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The SYNMESH™ Spacer is a vertebral body replacement device in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SYNMESH Spacer is intended to be used with Synthes supplemental internal fixation of the SYNMESH Spacer can be packed with bone graft.

The SYNMESH™ System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The SYNMESH System spacer is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy/vertebrectomy. Different cross section sizes and heights are available to suit the individual pathology and anatomical conditions.

The SYNMESH System spacer consists of a cylindrical round or oblong mesh, end rings, standard rings and screws. The round mesh is used in pairs and is available in various diameters and heights. The oblong mesh is used individually and is also available in various cross-section sizes and heights.

The provided text is a 510(k) summary from the FDA for a medical device called the "SYNMESH™ System." It describes the device, its intended use, and claims substantial equivalence to a predicate device based on material and non-clinical performance testing.

However, the document DOES NOT contain information regarding the acceptance criteria or study details for an AI/algorithm-driven device.

Specifically, the device described is a spinal implant (vertebral body replacement device), which is a physical product, not a software or AI-driven diagnostic/treatment tool. As such, the concept of "acceptance criteria" related to AI performance metrics (like sensitivity, specificity, AUC) and studies involving expert readers, ground truth establishment, training/test sets, or MRMC studies are not applicable to this particular 510(k) submission.

The "performance data" mentioned (static/dynamic torsion, compression, expulsion, subsidence) refers to mechanical testing of the physical implant, not the performance of an AI algorithm.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and study proving an AI device meets them, as the provided document describes a physical medical implant.

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FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). FORTIFY® Spacers (titanium) are also intended for use in the cervical spine (C2-T1). All FORTIFY® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), FORTIFY® Integrated devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

FORTIFY® Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The spacers include a central core and endplates, which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and the endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft comprised of cancellous or corticocancellous bone graft to be packed inside of the spacer. Protrusions (teeth) on the superior and inferior surface grips the endplate of the adjacent vertebrae to resist expulsion. FORTIFY® Variable Angle endplates provide adjustable lordosis/kyphosis.

The provided text is a 510(k) summary for a medical device called "FORTIFY® Corpectomy Spacers." This document is focused on demonstrating the substantial equivalence of a new version of the device (with variable angle endplates) to previously cleared predicate devices.

It's crucial to understand that a 510(k) submission for a spinal implant device like this is primarily based on demonstrating mechanical and material equivalence to a predicate device, not on clinical performance metrics or AI algorithm validation. The questions you've asked (about acceptance criteria, AI performance studies, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) are typical for the validation of Artificial Intelligence/Machine Learning (AI/ML) based medical devices, especially those involved in image analysis or diagnostic support.

Therefore, based on the provided text, I cannot answer your specific questions related to AI/ML device validation. The information provided by the FDA for this particular 510(k) focuses on the mechanical and material aspects of the physical implant.

Here's a breakdown of why your specific questions cannot be answered from this document:

• No AI Component: The device described, FORTIFY® Corpectomy Spacers, is a physical spinal implant. It does not appear to involve any AI/ML components for image analysis, diagnosis, or treatment planning.
• Performance Data Type: The "Performance Data" section explicitly states: "Mechanical testing (static and dynamic compression, static and dynamic torsion, and expulsion) was conducted in accordance with ASTM F2077 and 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011." This confirms the performance data is related to the physical properties and biocompatibility of the implant, not to the performance of an AI algorithm.
• Focus on Substantial Equivalence: The entire submission's purpose is to show "substantial equivalence" to existing physical devices, meaning it works similarly, has similar indications, and performs mechanically as well as the predicate. This is a common pathway for new versions of existing medical devices and does not typically involve clinical trials or AI validation studies.

In summary, the provided document is for a traditional physical medical device and therefore does not contain the information requested about AI acceptance criteria and validation studies.

If you have a document describing an AI/ML medical device, please provide that, and I would be able to address your questions.

