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The Trabecular Metal Vertebral Body Replacement System 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 ropidoo a conalization Metal Vertebral Body Replacement is intended from tradition of the rital internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.

The Trabecular Metal Vertebral Body Replacement (VBR) System is comprised wholly of Trabecular Metal Porous Tantalum. The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine. The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability.

The provided text is a 510(k) summary for a medical device (Trabecular Metal Vertebral Body Replacement System), which focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical and biocompatibility testing. It does not describe a study involving algorithms, human readers, or assessment of clinical performance using metrics like accuracy, sensitivity, or specificity. Therefore, I cannot extract information related to acceptance criteria and device performance in the context of AI/algorithm evaluation.

The sections you requested (1-9) are typical for the evaluation of AI/ML-driven medical devices, especially those that process image data or make diagnostic predictions. This 510(k) pertains to a physical implantable device, and its evaluation relies on different types of evidence.

Here's what I can infer from the provided text relevant to a physical device, even though it doesn't fit the requested AI/ML framework:

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

The document states that "Performance testing was provided to support equivalent mechanical behavior to the predicate devices. The results demonstrated that the device will perform as intended and is equivalent to the cited predicate devices." However, specific numerical acceptance criteria (e.g., minimum compression strength, torsion resistance) and the exact reported performance values are not detailed in this summary. It only lists the types of tests performed.

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

• Test Set (for mechanical & biocompatibility testing): The sample sizes for each mechanical test (static compression, dynamic compression, static torsion, dynamic torsion, abrasion) and biocompatibility tests are not specified in this summary.
• Data Provenance: The tests were likely conducted in a laboratory setting, as is typical for mechanical performance evaluation of orthopedic implants. No country of origin for "data" in the sense of clinical cases is applicable here, as it's a materials and mechanical performance study, not a clinical trial.

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

This is not applicable. The "ground truth" for mechanical testing is derived from established engineering standards and physical measurements, not expert consensus. For biocompatibility, it's evaluated against ISO standards or similar guidelines by toxicology or materials science experts.

4. Adjudication method for the test set:

This is not applicable. Mechanical and biocompatibility tests follow established protocols, and results are typically objective measurements.

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. This 510(k) is not for an AI device.

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

This is not applicable. This 510(k) is not for an AI device.

7. The type of ground truth used:

• Mechanical Performance: Ground truth is based on established engineering principles, material science, and comparison to the known performance of predicate devices.
• Biocompatibility: Ground truth is based on recognized biological safety standards for implantable materials.

8. The sample size for the training set:

This is not applicable. This 510(k) is not for an AI device, so there is no "training set."

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

This is not applicable. As above, no training set or medical image expert ground truth is relevant here.

In summary: The provided document is a 510(k) summary for a physical medical implant (a vertebral body replacement system), not for an AI/ML-driven device. Therefore, the requested information, which pertains to the evaluation framework of AI/ML technologies (e.g., sample sizes of test/training sets, expert readers, ground truth for image interpretation, MRMC studies), is not present and is not relevant to this specific premarket notification. The "study" described is a series of mechanical and biocompatibility tests for the device material and design, demonstrating equivalence to already cleared predicate devices.

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The Trabecular Metal Vertebral Body Replacement System 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 Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.

The Trabecular Metal Vertebral Body Replacement System is designed to be a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated. The Trabecular Metal Vertebral Body Replacement (VBR) System is comprised wholly of Trabecular Metal Porous Tantalum. The VBR is available to accommodate replacement of a vertebral body in the thoracolumbar spine. The device is available in a variety of cross sections and heights to properly tension the spine. The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability.

The provided text describes a 510(k) premarket notification for a medical device, the Zimmer Trabecular Metal Vertebral Body Replacement System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way one would expect for a novel AI/software as a medical device (SaMD).

Here's an analysis based on the information provided, highlighting what is present and what is not:

Acceptance Criteria and Device Performance Study (as per provided text)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implied as meeting or being equivalent to the predicate devices and applicable standards. Specific numerical thresholds for each test (e.g., "withstanding X N of static compression") are not provided in this summary.

