(27 days)
The Fixion Intramedullary Nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, tibia and femur. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the distal end of the medullary canal.
The Fixion Intramedullary Nailing System consist of the following main components:
- The Nail Implant is an expandable, sealed, stainless steel, cylindrical, ribbed rod without interlocking holes. The proximal end has a one-way valve for expansion. The nail is cap protected.
- The Insertion Handle is a device designed to be connected to the nail proximal end, and used for nail insertion. Its distal end has locking "teeth" to prevent relative rotation between the nail and the handle.
- The Inflation Device is a pump, which rotation of its handle delivers saline into the nail. The pump pressure gauge indicates the expansion pressure. This action causes the nail expansion and abutment to the bone medullary cavity.
In addition the system consists of additional accessories including a removal adapter, a slide hammer and a slide hammer adapter and a screwdriver.
Here's the analysis of the provided text regarding the acceptance criteria and study for the Fixion Intramedullary Nailing System:
This document is a 510(k) premarket notification for a medical device. FDA 510(k) clearances typically rely on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting extensive clinical efficacy studies with predefined acceptance criteria and performance metrics against a robust ground truth, as would be common for AI/ML-based software. Therefore, many of the requested categories are not applicable to this type of submission.
The "acceptance criteria" here are primarily about meeting existing material and handling standards and demonstrating similarity to already-cleared devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Standards: | |
| 1. Fixion IM Nail made from 316L stainless steel meeting ASTM F138. | The Fixion IM Nail is manufactured from 316L stainless steel, which meets the requirements of ASTM F138. |
| 2. Accessories incorporate surgical grade stainless steel (ASTM 899, ASTM F1586) and Celeron (ISO 16061). | The Fixion IM Nailing System accessories incorporate surgical grade stainless steel (ASTM 899, ASTM F1586) and Celeron (ISO 16061). |
| Handling Standards: | |
| 3. Fixion IM Nail designed to meet ASTM F565 for care and handling of orthopedic implants and instruments. | The Fixion IM Nail is designed to meet the requirements of ASTM F565. |
| Substantial Equivalence (Functional/Design Similarity to Predicates): | |
| 1. Same intended use as predicate devices. | Stated as having the "same intended use" as predicate devices (e.g., K990717, K003212, K003215, K010901, K010988, K012967). |
| 2. Same operating principles as predicate devices. | Stated as having the "same operating principles." |
| 3. Nail and Instrumentation Set incorporate same design as predicate devices. | Stated as incorporating the "same design." |
| 4. Nail and Instrumentation Set incorporate same materials as predicate devices. | Stated as incorporating the "same materials." |
| 5. Nail and Instrumentation Set have same packaging and sterilization (materials and processes) as predicate devices. | Stated as having the "same packaging and sterilization, using the same materials and processes." |
| 6. Components of Insertion Kit (now separate) are identical or similar in design, materials, packaging, and sterilization to other Fixion IM System components or Fixion IL and PF Nailing Systems components. | Stated as being "either identical or similar in design, materials, packaging, and sterilization" to predicate system components. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable to this 510(k) submission. There is no "test set" in the context of an algorithm or diagnostic performance evaluation described. The submission focuses on demonstrating compliance with material standards and substantial equivalence to existing devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. No ground truth for a test set (in the context of diagnostic accuracy or AI performance) was established or is relevant to this type of device submission.
4. Adjudication Method for the Test Set
This information is not applicable. No test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This is a physical medical device (intramedullary nail), not a diagnostic algorithm or AI-assisted system where human reader performance would be a relevant metric.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone performance evaluation (as would be done for an algorithm) was not done. This device is a surgical implant, not a standalone algorithm.
7. The Type of Ground Truth Used
The primary "ground truth" for this submission would be:
- Engineering Standards: Conformance to established ASTM and ISO standards for materials (e.g., 316L stainless steel meeting F138).
- Predicate Device Characteristics: The characteristics (intended use, operating principles, design, materials, packaging, sterilization) of the previously cleared Fixion IM Nailing System (K990717, K003212, K003215, K010901) and Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967). The new device's characteristics are compared against these known, legally marketed devices.
There is no "ground truth" related to disease pathology or patient outcomes in this particular 510(k) submission beyond the general safety and effectiveness implied by equivalence to predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of an algorithm or AI system for a physical medical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As there is no training set, there is no method for establishing its ground truth.
§ 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.