(378 days)
The Auxein's Varixis Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused.
Specifically,
Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, malunions and non-unions of the distal humerus.
Olecranon and Proximal ulna plates are indicated for fractures, malunions and non-unions of the olecranon and proximal ulna.
The Auxein Varixis Elbow System contains plates intended to treat fractures of the distal humerus and proximal ulna. A variety of plate configurations are included in the system to allow for fixation of multiple fracture patterns. Specifically, the system includes several plate configurations for fixation of the distal humerus which are intended to be used in a two-plate construct where plates are positioned medially and laterally. Additionally, the system includes plates for fixation of the olecranon and proximal ulna. Proximal ulna Plates enables the surgeon to address the specific biomechanical requirements of each fracture pattern while minimizing irritations of the adjacent soft tissue.
These implants are sold in both non-sterile and sterile conditions.
Note- Non sterile products have to be sterilized before use. All implants are for single use only.
This document is a 510(k) Premarket Notification for the Varixis Elbow System, a set of metallic bone fixation appliances. It focuses on demonstrating the substantial equivalence of the Varixis Elbow System to a legally marketed predicate device (Synthes Variable Angle LCP Elbow System, K120070).
The document does not describe a study involving an AI/ML device where acceptance criteria are set for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) and then proven through clinical studies with human readers or standalone algorithm performance. Instead, it describes a medical device, the Varixis Elbow System, which is a physical implant used for fracture fixation.
Therefore, the requested information regarding acceptance criteria for device performance (like sensitivity, specificity), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, ground truth types, and training set details are not applicable to this submission as it pertains to a mechanical orthopedic implant, not an AI/ML diagnostic or assistive device.
The "performance" referred to in this document relates to mechanical properties (e.g., static and fatigue strength of plates, driving torque, torsion, and axial pull-out of screws), material biocompatibility, and sterilization effectiveness.
Here's an analysis of the document in the context of your request, highlighting what is present and what is absent:
Acceptance Criteria and Proof of Device Meeting Criteria (for a mechanical implant)
The acceptance criteria for this device are demonstrated through a comparison to a predicate device and adherence to recognized industry standards for mechanical testing and material properties. The 'proof' is the declaration of substantial equivalence based on these comparisons and test results.
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents a comparison table (Section A.6) outlining the technological characteristics of the Auxein Varixis Elbow System and the predicate device. This indirectly serves as a basis for acceptance criteria by demonstrating similarity or conformity to established standards, which are the "acceptance criteria" for this type of device.
| S.N. | Characteristics | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Auxein Device) | Remarks (Meeting Criteria) |
|---|---|---|---|---|
| 1. | Product Code | HWC (Primary), HRS (Identical to predicate) | HWC (Primary), HRS | Identical as predicate device |
| 2. | Regulation Number | 21 CFR 888.3030 (Primary), 21 CFR 888.3040 (Identical to predicate) | 21 CFR 888.3030 (Primary), 21 CFR 888.3040 | Identical as predicate device |
| 3. | Regulatory Class | Class II (Identical to predicate) | Class II | Identical as predicate device |
| 4. | Indications for Use | Intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which growth plates have fused. Specific indications for distal humerus plates (intra-articular, comminuted supracondylar, osteotomies, malunions, non-unions) and olecranon/proximal ulna plates (fractures, osteotomies, malunions, non-unions). (Identical to predicate) | The Auxein's Varixis Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically; Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna. | Identical as predicate device |
| 5. | Material | Titanium Alloy and Stainless Steel (Identical to predicate) | Titanium Alloy and Stainless Steel. (Specific standards met: ASTM F136/ISO 5832-3, ASTM F899-12, ASTM F138/ISO 5832-1) | Identical as predicate device, specific standards met |
| 6. | Performance Standards | Conformance to ASTM F382 (Metallic Bone Plates) and ASTM F543 (Metallic Medical Bone Screws). (Identical to predicate) | The performance testing was done on the subject device as per the standard ASTM F382 and F543. (Specifically, Plates: 4-Point Static Test, 4-Point Fatigue Test. Screws: Driving Torque Test, Torsion Test, Axial Pull-out Test) | Identical as predicate device, results "Conforms" |
