(122 days)
The ORTHOLOC® 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodessis, in conjuction with osteotomies of the distal tibia, talus, and calcaneus.
ORTHOLOC® Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
The subject Universal Anterior Plate is designed to facilitate arthrodesis of the ankle and is composed of titanium alloy. The plate features poly-axial locking screw holes and one compression slot. It accepts screws of multiple diameters and lengths.
The provided text is a U.S. FDA 510(k) premarket notification document for a medical device. This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device.
The document does not describe the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device or a diagnostic device. It is for a mechanical orthopedic implant (an ankle fusion plating system).
The "study" referenced in this document is a "non-clinical" engineering analysis (Finite Element Analysis and cross-sectional analysis) rather than a clinical trial or performance study against specific acceptance criteria for diagnostic output.
Therefore, most of the information requested in your prompt (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, ground truth, MRMC study, standalone performance) is not applicable or not present in this document because it pertains to a different type of medical device evaluation.
However, I can extract the relevant information from the document as best as possible, focusing on how substantial equivalence was demonstrated:
1. Table of Acceptance Criteria and Reported Device Performance
For this orthopedic implant, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to a predicate device in terms of mechanical performance. The study aimed to show that the new device's bending strength was comparable to the predicate and did not introduce a new worst-case scenario.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bending strength comparable to predicate device | Demonstrated substantial equivalence in bending strength to the predicate. |
| No new worst-case scenario introduced compared to the predicate. | Did not introduce a new worst case into the system. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The "test" here refers to non-clinical engineering analysis (Finite Element Analysis and cross-sectional analysis), not a traditional clinical sample size or dataset for diagnostic performance.
- Data Provenance: Not applicable. As an engineering analysis, it relies on material properties, design specifications, and computational models, not patient data from a specific country or retrospective/prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of diagnostic performance, is not relevant for this mechanical engineering analysis.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not a diagnostic tool evaluated by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used
Not applicable. For a mechanical device evaluated through engineering analysis, "ground truth" as typically understood in diagnostic studies (e.g., pathology, outcomes data, expert consensus) is not applied. The "truth" is established by the laws of physics and engineering principles applied in the analysis.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a mechanical device evaluated through engineering analysis, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" or "ground truth" in the context of an engineering analysis for a mechanical device.
Summary of the Study for Substantial Equivalence:
The study performed was a non-clinical evaluation consisting of:
- Finite Element Analysis (FEA)
- Cross-sectional analysis
These analyses were conducted to compare the bending strength of the new ORTHOLOC® 3Di Universal Anterior Plate to its predicate device (K121425: ORTHOLOC® 3Di Ankle Fusion Plating System). The conclusion was that the new plate demonstrated substantial equivalence in bending strength and did not introduce a new worst-case scenario into the system. This type of evaluation is standard for demonstrating the safety and effectiveness of mechanical orthopedic implants for 510(k) clearance, rather than the clinical performance studies typically required for AI/ML or diagnostic devices.
§ 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.