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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 <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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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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