2. Sample Size and Data Provenance for Test Set

• Sample Size (Test Set): Not explicitly stated. The documentation refers to "test data" and "performance testing" but does not specify the number of units or samples tested for each mechanical test.
• Data Provenance: Not explicitly stated. Given the nature of mechanical and biocompatibility testing for a physical implant, the data would typically be generated in laboratory settings. There is no indication of patient data (e.g., country of origin, retrospective/prospective) because this submission is not focused on clinical performance in patients but rather on mechanical and chemical properties.

3. Number and Qualifications of Experts for Ground Truth

• Not applicable to this type of device submission. The ground truth for mechanical and biocompatibility testing is typically based on standardized testing procedures and material science principles, not expert consensus on interpretations of data like in diagnostic imaging.

4. Adjudication Method for Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for human interpretation tasks, especially in diagnostic studies, not for the direct measurement of mechanical properties or biocompatibility of an implant.

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

• Not applicable. This study type is used to evaluate the impact of AI on human reader performance for diagnostic tasks (e.g., imaging). The Trabecular Metal Vertebral Body Replacement System is a physical implant, not a diagnostic AI device.

6. Standalone Performance (Algorithm Only)

• Not applicable. This concept pertains to AI algorithms. The device is a physical implant, so there is no "algorithm only" performance to assess in this context.

7. Type of Ground Truth Used

• Mechanical Testing Results: The "ground truth" for the mechanical tests would be the measured physical properties (e.g., strength, durability) obtained through standardized engineering tests, compared against established performance benchmarks for predicate devices and relevant ASTM/ISO standards.
• Biocompatibility Data: The "ground truth" for biocompatibility would be the results of laboratory tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993 series standards, demonstrating that the material does not elicit an unacceptable biological response.

8. Sample Size for Training Set

• Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which are not described here.

9. How Ground Truth for Training Set Was Established

• Not applicable. (See point 8).

Summary of what the document indicates for substantial equivalence:

The Zimmer TMT Trabecular Metal Vertebral Body Replacement System demonstrated substantial equivalence by showing that it performs equivalently to the cited predicate devices (K010378, K021025, K021967, K022563, K031823, and K032527) based on mechanical performance data and biocompatibility data. The mechanical tests included static compression, dynamic compression, static torsion, dynamic torsion, and abrasion. The conclusion was that the device will perform as intended and is equivalent to the predicate devices.

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Trabecular Metal Knee System Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.

The Trabecular Metal Knee System Augments are manufactured to be compatible for use with Zimmer's NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System and Zimmer's NexGen Complete Knee Solution - Legacy Knee Constrained Condylar Knee (LCCK) System. When used with the RHK System, the Trabecular Metal Augments are for cemented use only. When used with the LCCK System, the Trabecular Metal Augments are for either cementless or cemented use.

This document is a 510(k) summary for a medical device (Trabecular Metal Knee System Augments) and explicitly states that no new performance data or studies were conducted for this submission:

• "The predicate and subject devices are identical; performance Performance Data: characteristics therefore remain as documented in the predicate submission (K024161)."

Because of this statement, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets them from the provided text. The submission relies entirely on the performance established for its predicate device (K024161).

Therefore, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not provided as no new studies were performed.
2. Sample sized used for the test set and the data provenance: Not applicable as no new studies were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new studies were performed.
4. Adjudication method for the test set: Not applicable as no new studies were performed.
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 a physical knee implant augment, not an AI software device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical knee implant augment, not an algorithm.
7. The type of ground truth used: Not applicable as no new studies were performed.
8. The sample size for the training set: Not applicable as no new studies were performed, and this is a physical device, not a software algorithm.
9. How the ground truth for the training set was established: Not applicable as no new studies were performed, and this is a physical device, not a software algorithm.

