(91 days)
Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.
Airlock® osteosynthesis plate systems are single-use bone fixation devices intended to be permanently implanted. Plates are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 3mm or 3,5mm locking and non-locking screws. The drill hole are aligned to make sure there is no risk of conflict between the screws. The plates vary essentially through different curvatures, lengths, number of holes and shape.
This document is a 510(k) Premarket Notification for the Airlock® osteosynthesis plate system. It describes the device, its intended use, and demonstrates its substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request for acceptance criteria and study information:
Key Finding: This document is concerned with demonstrating substantial equivalence of a new medical device (Airlock® osteosynthesis plate system) to an existing legally marketed device (Anchorage® Bone Plate System) based on similar technological characteristics and performance data. It explicitly states that clinical studies and animal studies were not required for this submission. Therefore, it does not describe a clinical study of the device to meet specific performance acceptance criteria in the way you might expect for an AI algorithm or diagnostic tool.
Instead, the "acceptance criteria" and "study" are focused on demonstrating that the new device is as safe and effective as the predicate device through bench testing and material characterization to meet recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a mechanical device submission, the "acceptance criteria" relate to material composition, mechanical properties, and biocompatibility, as established by recognized standards. The "performance" refers to the device meeting these standards.
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|
| Material Composition: | |
| ISO 5832-3 Implants for surgery - Metallic material - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy | The Airlock® osteosynthesis plate systems are made of Titanium (Alloy Ti-6Al-4V ELI) and have similar technological characteristics in terms of material to the predicate device, which also complies with ISO 5832-3. |
| Mechanical Characteristics (Plates): | |
| ASTM F382-99 Standard Specification and Test Methods for Metallic Bone plates | The Airlock® osteosynthesis plate systems have similar mechanical characteristics to the predicate device, which complies with ASTM F382-99. |
| Mechanical Characteristics (Screws): | |
| ASTM F543-13 Standard Specification and Test Methods for Metallic Bone screws Part A1, A2 & A3 | The Airlock® osteosynthesis plate systems screws have similar mechanical characteristics to the predicate device, which complies with ASTM F543-13. |
| Biocompatibility: | |
| Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" | Biocompatibility evaluation was conducted in accordance with these recognized standards. |
Regarding items 2 through 9:
Due to the nature of this 510(k) submission for a mechanical implant and the explicit statement that "Clinical studies was not required for this submission" and "Animal Study was not required for this submission," the following points related to clinical or AI algorithm performance studies are not applicable (N/A) in this context:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A (No clinical test set described)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): N/A (No clinical ground truth described)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No clinical test set described)
- 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: N/A (This is a mechanical implant, not an AI or diagnostic tool)
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is a mechanical implant, not an AI algorithm)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (The "ground truth" here is compliance with engineering and material standards through laboratory testing, not medical diagnostic ground truth.)
- The sample size for the training set: N/A (No AI training set described)
- How the ground truth for the training set was established: N/A (No AI training set described)
In summary: This document is an FDA 510(k) premarket notification for a bone plate system. It demonstrates substantial equivalence to a predicate device through engineering tests (material, mechanical properties, biocompatibility) and compliance with established industry standards (ISO, ASTM), rather than through clinical trials or performance studies on a test set of patient data, which are typically required for diagnostic software or AI algorithms.
§ 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.