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The ISS-JAZZ Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The ISS-JAZZ Screw 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 deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ISS-JAZZ Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The JAZZ systems (including the JAZZ Claw Connector) 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 Cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.

The JAZZ CAP SP is composed of three components, the Cap SP, the Base SP, and the Insert Lock. The head shape ISS pedicle screws is modified from the current tulip shape to a cylindrical shape to match the Cap SP, resulting in the JAZZ Screw. The ISS-JAZZ Screw System is composed of monoaxial and polyaxial screws and straight and pre bent rods. The JAZZ CAP SP is added to the proximal end of the JAZZ Screw and provides for an alternate method to attach the JAZZ Band and JAZZ Passer Band to skeletal structures as compared to the current method of using a JAZZ Connector (K171881).

This document is a 510(k) summary for a medical device called the ISS-JAZZ Screw System and JAZZ CAP SP. It describes the device, its intended use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.

Here's an analysis of the requested information based on the provided text, indicating when information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it refers to performance testing conforming to a standard and demonstrating substantial equivalence.

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

• Sample Size: Not explicitly stated. The document mentions "worst-case construct" for dynamic compression testing, implying a limited number of samples representative of the most challenging configuration. For static axial load, it states "Additional static axial load testing" without specifying the number of samples.
• Data Provenance: Not provided, but generally, such performance testing for medical devices is conducted in a controlled laboratory environment. The document is for submission to the U.S. FDA, so the data is intended for U.S. regulatory review. It is a premarket notification, so the data would be based on pre-clinical testing, not clinical data from patients.

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

• This information is not applicable to this type of submission. This document describes the performance testing of a spinal implant system. The "ground truth" here is based on engineering principles, standardized mechanical tests (ASTM F1717), and material science, not clinical expert consensus on diagnostic images or patient outcomes.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters where there might be disagreement in interpretations. This document pertains to mechanical performance testing.

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

• This information is not applicable. This is not an AI/software as a medical device (SaMD) submission. It is a traditional medical device (implant) submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• This information is not applicable. This is not an AI/software as a medical device (SaMD) submission.

7. The Type of Ground Truth Used

• The "ground truth" in this context is defined by engineering specifications, material properties, and established mechanical testing standards (ASTM F1717). The goal is to demonstrate that the device meets predefined physical and mechanical performance characteristics, and is substantially equivalent to predicate devices based on these objective measures.

8. The Sample Size for the Training Set

• This information is not applicable. This is not an AI/machine learning device. There is no "training set" in the context of mechanical performance testing for an implant.

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

• This information is not applicable. As there is no training set for an AI/ML model, there is no ground truth derivation process for such a set.

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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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