(180 days)
Ins Hilden Arzzt Nail Systems, consisting of intramedullary solid and cannulated nails, end cap and locking screws, are intended for fixation of fractures of different types: of the shaft, open and closed shaft fractures; and malunion and non-unions of the Femur, Tibia, and Humerus.
Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt.
I. The Ins Hilden Humeral Arzzt is a single use system that consist the following components:
- i. Nail, is solid and cannulated, with five orifices, two for distal locking and three for the proximal locking. One of the orifices on the proximal locking is for static locking and one for dynamic locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole.
- ii. End caps.
- iii. Locking Screws with conical head and self-tapping on the head and blunt.
II. The Ins Hilden Femoral Arzzt is a single use system that consist the following components:
- i. Nail, is solid and cannulated with four orifices, two for distal locking and two for the proximal locking. One of the orifices on the proximal locking is for static locking and one for dynamic locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extractionhole.
- ii. End caps.
- iii. Locking Screws with conical head and self-tapping on the head and blunt.
III. The Ins Hilden Femoral Retrograde Arzzt is a single use system that consist the following components:
- i. Nail, is solid and cannulated, with five orifices, two for distal locking and three for the proximal locking. All three proximal orifices for static locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole.
- ii. End caps.
- iii. Locking Screws with conical head and self-tapping on the head and blunt.
IV. The Ins Hilden Cannulated Tibial Arzzt is a single use system that consist the following components:
- i. Nail, is cannulated, with four orifices, two for distal locking and four for the proximal locking. All three proximal orifices for static locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole.
- ii. End caps.
- iii. Locking Screws with conical head and self-tapping on the head and blunt.
The system is manufactured from titanium alloy Ti6Al4V, a medical-grade material that is recognized as generally accepted for the manufacture of implants for their level of biocompatibility with surrounding tissues.
The provided document describes the Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt, and Ins Hilden Retrograde Femoral Arzzt systems, which are intramedullary fixation rods. The document asserts their substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics in the way one might expect for a diagnostic or AI-driven device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through engineering analysis and material biocompatibility.
The "acceptance criteria" can be inferred from the comparisons made:
- Mechanical Performance: The subject devices must show comparable or superior static bending and torsional yield performance to the predicate devices.
- Biocompatibility: The subject devices must be made of materials recognized as safe for medical implants and demonstrate no increased risk due to manufacturing processes.
- Intended Use & Design: The subject devices must have similar intended uses (fixation of fractures of different types, malunion, non-unions of Femur, Tibia, and Humerus) and their design differences (angles, curvatures, lengths) should not affect the final result or increase risks.
| Category | Acceptance Criteria (Inferred from comparison) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Static bending and torsional yield performance comparable or superior to predicate devices. | Engineering analyses confirmed substantial equivalence and that subject devices are stronger when applying the same force than predicate devices K033878 and K010801 (DEPUY ACE Antegrade Retrograde Humeral Nail System, T2 Femoral Nail). |
| Biocompatibility | Manufactured from medical-grade materials (Ti6Al4V) with no adverse impact from manufacturing processes. | System is manufactured from Titanium alloy Ti6Al4V, a recognized medical-grade material. Biocompatibility deemed acceptable based on prior FDA submissions (K133166 for Ti6Al4V and K162507 for Stainless Steel AISI 304, though the subject devices are Ti6Al4V). |
| Intended Use | Similar intended uses as predicate devices (fixation of fractures, malunion, non-unions of Femur, Tibia, Humerus). | Identical intended uses: fixation of fractures of different types; open and closed shaft fractures; and malunion and non-unions of the Femur, Tibia, and Humerus (same as predicate devices). |
| Design | Design differences (geometry, angles, curvatures, lengths) do not increase risks or complications. | Design differences exist (slight changes in geometry, angles, curvatures, lengths) to fit specific bones, but these "do not affect the final result" and "do not increase risks and complications" as systems are designed to fit specific bones, similar to predicate devices. |
| Patient Outcome | No complications experienced with either system during the healing process clinically. | "With similar clinical, the patients had no complications with either system during the healing process, after the reduction and fixation of the fracture with the subject devices." |
| Regulatory Standards | Compliance with relevant ASTM and ISO standards for materials. | The Ins Hilden Nails Arzzt Systems met the requirements of ASTM F-136-13, ASTM F-983-86, and ISO 5832-3:1996. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes engineering analyses and material testing, not clinical studies with "test sets" in the context of diagnostic performance or AI.
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it focuses on non-clinical performance (mechanical and material testing) rather than a clinical "test set" of patient data for a diagnostic device. The "engineering analysis" would involve a specific number of devices or material samples tested per standard protocols, but this number is not specified in the summary.
- Data Provenance: Not explicitly stated for the engineering analysis, but typically these tests are conducted in a controlled lab environment. The document refers to "similar clinical" outcomes, implying anecdotal or general clinical experience rather than a formal clinical study used as a "test set."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic test. The "ground truth" for mechanical properties is established by physical testing against engineering standards.
4. Adjudication Method for the Test Set:
Not applicable. There is no diagnostic "test set" requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No. This is a submission for an orthopedic implant (intramedullary fixation rod), not a diagnostic device that would involve human readers or AI assistance in image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. There is no algorithm or AI component in these devices. The "standalone" performance refers to the device's mechanical and material properties as an implant.
7. The Type of Ground Truth Used:
- Mechanical Performance: "Ground truth" is established by physical testing against established engineering standards (e.g., ASTM, ISO) for static bending and torsional yield, and comparison to the mechanical properties of predicate devices.
- Biocompatibility: "Ground truth" is based on the material specification (medical-grade Ti6Al4V) and prior FDA clearances/publications regarding the biocompatibility of this material and manufacturing processes (referenced K133166, K162507).
- Clinical Efficacy/Safety (implied): "Ground truth" for clinical outcomes is implied through clinical experience and historical data with predicate devices and similar materials, stating "patients had no complications with either system during the healing process." This is not a formal "ground truth" derivation as in a clinical trial.
8. The Sample Size for the Training Set:
Not applicable. There is no AI or algorithm involved that would require a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. No training set is used.
§ 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.