(107 days)
Airlock® Centrolock® osteosynthesis implant systems are single-use devices intended for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, ankle, fingers and toes.
Examples include:
- Mono or Bi-Cortical osteotomies in the foot or hand
- Distal or Proximal metatarsal or metacarpal osteotomies
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Calcaneus/cuboid arthrodesis
- Talar/navicular arthrodesis
The system may be used in adult patients.
Airlock® Centrolock® osteosynthesis implant systems are single-use bone fixation devices intended to be permanently implanted. implant systems are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 2mm cortical screws or 2,5mm locking screws. The drill holes are aligned to make sure there is no risk of conflict between the screws. The implant vary essentially through different curvatures and shapes.
Here's a breakdown of the acceptance criteria and study information for the Airlock® Centrolock® osteosynthesis implant system based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K192356) is a 510(k) summary for a medical device. For such devices, "acceptance criteria" are typically met through performance testing that demonstrates substantial equivalence to a predicate device, rather than specific numerical performance metrics for an AI algorithm. The document emphasizes mechanical and material characteristics.
| Acceptance Criterion (Established through substantially equivalent predicate) | Reported Device Performance (as demonstrated by testing and comparison) |
|---|---|
| Material Composition | Wrought Titanium 6-Aluminum 4-Vanadium Alloy (ISO 5832-3 Fourth edition 2016-10-15) |
| Mechanical Characteristics (Implants) | Similar static and dynamic bending resistance (tested per ASTM-F382-17) to predicate Novastep Airlock® osteosynthesis Plate System. |
| Mechanical Characteristics (Screws) | Similar pull-out strength and torsional resistance (tested per ASTMF543-17 sections A1 A3) to predicate Novastep Airlock® osteosynthesis Plate System. |
| Biocompatibility | Evaluation conducted in accordance with Blue Book Memorandum #G95-1 and ISO 10993-1. |
| Intended Use / Indications for Use | Same as predicate devices: Fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, ankle, fingers, and toes in adult patients. |
| Design | Similar technological characteristics in terms of design to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This is not an AI/software device submission. The "test set" in this context refers to the samples used for mechanical and biocompatibility testing.
- Sample Size: Not explicitly stated in terms of specific numbers of implants or screws tested for mechanical properties. Biocompatibility would involve various test samples, also not specified numerically.
- Data Provenance: Not applicable in the context of clinical data. The tests are material and mechanical characterization tests conducted in a laboratory setting. No country of origin for clinical data is relevant here as no clinical studies were performed. The tests are prospective in the sense that they were designed and executed for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is not an AI device where expert ground truth is typically established. The "ground truth" for mechanical testing is based on established engineering standards (ASTM, ISO).
4. Adjudication Method for the Test Set
Not applicable. This is not an AI device with human expert interpretation or adjudication.
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 is a medical implant, not an AI-powered diagnostic or assistive device. No MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Engineering Standards: Established international standards for material composition (ISO 5832-3), mechanical testing (ASTM F382-17, ASTM F543-17), and biocompatibility (ISO 10993-1).
- Substantial Equivalence: Comparison to legally marketed predicate devices in terms of intended use, indications for use, material, design, and function. The "truth" is that the new device is as safe and effective as the predicate.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.