(234 days)
Acutrak Fusion, Standard and Mini, AcuTwist and Acutrak 2 Micro, Mini, Standard, 4.7, and 5.5 screws are Intended as a fixation device for small bones, bone fragments, and osteotomies. It is not intended for interference or soft tissue fixation.
Acutrak Plus and (4/5), (6/7) and Acutrak 2 (7.5) and Dual-Trak screws are intended for fusions, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, and calcaneous.
The Acutrak Screw Systems are intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fracture fixation. The device is to be implanted by the surgeon in a sterile operating room setting.
The Acumed Acutrak and Acutrak 2 Screws are designed to provide fixation of various fractures and osteotomies while they heal. These systems offer screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the screws are manufactured from Titanium alloy per ASTM F136, are single use and are provided both sterile and non-sterile.
Instruments supplied to aid in the screw insertion and are supplied sterile and/or non-sterile and most are reusable. Sterilization trays provided to house non-sterile implants and instruments.
This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as effect size of AI assistance, standalone algorithm performance, training set details, and expert ground truth establishment for AI) are not applicable.
The acceptance criteria and studies described in this document relate to the safety and performance of the Acumed Acutrak System and Acumed Acutrak 2 System, which are metallic bone fixation fasteners.
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily by proving that the subject devices meet established mechanical and MR safety standards. The "acceptance criteria" are the thresholds or performance requirements defined by these standards, and "reported device performance" indicates that the devices met these criteria.
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| MR Conditional Safety | Magnetically induced displacement force | Per ASTM F2052 (within safe limits) | Devices are not adversely affected; meet criteria. |
| Magnetically induced torque | Per ASTM F2213 (within safe limits) | Devices are not adversely affected; meet criteria. | |
| Radiofrequency (RF) induced heating | Per ASTM F2182 (within safe limits) | Devices are not adversely affected; meet criteria. | |
| MR image artifact | Per ASTM F2119 (acceptable artifact levels for diagnostic utility) | Acceptable image artifacts; meet criteria. | |
| Marking for MR Safety | Per ASTM F2503 | Device is appropriately marked for MR environment. | |
| Mechanical Performance | Torsional Yield Strength | Per ASTM F543-17 | Passed acceptance criteria; demonstrated substantially equivalent mechanical performance to predicate screws. |
| Insertion Torque | Per ASTM F543-17 | Passed acceptance criteria; demonstrated substantially equivalent mechanical performance to predicate screws. | |
| Axial Pullout Force | Per ASTM F543-17 | Passed acceptance criteria; demonstrated substantially equivalent mechanical performance to predicate screws. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes used for each physical and mechanical test (e.g., number of screws tested for torsional yield strength). However, the testing was conducted on samples of the Acutrak and Acutrak 2 screws, comparing them to relevant predicate screws.
- Test Set: Acutrak and Acutrak 2 Screw Systems.
- Data Provenance: The tests are non-clinical, laboratory-based tests conducted in accordance with recognized industry standards (ASTM standards). The origin of individual samples is not specified beyond being manufacturing products of Acumed LLC. The data is prospective, generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a submission for a physical medical device, and its performance is evaluated against engineering and safety standards (e.g., MR safety, mechanical strength), not against expert interpretations of a test set in the way an AI/ML device would be evaluated (e.g., image interpretation).
4. Adjudication Method for the Test Set
Not applicable. The tests are objective, laboratory-based measurements against defined physical/engineering standards, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. This is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
For this device, "ground truth" is established by:
- Established Engineering Standards: Compliance with ASTM standards (e.g., F2052, F2213, F2182, F2119, F2503 for MR safety; F543-17 for mechanical performance). These standards define acceptable performance metrics based on engineering principles and industry consensus.
- Predicate Device Performance: The mechanical performance of the subject devices was compared to existing legally marketed predicate devices to demonstrate substantial equivalence, implying that the performance of the predicate devices serves as a benchmark for "ground truth" in terms of acceptable and safe mechanical characteristics.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device; there is no "training set."
§ 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.