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CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

When used in the cervical spine (C2-T1), CAPRI Static and Expandable cages 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 cord and neural tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors 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), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

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

When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the CAPRI Static and Expandable cages are intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.

The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths, and heights to match the patient's anatomy. Static (titanium) and expandable (titanium and cobalt chrome) cervical cages are available and are implanted via an anterior approach. The cervical implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium (per ASTM F3001 and ASTM 136) and Cobalt Chrome (per ASTM F1537). The purpose of this Traditional 510(k) submission is to introduce a new 12x14mm cervical expandable footprint size to the previously cleared CAPRI Corpectomy Cage System.

Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.

The provided text describes the 510(k) premarket notification for the K2M, Inc. CAPRI Corpectomy Cage System. This submission introduces a new 12x14mm cervical expandable footprint size to an already cleared system. As such, the study focuses on demonstrating the substantial equivalence of this new footprint to the predicate device, rather than proving a new device's performance against specific clinical acceptance criteria for effectiveness or safety in a clinical trial setting. The studies conducted are mechanical tests to ensure the new footprint maintains the same structural integrity and performance characteristics as the predicate.

Here's the information extracted from the provided text, addressing your points:

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

The document does not explicitly state "acceptance criteria" in terms of specific numerical thresholds for each test, but it lists the mechanical tests performed to demonstrate substantial equivalence to the predicate device. The performance is implied to be "met" if the device demonstrates substantial equivalence.

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

The document does not specify sample sizes (number of devices tested) for the mechanical tests. It also does not mention data provenance in terms of country of origin or whether a retrospective/prospective study was conducted, as these were benchtop mechanical tests, not clinical studies involving patient 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)

This is not applicable to the type of study described. The study involves mechanical testing against ASTM standards and comparison to a predicate device, not expert-based ground truth establishment as would be seen in diagnostic imaging or clinical effectiveness studies.

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

This is not applicable as the study involves mechanical testing against defined standards, not human evaluation requiring adjudication.

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

This is not applicable. The device is a spinal implant, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a medical implant, not an algorithm.

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

For mechanical testing, the "ground truth" is typically defined by adherence to established engineering standards (e.g., ASTM F2077-18, ASTM F2267-04 R18) and meeting performance characteristics comparable to the predicate device. There is no expert consensus, pathology, or outcomes data used as ground truth for this type of submission.

8. The sample size for the training set

This is not applicable. There is no training set mentioned, as this is a submission for a medical implant, not a machine learning algorithm.

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

Not applicable, as there is no training set.

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STGC-Lordotic 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). STGC-Lordotic is intended to be used with autograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.

STGC-Lordotic is a vertebral body replacement device manufactured from titanium allov (Ti-6Al-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. STGC-Lordotic is a single-piece device manufactured using electrical discharge machining, having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allograft bone. Intended for placement via an anterior approach, STGC-Lordotic is to be used in combination with supplemental fixation indicated for use in the thoracolumbar spine. STGC-Lordotic is provided with 8.2° to 11.5° of endplate angulation (lordosis). STGC-Lordotic is provided non-sterile to the end user.

This document describes a 510(k) premarket notification for the STGC-Lordotic device, a vertebral body replacement. The focus is on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical setting. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not directly available from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria or detailed performance metrics against those criteria. Instead, it states that "performance testing to demonstrate substantial equivalence included methods described in the standards ASTM F2077 Test Methods for Intervertebral Body Fusion Devices (static compression, dynamic compression, static torsion, dynamic torsion) and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression (subsidence). Static expulsion testing also was performed."

The conclusion is that "The performance data included in this submission demonstrate substantial equivalence to the predicate device K121176 and K003043." This implies that the device performed comparably to, or within acceptable ranges of, the predicate devices for these mechanical tests. Specific numerical performance values or defined acceptance thresholds are not presented in this document.

2. Sample Size Used for the Test Set and Data Provenance

This document describes non-clinical performance testing (mechanical testing), not a clinical study involving human patients or data. Therefore:

• Sample size for test set: Not applicable in the context of human data. For mechanical testing, the sample size would refer to the number of device units tested, which is not specified in this summary.
• Data provenance: Not applicable in the context of human data. The data originates from laboratory mechanical testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as no clinical study involving human assessment of ground truth is described. The "ground truth" here is the physical performance of the device against established mechanical standards.

4. Adjudication Method

This is not applicable as no clinical study with human readers/assessors or their adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done or reported in this document. The device is a physical implant, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

Yes, a form of standalone performance was done in the sense of non-clinical bench testing of the device's mechanical properties (static compression, dynamic compression, torsion, subsidence, expulsion). This testing was against recognized ASTM standards. However, this is "algorithm only" performance, given the device is mechanical.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical performance evaluation was the established mechanical testing standards (ASTM F2077 and ASTM F2267) and the performance of the predicate devices. The device's performance was compared against these standards and the known performance of the predicate devices to establish substantial equivalence.

