no "expert consensus" in the clinical sense, pathology, or outcomes data mentioned for the performance testing.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that would require a training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning 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.