(92 days)
The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.
The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
Gridlock Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.
The provided text describes a physical medical device (Gridlock Plating System), not an AI/software device. Therefore, the questions related to AI/software performance criteria, ground truth, expert consensus, and multi-reader studies are not applicable.
This 510(k) submission is for a Special 510(k), meaning it's for a modification to a previously cleared device (Gridlock Plating System, K121452). The change from the predicate is the addition of two specific plates for the first metatarsal phalangeal joint. The submission aims to demonstrate substantial equivalence to the predicate device.
Here's the relevant information based on the provided text, modified to address the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria were based on substantial equivalence to predicate devices, particularly regarding mechanical performance.
| Acceptance Criteria Category | Specific Test / Standard | Performance Goal | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static compression testing | Equivalent to predicate devices | The results of this testing indicate that the current Gridlock Plating System is equivalent to predicate devices. |
| Mechanical Performance | Dynamic compression testing per ASTM F382-99, Annexes 1 and 2 | Equivalent to predicate devices | The results of this testing indicate that the current Gridlock Plating System is equivalent to predicate devices. |
| Materials | CP Titanium per ASTM F67 | Same as predicate devices | Manufactured from the same material. |
| Materials | Titanium alloy per ASTM F136 | Same as predicate devices | Manufactured from the same material. |
| General Design | Features (low profile, limited contact, dynamic/manual compression, angulated-locking threaded screw holes) | Same as predicate devices | Systems are similar in principles of operation, technology, and indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical data. For mechanical testing, the number of samples tested per condition is not provided.
- Data Provenance: The mechanical testing was performed in a laboratory setting. There is no mention of data from human subjects or retrospective/prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. For a physical medical device proving mechanical equivalence, "ground truth" related to expert assessment of data is not relevant. The relevant "experts" would be engineering/materials scientists conducting and interpreting the mechanical tests according to standards.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert assessment of clinical data, which is not relevant here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. No clinical studies were performed. This submission relies on mechanical testing and substantial equivalence to a predicate device.
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
The "ground truth" for this device's performance demonstration is based on established engineering standards (ASTM F382-99) and comparison against the known performance of legally marketed predicate devices. In essence, the "truth" is that the new plates perform mechanically equivalently to the previously cleared plates.
8. The Sample Size for the Training Set
Not Applicable. No training set for an algorithm is involved.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. No training set for an algorithm is involved.
§ 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.