| 7. | Sterilization | Gamma Sterilization Method and Non-Sterile (Identical to predicate); Conform to ISO 11137 series, ISO 17665 series, ISO 11140-1, ISO 11737 series, ISO 11607 series, ASTM F1980, ASTM F88/F88M, ASTM F1929. | Gamma Sterilization Method and Non-Sterile used in subject device. (Compliance stated for ISO & ASTM sterilization/packaging standards) | Identical as predicate device |
| 8. | Shelf-life | 5 Years (For Sterilized Product) (Identical to predicate) | 5 Years (For Sterilized Product) | Identical as predicate device |
| 9. | Single Use/Reuse | Single Use (Identical to predicate) | Single Use | Identical as predicate device |
| 10. | Operating Principle | The plate is fixed to the bone by application of screws on both sides of the fracture. (Identical to predicate) | The plate is fixed to the bone by application of screws on both sides of the fracture. | Identical as predicate device |
| 11. | Dimensional Verification | The same dimensions are found in both new Devices as well as Predicate devices. (Implied acceptance based on similarity) | The same dimensions are found in both new Devices as well as Predicate devices. | Identical as predicate device |
| N/A | Biocompatibility | Raw materials evaluated according to ISO 10993-3. | Raw materials have been evaluated for biocompatibility according to ISO 10993-3. | Compliant |
| N/A | Bacterial Endotoxin | USP Bacterial Endotoxin Test; USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests. | Compliance to USP and USP for Bacterial Endotoxin. | Compliant |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify exact sample sizes for the mechanical tests (e.g., how many plates or screws were tested for ASTM F382 or F543). It simply states that "Bench tests were conducted" and "The results of this testing indicate that the Varixis Elbow System is equivalent to the predicate device."
- Data Provenance: The tests are bench tests performed on the physical device. The company, Auxein Medical Private Limited, is based in India, so it's presumed the testing was conducted there or by affiliated, qualified labs. It is not "retrospective or prospective" in the clinical study sense, as it involves physical testing of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a submission for a mechanical implant, not an AI/ML diagnostic tool. There is no concept of "ground truth" established by experts in the context of analyzing medical images or clinical data for diagnostic purposes. The "ground truth" for this device's performance is adherence to engineering standards and mechanical test results.
4. Adjudication Method for the Test Set:
- Not Applicable. As above, no medical image or clinical data interpretation by human experts requiring adjudication is involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is typically done for diagnostic imaging devices or AI/ML tools to assess human reader performance with and without AI assistance. It is not relevant for a mechanical bone fixation system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is not an AI/ML algorithm or software. It is a physical medical device.
7. The Type of Ground Truth Used:
- For mechanical performance: The ground truth is defined by established engineering and medical device standards (e.g., ASTM F382, ASTM F543) and material specifications (e.g., ASTM F136, ISO 5832). The device performance is compared against the requirements of these standards.
- For substantial equivalence: The ground truth is the performance and characteristics of the legally marketed predicate device (Synthes Variable Angle LCP Elbow System, K120070).
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No training set is involved.
Summary of Relevant Information from the Document:
- Device Name: Varixis Elbow System
- Intended Use: Fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) where growth plates have fused.
- Basis for Clearance: Substantial equivalence to predicate device Synthes Variable Angle LCP Elbow System (K120070).
- Key Evidence for Substantial Equivalence:
- Identical product codes, regulation numbers, regulatory class, and indications for use as the predicate device.
- Identical materials (Titanium Alloy and Stainless Steel) as the predicate, meeting specific ASTM/ISO standards.
- Performance testing (bench tests) on the subject device according to ASTM F382 (for plates: 4-Point Static Test, 4-Point Fatigue Test) and ASTM F543 (for screws: Driving Torque Test, Torsion Test, Axial Pull-out Test). The results "Conform" to these standards.
- Compliance with various ISO and ASTM standards for biocompatibility (ISO 10993-3), sterilization (ISO 11137, ISO 17665, ISO 11140, ISO 11737, ISO 11607, ASTM F1980, ASTM F88/F88M, ASTM F1929), shelf-life (5 years, identical to predicate), and bacterial endotoxin (USP , USP ).
- Identical operating principle and dimensional characteristics to the predicate device.
In conclusion, this document provides the necessary information for the FDA to confirm substantial equivalence for a mechanical orthopedic implant but does not contain information relevant to an AI/ML driven diagnostic 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.