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The Vista@-S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista®-S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista S Device is implanted via an anterior approach.

The purpose of this submission is a line extension to the Vista®-S Device adding additional height and footprint options. The Vista -S Device is a box-shaped device for interbody fusion fabricated from polyetheretherketone (PEEK). The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.

The provided 510(k) summary for the Vista®-S Device describes a line extension to an intervertebral body fusion device and relies on showing substantial equivalence to previously cleared predicate devices. Therefore, the "acceptance criteria" and "device performance" are established by demonstrating that the new line extension does not negatively impact the safety and efficacy compared to the predicate devices, and that it satisfies relevant ASTM standards and FDA guidance. This is primarily done through performance testing in the form of Finite Element Analysis (FEA).

Here’s a breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted to prove the device meets the acceptance criteria was a Finite Element Analysis (FEA) testing study.

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

• Sample Size: Not applicable in the traditional sense of patient data. FEA is a computational simulation. The "samples" would be the specific FEA models created for the various device configurations. The document implies that multiple FEA simulations were conducted for axial compression, torsion, and compression shear, but does not specify the exact number of models or iterations.
• Data Provenance: Not applicable as it's an engineering simulation, not human data.

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

This is not applicable for an FEA study. Ground truth, in this context, would be the established engineering principles, material properties, and the ASTM F2077-03 standard itself, which are developed by experts in the field through consensus. The "experts" reviewing the FEA results would be the internal engineering and regulatory teams at Zimmer and the FDA reviewers.

4. Adjudication Method for the Test Set:

Not applicable in the context of clinical adjudication. The FEA results were likely reviewed and accepted by internal engineering and regulatory teams at Zimmer and subsequently by the FDA for the 510(k) submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This device is an intervertebral body fusion device, and the submission is for a line extension based on mechanical equivalence, not on image interpretation or diagnostic accuracy where MRMC studies are typically employed.

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

Yes, the Finite Element Analysis (FEA) testing can be considered a standalone performance assessment of the device's mechanical properties, without human interaction during the test itself. The FEA simulates the device's behavior under specific loads.

7. The Type of Ground Truth Used:

The ground truth used for the FEA study is based on:

• Established engineering principles and biomechanical models.
• Material properties of PEEK.
• The specifications outlined in the ASTM F2077-03 Test Methods for Intervertebral Body Fusion Devices.
• Recommendations from the FDA Class II Special Controls Guidance Document: Intervertebral Fusion Device.

8. The Sample Size for the Training Set:

Not applicable. FEA is a simulation technology and does not involve "training sets" in the machine learning sense.

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

Not applicable, as there is no "training set" for FEA.

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The TM Ardis® Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.

The TM Ardis® Interbody System device is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

The TM Ardis® Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system is fabricated from surgical grade stainless steel and other applicable materials. TM Ardis Interbody System was cleared via 510(k) number K113561 on May 29, 2012.

The TM Ardis® Inserter instrument, that is the subject of this premarket notification, is intended for use with the TM Ardis® Interbody System. This instrument is designed specifically for use with the TM Ardis® Implants and is considered an accessory to the implants.

This 510(k) summary describes a modification to an accessory instrument (TM Ardis® Inserter instrument) for an already cleared intervertebral body fusion device (TM Ardis® Interbody System). The information provided focuses on the substantial equivalence of the modified instrument to the original, rather than the primary device's clinical performance. Therefore, many of the requested categories related to clinical studies and AI performance are not applicable.

Here's the breakdown of the available information:

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

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

• Sample size for test set: Not specified. The document refers to "Design Verification and Design Validation Testing," which would typically involve a sample of the modified inserter instruments. However, the specific number of units tested is not provided.
• Data provenance: Not explicitly stated, but it would be internal testing performed by Zimmer Trabecular Metal Technology, Inc. There is no mention of external data or patient data.

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

• Not applicable. This relates to clinical studies and ground truth establishment, which are not detailed for this instrument modification. The evaluation is based on mechanical performance testing and comparison to a predicate device.

4. Adjudication method for the test set

• Not applicable. This relates to clinical studies and expert review, which are not described for this instrument modification.

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 submission is for an interbody system's inserter instrument, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or reported.

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

• Not applicable. As mentioned above, this is not an AI device.

7. The type of ground truth used

• Not explicitly defined as "ground truth" in the context of clinical outcomes. For the mechanical testing, the "ground truth" would be the pre-defined engineering specifications and performance benchmarks for the inserter instrument, likely based on industry standards and internal design requirements.

