(90 days)
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Validation of Reprocessing | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
| Function Testing | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
| Substantial Equivalence to Predicate Devices | The design, materials, and intended use are identical to predicate devices. The mechanism of action is identical. There are no changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation. |
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Sample Size Used for the Test Set and Data Provenance:
The document states that "Bench and laboratory testing was conducted," but it does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is not provided in the submitted text. -
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on direct performance testing of the reprocessed devices against their original intended performance. -
Adjudication Method for the Test Set:
Since no experts were mentioned in establishing ground truth, there was no adjudication method described. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The study focused on the performance of the reprocessed devices themselves, not on human reader performance with or without AI assistance. -
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, the performance testing described appears to be a standalone evaluation of the reprocessed external fixation devices. It assesses whether the devices, after reprocessing, perform as originally intended, without human-in-the-loop interaction in the context of an AI algorithm. However, this is a medical device, not an AI algorithm, so the term "standalone" here refers to the device's functional performance. -
Type of Ground Truth Used:
The ground truth used was implied to be the original performance specifications and functionality of new, non-reprocessed external fixation devices. The goal of the testing was to demonstrate that the reprocessed devices perform "as originally intended," suggesting comparison to the known performance of new devices. -
Sample Size for the Training Set:
This is a submission for a medical device (reprocessed external fixation devices), not an AI algorithm. Therefore, the concept of a "training set" is not applicable in this context. -
How the Ground Truth for the Training Set Was Established:
As this is not an AI algorithm, the concept of a "training set" and establishing its ground truth is not applicable.
§ 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.