(106 days)
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroiliitis.
The TiLink-L Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to fixate the joint. There are various sacroiliac implant sizes available for implanting to accommodate a range of sacroiliac joint sizes and geometries.
This document is a 510(k) premarket notification for a medical device called the "TiLink-L SI Joint Fusion System." It establishes the substantial equivalence of this new device to previously cleared predicate devices. Therefore, the information provided focuses on demonstrating this equivalence rather than presenting an original study with acceptance criteria and device performance in the typical sense of a diagnostic or algorithmic device.
Here's an analysis based on your requested points, highlighting that this document is for a mechanical implant and not an AI or diagnostic device:
1. A table of acceptance criteria and the reported device performance:
This document does not present acceptance criteria or reported device performance in the manner expected for a device like an AI algorithm with metrics like sensitivity, specificity, or accuracy. Instead, the "performance data" listed are primarily related to general device safety and mechanical integrity, demonstrating that the new device performs comparably to the predicate devices in these aspects. The acceptance criteria implicitly refer to meeting established standards for medical implants.
| Acceptance Criteria (Implied from testing types) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility (per ISO 10993-1:2018) | Compliant with standard (essential for substantial equivalence) |
| Sterilization Validation (per ISO 17665-1:2006/(R) 2013) | Compliant with standard (essential for substantial equivalence) |
| Mechanical Static Testing (per ASTM F543) | Substantially equivalent to predicate (demonstrated through testing) |
| Mechanical Dynamic Testing (per ASTM F1264) | Substantially equivalent to predicate (demonstrated through testing) |
| V/V Mechanical and Safety Testing | Conforms to Mechanical and Safety requirements (essential for substantial equivalence) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of this submission. The "test set" here refers to the physical samples of the TiLink-L device that underwent engineering and biological testing, not a dataset of patient cases. The number of physical units tested for each mechanical or biocompatibility standard would be part of the detailed test reports (which are not included in this summary).
- Data Provenance: Not applicable in the context of this submission. The tests are laboratory-based engineering and biological assessments of the device itself, not analyses of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. "Ground truth" in this context is irrelevant as the tests are for physical and biological properties against established standards, not for diagnostic accuracy or clinical outcomes assessed by experts.
4. Adjudication method for the test set:
Not applicable. This concept applies to human interpretation of data where consensus is needed. For mechanical and biological testing, the outcome is determined by adherence to predefined standards and measurement against those 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:
Not applicable. This is for a physical implant, not an AI or diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a standalone physical implant, not an algorithm.
7. The type of ground truth used:
Not applicable in the AI/diagnostic sense. The "ground truth" for the performance data in this submission would be the established scientific and engineering standards (e.g., ISO 10993-1, ISO 17665-1, ASTM F543, ASTM F1264) that the device must meet or demonstrate equivalence against.
8. The sample size for the training set:
Not applicable. This device is not an AI model, so there is no training set in the machine learning sense.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
Summary for this specific document:
This 510(k) submission successfully demonstrates substantial equivalence for a physical medical implant (TiLink-L SI Joint Fusion System) by showing that its technological characteristics and performance (biocompatibility, sterilization, mechanical properties) are comparable to legally marketed predicate devices. The "study" here refers to the non-clinical performance data and engineering tests conducted on the device components themselves, which align with established standards for medical implants. It is crucial to understand that the requested questions about acceptance criteria, sample sizes, experts for ground truth, and MRMC studies are primarily relevant for diagnostic devices, especially those incorporating AI, and not for mechanical implants like the one described in this document.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.