(321 days)
The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the, acetabulum, pelvis, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula
Cannulated Screws and Kwires are a self-tapping, self-drilling screw with a cortico/cancellous or cancellous thread that can be guided into position by Kwire placement. Partial or fully threaded screws are available in various different lengths and diameters to provide fixation in various size bones. The screws are made of Stainless Steel. The Kirschner Wires (Kwires) are threaded, spaded or blunt ranging from 0.8mm to 1.4mm of an inch in diameter and 150mm in length and made of 316L Stainless Steel.
The provided text is a 510(k) Premarket Notification for a Cannulated Screw and Kirschner (K-wire) System, a type of orthopedic implant used for bone fixation. For this type of device, the "acceptance criteria" and "study" are not typically presented in the same way as for diagnostic AI software. Instead, the performance is demonstrated through substantial equivalence to predicate devices, focusing on design, materials, and dimensional comparisons rather than a clinical performance study with specific metrics like sensitivity or specificity.
Therefore, many of the requested sections (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.
Here's the information parsed from the document based on your request, with a clear indication of sections that are not applicable:
Acceptance Criteria and Device Performance Study for the Cannulated Screw and Kirschner (K-wire) System
For the Cannulated Screw and Kirschner (K-wire) System (K130613), acceptance criteria and performance were established through demonstrating substantial equivalence to legally marketed predicate devices, as is common for Class II medical devices of this nature. The "study" in this context refers to the comparison of design and material specifications rather than a clinical trial or AI performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Design Equivalence | The design of the Cannulated Screw and Kirschner (K-wire) System should be similar to legally marketed predicate devices to ensure equivalent function and safety. | The Cannulated Screw and Kirschner (K-wire) System is determined to be substantially equivalent to the predicate devices with respect to design. This implies the device shares fundamental design principles (e.g., self-tapping, self-drilling, cannulated screws, K-wire guidance) with the predicates. |
| Material Equivalence | The materials used in the device should be biocompatible and possess mechanical properties comparable to those in legally marketed predicate devices. | The Cannulated Screw and Kirschner (K-wire) System is determined to be substantially equivalent to the predicate devices with respect to material. Specifically, the screws are made of Stainless Steel, and Kirschner Wires (Kwires) are made of 316L Stainless Steel, similar to accepted orthopedic implants. |
| Dimensional Equivalence | The varying lengths and diameters of the screws and K-wires should fall within acceptable ranges established by predicate devices to allow for safe and effective use across different anatomical sites and fracture types. | The Cannulated Screw and Kirschner (K-wire) System is determined to be substantially equivalent to the predicate devices with respect to dimensional comparison. This indicates the available sizes of screws (partial or fully threaded, various lengths/diameters) and K-wires (0.8mm to 1.4mm diameter, 150mm length) are comparable to the predicate devices. |
| Intended Use | The device should be indicated for the same or similar uses as the predicate devices. | The Intended Use of the Cannulated Screw and Kirschner (K-wire) System is for the treatment and fixation of bone fractures and osteotomies of various bones, consistent with the function of bone fixation fasteners. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable. This device demonstrated substantial equivalence through comparison of design, materials, and dimensions to predicate devices, not through a "test set" of patient data in the manner of AI or diagnostic devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth in the context of expert consensus or pathological findings is not relevant for demonstrating substantial equivalence for this orthopedic implant. The "ground truth" here is the established safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. No formal adjudication method was used for a "test set" as described for AI or diagnostic performance studies. The FDA reviewed the comparison presented by the manufacturer.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Not applicable. This type of study is not relevant for an orthopedic implant device seeking substantial equivalence based on design and material comparisons.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is a hardware medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the predicate devices themselves, confirmed through their prior clearance by the FDA. The manufacturer provided a detailed comparison of the new device to these predicates based on:
- Design characteristics: How the screws and K-wires are constructed, their features (self-tapping, self-drilling, cannulated, thread types).
- Material composition: Type of Stainless Steel used.
- Dimensional specifications: Ranges of diameters and lengths available.
The predicate devices cited are:
- Internal Fixation Systems, Inc. Bone Fixation Devices (K071035)
- Internal Fixation Systems, Inc Cannulated Bone Screw (K061620)
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of an AI algorithm for this orthopedic implant. The "training" for the device design would implicitly come from general engineering principles and existing knowledge of bone fixation.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question does not apply.
§ 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.