(77 days)
The Periarticu!ar Clamp is intended to be used with the components of the Hoffmann® II Compact External Fixation System and the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments.
The Periarticular Clamp is an additional component of the Hoffmann® II Compact System and is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments. It is manufactured from a lightweight plastic material which is radiographically transparent and allows for fracture or joint visibility on x-ray. The clamp can be used with the existing rods, couplings, clamps and fixation pins of the existing Hoffmann® II Compact System.
Acceptance Criteria and Device Performance Study for Hoffmann® II Compact Periarticular Clamp
This document outlines the acceptance criteria and details of the study conducted to demonstrate the performance of the Hoffmann® II Compact Periarticular Clamp.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary states that "Testing was performed to demonstrate an equivalence in performance to the Original Hoffmann® Small Four-Hole Ball Joint." However, specific numerical acceptance criteria (e.g., minimum load, deflection, fatigue cycles) for mechanical performance and the corresponding reported performance values for the new clamp are not explicitly stated in the provided text. The summary only broadly asserts equivalence to the predicate device in performance.
Therefore, based only on the provided text, a table detailing specific acceptance criteria and reported device performance cannot be fully constructed. The document does not offer the granular data required for such a table.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the device is a medical implant (external fixation clamp) and the performance evaluation is based on mechanical testing, not interpretation of medical images or data requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for mechanical testing. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic or screening devices that involve human interpretation of outputs (e.g., medical images). The Hoffmann® II Compact Periarticular Clamp is a physical medical device.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. Standalone performance studies are pertinent to algorithmic or AI-based devices. The Hoffmann® II Compact Periarticular Clamp is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth for the performance evaluation of the Hoffmann® II Compact Periarticular Clamp is based on mechanical performance metrics (though not explicitly detailed in the provided text). This would typically involve measuring characteristics such as ultimate strength, stiffness, fatigue life, and clamping force under various loading conditions. The stated goal was to demonstrate equivalence to a predicate device's established mechanical performance.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information 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.