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The Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Trabecular Metal Reconstruction System may also be used with bone graft

The Trabecular Metal Reconstructive System is manufactured wholly of Trabecular Metal porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. Trabecular Metal porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter.
The components of this line extension are wedge-shaped components, similar to the cleared wedge-shapes (K032344). The smallest size wedge is 19mm height with a 5° angle and the largest size wedge is 28mm height with a 30° angle. The angles run in increments of 5 degrees and there are 6 heights for each range of angles. One 'arm' is longer than the other, with the shorter 'arm' contoured along its length and slightly wider than the longer 'arm'. The base of the wedge is contoured. The relief allows biological fixation to occur along both the outer and inner segments of the device.

The provided text is a 510(k) summary for the Hedrocel Trabecular Metal Reconstructive System. It does not describe a study to prove a device meets acceptance criteria. Instead, it states that the device was not tested directly for performance.

Here's a breakdown based on your request, highlighting the lack of a new study:

1. Table of Acceptance Criteria and Reported Device Performance:

Reasoning: The document explicitly states: "The subject devices of the Trabecular Metal Reconstructive System were not tested." Therefore, there are no specific acceptance criteria or direct performance data for this particular device in this submission.

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

• Sample Size: Not applicable. No new test set was used for this device.
• Data Provenance: Not applicable. No new data was generated for this device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Number of Experts: Not applicable. No new test set or ground truth was established for this device.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: 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:

• MRMC Study Done? No. This device is a surgical mesh, not an AI-powered diagnostic tool, so an MRMC study is irrelevant to its evaluation.
• Effect Size: Not applicable.

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

• Standalone Study Done? No. This device is a surgical mesh; it does not involve an algorithm.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not applicable. No new ground truth was established for this device.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. This device is a surgical mesh; it does not involve a training set.

9. How the Ground Truth for the Training Set was Established:

• How Ground Truth Established: Not applicable.

Summary of the Document's Approach to Performance:

Instead of conducting new studies, the submission relies on the concept of substantial equivalence to predicate devices. It states:

"The subject devices of the Trabecular Metal Reconstructive System were not tested. Rather previous device testing per FDA guidance documents and applicable standards were performed for the predicate devices described in K02388, Master File MAF #920, and other mechanical testing reported in K962468. These results indicate that the subject device will perform as indicated for use in support of weakened and/or deficient bony structures."

This means that the manufacturer asserts that because their new device is technologically similar to previously cleared devices (predicates) that did undergo testing and meet performance standards, the new device will also perform as intended. They are not presenting a new study for this specific device.

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The NexGen Trabecular Metal Tibial Cone Augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Tibial Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.

The NexGen Trabecular Metal Tibial Cone Augments are designed to be used in conjunction with Zimmer Inc.'s Legacy@ Stemmed Tibial Bases (LCCK) and Rotating Hinge Knee (RHK) tibial components. The subject devices are used to address proximal tibial cavitary defects encountered when implanting either of these two systems. The augments are manufactured from Trabecular Metal and have tapered posterior, medial and lateral walls. The periphery of the inferior surface is smaller than that of the superior surface. The augments are hollow such that they are to be filled with bone cement, and allow for placement of the stem and/or keel of the associated tibial base plate. Fixation of the augment to the tibial baseplate is accomplished by using bone cement. The inferior surface of the LCCK and RHK tibial baseplates must be cemented to bone. The Trabecular Metal Tibial Cone Augments are for cemented use along the bone in the USA, and for cementless or cemented use along the bone outside the USA.

This submission describes a medical device, the NexGen Trabecular Metal Tibial Cone Augments, and seeks to demonstrate its substantial equivalence to previously marketed predicate devices. This is a premarket notification for a medical device (510(k)), not a study to prove performance against specific acceptance criteria. Therefore, most of the requested information about a clinical study is not applicable to this document.

Here's a breakdown of the relevant information provided and how it addresses your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of acceptance criteria and reported device performance for the NexGen Trabecular Metal Tibial Cone Augments. The submission aims to establish substantial equivalence to predicate devices rather than proving performance against specific, pre-defined acceptance criteria through a new study.

The closest statement to "reported performance" is:

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 new test set or clinical study was performed for this 510(k) submission on the subject device. The determination of substantial equivalence was based on an engineering analysis and previous testing of the material (Trabecular Metal) and other Trabecular Metal devices, not a specific clinical test set for these augments.

