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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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The Jazz Claw System (hooks and rods) and the Jazz Frame System are 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 Jazz Claw System (hooks and rods) and the Jazz Frame System are intended for posterior 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 and/or lordosis), tumor, pseudarthrosis or revision of a failed fusion attempt.

The Jazz Claw System (hooks and rods) and the Jazz Frame System are indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The JAZZ Frame spinal implants are spinal fixation devices consisting of the following components: T-bars, straight rods, connectors, and surgical instruments. The T-bars are fixed closed transverse connectors. The rods have been previously cleared as part of the ISS system and are used with the JAZZ Frame. The JAZZ Connector and JAZZ Braid have been previously cleared and are also used with the JAZZ Frame. There is no change to the previously cleared JAZZ instruments.

Once the fusion rods have been bent to the desired shape, a T-bar is positioned at the top and middle of the two bars, and then tightened in place using the screwdriver. The caudal parts of the rods are inserted into heads of pedicle screws that have been previously implanted. The cranial end of the construct is then secured with JAZZ Connectors, and the screws of the T-bars undergo final tightening.

The provided text describes the 510(k) premarket notification for the JAZZ Frame System, a spinal fixation device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in a clinical or analytical setting against such criteria.

The "Performance Data" section briefly mentions:

• Static axial, rotational, and bending testing per ASTM F1798.
• Bacterial endotoxin testing (BET) as specified in ANSI/AAMI:ST72:2011 to achieve an Endotoxin limit of

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The JAZZ LOCK is a temporary implant to be used in orthopedic surgery. JAZZ LOCK is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. JAZZ LOCK is designed for a posterior approach. The indications for use include the following applications:

1. Spinal trauma surgery: Jazz Lock implants can be used in sublaminar wiring technique;

2. Spinal degenerative surgery: Jazz Lock implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of use.

The JAZZ LOCK consists of the following components and accessories: Titanium alloy Ti6Al4V locking base; PEEK Optima LT1 locking insert; polyester (polyethyleneterephthalate) braid; and stainless steel malleable strip and buckle. The braid is passed through the locking insert and around the pertinent spinal anatomy. The locking insert is compressed as it snaps into the locking base. locking the braid in place. The system also contains device-specific instrumentation used to position and tension the braid and lock the insert to the base.

The provided 510(k) summary for the JAZZ LOCK device focuses on establishing substantial equivalence to a predicate device through bench testing rather than clinical studies with human participants. Therefore, many of the requested categories related to clinical study design, ground truth establishment for patient data, and human reader performance are not applicable.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

Since this involves bench testing of a medical device, not a study on patient data, the concepts of "test set" sample size and "data provenance" (country of origin, retrospective/prospective) are not applicable. The "test set" would refer to the physical samples of the JAZZ LOCK device tested. The document does not specify the number of units tested for each bench test.

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

This is not applicable as the study is a bench test for mechanical properties and biocompatibility, not a clinical study requiring expert interpretation of patient data. The "ground truth" for bench testing is derived from engineering specifications and established test methodologies.

4. Adjudication Method for the Test Set

This is not applicable for bench testing. Adjudication methods are typically used in clinical studies where there's variability or disagreement among human readers or evaluators of patient data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study involves human readers evaluating cases, which is not relevant to the reported bench testing.

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

This is not applicable. The JAZZ LOCK is a physical implant, not an algorithm or AI.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" was established by engineering specifications, recognized industry standards (e.g., ISO 10993 for biocompatibility), and comparison with the mechanical properties and performance of the predicate device.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning study or a clinical study with patient data.

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

This is not applicable for the reasons stated above.

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