8. The sample size for the training set

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. As this is not an AI device, there is no "training set" or ground truth for such a set.

Summary of the Study:

The study referenced is an internal design verification and validation testing of the modified TM Ardis® Inserter instrument. The purpose was to demonstrate that the changes (design change to the Inserter Locking Nut and a dimensional change of the Inserter Body Housing) did not negatively impact the instrument's performance and that it remained substantially equivalent to the original, already-cleared predicate device.

The study involved mechanical performance testing to ensure the modified inserter met its design specifications, particularly regarding its ability to release the implant and axial clearance. The results indicated that the acceptance criteria were met, confirming that the modified inserter performs as intended and is substantially equivalent to the predicate device in terms of safety and effectiveness.

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The Trabecular Metal LCCK Coupled Tibial Cones 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 - Legacy Constrained Condylar Knee System, the Trabecular Metal Coupled Tibial Cones are for cementless or cemented use.

The NexGen® LCCK Trabecular Metal™ Coupled Tibial Cones™ are manufactured of Trabecular Metal™, porous tantalum with titanium alloy screws and screw inserts. The proposed TM Coupled Tibial Cones intend to combine the function of TM Tibial Augments and TM Tibial Cone Augments. The TM Coupled Tibial Cone design uses the same cavitary filling geometries of the TM Tibial Cone Augment and the mating functions of the TM Tibial Augment to specifically address small to medium segmented, contained, cavitary bony defects of the proximal tibia found during revision surgery. The TM Coupled Tibial Cone design provides the use of mechanical attachment to the tibial baseplate to allow for modularity and intra-operative assembly. The design is intended to provide stability to the tibial baseplate construct after reconstruction of the proximal tibia when subjected to normal gait activities.

The provided document, K120990, describes a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies with human participants. Therefore, many of the requested data points related to human reader studies, training sets, and expert ground truth are not applicable in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The study referenced is a Finite Element Analysis (FEA), which is a computational simulation. Therefore, there isn't a "sample size" in the traditional sense of patient data. The "test set" would be the conditions and parameters used in the FEA model. The document does not specify the number of simulations or variations performed within the FEA.

• Data Provenance: Not applicable in the context of an FEA study comparing mechanical performance to a predicate device. This is a design and engineering analysis, not based on patient data.

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

• Not Applicable: For an FEA study evaluating mechanical performance, "ground truth" is established through engineering principles, material properties, and validated simulation methods, not by expert human review of images or clinical data. The "experts" would be the engineers and biomechanical analysts who designed and validated the FEA model.

4. Adjudication Method for the Test Set:

• Not Applicable: Since this is an FEA study, there is no adjudication method in the context of human interpretation of results. The output of the FEA is numerical and visual data representing stress, strain, and deformation, which is then interpreted against predetermined engineering criteria.

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

• No: An MRMC comparative effectiveness study was not performed. This type of study is typically conducted for diagnostic or screening devices where human reader performance is a critical outcome. The K120990 submission focuses on the mechanical substantial equivalence of an orthopedic implant.

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

• Yes, in the context of mechanical engineering: The Finite Element Analysis (FEA) can be considered a "standalone" or "algorithm only" study in that it computationally models the device's behavior under various loads without human interpretation of clinical images or data being part of the primary assessment. The FEA algorithm calculates stress and strain, and these calculations are then reviewed by engineers.

7. The Type of Ground Truth Used:

• Engineering Principles and Predicate Device Performance: The "ground truth" for the FEA study is based on established biomechanical engineering principles, material properties of the device and surrounding bone, and the known acceptable mechanical performance of the predicate devices under similar loading conditions (normal gait activities). The FEA models the real-world mechanical behavior of the device.

8. The Sample Size for the Training Set:

• Not Applicable: The FEA study does not involve a "training set" in the context of machine learning. The FEA model is built based on design specifications, material properties, and biomechanical principles.

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

• Not Applicable: As there is no training set in the machine learning sense, this question is not relevant to the K120990 submission. The parameters and assumptions of the FEA model are based on established engineering practices and validated material data.

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The TM-400 device 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 TM-400 device is intended for use with supplemental internal fixation systems, and may be used with autograft or allograft.

The TM-400 device is also intended for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The TM-400 device is intended for use with supplemental internal fixation and autogenous bone graft.

