(93 days)
The Impact Medical, LLC screws, plates, and K-Wires are single use, non-sterile and are indicated for use in:
- . Fixation and stabilization of fractures in small and long bones; including at a minimum: the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle foot bones, calcaneus and for fixation of fractures in the proximal femur and trochanteric, intertrochanteric, and basilar neck fractures.
- . Kirschner (K) wires are used in support of fracture fixation, for ostedtomies in the presence of adequate immobilization and implant guide wires.
The Impact Medical, LLC Orthopedic Fixation Systems (OFS) consists of various plates, screws and K-Wires that can be provided in sets or individually. Sets are designed for a specific plate and screw combination. They are sold Non-Sterilized by the facility according to a validated and monitored hospital or facility protocol prior to use. All plates, screws and wires are made from 316L stainless steel that meets ASTM F138 Standard Specification for Wrought 18-Chromium-14Nickel-2.5 Molybenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) 2008. The screws are in various sizes of Cancellous, Cortex, Cannulated, Locking and Headless Compression. Inclinal, LLC's Orthopedic Fixation System (OFS) of plates, screws and wires are single use only.
The provided text describes Impact Medical, LLC's Orthopedic Fixation Systems (OFS), which consist of various plates, screws, and K-wires for orthopedic fracture fixation. This is a 510(k) submission, indicating a claim of substantial equivalence to predicate devices rather than a new device requiring extensive clinical trials to prove efficacy.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was tested for) | Reported Device Performance (How the device performed) |
|---|---|
| Compliance with established requirements and standards (e.g., ASTM F138 for 316L stainless steel) | "Impact Medical, LLC has confirmed that [Orthopedic] Fixation Systems meet the established requirements and the systems have been tested for compliance with standards in comparison with the predicates." |
| Monotonic and cyclic bending tests of plates | Performed. Results indicate safety, effectiveness, and substantial equivalence to predicates. |
| Insertion/removal, torsion, and pullout tests of screws | Performed. Results indicate safety, effectiveness, and substantial equivalence to predicates. |
| Geometric analysis of components | Performed. Results indicate safety, effectiveness, and substantial equivalence to predicates. |
| Substantial equivalence to predicate devices (K110086, K962011, K071035, K061620, K000684, K043185, K021556) | The device "demonstrated to be safe and effective for their intended use" in comparison with the predicates, and "performance characteristics as the predicates." |
| Intended Use/Indications for Use matching predicate devices | Similar indications for use as predicate devices. |
| Material composition (316L stainless steel meeting ASTM F138) | All plates, screws, and wires are made from 316L stainless steel that meets ASTM F138 Standard Specification. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the non-clinical performance and testing (e.g., number of plates, screws, or wires tested). The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that this is a 510(k) submission for orthopedic fixation systems and the testing described is bench testing, it is implied that the data is from prospective non-clinical bench testing conducted by Impact Medical, LLC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document explicitly states: "No clinical testing was required nor was performed." The "ground truth" in this context refers to the compliance with engineering standards and performance characteristics in bench testing, not clinical outcomes evaluated by medical experts.
4. Adjudication Method for the Test Set
This information is not applicable. Since no clinical testing was performed, there was no need for expert adjudication of patient outcomes or imaging.
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
This information is not applicable. The device is an orthopedic fixation system (physical hardware), not an AI diagnostic or assistance tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical device (orthopedic implants), not an algorithm or software. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the device's performance in this context is based on engineering standards compliance and direct comparison of physical and mechanical properties with established predicate devices. This includes:
- ASTM F138 for material composition.
- Results from monotonic and cyclic bending tests for plates.
- Results from insertion/removal, torsion, and pullout tests for screws.
- Geometric analysis.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this traditional 510(k) submission for a physical medical device. The device is not an AI/ML algorithm that is trained on data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8. There is no training set mentioned or implied.
§ 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.