(294 days)
The DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.
System indications include the following:
- Open reduction and internal fixation of fractures, mal-unions, and non-unions
- Following excision of benign bone tumors
- Replantations and reconstructions
- Arthrodeses of joints involving small bones
- Osteotomies, including deformity correction such as rotation, lengthening, shortening
- Pathological fractures, including impending pathologic fractures
The DePuy Synthes Variable Angle Locking Hand System consists of metallic plates and screws that offer screw-to-plate locking designed for various fracture modes of the hand. Generally, the system consists of plates, screws, and instruments which feature variable angle locking technology. The plates contained in the DePuy Synthes Variable Angle Locking Hand System are offered in a range of configurations to accommodate patient anatomy and surgical need. The plates are designed to accept existing 1.5mm cortex screws (K090047), previously cleared 1.5mm Locking Screws at the nominal angle only (K090047), and new 1.5mm VA Locking Screws. The new 1.5mm VA Locking Screws feature existing variable angle locking technology (K100776, K120689, K110354), and are designed to fit in the 1.5mm holes of the subject plates.
The provided text is a 510(k) premarket notification for a medical device (DePuy Synthes Variable Angle Locking Hand System). This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with acceptance criteria for device performance as would be seen in a PMA or De Novo submission.
Therefore, the document does not contain information typically found in acceptance criteria and study reports for software/AI devices (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details).
However, it does describe the non-clinical testing performed to demonstrate the substantial equivalence of the mechanical aspects of the device.
Here's an analysis of what information is available in the provided text, structured to address your request as much as possible given the limitations of the document:
Acceptance Criteria and Study to Prove Device Performance
This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing rather than clinical performance metrics with specific acceptance criteria typically associated with software or AI devices. The information below reflects the mechanical performance testing mentioned.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for the non-clinical tests in the format of a table, nor does it provide the quantitative results of these tests. Instead, it lists the types of tests performed to support the device's performance and substantial equivalence to predicates.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied by testing) |
|---|---|
| Mechanical Strength & Durability | Dynamic Fatigue Testing: Performed on representative constructs to assess long-term durability and resistance to cyclic loading. |
| Screw Torsional Properties | Torsional properties of 1.5mm VA Locking Screws per ASTM F543: Demonstrates the screw's resistance to twisting forces during insertion or under load. |
| Screw Pullout Strength | Pullout strength of 1.5mm VA Locking Screws per ASTM F543: Assesses the strength of the screw's fixation in bone. |
| Screw Insertion Torque | Insertion Torque of 1.5mm VA Locking Screws per ASTM F543: Evaluates the force required to insert the screws. |
| Structural Integrity & Stress Distribution | Finite Element Analysis (FEA): Used to determine worst-case constructs and analyze stress distribution within the device and its interaction with simulated bone. |
| Material Biocompatibility | Not explicitly mentioned in the "Substantial Equivalence" section but implied for all implantable devices. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not specified for the mechanical tests. For non-clinical mechanical testing, sample sizes are typically determined by relevant ASTM standards or internal validation protocols, often involving a small number of representative samples.
- Data Provenance: The tests are non-clinical (laboratory-based) and conducted by the manufacturer (DePuy Synthes). Country of origin is implied to be within the manufacturer's operational locations (e.g., USA, as the submitting entity is Synthes USA). The data is by nature "prospective" in the sense that the tests were designed and executed to evaluate this specific device configuration.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a mechanical implant, not an AI/software device requiring expert interpretation for ground truth establishment. The "ground truth" for mechanical testing is established by the physical properties of the materials and designs under standardized test conditions.
4. Adjudication Method
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for clinical image interpretation or diagnostic decisions, not for mechanical testing of orthopedic implants.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a mechanical orthopedic implant, not an imaging device or AI diagnostic tool that would typically involve human readers.
6. Standalone Performance
The "standalone performance" in this context refers to the device's mechanical performance in laboratory settings, independent of human interaction during the test itself. The non-clinical tests (Dynamic Fatigue, Torsional, Pullout, Insertion Torque, FEA) evaluate the device in this standalone capacity.
7. Type of Ground Truth Used
For the mechanical tests, the "ground truth" is defined by:
- Standard ASTM methodologies: (e.g., ASTM F543 for screw properties).
- Engineering principles and material properties: Used in Finite Element Analysis.
- Physical measurements under controlled laboratory conditions.
This differs significantly from a "ground truth" for a diagnostic medical device which would involve expert consensus, pathology, or outcomes data.
8. Sample Size for Training Set
Not applicable. This is a mechanical device, not an AI/machine learning algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm involved in the primary function or evaluation of this mechanical 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.