The TM-400 Device is an oval shaped ALIF device for interbody fusion of the anterior column of the spine. The TM-400 Device is currently cleared to accommodate the replacement of a vertebral body in the thoracic and lumbar region of the spine. Use of this device is expanded to include use as an interbody fusion device. TM-400 Device is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. TM-400 implants are also available in two lordotic angles 7 degree and 13 degree. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. The device also has slots to mate with the insertion instrument. The TM-400 device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system are fabricated from surgical grade stainless steel and other applicable materials.

The provided text is a 510(k) summary for the Zimmer Trabecular Metal Technology, Inc. TM-400 Device. This document describes a medical device and its equivalence to predicate devices, focusing on its mechanical performance rather than AI/software performance. Therefore, most of the requested information regarding AI study design and performance criteria is not applicable.

Here's the information that can be extracted or that is not applicable, based on the document:

Acceptance Criteria and Device Performance

This document describes a medical device (an intervertebral body fusion device), not an AI/software device. The "acceptance criteria" discussed are related to the mechanical performance of the physical implant, rather than the performance of an algorithm. The study described is mechanical testing, not a clinical or AI performance study.

Note: The document states that "The results of testing and analyses conducted demonstrate that the proposed system adequately meets the predetermined requirements established for its mechanical performance." Specific numerical performance data for these tests (e.g., actual compression load, torsion values) are not provided in this summary.

Study Details (for AI/Software - Not Applicable Here)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   • Not Applicable. This is not an AI/software device, and there is no test set of data as would be used for an AI algorithm. The "test set" here refers to physical samples of the device undergoing mechanical stress tests in a lab.
2. 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 the context of expert consensus, is not relevant for mechanical testing of a physical implant. The "ground truth" for mechanical performance would be the physical properties as measured by scientific instruments following standardized test methods.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   • Not Applicable. Adjudication methods are used in clinical studies or for establishing ground truth from expert opinions, which is not relevant for mechanical testing.
4. 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 an AI-assisted device, so no MRMC study involving human readers and AI was conducted.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • Not Applicable. This is a physical medical implant, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   • Not Applicable. The "ground truth" for the device's mechanical performance is derived from the results of standardized mechanical tests (ASTM standards) in a laboratory setting, not from expert consensus, pathology, or outcomes data in the traditional sense.
7. The sample size for the training set:
   • Not Applicable. There is no training set as this is not an AI/machine learning device.
8. How the ground truth for the training set was established:
   • Not Applicable. There is no training set for this device.

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The TM Ardis® Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies: Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.

The TM Ardis® Interbody System device is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

The TM Ardis® Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-SI. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.

The provided text describes a 510(k) premarket notification for the "TM Ardis® Interbody System." This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than a clinical study evaluating diagnostic accuracy or a human-AI comparison. Therefore, many of the requested categories related to clinical studies, ground truth, expert involvement, and AI performance metrics are not applicable or cannot be extracted from this specific document.

Here's the breakdown of the information that can be extracted and a clear indication of what cannot be determined:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by the referenced ASTM standards and FDA guidance documents for mechanical performance. The reported performance is a qualitative statement of compliance.

Study Details

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

   • Sample Size: Not applicable. This document refers to mechanical testing of the device itself, not a clinical study involving human patients or a test set of data. The "sample size" would refer to the number of devices tested, which is not specified but would be aligned with standard mechanical test protocols.
   • Data Provenance: Not applicable, as it's mechanical testing, not patient data.

2. 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 be the physical properties and performance metrics measured during mechanical testing, established by engineering and testing standards, not by human experts interpreting clinical data.

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

   • Not applicable. This is not a clinical study requiring adjudication of expert interpretations.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This document describes mechanical testing of an intervertebral body fusion device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assistance evaluation was performed.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • Ground Truth: The "ground truth" for this device is its physical and mechanical performance characteristics as measured against established engineering standards (ASTM F2077-03, ASTM F2267-04) and FDA guidance documents for intervertebral body fusion devices. This is a physical/mechanical ground truth, not a clinical or diagnostic ground truth.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

   • Not applicable. There is no training set for this type of device submission.

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The Vista S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista® S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista -S Device is implanted via an anterior approach.

The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.

The Vista -- S Device is a box-shaped device for interbody fusion and vertebral body replacement fabricated from polyetheretherketone (PEEK). The Vista -S currently cleared to accommodate the replacement of a vertebral body in the thoracic and lumbar region of the spine. Use of this device is expanded to include use as a cervical interbody fusion device at one level from C2-T1. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.

