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

The AFFIXUS Natural Nail System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail.

The AFFIXUS Humeral Nails are indicated for use in a variety of fractures, such as:

· Proximal fractures (proximal short and long nails only)
· Diaphyseal fractures (proximal long, antegrade/retrograde nails)
Open and closed fractures
· Comminuted fractures
Nonunions and malunions
· Pathologic fractures .

Device Description

The Affixus Natural Nail System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs.
Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. Nails and nail caps are made from Tivanium® Ti-6Al-4V alloy. Screws are also made from Tivanium alloy. Package labels indicate the material of each component.
Selected components of the Affixus Natural Nail System are color coded to aid in identifying which components should be used together. Refer to the color coding chart and/or surgical technique for more detailed instructions on the use of Affixus Natural Nail System components.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Affixus Natural Nail System Humeral Nail." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not include information on acceptance criteria for a device performance study as typically seen in evaluations of AI/ML-driven devices.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training) are not applicable to this type of regulatory submission, which relies on demonstrating physical and mechanical equivalence through non-clinical testing.

Here's an analysis based on the information available:

A table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in the format of a performance study for, for example, accuracy, sensitivity, or specificity. Instead, the acceptance is based on the results of non-clinical performance tests demonstrating that the device is "as safe, as effective, and performs as well as or better than the legally marketed devices predicate." The performance is reported through the successful completion of various mechanical and biological tests.

Acceptance Criteria (Implicit)	Reported Device Performance
Bioburden requirements (ISO 11137-2)	Study performed, technical review completed.
Biocompatibility (ISO 10993-1)	Study performed.
Material composition (ASTM 136-13 for Tivanium® Ti-6Al-4V alloy)	Complies with material specifications.
Torsional Stiffness (no specific standard cited for this)	Measurement performed.
Static Four-Point Bend Test (no specific standard cited)	Performed.
Fatigue Strength (Three-point bending) (ASTM F543-17)	Evaluation performed.
Self-tapping Performance (no specific standard cited)	Performed.
Four-Point Bending Fatigue Properties (ASTM F1264-16)	Performed.
Driving Torque (no specific standard cited)	Determined.
Axial Pull-out Strength (no specific standard cited)	Determined.
Torsional Properties (ISO 6475)	Performed.
Bending fatigue strength and CoreLock Evaluation	Evaluation performed for the proximal segment.
Axial Push-out Strength (CoreLock mechanism)	Evaluation performed.
Cleaning, Autoclave, Targeting Functionality, Impact Testing	Performed for targeting guides.
Overall performance	"Results of non-clinical performance testing and analyses demonstrate that the Affixus Humeral Nails is as safe, as effective, and performs as well as or better than the legally market devices predicate. The results of non-clinical data demonstrate that the subject device is substantially equivalent with the predicate devices." (This is the ultimate 'performance' against the implicit criterion of substantial equivalence through testing).

Sample size used for the test set and the data provenance: Not applicable. These are non-clinical (mechanical, material, biological) tests, not studies involving patient data or test sets in the context of AI/ML. The "test set" would refer to the physical devices and components subjected to the various laboratory tests. The provenance is the manufacturer's internal testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of tests is established by engineering specifications, material standards, and validated testing protocols, not by expert medical review.
Adjudication method: Not applicable. This concept is relevant for clinical studies or studies using human interpretation (e.g., radiological reads), not for non-clinical mechanical or material testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI-assisted device; it's a physical intramedullary nail.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an algorithmic device.
The type of ground truth used: For non-clinical tests, the "ground truth" is typically defined by:
- Engineering Specifications: Design tolerances, material properties.
- Industry Standards: Adherence to standards like ISO 11137-2 (sterilization), ISO 10993-1 (biocompatibility), ASTM F136-13 (material), ASTM F543-17 (fatigue), ASTM F1264-16 (fatigue), ISO 6475 (torsional properties).
- Benchmarking against predicate devices: Performance (e.g., stiffness, strength) is compared to that of existing, legally marketed devices.
The sample size for the training set: Not applicable. This is not a machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.