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The Jazz Systems are temporary implants to be used in orthopedic surgery. The Jazz Systems are 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 Systems may also be used in conjunction with other medical implants made of titanium alloy or cobaltchromium-molybdenum allov 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.

This document is a 510(k) summary for the JAZZ Passer Band. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study against specific acceptance criteria for a novel device. Therefore, much of the requested information (like expert-established ground truth, MRMC studies, or training set details) is not applicable or not provided in the given text.

Here's an analysis based on the provided input:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "static tensile testing," which inherently involves a test set of physical devices. However, the specific sample size (e.g., number of JAZZ Passer Bands tested) is not provided.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. Given it's a 510(k) submission, the testing would generally be conducted by the manufacturer (Implanet, S.A., based in France) or a contracted lab.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information is not applicable to this submission. The "ground truth" for mechanical testing is typically based on engineering specifications and material properties, not expert clinical consensus.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing results are objectively measured and do not require an adjudication method like clinical assessments.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or imaging interpretation devices. The JAZZ Passer Band is a physical orthopedic implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This is not relevant for a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on engineering specifications and established mechanical testing standards for medical implants. The specific and detailed acceptance criteria for the static tensile testing (e.g., passing a certain load threshold without failure) are not explicitly detailed in this summary but would be part of the full submission.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" of data in the context of this physical device's mechanical performance testing.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set.

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