The provided text describes a 510(k) premarket notification for a medical device called the Vista®-S Device. This submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of diagnostic performance against acceptance criteria in the way one might for an AI/ML medical device.

Based on the information provided, here's a breakdown of the requested points:

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

   Acceptance Criterion Topic	Acceptance Criteria	Reported Device Performance
   Substantial Equivalence	Device is substantially equivalent to legally marketed predicate devices.	The Vista®-S Device was shown to be substantially equivalent. No significant differences that would adversely affect use. No new issues of safety or efficacy.
   Material	Identical or similar material to previously cleared predicate devices.	Identical material to previously cleared predicate devices.
   Intended Use/Indications	Similar to predicate devices.	Similar to its predicate devices. Expanded indications for cervical interbody fusion (C2-T1) in addition to existing thoracolumbar vertebral body replacement (T1-L5).
   Design Features/Geometry	Similar to cleared predicate devices.	Similar to cleared predicate devices.
   Mechanical Performance	Adequately meets predetermined requirements established for its mechanical performance as per FDA guidance.	Mechanical testing results and analyses demonstrate that the proposed system adequately meets predetermined requirements.

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

   This document describes mechanical testing and comparison to predicate devices for a physical implant, not a study involving a "test set" of patient data or images in the way an AI/ML diagnostic device would. There is no mention of a clinical test set, patient data, or provenance (country of origin, retrospective/prospective). The "test set" here refers to the actual device units subjected to mechanical tests.

   • Sample Size: Not specified for mechanical testing, but typically involves a certain number of devices per test.
   • Data Provenance: Not applicable in the context of device mechanical testing.

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

   Not applicable. This is not a diagnostic device involving expert ground truth for interpretation. Ground truth for mechanical testing would be defined by engineering specifications and standards.

4. Adjudication method for the test set

   Not applicable. This is not a study requiring adjudication of expert interpretations. Mechanical testing results are objective measurements against predefined engineering standards.

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

   No, an MRMC study was not done. This device is a physical implant (interbody fusion device/vertebral body replacement), not an AI-assisted diagnostic tool.

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

   No, a standalone algorithm performance study was not done. This is a physical medical device.

7. The type of ground truth used

   For the mechanical performance testing, the ground truth would be established by engineering standards and specifications based on recommendations from the FDA Class II Special Controls Guidance Document: Intervertebral Fusion Device. For the substantial equivalence argument, the "ground truth" is the established safety and efficacy of the predicate devices.

8. The sample size for the training set

   Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

   Not applicable. As above, there is no training set for this type of medical device submission.

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Trabecular Metal Femoral Cone 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 Femoral Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Femoral Cone Augments are for cementless or cemented use.

The NexGen® Trabecular Metal™ Femoral Cone Augments are manufactured wholly of Trabecular Metal™, porous tantalum. The existing, commercially available NexGen® Trabecular Metal™ Femoral Cone Augments have a tapered elliptical cross-section. The periphery of the distal end is larger than that of the proximal end. The cone is not fully enclosed at its top most proximal section (giving the impression of U-Shape through slot). A similar pattern is also present in the modified femoral cones, with the exception that these cones are fully enclosed at its top most proximal section.

Both the modified femoral cones augments and the existing, commercially available femoral cone augments are to be used in conjunction with Zimmer's NexGen® Complete Knee Systems -both the Legacy® Constrained Condylar Knee (LCCK) Stemmed Femoral Implant and the femoral component of Zimmer's Rotating Hinge Knee (RHK) System. When used with the RHK System, the Trabecular Metal™ Femoral Cone Augments are for cemented use only. Fixation of all of the cone augments to the femoral implant is accomplished by cementing the internal portion of the augment to the superior side (non-articulating side) of the femoral component. Apposition of the cone to bone inside the medullary canal is with or without cement when used with the LCCK femoral implant and with cement for the RHK femoral implant.

The existing, commercially available augments come in three sizes; small, medium and large and three height options. The proposed additional femoral cones will come in the same three sizes: small, medium and large and two height options.

Here's an analysis of the acceptance criteria and study information based on the provided text:

This document is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial results for novel performance criteria. As such, information regarding AI-specific studies, ground truth establishment, and expert involvement for evaluation of an AI model will not be found in this type of submission.

