(55 days)
The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 is indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).
The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 consists of:
LOQTEQ® Distal Anterolateral Tibia Plate 3.5 (left and right)
to be used with LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 3.5, self-tapping LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapp. Cortical Screw 3.5, small head, self-tapping
Implants are made of Ti6A14V (ASTM F136 or ISO 5832-3)
The provided text describes the "aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5" and its premarket notification (K133675). The study conducted focuses on the mechanical performance of the device through non-clinical testing.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance for clinical use | Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. |
| Safety and effectiveness | The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses. "Non-clinical tests have been performed and show the effectiveness and safety of the device." |
| Meet pre-defined acceptance criteria | The device's performance meets the requirements of its pre-defined acceptance criteria. |
| Substantial equivalence to predicate device (Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates, K092812) | "Substantial Equivalence of the new device and the predicate device is based on similar intended use, design, functionality, components and materials in use." |
| "Documentation including mechanical testing to show the substantial equivalence and safety and effectiveness has been provided..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text only mentions "Implant Fatigue tests with progressive loadings, representing worst case scenario with respect to clinical use." This suggests a series of tests, but the specific number of implants or test cycles is not given.
- Data Provenance: The tests are "Non-clinical tests," implying laboratory-based testing rather than patient data. The manufacturer, aap Implantate AG, is based in Berlin, Germany. Therefore, the tests were likely conducted in Germany or by a contract lab on behalf of the German manufacturer. The data is prospective in the sense that the tests were designed and conducted specifically for this submission, not retrospectively collected from existing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This study is a non-clinical, mechanical performance study, not one involving expert assessment of medical images or patient outcomes. The "ground truth" here is objective mechanical measurements against engineering standards or comparisons to the predicate device's known performance.
4. Adjudication Method for the Test Set
- Not applicable. As a non-clinical mechanical test, there is no expert adjudication process. The assessment of test results would be based on comparison to pre-defined technical specifications and measurement outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This was a non-clinical mechanical performance study, not a study involving human readers or cases. Therefore, no MRMC study was conducted, and no effect size for human reader improvement with AI assistance is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical bone plate, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for this study is based on mechanical test results (specifically implant fatigue tests with progressive loadings) compared against pre-defined acceptance criteria and against the known performance of the predicate device (Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates). This is objective, quantitative data from physical testing.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set exists for this device.
§ 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.