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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:

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 System may also be used in conjunction with other medical implants made of titanium allov 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 JAZZ System consists of the following components and accessories: polyester (polyethylene-terephthalate) braid; titanium alloy connector and stainless steel malleable strip and buckle.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Implanet S.A.'s JAZZ System, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes the JAZZ System as a bone fixation cerclage used in spinal surgery. The performance data focuses on mechanical and biocompatibility testing. The acceptance criteria generally state that the product met "necessary specifications" and "functioned as intended." Specific quantitative acceptance criteria are not detailed in the document, nor are specific quantitative performance results for each test.

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

The document does not specify the sample sizes used for the individual bench tests. It also does not explicitly state the provenance of the data (e.g., country of origin) or whether the tests were retrospective or prospective, although bench testing would inherently be prospective in nature.

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

This information is not applicable to the provided document. The "ground truth" in this context refers to the results of engineering and biocompatibility tests, not clinical evaluations by human experts.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or assessment, not for direct engineering bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The document focuses on the mechanical and biocompatibility performance of the device itself, rather than its impact on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to an orthopedic implant like the JAZZ System. The device is a physical implant, not an algorithm. Therefore, "standalone performance" refers to its mechanical and biological characteristics, which were assessed through the described bench testing.

7. Type of Ground Truth Used

The ground truth used for performance evaluation was based on engineering specifications and established test methodologies for mechanical performance (e.g., tensile strength, compression resistance, viscoelastic characteristics, dynamic loading) and recognized industry standards (ISO-10993) for biocompatibility.

8. Sample Size for the Training Set

This information is not applicable. The JAZZ System is a physical implant, not an AI or machine learning model that requires a training set.

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

This information is not applicable, as there is no training set mentioned for this medical device.

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The Implanet Calypso System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Implanet Calypso System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.

The Calypso System is a posterior instrumentation system consisting of monoaxial and polyaxial pedicle screws, union rods, transverse connectors, and hooks. The implants in the system are composed of Ti6Al4V titanium alloy described by ISO 5832-3.

The Implanet S.A.'s Calypso System is a spinal fixation device. The provided text details the performance data for the device, focusing on its mechanical strength and biological compatibility to demonstrate substantial equivalence to predicate devices. It does not describe an AI medical device. Therefore, several of the requested categories (e.g., number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable as they pertain to AI/ML device studies.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the "sample size" in terms of number of devices tested for each mechanical test. It mentions "bench testing," implying a set of physical samples were tested.

• Data Provenance: The tests are bench tests performed by Implanet S.A. No country of origin for data or retrospective/prospective status is relevant for these types of mechanical and biological tests.

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

Not applicable. Ground truth for mechanical and biological testing is established by adherence to recognized international standards (e.g., ASTM, ISO) and laboratory measurements, not by expert consensus interpreting complex data like medical images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., imaging studies) to resolve disagreements. Here, objective measurements against pre-defined standards are used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a spinal fixation device, not an AI medical device, so an MRMC study is not relevant to its regulatory submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is defined by established industry standards and specifications (e.g., ASTM F1798, ASTM F1717, ISO 10993, ISO 11137, ISO 17665). The measurements taken during bench testing are compared directly against these quantitative and qualitative criteria.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for such a set.

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