Therefore, many of the requested categories related to AI performance metrics cannot be directly extracted from this document. The "device" in question is a physical orthopedic implant, not an AI system.

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

• Static shear
• Axial compression fatigue
• Rotational beam fatigue
• Young's modulus of elasticity (in tension and compression) |
  | Mechanical Performance (Predicate Devices) | Maintain assembly integrity using surgical technique instructions after: | - Fatigue testing
• Wear testing
• Assembly torque testing |
  | Mechanical Performance (Proposed Device - Strength) | Adequately meets predetermined requirements for mechanical performance during normal gait activities (walking, stair ascent/decent, deep flexion). | - Comparative Finite Element Analysis (FEA) study demonstrated adequate strength. |
  | Substantial Equivalence | - Same material as previously cleared predicate devices.
• Identical intended use and indications for use as predicate devices.
• Similar sizes, cross-sectional dimensions, design features, and overall geometry to predicate device.
• No significant differences that would adversely affect product use.
• No new issues of safety and efficacy raised by technological characteristics. | - All criteria met and detailed in the "DEVICE TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICES" and "CONCLUSION" sections. The FDA concurred with substantial equivalence (K103517). |

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

• Test Set Sample Size: Not applicable. The "tests" here are mechanical engineering tests (material properties, fatigue, wear, FEA), not human subject or imaging dataset evaluations for an AI model. The sample sizes for these engineering tests are not specified in the summary, nor is the "provenance" in the context of data origin relevant for these types of physical tests.

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)

• Number of Experts & Qualifications: Not applicable. This information is relevant for AI model validation where human experts establish ground truth for image interpretation or diagnosis. For mechanical testing of an orthopedic implant, "ground truth" is typically defined by engineering specifications, material standards, and validated simulation models, carried out by engineers and material scientists. The document does not specify the number or qualifications of experts involved in the material property or FEA analyses beyond stating that analyses were conducted.

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

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI performance evaluations to resolve disagreements among human annotators or diagnosticians when establishing ground truth. For mechanical engineering tests and FEA, the results are typically derived algorithmically or through physical measurement against established engineering standards, not through expert adjudication in this typical sense.

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 / AI Assistance: No. This device is a physical knee implant, not an AI system. Therefore, an MRMC study demonstrating human reader improvement with AI assistance is not relevant and was not performed.

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

• Standalone Algorithm Performance: No. This device is a physical knee implant, not an AI algorithm. "Standalone performance" in this context refers to the algorithm's performance without human interaction, which is not applicable. The device itself performs its mechanical function "stand-alone" in the body, but this is a different meaning than used for AI.

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

• Type of Ground Truth: For the mechanical aspects, the "ground truth" is based on:
  • Engineering Specifications and Standards: "Predetermined requirements established for its mechanical performance."
  • Material Science Principles: Properties of Trabecular Metal™ measured against established scientific understanding.
  • Validated Mechanical Testing Methods: Fatigue, wear, and assembly torque testing.
  • Finite Element Analysis (FEA) Models: Computational models validated against physical principles and potentially prior experimental data.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This submission is for a physical medical device, not an AI model requiring a training set.

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

• Ground Truth for Training Set: Not applicable. No AI model or training set is mentioned in the document.

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The Trabecular Metal Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/ without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The Trabecular Metal Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft. The Trabecular Metal Fusion Device is implanted via an anterior approach.

The Trabecular Metal™ Fusion Device is an interbody fusion device comprised wholly of Trabecular Metal. The Trabecular Metal™ Fusion Device is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrae onto another.

The Trabecular Metal™ Fusion Device is offered in three cross sectional sizes and is available in various height options to accommodate variations in patient anatomy. The height is measured at the posterior aspect of the device is tranezoidal in shane and is offered in lordotic and non-lordotic configurations, i.e., with 7 degree and 0 degree profiles. The superior and inferior surfaces of the device have a pattern of ripples and a central hole in the device extending in the superior-inferior direction for placement of bone graft. Additionally, certain parts of the proposed system contain a central slot on the anterior surface to allow interface with a central inserter.

The provided document is a 510(k) summary for a medical device (Trabecular Metal™ Fusion Device), not a study report for an AI/ML powered device. As such, it does not contain information about acceptance criteria for an algorithm's performance, details of a study demonstrating such performance, or other specific metrics typically associated with AI/ML device evaluations.