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 clinical test set with ground truth established by experts was used for this submission.

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

Not applicable. No clinical test set was used.

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 a passive implant (tibial cone augment), not an AI-powered diagnostic tool. Therefore, an MRMC study or assessment of AI assistance for human readers is irrelevant.

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

Not applicable. This device is an implant, not an algorithm.

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

Not applicable. No new ground truth was established for the subject device. The basis for the submission is demonstrating substantial equivalence through an engineering analysis and previously conducted testing on the material itself.

8. The sample size for the training set:

Not applicable. There was no "training set" in the context of an algorithm or AI model development. The basis of the submission is the material properties of Trabecular Metal and its prior use in other devices.

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

Not applicable. As there was no training set, there was no ground truth for a training set to be established.

In summary: This 510(k) submission for the NexGen Trabecular Metal Tibial Cone Augments relies on demonstrating substantial equivalence to existing predicate devices. This typically involves comparing device design, materials, manufacturing processes, and intended use. The submission states that "Testing of the subject devices were not performed" and instead, "Previous testing of Trabecular Metal and Trabecular Metal devices support a determination of substantial equivalence. An engineering analysis was provided to support this." This means the regulatory decision was made based on a comparison to known, safe, and effective devices already on the market, rather than a new clinical study with acceptance criteria and measured performance of this specific augment.

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The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel Trabecular Metal Reconstruction System may also be used with bone graft.

The Hedrocel Trabecular Metal Device Reconstruction System is manufactured wholly of Hedrocel porous tantalum. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. This line extension adds new components to the Hedrocel Trabecular Metal Reconstruction System.

The provided text describes a 510(k) submission for "The Hedrocel Trabecular Metal Reconstructive System" and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance criteria against predefined acceptance thresholds for a diagnostic AI device.

Therefore, many of the requested items related to acceptance criteria, ground truth establishment, expert review, and AI performance studies (MRMC, standalone) are not applicable or cannot be extracted from this document.

Here's an analysis based on the information available:

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

• Not applicable in the context of this 510(k) summary. This document is for a reconstructive surgical system, not a diagnostic AI device. The "acceptance criteria" here are related to demonstrating substantial equivalence in terms of material properties and mechanical performance to existing predicate devices, not diagnostic accuracy metrics.
• Reported Device Performance: The summary states: "The Hedrocel Trabecular Metal Reconstructive System was tested per FDA guidance documents and applicable standards for K010378, as referenced in the predicate K023882, K032282 and K032344. In addition, mechanical test data found in MAF #920 and K962468, and calculations found herein indicate the subject Hedrocel porous tantalum devices possess sufficient strength for the indicated use."
  • This indicates the device's performance was evaluated based on mechanical strength to ensure it can support weakened/deficient bony structures as intended. Specific quantitative results (e.g., tensile strength, fatigue life) are referenced in MAF #920 and K962468 but are not detailed in this summary.

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/Not specified. This pertains to clinical or diagnostic study data. The testing mentioned in the document refers to mechanical testing of the material and device components. Sample sizes for these types of engineering tests are typically determined by standards and are not described here in terms of "test sets" or data provenance.

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. There is no "ground truth" in the diagnostic sense for this type of surgical implant. The closest equivalent would be the engineering expertise used to design the tests and interpret the mechanical data, but this is not detailed.

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

• Not applicable. No adjudication method is mentioned as there's no diagnostic test set or expert disagreement to resolve.

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 a surgical reconstructive system, not an AI diagnostic tool. Therefore, MRMC studies are irrelevant.

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

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

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

• Not applicable. As mentioned, there is no diagnostic "ground truth." The performance is measured against established engineering standards and material properties deemed suitable for the indicated orthopedic uses.

8. The sample size for the training set

• Not applicable. No machine learning or AI model is involved, so there's no training set.

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

• Not applicable. No machine learning or AI model is involved.

