(527 days)
The DHS/DCS Plate System is intended for use in treating fractures of femoral head (Dynamic Hip Plates) and condylar part of the femur (Dynamic Condylar Plates).
Specific indications, which are dependent on the angle of the plate, include:
130°-135°: fractures of the trochanter region, simple and multifragmentary pertrochanteric, intertrochanteric.
95°: distal and intercondylar fractures of the femur.
The Auxein's DHS/DCS Plate System offers a variety of treatment options depending on the fracture site and the patient. The DHS/DCS Plate System is composed of plates, compression screw and bone screws. The devices are made from either Stainless Steel as per ASTM F138-19 or Titanium alloy as per ASTM F136-13(2021)e1.
These implants will be available either in sterile or non-sterile state.
Note- Non sterile products have to be sterilized before use.
The system is indicated for use in skeletally mature patients only. All implants are for single use only.
The provided document is a 510(k) summary for Auxein Medical Private Limited's DHS/DCS Plate System. This summary details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.
It's crucial to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct performance against specific predetermined acceptance criteria through a clinical study for a new device on the market. Performance is typically demonstrated through non-clinical bench testing, material characterization, and comparison to the predicate.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria is interpreted within the context of a 510(k) submission, specifically focusing on the non-clinical testing performed to establish substantial equivalence. A 510(k) does not typically include a clinical study with human patients demonstrating effectiveness in the same way a PMA (Pre-Market Approval) would, nor does it typically involve human expert readers evaluating AI performance in the way described in the prompt.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines applicable product standards considered for non-clinical standards as the de facto acceptance criteria for mechanical performance and biocompatibility. The "reported device performance" is the conclusion that the device complies with these standards and that test results were similar to those of predicates.
| Category | Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|---|
| Material | ASTM F138-19 (Stainless Steel) or ASTM F136-13(2021)e1 (Titanium alloy) | Device components are made from either Stainless Steel as per ASTM F138-19 or Titanium alloy as per ASTM F136-13(2021)e1. |
| Biocompatibility | ISO 10993 series | Device evaluated for biocompatibility according to ISO 10993. (No specific test results are detailed, but the implied acceptance is compliance with the standard). |
| Mechanical (Bone Plates) | ASTM F384-17: Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices (Static four-point bend test, Fatigue four-point bend test) | Auxein's DHS/DCS Plate System was mechanically tested for static and fatigue four-point bend. Test results were similar to those of predicates. "The performance of the subject device was assessed through tests. According to the results, the Auxein's DHS/DCS Plate System is considered substantially equivalent to the predicate device." |
| Sterilization, Shelf-life, Packaging | ISO 11137-1, -2, -3; ISO 17665-1, -2, -3; ISO 11140-1; ISO 11737-1, -2; ISO 11607-1, -2; ASTM F1980-21; ASTM F88/F88M-21; ASTM F1929-15 | The document lists these standards as applicable. The implied performance is compliance with these standards for sterile products, ensuring sterility, packaging integrity, and shelf-life. (No specific test results are detailed). |
| Bacterial Endotoxin | USP Bacterial Endotoxin Test; USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests | The document lists these standards as applicable. The implied performance is compliance with these standards, ensuring low endotoxin levels. (No specific test results are detailed). |
| Overall Equivalence | No significant differences from predicate devices that would adversely affect use; as safe and effective, performs same indications for use. | "There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, and operational principles as internal fixation components." |
Regarding the "Study that proves the device meets the acceptance criteria":
The "study" in this context refers to non-clinical bench testing and comparison to predicates, not a clinical trial or an AI performance study as implied by some of the prompt's more specific questions.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated in terms of a "test set" as one might refer to a data set for an AI algorithm. For mechanical testing, this refers to the number of physical samples tested. This information is typically detailed in the full test reports, which are not included in this summary.
- Data Provenance: The tests are bench tests performed on manufactured devices. The manufacturing country is India (Auxein Medical Private Limited). The tests themselves are laboratory-based, not based on patient data (retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This question is not applicable to this type of device submission (510(k) for an orthopedic implant) or the non-clinical studies performed. Ground truth for mechanical properties is established by adherence to defined ASTM and ISO standards, not by expert consensus from radiologists or other medical professionals.
4. Adjudication Method for the Test Set:
This question is not applicable. Adjudication methods are relevant in studies involving human interpretation or AI output, where discrepancies need to be resolved. For mechanical and biocompatibility testing, results are quantitative and compared against established limits defined by the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:
This question is not applicable. This device is a physical orthopedic implant (DHS/DCS Plate System), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance are irrelevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable. This refers to AI algorithm performance without human interaction. The device is a physical implant.
7. The Type of Ground Truth Used:
For the non-clinical testing performed:
- Mechanical Performance: Ground truth is established by the specified limits and methodologies defined within the applicable ASTM and ISO standards (e.g., ASTM F384-17 for bone plates). The "truth" is whether the device's measured mechanical properties fall within the acceptable range or perform similarly to the predicate devices as per the standard's requirements.
- Biocompatibility: Ground truth is established by compliance with ISO 10993 standards, indicating the material's safety for biological contact.
- Material Composition: Ground truth is established by adherence to specified material standards (e.g., ASTM F138-19, ASTM F136-13(2021)e1).
8. The Sample Size for the Training Set:
This question is not applicable. There is no "training set" in the context of a 510(k) submission for a physical orthopedic implant. This question is relevant for machine learning model development.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as 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.