Therefore, I cannot provide the requested information in the format requested. The document describes a traditional medical device (an intervertebral body fusion device) and demonstrates its substantial equivalence to predicate devices through mechanical testing and an animal study, not through assessment of an AI algorithm's performance.

Here's a summary of the available performance data for the Trabecular Metal™ Fusion Device, as presented in the document:

The study did not involve an AI/ML powered device and therefore does not have acceptance criteria or performance metrics related to AI. The performance data provided is for the physical medical device itself.

Performance Data for the Trabecular Metal™ Fusion Device:

• Mechanical Testing:

  • Tests Performed: Axial Compression - Static and Dynamic, Torsion - Static and Dynamic (per ASTM F2077), Expulsion (as recommended by FDA guidance), and Subsidence (per ASTM F2267).
  • Acceptance Criteria & Reported Performance: The document states, "The results of testing and analyses conducted demonstrate that the proposed system adequately meets the predetermined requirements established for its mechanical performance." Specific numerical acceptance criteria or reported values are not detailed in this summary. These "predetermined requirements" would typically be derived from standards and predicate device performance.

• Animal Study:

  • Purpose: To compare the host bone response of the Trabecular Metal Fusion Device to a predicate device (Crystal by Spinal Elements, made from PEEK) in anterior cervical discectomy and interbody fusion procedures.
  • Findings: "Histological results confirmed definitive bone ingrowth and showed that The Trabecular Metal cervical interbody fusion implant supports bone growth into and around the implant margins."
  • Sample Size, Ground Truth, etc.: The document does not provide details on the sample size of animals used, the specific methodology of histological analysis, or who established the ground truth for bone ingrowth.

In summary, the provided document relates to a physical medical device and its mechanical and biological performance, not the performance of an AI/ML algorithm.

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Trabecular Metal Tibial Cone 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 Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.

The existing, commercially available NexGen® Trabecular Metal™ Tibial Cone Augments are manufactured wholly of Trabecular Metal porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. The devices which are the subject of this 510(k), the modified NexGen Trabecular Metal Tibial Cone Augments are also manufactured of the same Trabecular Metal material, using the same methods as the predicate device. The existing, commercially available NexGen Trabecular Metal Tibial Cone Augments have tapered posterior, medial and lateral walls. The periphery of the inferior surface is smaller than that of the superior surface. A similar taper pattern is also present in the modified tibial cones.

Both the modified tibial cones augments and the existing, commercially available tibial cone augments are to be used in conjunction with Zimmer's NexGen® Complete Knee Systems- both the Legacy® Constrained Condylar Knee (LCCK) Stemmed Tibial Bases and the tibial component of Zimmer's Rotating Hinge Knee (RHK) System. Fixation of all of the cone augments to the tibial implant is accomplished by cementing the superior portion of the augment to the underside of the tibial baseplate. Apposition of the cone to bone inside the medullary canal is with or without cement when used with the LCCK tibial implant and with cement for the RHK tibial implant. With all of these tibial cone augments the LCCK tibial baseplate inferior surface must be cemented to the bone and the required stem extensions can either be cemented or press-fit.

The existing, commercially available augments come in four medium & large sizes, two height options and stepped augments. They can be used in conjunction with Zimmer's LCCK or RHK Knee Systems.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zimmer Trabecular Metal™ Tibial Cone Augments:

1. Table of Acceptance Criteria and Reported Device Performance

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

The study described is a Finite Element Analysis (FEA), which is a computer simulation, not a study involving physical samples or human patients as a "test set" in the traditional sense. Therefore, concepts like "sample size" for a test set and "country of origin of the data" are not directly applicable. The data provenance would be the computational models and parameters used in the FEA.

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

Since this was an FEA study, the concept of "ground truth" derived from expert review of patient data is not applicable. The "ground truth" for an FEA study would be the underlying physics and engineering principles validated through previous research and material properties. The document does not specify experts involved in establishing this, but it implies reliance on established engineering and biomechanical principles.

4. Adjudication Method for the Test Set

Not applicable for an FEA study, as there is no human interpretation of data for adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI or imaging diagnostic tool, so "human readers" and "AI assistance" are not relevant to this submission.

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

Again, this is not applicable as the device is a physical implant. The "standalone" performance here refers to the mechanical performance of the implant itself, which was assessed through the FEA.