Summary of Relevant Information from the Document:

• Device Type: Surgical Mesh / Reconstructive System (Hedrocel Trabecular Metal Reconstructive System)
• Purpose: Reinforcing weak and/or deficient bony tissues in orthopedic surgical procedures.
• Performance Evaluation Method: "Mechanical test data... and calculations... indicate the subject Hedrocel porous tantalum devices possess sufficient strength for the indicated use." This was done "per FDA guidance documents and applicable standards" and referenced previous 510(k) submissions (K010378, K023882, K032282, K032344) and specific mechanical test data (MAF #920 and K962468).
• Conclusion: The device is "substantially equivalent" to predicate devices, based on technological characteristics and performance data.

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Hedrocel® Vertebral Body Replacement System 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 Hedrocel® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.

The Hedrocel® Vertebral Body Replacement System is designed to be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated. The Hedrocel® Vertebral Body Replacement (VBR) System is comprised wholly of Hedrocel® Porous Tantalum (tantalum deposited on a vitreous carbon skeleton). The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine. The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability. The Hedrocel® Vertebral Body Replacement implants have an included angle to maintain the natural contour of the lumbar spine.

The Hedrocel Vertebral Body Replacement System is a medical device designed to replace a diseased or damaged vertebral body in the thoracic and lumbar spine. The acceptance criteria and performance of the device are based on demonstrating substantial equivalence to predicate devices through mechanical performance testing and biocompatibility data.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not specify the sample size used for the mechanical performance tests. It states that "Predicate devices that are a part of the Hedrocel Vertebral Body Replacement System were tested per applicable standards (reference K010378)." It also mentions "Performance testing was provided to support equivalent mechanical behavior to the predicate devices."

Data Provenance: The data appears to be from retrospective testing of the device and its predicate components/materials, conducted by the manufacturer, Implex Corp., in the United States (as indicated by the submission to the U.S. FDA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable for this type of device. The "ground truth" for mechanical performance and material safety is established through adherence to recognized mechanical testing standards and biocompatibility testing guidelines, rather than expert consensus on imaging or clinical findings.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., medical imaging) to resolve disagreements among experts. This submission focuses on objective mechanical and biocompatibility testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic or screening devices where human readers interpret results, often with and without AI assistance, to assess improvements in diagnostic accuracy. This submission concerns a surgical implant, not a diagnostic tool requiring human interpretation of results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical surgical implant, not an algorithm or AI system. Its performance is evaluated through physical mechanical tests and biocompatibility, not through algorithmic output.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Mechanical Testing Standards: Established engineering standards for evaluating the static and dynamic strength, fatigue, and wear characteristics of spinal implants. The "ground truth" is that the device must meet or exceed the performance of predicate devices or established safety thresholds defined by these standards.
• Biocompatibility Standards: Standards to ensure the material (Hedrocel Porous Tantalum) is safe for implantation in the human body and does not elicit adverse biological responses. The "ground truth" is that the material must demonstrate satisfactory biocompatibility as per relevant ISO or ASTM standards.

8. The Sample Size for the Training Set

Not applicable. This submission does not describe a training set in the context of machine learning or AI. The term "training set" is not relevant here as the device is a physical implant, not an AI or algorithm. The development of the device likely involved engineering design iterations and material selection, but not a "training set" in the computational sense.

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

Not applicable. As a training set for an AI or algorithm is not relevant, the establishment of ground truth for such a set is also not applicable. The design and validation of the Hedrocel VBR System would have relied on engineering principles, materials science data, and pre-clinical testing to optimize its mechanical properties and biocompatibility.

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The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures, such as pelvic reconstruction, acetabular reconstruction, cement restriction and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel® Trabecular Metal Reconstruction system may be used with bone graft.

The Hedrocel Trabecular Metal Reconstructive System is manufactured wholly of Hedrocel porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. The devices in this line extension are wedge shaped and contoured so as to fit a variety of anatomical bone structures. The devices are available in small, medium and large sizes, with the cross-sectional dimensions being 0.52in x 0.88in for the small size; 0.58in x 0.96in for the medium size, and 0.62in x 1.06in for the large size. Each size consists of varying heights ranging from 2mm - 8mm in 2mm increments. There is a consistent inclination angle of 10 degrees along the length in all size ranges. A secondary inclination angle along the width ranges from 20-35 degrees in 5-degree increments. The resultant geometry is a bi-plane wedge. The devices have a 6mm central hole for optional bone graft placement. A tapered slot is provided for implantation instrumentation.

