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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 <20EU/Device.

It also states: "Interconnection strength testing has shown the T-bars to possess at least equivalent gripping strength to the crosslink components of the JAZZ Frame has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices." This implies a comparative test was done but doesn't provide the detailed results or specific acceptance criteria met.

Therefore, most of the requested information cannot be extracted from this document as it focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than a detailed performance study with defined acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria Mentioned:
  • Static axial, rotational, and bending testing per ASTM F1798.
  • Bacterial endotoxin testing to achieve an Endotoxin limit of <20EU/Device per ANSI/AAMI:ST72:2011.
  • Interconnection strength: T-bars possess at least equivalent gripping strength to predicate device crosslink components.
• Reported Device Performance: The document generally states that "Performance data demonstrate that the JAZZ Frame is substantially equivalent to its predicates" and that the T-bars showed "at least equivalent gripping strength." Specific numerical results from the ASTM F1798 tests or the exact gripping strength values are not provided.

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

• Not provided. The document mentions mechanical and endotoxin testing, but no details on the number of samples tested or where the testing was conducted. This is not a clinical study, so provenance of patient data is not applicable.

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

• Not applicable. This device is a mechanical implant; ground truth for its performance would be established through engineering specifications and mechanical testing, not expert clinical consensus.

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

• Not applicable. This applies to clinical studies, not mechanical device 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 mechanical implant, not an AI diagnostic device where MRMC studies would be relevant.

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

• Not applicable. This is a mechanical implant, not an algorithm.

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

• The "ground truth" for this device would be established by engineering design specifications and recognized international or national mechanical testing standards (e.g., ASTM F1798) to ensure biocompatibility and mechanical integrity.

8. The sample size for the training set

• Not applicable. This is a mechanical implant, not an AI algorithm requiring a training set.

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

• Not applicable. See point 8.

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