(440 days)
TransLoc 3D is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroilitis. When the TransLoc 3D Posterior Implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.
The TransLoc 3D System implants are intended to transfix the sacroiliac (SI) joint for fusion procedures. These titanium 3D-printed devices are available in a range of lengths and include a threaded Screw version, as well as Posterior Implant version that incorporates circumferential teeth and a porous lattice pattern. The TransLoc 3D Screw may be implanted alone. The TransLoc 3D Posterior Implant is intended only for use along with a TransLoc 3D Screw implanted in the same sacroiliac joint.
The provided document is a 510(k) summary for the TransLoc 3D device, which is a sacroiliac joint fusion implant. The document does not describe a study involving device performance related to diagnostic accuracy, AI, or human-in-the-loop performance.
Instead, it details the non-clinical testing performed to demonstrate substantial equivalence of the TransLoc 3D device to predicate devices, primarily focusing on mechanical and material properties.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance as it relates to AI/diagnostic studies, human readers, or ground truth establishment in that context. The document only covers the following:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a specific table of "acceptance criteria" in the traditional sense of performance metrics for an AI-driven device (e.g., sensitivity, specificity). Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence to predicate devices:
| Test Type | Standard/Method | Reported Performance Comment |
|---|---|---|
| Dynamic compression-shear | ASTM F2077 | Results demonstrated that TransLoc 3D is substantially equivalent to the predicate devices. |
| Dynamic 3-point bending | ASTM F2193 | Results demonstrated that TransLoc 3D is substantially equivalent to the predicate devices. |
| Static and dynamic cantilever bending | ASTM F2193 | Results demonstrated that TransLoc 3D is substantially equivalent to the predicate devices. |
| Insertion and pullout/pushout testing | ASTM F543 | Results demonstrated that TransLoc 3D is substantially equivalent to the predicate devices. |
| Cadaver implantation and biomechanical studies | Lab protocols | Results demonstrated that TransLoc 3D is substantially equivalent to the predicate devices. |
| Particulate analysis | USP | Results demonstrated that TransLoc 3D is substantially equivalent to the predicate devices. |
The document states that "No FDA performance standards have been established for TransLoc 3D." The acceptance criteria are implicitly that the device performs equivalently to the predicate devices in the listed mechanical and material tests.
2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical, mechanical, and material testing, not a diagnostic or AI performance study with a test set of human 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 as typically understood for diagnostic AI (e.g., expert labels on images) is not relevant to the non-clinical tests described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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, an MRMC study was not done, as this document concerns a medical implant, not an AI diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be the established mechanical properties and material composition as defined by the ASTM standards and USP .
8. The sample size for the training set: Not applicable. There is no AI training set mentioned.
9. How the ground truth for the training set was established: Not applicable.
§ 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.