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The Xultan 5.5 Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients. The Xultan 5.5 Pedicle Screw System is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine (T1-S2/ilium); degenerative disc disease (DDD) (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; curvature (i.e., scoliosis and/or lordosis); tumor; and failed previous fusion (i.e., pseudoarthrosis).

The Xultan 5.5 Pedicle Screw System is an implant device manufactured from titanium and silicone. The screws are available cannulated or non-cannulated in various diameters and lengths to accommodate various patient anatomies. The system includes straight rods, curved rods, crosslinks, and associated instrumentation.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document describes a 510(k) premarket notification for a medical device called the "Xultan 5.5 Pedicle Screw System," which is a spinal implant.

The document focuses on the substantial equivalence of this device to existing predicate devices based on:

• Indications for Use: The stated medical conditions the device is designed to treat.
• Technological Characteristics: Materials, design, and principles of operation.
• Performance Data: Results of non-clinical mechanical testing (static and dynamic axial compression bending, static torsion) according to ASTM F1717-15 standards.

There is no mention of:

• Any AI/ML component or software.
• Acceptance criteria for AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, AUC).
• Clinical studies involving human-in-the-loop performance or standalone AI performance.
• Details about ground truth establishment, expert adjudication, or sample size for training/test sets related to AI/ML development.
• Any multi-reader multi-case (MRMC) studies.

Therefore, I cannot provide the requested information based on the given text.

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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 CorticaLINK Spinal Fusion Platform is intended for non-cervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients:

• 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;
• curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• tumor;
• pseudoarthrosis;
• and failed previous fusion.

The CorticaLINK Spinal Fusion Platform is a comprehensive suite of fixation implants which can be used to stabilize the spine as an adjunct to fusion following surgical decompression. The platform is comprised of screws. rods and locking caps, with the screws being offered in several different lengths, diameters, and thread pitches to accommodate varying anatomies, pathologies, and surgeon preferences.

The provided document is a 510(k) premarket notification for the CorticaLINK Spinal Fusion Platform. It describes the device, its indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices. However, it does not contain acceptance criteria or detailed results of a study demonstrating the device meets specific performance criteria in a clinical context that would require ground truth, human readers, or AI.

This document describes a medical device called the "CorticaLINK Spinal Fusion Platform," which is a system of implants used to stabilize the spine. The performance data provided is for non-clinical mechanical testing of the device's components (screws, rods, and locking caps), not a study involving human or AI performance.

Therefore, I cannot fulfill the request to provide details about acceptance criteria and a study proving the device meets those criteria, as the information required (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training and test sets) is not present in the given text.

The document only states that the device was tested mechanically according to ASTM standards and found to be substantially equivalent to predicate devices for its intended use, indicating sufficient strength.

Here's what I can provide based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions ASTM F1717-14 standards, which are general test methods for spinal implant constructs. However, specific numerical acceptance criteria (e.g., minimum bending strength in Nm) and the corresponding reported device performance values are not detailed in this summary. It only states that the results "show that the strength of the CorticaLINK Spinal Fusion Platform is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Missing Information (Not Available in the Document):

2. Sample size used for the test set and the data provenance: Not applicable, as this was mechanical testing, not a clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable, as this was mechanical testing, not a study requiring ground truth for diagnostic or expert agreement.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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