FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

· Augmenting immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORO Navigation instruments are intended to be used with the Medtronic StealthStation System.

Device Description

The iFuse TORQ Implant System consists of the iFuse TORQ Implants and associated Instruments. Implants are threaded, fenestrated, cannulated, 3D-printed from medical grade titanium alloy (Ti-6A1-4V ELI per ASTM F3001). The implants are fully threaded or a lag design that is provided with optional washers. The washers are intended to add additional support under the head of the screw in situations where the bone quality is poor. The cannulated implants are compatible with off-the-shelf 3.2 mm guidewires. The implants, available in various lengths and diameters, allow for packing of autograft and allograft materials.

This 510(k) covers extension of the porous lattice surface over the entire shank of the Ø10.0 mm screws, an optimized laser path during additive manufacturing process, and use of two implants in the SAI (posteromedial) trajectory for sacroiliac joint fusion.

AI/ML Overview

This looks like a 510(k) clearance letter for a medical device (iFuse TORQ® Implant System), not an AI/ML device. Therefore, the questions related to AI/ML device performance (like sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) are not applicable in this context.

The document discusses acceptance criteria and studies for the mechanical and material properties of the iFuse TORQ® Implant System, which is a physical implant for sacroiliac joint fusion and fracture fixation.

Here's the information relevant to the provided document, based on the non-AI device context:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a tabular format with specific numerical targets. Instead, it lists the types of performance tests conducted and then concludes that "The test results demonstrate that the device is substantially equivalent to the predicate device." This implies that the performance in these tests met the established criteria for substantial equivalence to the previously cleared predicate device.

Test Type	Standard Used	Reported Performance
Porosity testing	ASTM F1854	Results demonstrate substantial equivalence to the predicate device, indicating suitable porous lattice surface characteristics.
Static Shear	ASTM F1044	Results demonstrate substantial equivalence to the predicate device, indicating adequate shear strength.
Static Fatigue	ASTM F1160	Results demonstrate substantial equivalence to the predicate device, indicating adequate fatigue resistance.
Static Tensile	ASTM F1147	Results demonstrate substantial equivalence to the predicate device, indicating adequate tensile strength.
Abrasion	ASTM F1978	Results demonstrate substantial equivalence to the predicate device, indicating adequate abrasion resistance.
Dynamic Cantilever Testing	ASTM F2193	Results demonstrate substantial equivalence to the predicate device, indicating adequate dynamic load bearing.
Static Torsion Testing	ASTM F543	Results demonstrate substantial equivalence to the predicate device, indicating adequate torsional strength.

2. Sample sizes used for the test set and the data provenance:

Sample Size: The document does not specify the sample sizes (number of implants tested) used for each of the listed bench tests.
Data Provenance: The tests are "bench testing," meaning they are conducted in a laboratory setting, not with human or animal data. The provenance is internal laboratory testing by the manufacturer (SI-BONE Inc.) or a contracted testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the studies are mechanical bench tests, not clinical studies reviewed by medical experts. The "ground truth" is defined by the physical properties and engineering standards (ASTM).

4. Adjudication method for the test set:

This question is not applicable as the studies are mechanical bench tests, not clinical studies requiring adjudication. The results are quantitative measurements against established engineering 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:

This question is not applicable. This device is a physical implant, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

For the performance data, the "ground truth" is established by adherence to recognized ASTM (American Society for Testing and Materials) standards for material and mechanical testing of medical implants. The goal is to demonstrate that the modified device performs similarly to or better than the predicate device under these standardized conditions.

8. The sample size for the training set:

This question is not applicable. This device is a physical implant, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

This question is not applicable. As above, there's no training set for a physical implant.

Summary of what the K241574 document does provide regarding acceptance and proof:

The document describes modifications to an existing device (iFuse TORQ® Implant System). The acceptance criteria for these modifications, and the proof that they are met, revolve around demonstrating that the modified device is substantially equivalent to its predicate device(s) in terms of safety and effectiveness.

This is primarily shown through:

Bench Testing: Mechanical and material tests (Porosity, Static Shear, Static Fatigue, Static Tensile, Abrasion, Dynamic Cantilever, Static Torsion) were performed according to recognized ASTM standards.
Conclusion of Equivalence: The submission concludes that "The test results demonstrate that the device is substantially equivalent to the predicate device" and that "The differences in the technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness."

The FDA's clearance letter confirms this conclusion, stating that the device is "substantially equivalent... to legally marketed predicate devices."

Summary

Regulation Number and Section

§ 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.