(142 days)
The DAC plate system with proprietary compression technology is indicated for use in skeletally mature patients for stabilization and fixation of fractures, revisions, arthrodeses and reconstruction of small bones of the foot such as:
- Midfoot and hindfoot arthrodeses or osteotomies
- Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocuboid, Lapidus)
- Intercuneiform arthrodeses
- Naviculocuneiform arthrodeses
- Talonavicular arthrodeses
- Calcaneocuboid arthrodeses
- Linsfranc arthrodeses
- Mono-or-bi-cortical osteotomies in the forefoot, midfoot and hindfoot
- First metatarsophalangeal arthrodeses
The DAC Dynamic Active Compression Plate (DAC plate) System is a zero-step locking plate that provides stability and active compression. The system includes screws and plates of varying sizes and configurations to accommodate various patient anatomies. The plates contain nitinol wires housed under tension in sliders kept in place with release pins. When the built-in release pins are removed, the nitinol wires return to their straight condition, creating compression. The implant components of the system are manufactured from titanium alloy (ASTM F136) and nitinol (ASTM F2063). The components of this system should not be used with components of any other system. The implants are provided non-sterile and are supplied with instrumentation to facilitate use of the device components.
This document describes the DAC Dynamic Active Compression Plate (DAC plate) System, for which Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. sought FDA clearance (K200513).
Based on the provided information, the device is a bone fixation system, and the clearance was based on non-clinical evidence demonstrating substantial equivalence to predicate devices, rather than a clinical study involving human patients. Therefore, information related to clinical study design, patient samples, expert reads, MRMC studies, or standalone algorithm performance is not applicable in this context.
Here's a breakdown of the requested information based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-clinical evaluation based on direct comparisons to standards and predicates, the "acceptance criteria" are the established standards, and "reported device performance" refers to the device's ability to meet those standards or demonstrate equivalent mechanical properties to the predicate.
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| ASTM F382-17: Standard Specification and Test Method for Metallic Bone Plates (static and dynamic 4-point bend) | Mechanical testing showed equivalent performance to predicate devices. The minor design difference (nitinol wires for compression) was evaluated, demonstrating equivalent performance with no new failure modes. |
| ASTM F543-17: Standard Specification and Test Methods for Metallic Medical Bone Screws (axial pull-out, | Mechanical testing showed equivalent performance to predicate devices. The minor design difference (nitinol wires for compression) was evaluated, demonstrating equivalent performance with no new failure modes. |
| insertion-removal torque, and torsional strength tests) | |
| ASTM F564-17: Standard Specification and Test Methods for Metallic Bone Staples (static and dynamic tension) | Mechanical testing showed equivalent performance to predicate devices. The minor design difference (nitinol wires for compression) was evaluated, demonstrating equivalent performance with no new failure modes. |
| Engineering analysis of compression forces | Performed to validate the device's compression mechanism. (Specific results not detailed, but implied successful demonstration of function without introducing new safety/effectiveness issues). |
| MR Safety Evaluation (MR Conditional Claim): | |
| ASTM F2052-15: Measurement of Magnetically Induced Displacement Force | Testing confirmed the device meets criteria for an MR Conditional label. (Specific thresholds not provided, but implies compliance with standard). |
| ASTM F2213-17: Measurement of Magnetically Induced Torque | Testing confirmed the device meets criteria for an MR Conditional label. (Specific thresholds not provided, but implies compliance with standard). |
| ASTM F2182-11a: Measurement of Radio Frequency Induced Heating | Testing confirmed the device meets criteria for an MR Conditional label. (Specific thresholds not provided, but implies compliance with standard). |
| ASTM F2119-07 (Reapproved 2013): Evaluation of MR Image Artifacts | Testing confirmed the device meets criteria for an MR Conditional label. (Specific thresholds not provided, but implies compliance with standard). |
| Biological Safety Evaluation: | |
| ISO 10993-1 Biological safety evaluation | Biological safety evaluation concluded the materials (titanium alloy ASTM F136, nitinol ASTM F2063) are well-established for orthopedic implants, ensuring biological compatibility. |
| ASTM F2129 Cyclic Potentiodynamic Polarization study for corrosion susceptibility | Corrosion susceptibility study demonstrated acceptable performance for the implant materials. |
| Cleaning and Sterilization Validations | Validations performed to ensure the device can be properly cleaned and steam sterilized by the user as intended (as it is supplied non-sterile). |
2. Sample size used for the test set and the data provenance
Not Applicable. No human-based "test set" or clinical data was used. The evaluation relied on non-clinical, in-vitro mechanical testing, engineering analysis, and MR safety testing performed on device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. No human experts were used to establish "ground truth" for a test set in the context of this non-clinical submission. Ground truth was established by adherence to recognized ASTM and ISO standards for mechanical, biological, and MR safety performance.
4. Adjudication method for the test set
Not Applicable. As no human-based test set was used, no adjudication method was required.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This submission does not involve an AI device or a MRMC comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a hardware medical device (bone plate system), not a software or AI algorithm.
7. The type of ground truth used
The "ground truth" for this device's substantial equivalence determination was:
- Adherence to recognized international standards: ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for mechanical properties, biological safety, and MR safety.
- Comparison to predicate devices: Demonstration that the subject device's technological characteristics and performance were equivalent to legally marketed predicate devices, with no new safety or effectiveness issues.
8. The sample size for the training set
Not Applicable. There was no "training set" in the context of an algorithm or AI. This was a physical device subjected to standard engineering and materials testing.
9. How the ground truth for the training set was established
Not Applicable. Please refer to 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.