(66 days)
The Hoffmann® II Compact External Fixation System is intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting. And other means of internal fixation.
This submission describes a system of external fixation components consisting of Rodto-Rod Couplings, Pin-to-Rod Couplings, Straight and Angled Posts, a Pin Clamp Assembly, Compression/Distraction Rod-to-Rod Coupling, a Compression/Distraction Rod and Curved and Straight 5mm Rods. These components are intended to be used in conjunction with the Half Pins and Transfixing Pins of the Hoffmann® External Fixation System and may be used with the components of the Hoffmann® II External Fixation System.
Here's a breakdown of the requested information based on the provided text, recognizing that this document is a 510(k) summary for a medical device and not a detailed study report. Therefore, some information like "sample size for the test set" or specific "effect size" for MRMC studies will not be present as these are not typically found in a 510(k) summary for such a device. This document focuses on demonstrating substantial equivalence through comparison to predicate devices, primarily via material, design, and operational principles, rather than clinical performance studies with acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not present specific quantitative acceptance criteria or detailed device performance metrics in the format of a clinical study. Instead, it asserts substantial equivalence based on similarities to predicate devices. The "acceptance criteria" are implied to be the successful demonstration of equivalence in:
| Acceptance Criterion (Implied) | Reported Device Performance (as stated in 510(k)) |
|---|---|
| Intended Use Equivalence | "Intended to be used in conjunction with the Half Pins and Transfixing Pins of the Hoffmann® External Fixation System and may be used with the components of the Hoffmann® II External Fixation System." |
| "Intended to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments." (Same as predicate devices) | |
| Material Equivalence | "Manufactured from Stainless Steel and Aluminum." (Equivalent to Hoffmann® II External Fixation System; Original Hoffmann® Components are Stainless Steel). |
| Design Equivalence | "The design of the Hoffmann® II Compact Components, the Hoffmann® II Components and the Original Hoffmann® Components are substantially equivalent." |
| Operational Principles Equivalence | "Basic operational principles... are to provide external stabilization of a fracture by means of percutaneous pins connected to a frame by means of Pin Clamps, Couplings and Rods." (Equivalent to other named external fixation systems). |
| Method of Site Preparation/Indications/Contraindications | "The method of site preparation, relative indications and contraindications for all of the external fixation systems are similar." |
| Mechanical Performance (Implied by testing) | "Testing compares the performance of the new components with the components of the Original Hoffmann® System or the Hoffmann II External Fixation System." (Specific test results or acceptance limits are not provided in this summary, but the assertion is that performance is comparable). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly mentioned. The document states "Testing of the components of this system is presented in this document," but does not detail the number of components tested or the specific test setup quantities.
- Data Provenance: Not specified, but standard for 510(k) submissions relies on bench testing data, typically conducted by the manufacturer or a contracted lab. It is not clinical data, so country of origin of data or retrospective/prospective status are not applicable in the clinical sense. This refers to engineering test data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable. The "ground truth" for a mechanical device like an external fixator, when establishing substantial equivalence through bench testing, is typically based on engineering specifications, recognized standards (if applicable), and comparison to the predicate device's established performance characteristics. It does not involve expert clinical consensus on "ground truth" labels for a test set in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set
- Not applicable. As this is not a diagnostic or clinical study with human interpretation, there's no "adjudication method" in the sense of resolving conflicting expert opinions. Mechanical testing results are objective measurements against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, and it is not relevant for this type of device (mechanical external fixator). MRMC studies are typically performed for diagnostic imaging AI devices to assess the impact of AI on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm-only) performance study was not done. This device is a mechanical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" in this context refers to established mechanical performance characteristics and design specifications of the predicate devices (Original Hoffmann® External Fixation System and Hoffmann® II External Fixation System). The new device's components were likely tested against engineering standards and compared to the performance of these predicate devices to demonstrate equivalence. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a mechanical device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.