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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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Use of the TM-400 powered traction device is indicated for the following:

• Providing standard therapeutic and custom user-defined treatments in static, intermittent, . progressive, regressive, cyclical and combination distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder).
• Providing traction and mobilization of skeletal structures and skeletal muscles. .
• . Relieving peripheral radiation / sciatica and pain associated with:

Discs:

• A Protruding, bulging, herniated and prolapsed discs
• A Degenerative disc disease
• A Discogenic pain

Facets:

• A Facet syndrome
• A Posterior facet syndrome
• Acute facet problem A

Muscles & Joints:

• Muscle pain and spasms A
• Degenerative joint disease A

Spinal Structures:

• Spinal root impingement A
• a Pinched nerves
• A Compression fractures

Pain:

• Back, lower back, neck, joint, sciatic and radicular pain A
  Mobility & Flexibility:

• Hypomobility

• Limited spinal and joint flexibility

The TM-400 is a simple to use powered traction unit that offers static, intermittent, and cycle traction with user-definable hold, rest and treatment times. The unit consists of a software-controlled electro-mechanical traction system. The physical characteristics of the TM-400 are substantially equivalent to the predicate traction devices including size, weight, materials of construction, and user interface. In addition, the unit has incorporated similar features as the predicate devices such as:

• ア Automatic calibration of traction force

• An internal memory that stores up to 30 treatment patterns

• A Traction speed selectable from five preset values
• 公 Eight traction modes
• A Remote patient-controlled treatment shutoff switch
• ﺮ Large and high-visibility LCD screen

The TM-400 traction device operates by attaching the cable hook to a harness accessory, which is in turn attached to the patient treatment area, for traction and mobilization of skeletal muscles according to the detailed indications of use.

The provided text describes the TM-400 powered traction device and its intended use, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) summary for a medical device submitted to the FDA, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and performance study results based solely on the provided text.

Here's why and what information would typically be expected for such a request:

• Acceptance Criteria and Reported Device Performance: This would require a table outlining quantitative or qualitative performance targets (e.g., accuracy of traction force, speed consistency) and the actual validated performance values from testing. The document states "Testing was carried out to assure compliance to FDA recognized electrical safety standards," and "Non-clinical verification and validation testing was conducted on final TM-400 production units, and the results of such testing appear in Section 12 and Section 14 of this submission." However, these sections are not provided in the input, so the specific acceptance criteria and performance data are missing.
• Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, ground truth type, training set size, and training set ground truth establishment: These are all elements typically found in detailed clinical or non-clinical performance studies, often in sections beyond a 510(k) summary. The provided text only mentions "non-clinical verification and validation testing." For a powered traction device, these studies would likely focus on mechanical performance, safety, and potentially effectiveness if a clinical study were performed (though typically not required for substantial equivalence).

In summary, the provided document focuses on:

• Device description and features.
• Intended use and indications for use.
• Comparison to predicate devices (K992545 and K053223).
• Compliance with electrical safety (UL60601-1) and electromagnetic compatibility (IEC60601-1-2) standards.
• The FDA's decision of substantial equivalence.

It does not disclose the detailed results of non-clinical verification and validation testing or any clinical studies that would address the acceptance criteria and performance metrics you've requested.

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