(17 days)
Wright's ORTHOLOC™ 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:
- Lateral Malleolar Fractures .
- Syndesmosis injuries
- Medial Malleolar Fractures
- Bi-Malleolar Fractures
- Tri-Malleolar Fractures
- Posterior Malleolar Fractures .
- Distal Anterior Tibia Fractures
- Vertical Shear Fractures of the Medial Malleolous
- Pilon Fractures
- Distal Tibia Shaft Fractures
- Distal Fibula Shaft Fractures
- Distal Tibia Periarticular Fractures
- Medial Malleolar Avulsion Fractures
- Lateral Malleolar Avusion Fractures
The ORTHOLOC™ 3Di locking screws are intended for use with Wright's ORTHOLOC™ 3Di Plating Systems of the same base material.
ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.
The ORTHOLOC™ 3Di Locking Screws subject to this premarket notification include the 2.7mm diameter-26, 28, and 30mm length locking screws. The ORTHOLOC™ Bone Screws subject to this premarket notification include the non-locking 2.7mm low profile bone screws. All screws are manufactured from titanium alloy and have a solid core. The implants are single use only devices.
The provided text describes a 510(k) premarket notification for ORTHOLOC™ 3Di Locking Screws and ORTHOLOC™ Bone Screws. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove safety and effectiveness. Therefore, the information requested about acceptance criteria and a study proving device performance in the context of clinical outcomes or diagnostic accuracy is not applicable here.
The document explicitly states: "N/A-clinical evidence not required" in section B.2. Substantial Equivalence - Clinical Evidence. This means no clinical study with human subjects was performed or required to establish the device's performance against specific acceptance criteria.
Instead, the submission focused on non-clinical evidence to demonstrate substantial equivalence.
Here's how the provided information relates to your request:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. No explicit clinical acceptance criteria or reported device performance from clinical studies are mentioned. The "performance" is demonstrated through non-clinical testing and comparison to the predicate device.
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. No human-based test set or data provenance is mentioned as no clinical studies were performed. The "test set" in this context would refer to physical device samples tested in a lab.
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 ground truth establishment by medical experts is mentioned, as no clinical studies were conducted for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set or adjudication method is mentioned.
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. No MRMC study was done, and the device is a medical screw system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This pertains to an algorithm, not a physical medical device like a screw.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For this submission, the "ground truth" for demonstrating equivalence relied on established engineering and materials standards, worst-case analyses, and physical testing of the device properties (ultimate, insertion, and removal torque).
8. The sample size for the training set
- Not Applicable. No training set is mentioned as no machine learning algorithm is involved.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth establishment for it is mentioned.
In summary, the K120802 submission demonstrates substantial equivalence primarily through non-clinical evidence, specifically:
- Comparison of design characteristics: The subject 2.7mm locking screws are identical to the predicate 2.7mm locking screws except for screw length. The subject 2.7mm bone/non-locking screws have an identical low-profile head and neck as the predicate 3.5 mm low-profile non-locking bone screws and identical thread form as the predicate 2.7mm locking screw.
- Materials information: Both the subject and predicate devices are manufactured from titanium alloy.
- Worst-case analyses: Performed to ensure the subject devices perform at least as well as the predicate devices under various conditions.
- Ultimate, insertion, and removal torque testing: These mechanical tests were conducted to demonstrate that the subject screws perform at least as well as the legally marketed predicate screws in terms of mechanical properties.
The "acceptance criteria" in this context are inferred to be that the subject device's performance in these non-clinical tests (e.g., torque values) must be comparable to or better than that of the predicate device, thereby supporting its substantial equivalence and safety/effectiveness for the stated indications.
§ 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.