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The Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture), to achieve anterior decompression of the spinal cord and other neutral tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period

The Titanium Mesh is a vertebral body replacement system comprised of several different cross-sectional shaped implants with various heights. The different cross-sectional shaped shapes include: round, oval, oblong and kidney (banana) shaped implants. The height of the implants varies from 7mm to 130mm. In addition, some of the implants are trapezoidal, i.e., the posterior side of the implant is lower than the anterior side of the implant. A cutting tool allows for trimming of the implants to the desired height at surgical site. The interior of the mesh is open and provides a space that can be filled with bone graft material. The sidewalls of the mesh are perforated by several holes and allow for bone fusion through the sidewalls of the mesh. There are several ribs running longitudinally along the internal walls of the mesh. Standard and trapezoidal end caps that correspond to the various cross-sectional shapes of meshes are included in the system. The end caps are placed on top of and supported by the longitudinal ribs located at the internal wall of the mesh. Also the end caps have prongs that provide a friction-locking feature between the caps and the ribs of the mesh. The end caps are manually pressed into the mesh. Serrations on the superior/inferior surface of the end caps provide stability and prevent movement of the implant.

The Titanium Mesh System is intended for use with supplemental internal fixation spinal systems.

This 510(k) premarket notification for the Titanium Mesh System (K032371) does not contain information on acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

1. Indications for Use: The Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (fracture), to achieve anterior decompression of the spinal cord and other neural tissues, and to restore the height of a collapsed vertebral body. It is designed to restore biomechanical integrity of the spinal column even in the absence of fusion for a prolonged period.
2. Materials: Manufactured from surgical grade titanium alloy as described by ASTM F-1108 (Ti-6Al-4V).
3. Design: The device is a vertebral body replacement system comprising various cross-sectional shaped implants (round, oval, oblong, kidney/banana, some trapezoidal) with varying heights (7mm to 130mm). It includes a cutting tool for trimming, an open interior for bone graft material, perforated sidewalls for bone fusion, longitudinal ribs, and standard/trapezoidal end caps with prongs for friction-locking and serrations for stability.

The submission claims substantial equivalence to the SynMesh™ Spacer System (K003275), Surgical Dynamics™ Mesh Cage System (K003709), and DePuy AcroMed™ Surgical Titanium Mesh™ System (K003043).

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in the provided text, as this type of information is typically associated with clinical performance studies or specific performance testing data, which are not detailed in this 510(k) summary.

For medical devices like spinal implants, substantial equivalence generally relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness and is as safe and effective as the predicate device. This often involves mechanical testing to demonstrate performance (e.g., strength, fatigue, subsidence) but the details of such tests and their acceptance criteria are not included in this summary.

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The Sustain Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Sustain Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.

The Sustain Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The Sustain Spacer is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion.

The Sustain Spacer devices are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136 and F1295.

The Sustain Spacer is a vertebral body replacement device. The provided text indicates that its acceptance criteria and performance were established through mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided text details mechanical testing and material specifications. This type of testing typically involves physical samples of the device components. The document does not specify the sample size used for the mechanical tests, nor does it explicitly mention data provenance in terms of country of origin or whether the data was retrospective or prospective. Such details are usually found in the full test report, not the 510(k) summary.

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

For mechanical testing, "ground truth" is typically established by engineering standards and validated testing protocols, not by expert medical review. Therefore, this section is not applicable in the context of the provided information, which focuses on mechanical and material properties. The standard mentioned, "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", sets the technical benchmark.

4. Adjudication method for the test set:

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes. For mechanical testing, the "adjudication" is inherent in the objective, quantitative nature of the tests and their alignment with established engineering standards. Therefore, this section is not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The provided information focuses on the mechanical and material equivalence of the Sustain Spacer to predicate devices through engineering testing, not on clinical effectiveness with human readers.

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

This question is typically relevant for AI/software devices. Since the Sustain Spacer is a physical medical implant, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable.

7. The type of ground truth used:

The ground truth used for demonstrating the device's performance is based on engineering standards and specifications. Specifically, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000, and ASTM material standards (F67, F136, F1295) serve as the benchmarks against which the device's mechanical and material properties are measured.

8. The sample size for the training set:

The concept of a "training set" is relevant for machine learning algorithms. Since the data described pertains to mechanical and material testing of a physical implant, a "training set" in the machine learning sense is not applicable.

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

As mentioned above, the concept of a "training set" is not applicable here. The "ground truth" for the device's performance was established by recognized industry standards and guidance documents for spinal implants, which dictate the required mechanical properties and material composition.

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