(278 days)
ALPHALOK™ Plating System bone plates and screws are indicated for use in bone fractures and osteotomies of small bones or small bone fragments of the hand and wrist.
The ALPHALOK™ Plating System, consisting of the ALPHALOK™ Met Fx Mini Plates, is a multi-indication reconstruction solution providing polyaxial locking technology and low profile design.
All implant components are manufactured from titanium (Ti-6Al-4V, ASTM F136).
Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel.
This K212348 FDA 510(k) summary provides information for the ALPHALOK™ Plating System, a bone fixation device. Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document details performance data provided in support of substantial equivalence. The acceptance criteria are implicitly met by demonstrating performance equivalent to the predicate devices through standardized testing. The "reported device performance" is that the device passed these tests, indicating it performs comparably to the predicate.
| Acceptance Criteria (Implied by ASTM Standards) | Reported Device Performance (as stated in document) |
|---|---|
| Material Properties: | |
| - Biocompatibility (Titanium (Ti-6Al-4V, ASTM F136)) | - Material used: Titanium (Ti-6Al-4V, ASTM F136) |
| Mechanical Properties (Screws): | |
| - Torsional properties (per ASTM F543-17) | - Torsional properties testing per ASTM F543-17 was performed. (Implicitly passed, demonstrating equivalence) |
| - Axial pullout (per ASTM F543-17) | - Axial pullout testing per ASTM F543-17 was performed. (Implicitly passed, demonstrating equivalence) |
| - Driving torque (per ASTM F543-17) | - Driving torque testing per ASTM F543-17 was performed. (Implicitly passed, demonstrating equivalence) |
| Mechanical Properties (Plates): | |
| - Static four-point bend (per ASTM F382-17) | - Static four-point bend testing per ASTM F382-17 was performed. (Implicitly passed, demonstrating equivalence) |
| Cleaning and Sterilization: | |
| - Cleaning validation (per ANSI/AAMI/ISO 17665-1) | - Cleaning validations performed (leveraged from predicate device). (Implicitly passed, demonstrating equivalence) |
| - Sterilization validation (per ANSI/AAMI/ISO 17665-1) | - Sterilization validations performed (leveraged from predicate device). (Implicitly passed, demonstrating equivalence) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each mechanical test. The tests are described as being performed "per ASTM F543-17" and "per ASTM F382-17," which implies that the sample sizes would adhere to the recommendations or requirements within those specific ASTM standards.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be prospective in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate the performance of the ALPHALOK™ Plating System.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This section is not applicable as the studies are mechanical performance tests of a physical device (bone plates and screws), not a diagnostic or AI-driven system requiring expert ground truth for interpretation. The "ground truth" here is the physical performance data measured according to established engineering standards.
4. Adjudication Method for the Test Set:
This section is not applicable for the same reason as point 3. Mechanical performance tests typically do not involve human adjudication; the results are quantifiable measurements against established engineering benchmarks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or imaging devices that rely on human interpretation, often assisted by AI. The ALPHALOK™ Plating System is a surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone algorithm performance study was not done. This device is a physical surgical implant, not an algorithm or software.
7. The Type of Ground Truth Used:
The "ground truth" for the performance studies of this device is based on standardized engineering specifications and measurements defined by the ASTM (American Society for Testing and Materials) and ANSI/AAMI/ISO standards. This includes:
- Mechanical properties: Measured values for torsional strength, axial pullout force, driving torque, and static four-point bend strength.
- Material properties: Chemical composition and physical properties of the titanium alloy, specified by ASTM F136.
- Cleaning and sterilization efficacy: Measured outcomes of cleaning and sterilization processes against predefined acceptance criteria for microbial reduction and residue levels.
8. The Sample Size for the Training Set:
This question is not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.