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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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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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