8. Sample Size for the Training Set

This is not applicable. The device is a physical implant assessed through mechanical testing; there is no "training set" in the context of an algorithm or AI.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated above.

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The Titanium Mesh Implant is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for total replacement of diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and ncural tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh Implant is also indicated for total vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Titanium Mesh Implant 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 Implant is intended to be used with supplemental internal fixation. The supplemental fixation system that must be used with this implant is the Synergy Spinal System. In addition, the Titanium Mesh Implant is intended for use with bone graft.

The Titanium Mesh Implant is a hollow cylindrical tube made from commercially pure (CP) titanium (ASTM F-67). The sides of the cylinder implants contain concentric oval patterned openings. These openings allow the surgeon to trim the cylinder to the desired length at a pre-specified angle relative to the longitudinal axis of the cylinder. The external surface of the implant contains concentric circular grooves perpendicular to the axis of the cylinder which provides a guide in the event that a perpendicular end is desired.

The provided text is for a 510(k) summary for a medical device called the "Titanium Mesh Implant." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a traditional clinical study.

Therefore, many of the requested categories (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable in the context of this 510(k) submission as it is presented. The FDA's review for such a device primarily relies on comparing its design, materials, and intended use to an already legally marketed device to ensure it is equally safe and effective.

Here's how the available information relates to your request:

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

• Not Applicable. This document does not specify acceptance criteria or report performance data in the way a clinical study would for a new AI or diagnostic device. The basis for clearance here is "substantial equivalence."

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

• Not Applicable. No test set or associated data provenance is described. The approval is based on comparison to a predicate device.

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. No ground truth establishment by experts is mentioned, as this is not a diagnostic device undergoing performance validation with a test set.

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

• Not Applicable. No test set or adjudication process is described.

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 physical implant, not an AI or diagnostic tool that would involve human readers or MRMC studies.

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

• Not Applicable. This is a physical implant.

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

• Not Applicable. No specific ground truth is referenced for this type of device submission. The "ground truth" for its safety and effectiveness is implicitly derived from the existing predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not Applicable. There is no training set described.

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

• Not Applicable. There is no training set described.

Summary of what the document does provide regarding "proof":

The "study that proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which aims to demonstrate substantial equivalence to an already legally marketed predicate device, rather than proving performance against new acceptance criteria.

The key points from the document that serve this purpose are:

• Predicate Device: DePuy Acromed Surgical Titanium Mesh (K003043 and K020522)
• Comparison Statement: "Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Titanium Mesh Implant is considered substantially equivalent to the legally marketed predicate devices."
• Intended Use: The Titanium Mesh Implant's intended use (thoracolumbar spine (T1 to L5) for total replacement of diseased vertebral bodies due to tumors or fractures, to achieve anterior decompression and restore height, with supplemental fixation and bone graft) is explicitly stated to be the same as the predicate device.
• Device Description: The device is a hollow cylindrical tube made from commercially pure (CP) titanium (ASTM F-67), with specific design features (concentric oval openings, concentric circular grooves) which presumably are similar to or justify equivalence to the predicate device.
• FDA Clearance: The FDA's letter (DEC 29, 2004) states they have "determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, the "proof" is the successful demonstration of substantial equivalence based on a comparison of intended use, materials, and biomechanical performance to an existing cleared device, as reviewed and accepted by the FDA.

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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 Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium Mesh System 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 Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).

Not Found

The provided text describes the regulatory clearance for the "Surgical Titanium Mesh™ System" as a medical device, focusing on its intended use and general performance data (biomechanical testing). It does NOT contain information about acceptance criteria for device performance, a study to prove it meets those criteria, sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training sets was established.

Therefore, most of the requested information cannot be extracted from the given text.

Here's what can be extracted based on the provided document:

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

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. This document pertains to a 510(k) submission for a medical device and typically such submissions detail testing protocols and results, but this specific excerpt doesn't provide those details.

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 as this is a physical medical device (implant) and not related to AI or diagnostic image analysis where expert-established ground truth for a test set would be relevant.

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

• Not applicable for a physical medical device.

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 physical medical device, not an AI diagnostic tool.

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

• Not applicable. This is a physical medical device, not an AI algorithm.

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

• Not applicable. Performance for this device would be based on engineering and biomechanical standards, not a clinical "ground truth" as typically defined for diagnostic AI. The "performance data" mentioned is biomechanical testing.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI algorithm.

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

• Not applicable. This is a physical medical device, not an AI algorithm.

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