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510(k) Data Aggregation
(70 days)
Ti-Diagon Oblique TLIF
The Camber Spine Technologies Ti-Diagon® Oblique TLIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Camber Spine Technologies Ti-Diagon® Oblique TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. Camber Spine Technologies Ti Diagon Oblique TLIF implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The Camber Spine Technologies Ti-Diagon Oblique TLIF is an interbody fusion device with a hollow chamber to permit packing of autologous bone graft in order to facilitate fusion. The inferior and superior surfaces of the Ti-Diagon Oblique TLIF have a rough texture, as the result of a photochemical etching process, to help prevent movement of the device.
The provided text is a 510(k) summary for a medical device (Ti-Diagon Oblique TLIF), which primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance. It does not contain information about studies involving human readers, AI, or clinical ground truth in the way a diagnostic device submission might. Therefore, many of the requested fields cannot be populated from the provided document.
Here's an analysis of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Compression Shear | Defined by predicate device performance (not explicitly stated in quantitative terms) | Met accepted criteria (implied to be comparable to predicate devices) |
| Dynamic Compression | Defined by predicate device performance (not explicitly stated in quantitative terms) | Met accepted criteria (implied to be comparable to predicate devices) |
| Dynamic Compression Shear | Defined by predicate device performance (not explicitly stated in quantitative terms) | Met accepted criteria (implied to be comparable to predicate devices) |
| Expulsion | Defined by predicate device performance (not explicitly stated in quantitative terms) | Met accepted criteria (implied to be comparable to predicate devices) |
| Subsidence | Defined by predicate device performance (not explicitly stated in quantitative terms) | Met accepted criteria (implied to be comparable to predicate devices) |
2. Sample size used for the test set and the data provenance:
- The document refers to "Performance Testing Summary" which included mechanical tests per ASTM F2077-14 and F2267-04. These standards are for in vitro mechanical testing of intervertebral body fusion devices.
- Sample Size: Not specified in the provided text.
- Data Provenance: The data provenance for this type of testing is generally lab-generated data from mechanical testing setups, not human or clinical data. Not explicitly stated where the tests were performed.
- Retrospective/Prospective: Not applicable for mechanical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for mechanical testing is derived from quantitative measurements of physical properties, not expert opinion.
4. Adjudication method for the test set:
- Not applicable. Mechanical testing results are typically compared against pre-defined engineering specifications and predicate performance, not adjudicated by human experts.
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. This document does not pertain to an AI-assisted diagnostic device or any study involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This document does not describe an algorithm or AI device.
7. The type of ground truth used:
- For the mechanical testing, the "ground truth" is the quantitative measurement of the device's physical properties and mechanical performance, compared against the performance of predicate devices and relevant ASTM standards (ASTM F2077-14 and F2267-04).
8. The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. There is no mention of a "training set" or "ground truth" in the context of AI/ML.
Summary of what cannot be answered from the provided text:
The document describes a 510(k) submission for a spinal implant (intervertebral body fusion device). The "acceptance criteria" and "study" refer to mechanical performance testing to demonstrate the device is as mechanically sound as its predicate devices. The information requested regarding AI performance, human readers, clinical ground truth, and specific sample sizes for such studies is not present because this device is a physical implant, not a diagnostic or AI-powered tool.
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