(27 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.
The provided text describes an FDA 510(k) summary for Reprocessed External Fixation Devices. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or conducting a study to prove performance against specific metrics for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable or present in this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (as originally intended for predicate device) | Bench and laboratory testing was conducted to demonstrate performance. |
| Functional Equivalence to Predicate Device | Validation of reprocessing function testing performed. |
| Performance Equivalence to Predicate Device | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
| Design, Materials, Intended Use, Mechanism of Action, Claims, Clinical Applications, Patient Population, Performance Specifications, Method of Operation identical to predicate device | The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices. The mechanism of action is identical. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. |
| Sterility (after reprocessing) | Modified external fixation devices will be provided non-sterile. Sterilization of the devices will occur in the hospital prior to use. (This is a change, but implies the expectation for pre-use sterility.) |
Explanation: The "acceptance criteria" for a reprocessed device in a 510(k) submission are primarily centered around demonstrating that the reprocessed device is substantially equivalent to the original, legally marketed predicate device(s) and performs "as originally intended" after reprocessing. Specific quantitative, measurable acceptance criteria in the sense of an algorithm performance are not typically included in such submissions for mechanical devices.
Missing Information/Not Applicable to this Device/Submission Type:
- 2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device undergoing a diagnostic performance test. The "test set" here refers to the actual reprocessed devices that underwent bench and laboratory testing. The submission does not specify the number of individual reprocessed units tested. Data provenance is also not relevant in the context of device reprocessing.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/software devices (e.g., expert consensus on medical images) does not apply here. The "ground truth" for a reprocessed device's performance is its original specifications and how untouched, new versions of the device perform.
- 4. Adjudication method for the test set: Not applicable for a reprocessed mechanical device.
- 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. This is not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this reprocessed device is its performance against the original device's specifications and intended function. The benchmark is the performance of the new, original (predicate) fixation devices.
- 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- 9. How the ground truth for the training set was established: 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.