7. The Type of Ground Truth Used

The ground truth used in this context is computational modeling and engineering principles, specifically validated through a Finite Element Analysis (FEA). The results of the FEA are compared against predetermined requirements for mechanical performance.

8. The Sample Size for the Training Set

Not applicable in the context of an FEA study. FEA models are built based on material properties, design specifications, and biomechanical loads. There isn't a "training set" of data in the sense of machine learning.

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

As above, the concept of a "training set" doesn't directly apply. The "ground truth" for an FEA model would be based on well-established engineering principles, material science data for Trabecular Metal and bone, and biomechanical studies defining forces during gait. These parameters are inputs to the FEA, not derived from a "training set" in the typical sense.

Summary of the Study:

The study undertaken to demonstrate device performance was a comparative Finite Element Analysis (FEA). This computational modeling technique was used to simulate the mechanical behavior of the proposed modified tibial cone augments under "normal gait activities (walking and deep flexion)." The goal was to determine if the modified design met predefined mechanical performance requirements and to compare its performance to the predicate device, thereby supporting substantial equivalence. The document states that the FEA results demonstrated that the implants adequately meet the predetermined requirements established for its mechanical performance, thus supporting their substantial equivalence.

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The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in 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 existing, commercially available Trabecular Metal Vertebral Body Reconstruction System is intended for use in thoracolumbar (TI-L5) surgical cases to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Reconstruction System is wholly comprised of Trabecular Metal Porous Tantalum (tantalum deposited on a vitreous carbon skeleton) and is available in a variety of configurations to accommodate the anatomical requirements of different patients.

The Trabecular Metal Vertebral Body Replacement System Instrumentation Set which is the subject of this premarket notification is intended for use in these thoracolumbar surgical cases and facilitates the implantation of the Trabecular Metal Vertebral Body Replacement implant system. The provisionals size the surgical site in order to determine the appropriate TM-400 implant size. The straight inserter and tamp facilitate implantation of the TM-400 implant via anterior or lateral lumbar approach. All instruments included in the set are made from 17-4 stainless steel.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study for the Trabecular Metal Vertebral Body Replacement System Instrumentation:

Device Description:
The device in question is the Trabecular Metal™ Vertebral Body Replacement System Instrumentation Set. This set facilitates the implantation of the Trabecular Metal Vertebral Body Replacement implant system in thoracolumbar (T1-L5) surgical cases. The instruments (provisional sizers, straight inserter, and tamp) are made from 17-4 stainless steel.

Lack of Specific Acceptance Criteria and Performance Data in the Summary:
It's crucial to note that the provided 510(k) summary does not explicitly state specific numerical acceptance criteria or detailed device performance metrics in a table format. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance targets for the instrumentation set itself.

The key statement regarding performance is: "The results of testing and analyses conducted demonstrate that the worst cases of the proposed instruments adequately meet the predetermined requirements established for its mechanical performance." This is a high-level summary and lacks the granular detail requested.

Given this, I will construct the table based on the most relevant information provided about the study's scope and outcome.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not specified. The document refers to "worst cases of the proposed instruments" and "testing and analyses," but does not provide a numerical sample size for the test set.
   • Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective. It is implied to be laboratory/bench testing.

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

   • This information is not provided in the 510(k) summary. The testing described appears to be mechanical/bench testing of instruments rather than a clinical study requiring expert assessment of outcomes or images.

3. Adjudication method for the test set:

   • Not applicable / Not provided. The study described is mechanical testing, which typically involves objective measurements against engineering specifications rather than human adjudication.

4. 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:

   • No. An MRMC study was not conducted. This device is a surgical instrumentation set, not an AI-powered diagnostic tool. Therefore, a study comparing human reader performance with and without AI assistance is irrelevant and was not performed.

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

   • Not applicable. This device is a manual surgical instrument set, not an algorithm or AI system. Standalone performance of an algorithm is not relevant here.

6. The type of ground truth used:

   • The "ground truth" for this type of device (surgical instruments) would be engineering specifications and mechanical performance requirements. The test results would be compared against these predefined physical and functional specifications. The summary states "predetermined requirements established for its mechanical performance."

7. The sample size for the training set:

   • Not applicable / Not provided. This is a hardware surgical instrument set, not a machine learning or AI model. Therefore, there is no "training set" in the context of an algorithm.

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

   • Not applicable. As a manual surgical instrument set, there is no "ground truth for a training set" as would be relevant for an AI device. The design and manufacturing would adhere to established engineering principles and material science.

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