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The Wiltrom Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6AI-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided non-sterile, and the implants are for single use only.

This document is a 510(k) Premarket Notification for a Wiltrom Spinal Fixation System. The provided text focuses on demonstrating the substantial equivalence of the subject device to a predicate device, primarily by showing that the proposed changes (updated surgical instruments) do not affect the safety and effectiveness of the spinal fixation system's core implants.

Therefore, the information you are asking for regarding acceptance criteria and a study proving device performance (like an AI/ML medical device where performance metrics are key) is not present in this document. This document is for a mechanical medical device, and its "performance data" refers to mechanical testing according to established ASTM standards, not clinical performance or diagnostic accuracy.

Here's why your request cannot be fulfilled by this document:

• Type of Device: This is a Class II Thoracolumbosacral Pedicle Screw System (a mechanical implant), not a diagnostic device, imaging AI, or therapeutic software.
• Approval Process: 510(k) clearance for this type of device relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, often through design comparison, material testing, and mechanical performance testing to established standards (like ASTM F1717-15, as mentioned).
• Nature of "Performance Data": For this device, "performance data" means the results of mechanical tests (static torsion, axial compression bending) to ensure the device can withstand physiological loads, not accuracy, sensitivity, or specificity as would be relevant for an AI/ML device.

Therefore, the sections below cannot be populated from the provided text, as the information is not relevant to this type of medical device submission.

Acceptance Criteria and Study for Wiltrom Spinal Fixation System (Based on provided text)

Based on the provided 510(k) summary for the Wiltrom Spinal Fixation System, the device is a mechanical implant (Thoracolumbosacral Pedicle Screw System). The "study that proves the device meets the acceptance criteria" for such a device primarily involves demonstrating substantial equivalence to an existing predicate device, backed by mechanical performance testing to established standards.

The concept of "acceptance criteria" and "study" as you've outlined involving human readers, AI assistance, ground truth establishment by experts, and specific clinical performance metrics (sensitivity, specificity, AUC) is typically applicable to diagnostic devices, particularly those incorporating AI/Machine Learning. It is not applicable to a mechanical spinal fixation system like the Wiltrom device based on the information provided in this 510(k) submission.

The "performance data" for this device, as stated in the document, refers to:

• Mechanical testing in accordance with ASTM F1717-15.
• Tests included: static torsion testing, static and dynamic axial compression bending testing.

The conclusion drawn from this testing is that "The performance of Wiltrom spinal implants in stabilizing the operative site and the mechanical safety was demonstrated, which is not affected by the proposed changes."

As such, I cannot provide the requested information in the format of AI/ML device performance. The provided document does not contain data on human reader studies, AI assistance, or expert ground truth adjudication for diagnostic purposes.

Specifically, for the points you asked for:

1. A table of acceptance criteria and the reported device performance: Not applicable in the context of diagnostic performance metrics. The acceptance criteria here would be meeting the mechanical performance requirements of ASTM F1717-15, which are not detailed in terms of specific force or displacement values in this summary.
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of patient data for diagnostic evaluation. Mechanical testing typically uses a specific number of devices per test, as per ASTM standards, but these details are not provided.
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 ground truth established by experts for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: 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 (expert consensus, pathology, outcomes data, etc): Not applicable for diagnostic ground truth. The "ground truth" for this device is its mechanical integrity and ability to stabilize the spine, demonstrated through in vitro mechanical testing to established engineering standards.
8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable.

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The Wiltrom Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided non-sterile, and the implants are for single use only.

This document is a 510(k) premarket notification for a medical device called the Wiltrom Spinal Fixation System. It focuses on establishing substantial equivalence to a predicate device, the Fortex Pedicle Screw System (K090224). The information provided is primarily related to mechanical testing for safety and effectiveness, rather than a clinical study evaluating diagnostic or prognostic performance based on specific acceptance criteria for AI or algorithmic output. Therefore, many of the requested sections about AI/algorithm performance and ground truth establishment cannot be directly answered from this document.

Here's a breakdown of what can be extracted and what cannot:

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

The document discusses mechanical testing criteria for the physical device, not for an AI or algorithm.

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

This information is for mechanical testing of the physical device, not an AI test set. The sample size would refer to the number of implants/constructs tested. The document states "mechanical testing including static torsion testing, static and dynamic axial compression bending testing were conducted," but does not specify the number of samples for each test or the provenance of the data in the context of clinical or image data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth, in this context, would relate to the physical integrity and performance of the device under stress, measured through engineering standards, not expert evaluation of clinical data.

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

Not applicable. Adjudication methods are typically for clinical or imaging studies where expert consensus is needed. The testing here is mechanical.

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 not a study involving human readers or AI assistance.

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

Not applicable. This document does not describe an AI algorithm.

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

For mechanical testing, the "ground truth" would be established by the engineering standards themselves (e.g., ASTM F1717-15) and the objective measurements of force, deformation, and failure points taken during the tests.

8. The sample size for the training set

Not applicable. This document does not pertain to the development of an AI algorithm with a training set.

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

Not applicable. This document does not pertain to the development of an AI algorithm with a training set.

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