(228 days)
The Agile Nail is intended for insertion in the medullary canal of a femur for the alignment and the stabilization of fractures, and for the correction of deformities.
It is indicated for the treatment of subtrochanteric fractures and of femoral shaft fractures, with the exception of newborns and infants, and in adult patients with an appropriate medullary canal.
The indications include:
prophylactic nailing of impending pathologic fractures;
fixation of femurs that have been surgically prepared (osteotomy);
nonunions and malunions;
reconstruction following tumor resection and grafting and bone lengthening and shortening.
The Agile Nail consists of ante grade intramedullary nails, end caps and screws, and related instrumentation for insertion and extraction of the implantable components.
The System is designed to address femoral fractures and deformity corrections procedures.
The provided document describes the Orthofix Agile Nail, an intramedullary fixation rod, and its 510(k) submission for FDA clearance. The submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting a de novo clinical study with specific performance acceptance criteria for an AI/device algorithm.
Therefore, many of the requested details about acceptance criteria, study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance), and training data for an AI-powered medical device are not applicable to this submission. This is a traditional medical device (implantable hardware) clearance, not an AI software as a medical device (SaMD) clearance.
However, based on the information provided, I can construct an answer that reflects the type of "acceptance criteria" and "proof" used for this mechanical device.
Acceptance Criteria and Device Performance for Orthofix Agile Nail
This device, the Orthofix Agile Nail, is a mechanical intramedullary fixation rod, not an AI-powered medical device. As such, the "acceptance criteria" and "study proving the device meets the acceptance criteria" differ significantly from those for an AI algorithm. The clearance for this device was based on substantial equivalence to predicate devices, primarily demonstrated through mechanical performance testing and biocompatibility.
Here's how the requested information applies to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For a mechanical device like the Agile Nail, the "acceptance criteria" are tied to established engineering standards and comparative performance against predicate devices, rather than a diagnostic accuracy metric.
| Area of Performance | Acceptance Criteria (Implicit from 510(k) Process) | Reported Device Performance (as stated in document) |
|---|---|---|
| Mechanical Performance | Device capable of withstanding expected loads without failure, and equivalent/better mechanical properties compared to predicate devices, as per recognized standards (e.g., ASTM F1264, ASTM F543). | "All testing met or exceeded the requirements as established by the test protocols and applicable standards." |
| "A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure." | ||
| "The Agile Nail was therefore found to be substantially equivalent to the predicate involved in the performance." | ||
| "Mechanical testing demonstrate how the mechanical properties of the Subject Device are equivalent / better than the predicate involved." | ||
| Biocompatibility | Device materials must be non-pyrogenic and biocompatible, meeting established international and FDA standards (e.g., USP, ANSI/AAMI ST72). | "In order to establish the Subject device non-pyrogenicity, some tests were performed on an equivalent System implants, according to the following international standard: |
| • USP 38: 2014 "Bacterial endotoxin test (LAL)". | ||
| • USP 38: 2014 "Medical devices – bacterial endotoxin and pyrogen tests". | ||
| • ANSI / AAMI ST72: 2011 "Bacterial endotoxins – Test methodologies, routine monitoring and alternative batch testing". | ||
| • FDA 2012 Q&A "Guidance for Industry Pyrogen and Endotoxins Testing: Question and Answers"." | ||
| Multiple test reports are referenced. | ||
| Intended Use & Indications for Use | Intended use and indications for use must be substantially equivalent to predicate devices. | The Agile Nail has identical indications for use as stated for the predicate devices (Synthes Adolescent Lateral Entry Femoral Nail System K070843 and Orthopediatrics PediNal Intramedullary Nailing System K083726), addressing femoral fractures and deformity corrections. |
| Technological Characteristics | Operating principles, materials, and overall design must be substantially equivalent to predicate devices. | "The Agile Nail is substantially equivalent to the predicate devices in: intended use, site of application, patient population, conditions of use, mechanical performances, operating principles and materials." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of patient data for an AI algorithm. For mechanical testing, the "sample size" refers to the number of physical devices or components tested. The document does not specify the exact number of devices tested but indicates that "All testing met or exceeded the requirements."
- Data Provenance: The "data" for this submission consists of engineering test results and biocompatibility test results, not patient data in the typical sense of a clinical study for an AI device. These tests are conducted in laboratories (e.g., in Italy, given the manufacturer's location). The testing is prospective (performed specifically for the submission).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. For a mechanical device, ground truth is established by engineering standards (e.g., ASTM standards define how tests are to be performed and what constitutes passing criteria) and comparator device specifications, not by human expert interpretation of images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or "adjudication" in the sense of an expert consensus on a diagnostic outcome for this type of device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance for diagnostic tasks (e.g., radiologists reading images). This device is an implantable orthopedic rod, not a diagnostic imaging AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an algorithm. The "performance" is the mechanical integrity and biocompatibility of the physical implant.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Established engineering standards (e.g., ASTM F1264 for intramedullary fixation devices, ASTM F543 for bone screws) which specify test methods and performance requirements.
- Biocompatibility standards (e.g., USP, ANSI/AAMI ST72) which provide methods and criteria for assessing pyrogenicity and other biological responses.
- The performance characteristics of legally marketed predicate devices, against which the Agile Nail's performance is directly compared to demonstrate equivalence.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this mechanical device.
In summary, the K172699 submission for the Orthofix Agile Nail exemplifies a traditional 510(k) clearance pathway for a mechanical medical device, where the "acceptance criteria" and "proof" are rooted in engineering specifications, established consensus standards, and direct comparison to predicate devices, rather than clinical studies with human evaluators or AI algorithm performance metrics.
§ 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.