(132 days)
The Wright Jones Fracture System is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include:
- Fixation of malunions and nonunions
- Acute fractures
- Avulsion fractures
- Repetitive stress fractures
- Jones Fractures
- Malleolar Fractures
- Talus Fractures
- Greater Tuberosity Fractures
The Wright Jones Fracture System consists of partially threaded, solid screws offered in 4.5, 5.5, and 6.5 mm diameters and various lengths. The screws are manufactured from titanium alloy (ASTM F136).
The provided text does not describe an AI/ML device but rather a medical device for bone fixation (Wright Jones Fracture System). Therefore, the information typically requested for AI/ML device studies, such as acceptance criteria in terms of accuracy, sensitivity, specificity, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies, is not applicable or present in this document.
Instead, the document details the substantial equivalence of the "Wright Jones Fracture System" to existing predicate devices based on non-clinical performance testing.
Here's a summary of the relevant information provided for this device:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical Evidence):
The document states that the performance testing and analysis demonstrated substantial equivalence to the predicate device in several mechanical properties. While specific numerical acceptance criteria (e.g., minimum torque values) are not reported in this summary, the type of tests performed serves as the criteria for demonstrating equivalence.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Insertion Torque | Demonstrated substantial equivalence to predicate device. |
| Removal Torque | Demonstrated substantial equivalence to predicate device. |
| Pull Out | Demonstrated substantial equivalence to predicate device. |
| Ultimate Torque | Demonstrated substantial equivalence to predicate device. |
| Yield Torque Strength | Demonstrated substantial equivalence to predicate device. |
2. Sample size used for the test set and the data provenance: Not applicable. This refers to non-clinical mechanical testing, not a data-driven AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/ML context. For this device, "ground truth" would relate to accepted engineering standards and validated testing methodologies for mechanical properties of bone screws, which are implicitly used in demonstrating "substantial equivalence."
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
Additional Information from the Document:
- Device Name: Wright Jones Fracture System
- Intended Use: Fixation of bone fractures or for bone reconstruction of the 5th Metatarsal (including malunions, nonunions, acute fractures, avulsion fractures, repetitive stress fractures, Jones Fractures, Malleolar Fractures, Talus Fractures, Greater Tuberosity Fractures).
- Technological Characteristics Comparison: The system includes additional sizes, chamfered and headless screw options, and an updated driver interface compared to predicates.
- Clinical Evidence: "N/A" - No clinical evidence was submitted as part of this 510(k) summary for substantial equivalence.
- Conclusion: The design characteristics do not raise new questions of safety or effectiveness, and the device is expected to perform at least as well as the predicate device based on non-clinical evidence.
§ 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.