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The Jazz Claw System (hooks and rods) is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic. Jumbar and/or sacral spine. The Jazz Claw System (hooks and rods) is 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 (fracture or dislocation);
• spinal stenosis; ●
• spinal deformities (scoliosis, kyphosis and/or lordlosis) ●
• tumor:
• . pseudarthrosis; and
• revision of a failed fusion attempt. ●

The Jazz Claw System (hooks and rods) is indicated as an adjunct to freat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft.

The JAZZ CLAW connector consists of temporary implants to be used in orthopedic surgery. The JAZZ CLAW connector 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:
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities 2 such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
• 3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The JAZZ CLAW connector 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 CLAW System consists of the JAZZ CLAW hook and JAZZ CLAW rod.

The JAZZ CLAW connector and the cleared JAZZ braid are also separate components, as well as manual surgical instruments.

This looks like a 510(k) premarket notification for a medical device called the JAZZ CLAW System, which includes hooks, rods, and a connector. However, this document does not describe the acceptance criteria or a study proving the device meets specific performance criteria.

Instead, this document is a regulatory submission to the FDA for a substantial equivalence determination. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed predicate device, and therefore does not require a full Premarket Approval (PMA) application.

Here's why the requested information about acceptance criteria and study data is largely absent:

• Substantial Equivalence (510(k)) vs. Clinical Trials/Performance Studies: A 510(k) often relies on bench testing, comparison to predicates, and engineering rationale rather than extensive, de novo clinical trials or detailed performance studies with human subjects. The goal is to show similarity, not necessarily to independently prove a specific performance metric against a defined acceptance criterion through rigorous clinical data.
• Focus on Safety and Effectiveness: The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration." This emphasizes regulatory compliance and similarity to existing devices, not a detailed breakdown of a device's specific acceptance criteria from a performance study.

Based on the provided text, I can extract the following, but many of your requested points are not present:

1. Table of acceptance criteria and the reported device performance

No explicit acceptance criteria or a table of specific performance metrics are provided in this document. The document states:

• "The strength of the overall construct (JAZZ CLAW connector used with hooks and rods) was assessed per ASTM F1717 dynamic axial compression testing and found to be equivalent to the predicate JAZZ system (K151740) and Implanet Spinal System (K143731)."
• "In addition, engineering rationales were performed to support device performance of the JAZZ CLAW connector and the JAZZ CLAW System (hooks and rods)."

This indicates that performance was evaluated against a standard (ASTM F1717) and compared for equivalence to predicate devices, rather than meeting predefined acceptance criteria for a new performance claim.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for the ASTM F1717 testing.
• Data Provenance: Not specified. This would typically be bench testing, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth as typically understood in AI/imaging studies is not relevant here. The "ground truth" for this type of device (spinal implant) is its mechanical integrity and biocompatibility, typically assessed through engineering tests and material science, not expert consensus on medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept is typically used in clinical studies or expert review processes, not mechanical bench 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

Not applicable. This is a spinal implant, not an AI diagnostic device.

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

Not applicable. This is a spinal implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated. For mechanical devices like this, the "ground truth" for performance would be objective measurements obtained through standard mechanical tests (e.g., force, displacement, fatigue cycles) that demonstrate structural integrity and durability. The document mentions "ASTM F1717 dynamic axial compression testing," which is a standardized test for spinal implant constructs.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable.

Summary of what is available:

• Device: JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
• Purpose of Evaluation: To demonstrate substantial equivalence to predicate devices for a 510(k) premarket notification.
• Testing Mentioned: ASTM F1717 dynamic axial compression testing.
• Outcome: Found to be "equivalent" to predicate devices (JAZZ system (K151740) and Implanet Spinal System (K143731)).
• Other Evidence: Engineering rationales to support device performance.
• Conclusion: Minor technological differences between the new device and predicate devices raise no new issues of safety or effectiveness.

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