(88 days)
The wire protecting caps K-FIX® are indicated for use in the protection of protruding ends of wires. Examples of protruding wires include: Osteotomies, arthrodesis or fractures management in the foot or hand. Fixation of small bone fragments, in long bones or small bones fractures.
The K-Fix® pin protector is a simple and reliable system to protect patients or hospital staff from K-wire sharp ends and reduce bandages size. It presents an ergonomic profile. Thanks to its patented "Push, Lock and Twist" system, its fixation requires no instrument. An optional possibility for using K-Fix on wires bent at right angle allows manual rotational and axial maneuvers for the removal of the pin. Delivered sterile, it can be used intraoperatively to protect temporarily the surgeon from cuts and pricks when placing multiple wires in a small area.
Here's an analysis of the provided text regarding the K-FIX® device, focusing on acceptance criteria and study details.
Based on the provided document, the K-FIX® is a K-Wire end protector, and the provided text is a 510(k) summary for regulatory clearance, not a study report detailing performance data and acceptance criteria.
Therefore, most of the requested information regarding a study that proves the device meets acceptance criteria is not present in this document. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.
However, I can extract the following information:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics in this document. The implicit acceptance criterion for 510(k) clearance is "substantial equivalence" to legally marketed predicate devices, meaning it is as safe and effective as the predicate devices.
- Reported Device Performance: The document describes the device's function and attributes, which implicitly define its intended performance.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Protection of protruding ends of wires | "The K-Fix® pin protector is a simple and reliable system to protect patients or hospital staff from K-wire sharp ends and reduce bandages size." |
| "The wire protecting caps K-FIX® are indicated for use in the protection of protruding ends of wires." | |
| Ergonomic profile | "It presents an ergonomic profile." |
| Fixation method | "Thanks to its patented "Push, Lock and Twist" system, its fixation requires no instrument." |
| Compatibility with right-angle bent wires | "An optional possibility for using K-Fix on wires bent at right angle allows manual rotational and axial maneuvers for the removal of the pin." |
| Sterility | "Delivered sterile..." |
| Intraoperative use (temporary protection) | "...it can be used intraoperatively to protect temporarily the surgeon from cuts and pricks when placing multiple wires in a small area." |
| Material composition | "K FIX® (Newdeal)...are made of polymer." |
| Fit comparable ranges of wire diameters | "K FIX® (Newdeal)...fit comparable ranges of wires diameters." |
| Substantially equivalent to predicate devices (K-CAP-ES, Jurgan pin Ball®) | The entire 510(k) submission is predicated on demonstrating this. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document does not describe a performance study with a test set. It's a regulatory submission demonstrating substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No performance study with a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No performance study with a test set is described.
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
- Not Applicable. This is a physical medical device (K-wire end protector), not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices (K-CAP-ES and Jurgan pin Ball®). The K-FIX® is deemed safe and effective if it shares the same technological characteristics and indications for use as these predicate devices without raising new questions of safety or effectiveness.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set for a machine learning model.
Summary of the Document's Purpose:
This document is a "Summary of Safety and Effectiveness" (a 510(k) summary) submitted to the FDA for the K-FIX® K-wire end protector. Its primary goal is to demonstrate that the K-FIX® device is substantially equivalent to legally marketed predicate devices (K-CAP-ES and Jurgan pin Ball®). This equivalence is established by comparing indications for use, technological characteristics (e.g., polymer material, sterility, fit for wire diameters, external device), and addressing the same clinical problem (protection of protruding wire ends). The FDA's letter confirms that based on this submission, the device is substantially equivalent and can be legally marketed. It does not contain primary performance study data or explicitly defined acceptance criteria in the analytical or clinical sense.
§ 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.