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The ST360° Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: 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, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

When used as a hook and sacral screw system, the ST360 Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The ST36000 Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, fixed and adjustable transverse connectors. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ASTM F-136.

This document is a 510(k) summary for the ST360® Spinal Fixation System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way a new drug or novel high-risk device might.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a detailed performance study with statistical measures.

Here's why and what can be inferred:

• Type of Device and Submission: The ST360® Spinal Fixation System is a Class III spinal fixation system. This is a 510(k) premarket notification. For devices like this, the primary focus for FDA clearance is demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. This is often done through bench testing (mechanical properties, materials), design comparisons, and sometimes cadaveric studies, rather than large-scale human clinical trials with specific performance endpoints like accuracy, sensitivity, or specificity.
• Lack of Performance Metrics for AI/Algorithm: The questions provided are highly relevant to AI/ML-driven diagnostic or prognostic devices. This device is a physical implantable medical device (spinal fixation hardware), not a software algorithm or AI diagnostic tool. Therefore, concepts like "acceptance criteria" for accuracy, sensitivity, "MRMC comparative effectiveness study," "standalone algorithm performance," "ground truth" (especially in the context of expert consensus or pathology for diagnostic outcomes), "sample size for training set," etc., do not apply to this specific device or its regulatory submission.

Summary of missing information based on the prompt's categories:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence to a predicate device through material, design, and intended use comparisons, not a new performance study with specific metrics.
2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device testing. Any "testing" for this device would be mechanical or biomechanical, not based on a "test set" of patient data for diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no diagnostic "ground truth" established by experts for this physical device.
4. Adjudication method for the test set: Not applicable.
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 device is not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. This device does not use a training set in the AI/ML sense.
9. How the ground truth for the training set was established: Not applicable.

What can be inferred from the document:

• Acceptance Criteria (Implied): The implied acceptance criterion is "substantial equivalence" to the predicate devices (ST360® Spinal Fixation System, K022374, K041925). This is a regulatory standard, not a performance metric for the device itself.
• Study Proving Acceptance (Implied): The "study" is the 510(k) submission itself, which argues for substantial equivalence by stating: "There are no changes to the material of construction or the mechanism of action to the ST360° Spinal Fixation System. The modified system has the same fundamental scientific technology and intended use and indications as the predicate device." This is a declarative statement of comparison rather than a report of specific experimental results.
• Regulatory Decision: The FDA's letter (K072183) confirms that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This is the "proof" that the regulatory acceptance criterion (substantial equivalence) has been met.

In conclusion, the input document is for a physical medical implant (spinal fixation system) seeking 510(k) clearance, which relies on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria typically associated with AI/ML or novel diagnostic technologies.

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The ST360™ Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: 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; deformities (i.e., scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

When used as a hook and sacral screw system, the ST360 Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The ST360™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varying diameters and lengths; fixed screws of varving diameters and lengths; rods in varying lengths; hooks in varying designs; and transverse connectors in the various configurations of fixed, adjustable, variable angle offset and axial. All implant components are either top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.

This appears to be a 510(k) Summary for a medical device called the ST360™ Spinal Fixation System, not a study evaluating its performance against acceptance criteria in the way described by the request. The document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to predicate devices, rather than a prospective study demonstrating specific performance metrics.

Therefore, most of the requested information cannot be extracted from the provided text because it describes a different type of evaluation.

However, I can provide what is available, noting the differences:

The "study" cited is a mechanical testing comparison to demonstrate substantial equivalence, not a clinical performance study with human subjects, expert adjudication, or AI components.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and where the requested information is absent:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the format of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity for an AI device). The document states:

   • Acceptance Criteria (Implied): Substantial equivalence in mechanical properties to predicate devices (Silhouette™ Spinal Fixation System and previous ST360™ components) as measured by ASTM F 1717 and ASTM F 1798.
   • Reported Device Performance: "The testing demonstrated substantially equivalent mechanical properties to the previously cleared Silhouette™ Spinal Fixation System and ST360™ Spinal Fixation System components." No specific numerical performance values are given.

2. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified (refers to mechanical test samples, not clinical data).
   • Data Provenance: N/A (mechanical testing, not clinical data from countries). The text implies laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is mechanical testing outcomes, not expert medical opinion.

4. Adjudication method for the test set: Not applicable. This is for clinical or AI performance, not mechanical 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 document describes a spinal fixation system, not an AI-assisted diagnostic or therapeutic device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.

7. The type of ground truth used: Mechanical properties measured according to ASTM F 1717 and ASTM F 1798 standards, demonstrating equivalence to predicate devices.

8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) Summary for a spinal implant system, focusing on its regulatory clearance based on substantial equivalence demonstrated through mechanical testing. It does not provide the kind of performance data, clinical study details, or AI-specific information requested in the prompt.

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