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510(k) Data Aggregation
(64 days)
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.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Static Compression | Equivalent to predicate devices | Performed as intended, equivalent to predicates |
| Dynamic Compression | Equivalent to predicate devices | Performed as intended, equivalent to predicates |
| Static Torsion | Equivalent to predicate devices | Performed as intended, equivalent to predicates |
| Dynamic Torsion | Equivalent to predicate devices | Performed as intended, equivalent to predicates |
| Abrasion | Equivalent to predicate devices | Performed as intended, equivalent to predicates |
| Biocompatibility | Meet established standards for the material | Data provided, supports material's use |
| Geometry (dimensional) | Comparable to predicate devices | Comparable to predicate devices |
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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