(231 days)
The iFuse Hammertoe system is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.
The iFUSE Hammertoe System by OrthoPro is a single piece metal implant that is surgically inserted into the intramedullary canal of the bones in the toe, finger or small bones, designed to create a fusion.
The provided text does not contain information about a study proving the device meets acceptance criteria in the way typically required for AI/ML device submissions (i.e., with performance metrics, ground truth establishment, or human-in-the-loop studies).
Instead, this document is a 510(k) summary for a medical device (iFUSE Hammertoe System), which is a premarket submission to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. For this type of device (a bone fixation screw), substantial equivalence is primarily demonstrated through non-clinical testing (mechanical properties) and comparison to predicate devices, rather than clinical studies or performance against acceptance criteria derived from a complex AI/ML algorithm.
Here's why the provided text doesn't fit the requested criteria and what it does say:
-
Acceptance Criteria & Device Performance Table: Not applicable. The submission focuses on demonstrating substantial equivalence through mechanical testing rather than meeting specific performance thresholds against a diagnostic benchmark. The non-clinical tests performed are:
- Pullout strength
- Four-point bending and fatigue strength
The document states: "The results of this testing indicate that the iFUSE Hammertoe System is equivalent to predicate devices." This is the "performance" relative to the "acceptance criteria" of being equivalent to predicates for mechanical properties.
-
Sample Size for Test Set & Data Provenance: Not applicable for a clinical test set. The "testing" refers to mechanical properties of the device itself (hardware), not observational data.
-
Number of Experts & Qualifications / Adjudication Method: Not applicable. There was no clinical study involving human readers or expert radiologists for establishing ground truth from medical images.
-
MRMC Comparative Effectiveness Study: Not applicable. This device is a surgical implant, not an AI diagnostic tool.
-
Standalone (Algorithm Only) Performance: Not applicable. There is no algorithm.
-
Type of Ground Truth Used: Not applicable for a clinical study. For the mechanical tests, the ground truth would be the established engineering standards for strength and fatigue, and data from the predicate devices.
-
Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. There's no AI/ML algorithm requiring training data.
Key Information from the Document that Relates to "Proof" of Meeting "Acceptance Criteria" for this specific device:
- Acceptance Criteria (Implicit): The primary "acceptance criterion" for this 510(k) submission is that the iFUSE Hammertoe System is substantially equivalent to legally marketed predicate devices (Stayfuse, Pioneer Surgical Technology, K990804 and OthoPro Stemman Pins and Kirschner Wires, OrthoPro LLC, K070555) in terms of:
- Intended use
- Design
- Materials used
- Mechanical safety
- Performance
- Study Proving Device Meets Acceptance Criteria: The "study" was non-clinical testing:
- Tests Performed: Pullout strength; Four-point bending and fatigue strength.
- Results/Conclusion: "The results of this testing indicate that the iFUSE Hammertoe System is equivalent to predicate devices." And "The conclusions drawn from the comparison between the devices demonstrate that the iFUSE Hammertoe System is as safe, as effective, and performs as well as the predicate devices."
- Clinical Studies: "No clinical studies were performed."
In summary, the provided text describes the submission for a Class II metallic bone fixation fastener, where "acceptance criteria" and "proof" primarily revolve around demonstrating mechanical equivalence to existing devices through non-clinical laboratory testing, not through clinical trials or performance metrics of an AI/ML system.
§ 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.