The provided document is a 510(k) summary for the Hedrocel Trabecular Metal Reconstructive System. It states that the device was deemed "substantially equivalent" to predicate devices without performing new testing on the subject device itself. Therefore, the information requested regarding acceptance criteria and performance studies in the prompt is not available for this specific device.

Instead, the summary refers to performance data for predicate devices (K023882 and K962468) as evidence of the subject device's anticipated performance. This means there are no specific acceptance criteria or a dedicated study described for the Hedrocel Trabecular Metal Reconstructive System in this document.

Here's a breakdown of why I cannot answer the specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document states, "The subject device of the Hedrocel Trabecular Metal Reconstructive System was not tested. Rather previous device testing per FDA guidance documents and applicable standards were performed for the predicate devices described in K023882 and other mechanical testing reported in K962468." Therefore, no acceptance criteria or performance data for this specific device are reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available for the subject device. The document explicitly states the subject device was not tested.

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 test set for the subject device was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for the subject device was used.

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 a surgical mesh, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical mesh, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No specific ground truth was established for the subject device's performance through new testing.

8. The sample size for the training set: Not applicable. The device is a surgical mesh, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established: Not applicable. The device is a surgical mesh, not a machine learning model.

In summary, the 510(k) clearance for the Hedrocel Trabecular Metal Reconstructive System was based on demonstrating "substantial equivalence" to previously cleared predicate devices, rather than new performance testing of the subject device itself.

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Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional non-constrained arthroplasty is not acceptable. The Trabecular Metal Glenoid must be fully or partially cemented in place in the USA.

The device is a monoblock glenoid component comprised of a Trabecular Metal base with an articular surface comprised of direct compression molded polyethylene. This device was cleared in K022377. The TM Glenoid is designed to interface & articulate with Zimmer B/F humeral components and is available in one thickness option of 5 mm, and the same outer profile options as the B/F allpolyethylene glenoid.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Trabecular Metal Glenoid:

This document is a 510(k) Summary for a medical device called the Trabecular Metal Glenoid. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence for regulatory clearance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document states "Component stability testing was performed per ASTM F 2080-00 for the subject and predicate devices and cementing techniques."
• Sample Size: The exact number of samples (e.g., individual glenoid components tested) is not explicitly stated. However, it implies multiple samples were tested to generate "displacement data."
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It describes laboratory testing of the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not applicable. This study is a mechanical performance test (component stability testing) against an ASTM standard, not a clinical study involving human assessment of ground truth. Therefore, there were no "experts" establishing ground truth in the traditional sense of a clinical trial. The "ground truth" here is the performance against the defined parameters of the ASTM F 2080-00 standard.

4. Adjudication Method for the Test Set:

• None. As this is a mechanical performance test, there is no need for an adjudication method for a test set in the way one would adjudicate clinical data. The results are based on objective measurements of displacement during cyclic loading.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No. This document describes a mechanical performance study, not a clinical MRMC study. There is no assessment of human reader performance, with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Yes, in spirit. The performance described is for the device itself ("algorithm only" in the context of mechanical testing), not involving human interaction as part of the primary performance evaluation. The "displacement data" is a direct measurement of the device's physical properties under specific loading conditions.

7. The Type of Ground Truth Used:

• The ground truth is based on mechanical performance specifications/standards, specifically ASTM F 2080-00 for component stability. The "ground truth" is that the device should demonstrate similar or equivalent stability performance to the predicate device under the defined testing parameters.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set" of data. The "training" for such a device is its design, manufacturing processes, and adherence to established engineering principles.

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

• Not applicable. As above, there is no "training set" for a physical device in the context described in the prompt. The "ground truth" for the device's design and manufacturing is established through engineering specifications, material science, and adherence to quality control standards.

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