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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.

JAZZ PF enables the passing of a JAZZ braid around or through the upper spinous process. The main difference with the JAZZ regular connector is that in the subject device the braid is locked horizontally, that is, along the spine axis, instead of vertically. On each side of the instrumented levels, a JAZZ PF connector is implanted on the union rod below the upper pedicle screw. A JAZZ braid is passed and locked through a 1st connector, above or through the spinous process and back through the second connector on the other side. The slack that can exist in the band is removed using the JAZZ PF Band Reducer (Enrouleur Instrument) without applying any tension in the band and the 2nd connector is locked. By doing so, flexion is controlled which helps in the primary stabilization of the levels where fusion has to be achieved.

The provided text describes a medical device, JAZZ PF, and its substantial equivalence determination by the FDA. However, it does not include detailed information regarding "acceptance criteria" for a study in the context of device performance, nor does it present a study that rigorously proves the device meets specific acceptance criteria in a quantitative sense as might be expected for an AI/CADe device.

Instead, the document focuses on regulatory approval based on substantial equivalence to predicate devices. This means the device is considered safe and effective because its technological characteristics and intended use are similar to those of devices already legally marketed. The performance data mentioned is for mechanical durability testing, not for diagnostic or analytical performance against ground truth.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's what can be provided based on the text:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the primary "acceptance criterion" for this type of device (spinal implant) in a 510(k) submission is typically demonstrating mechanical durability and safety comparable to predicate devices. The study mentioned is a mechanical test.

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated as "test set" in the context of an analytical or diagnostic study. For the dynamic compression testing, the number of devices or constructs tested is not specified, only that "JAZZ PF constructs passed."
• Data Provenance: Not applicable in the context of clinical data for AI/CADe. The performance data is from mechanical testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth in the context of a diagnostic or analytical AI study (e.g., expert consensus on medical images) is not relevant for this device's mechanical performance testing.

4. Adjudication method for the test set

Not applicable. There's no adjudication process mentioned for a mechanical test.

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. This is a spinal implant, not an AI/CADe device that assists human readers.

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

No. This is a spinal implant, not an algorithm.

7. The type of ground truth used

Not applicable in the context of an AI/CADe device. The "ground truth" for the mechanical test is adherence to engineering specifications for load and cycles.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of Device and Study from Text:

The JAZZ PF is a temporary spinal implant for stabilization during fusion and fracture repair. Its approval (K191217) was based on demonstrating substantial equivalence to existing predicate devices (NuVasive VersaTie System - K173117 and JAZZ System - K182771). The key performance data provided in the submission was a dynamic compression test where JAZZ PF constructs "passed 5 million cycles at a load of 600N," indicating its mechanical durability. The submission also addressed sterilization, cleaning, and biocompatibility by providing rationales that the device did not constitute a new worst-case compared to predicates. The document does not describe a study involving human readers, AI algorithms, or clinical performance against a diagnostic ground truth.

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