(315 days)
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation oand 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 a 510(k) submission for "Reprocessed External Fixation Devices" by Alliance Medical Corporation. This submission focuses on demonstrating substantial equivalence to predicate devices, not on a new, AI-powered diagnostic or therapeutic device. As such, many of the requested criteria (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, AI improvement effect size) are not applicable to this type of submission.
The core of this submission is about proving that reprocessing existing external fixation devices does not alter their safety and effectiveness compared to new, predicate devices.
Here's an analysis of the available information based on your request:
Description of Acceptance Criteria and Study to Prove Device Meets Them
The acceptance criteria for the "Reprocessed External Fixation Devices" are implicitly tied to demonstrating that the reprocessed devices perform identically to their original, new counterparts, and to the predicate devices, in terms of safety and effectiveness. The study described focuses on proving that the reprocessing procedure maintains these critical performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Reprocessed devices must perform functionally equivalent to new devices. | "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." "The mechanism of action of the Reprocessed External Fixation Device is identical to the predicate devices in that the same standard mechanical design, materials, shapes and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
| Biocompatibility: Reprocessing must not introduce unacceptable biocompatibility risks. | "Biocompatibility Validation of reprocessing" (mentioned as conducted to demonstrate performance). |
| Sterility/Cleanliness: Reprocessing must ensure proper sterilization and removal of contaminants. | While not explicitly detailed in the provided text, "Biocompatibility Validation of reprocessing" would inherently include aspects of cleanliness and sterilization efficacy to ensure patient safety. |
| Material Integrity: Reprocessing must not degrade the materials of the device. | "The design, materials, and intended use of the Reprocessed External Fixation Device s are identical to the predicate devices." Implies that reprocessing does not fundamentally alter these. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the devices tested as part of the "bench and laboratory testing."
- Data Provenance: The data comes from "bench and laboratory testing" conducted by Alliance Medical Corporation. No country of origin is specified for the data itself, but the submitter is based in Phoenix, Arizona, USA. The testing is retrospective in the sense that it evaluates the performance of reprocessed versions of already existing devices. It is not prospective clinical trial data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This submission does not involve a diagnostic device or a study requiring expert readers to establish ground truth for a test set in the traditional sense (e.g., radiology interpretation). The "ground truth" here is the established performance and safety of the original, new devices and the predicate devices. The study aims to show the reprocessed device meets these existing standards, rather than defining a new ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. There is no mention of an adjudication method as it relates to expert reader interpretation. The testing is bench and laboratory-based.
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-powered device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI-powered device or algorithm.
7. The type of ground truth used
- The "ground truth" for this submission is implicitly the established performance specifications, material properties, biocompatibility, and intended use of the original, new, and predicate external fixation devices. The study aims to demonstrate that the reprocessed devices meet these existing, well-defined standards. This is akin to using established engineering standards and material science data as a basis for comparison.
8. The Sample Size for the Training Set
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. This is not a machine learning or AI device.
§ 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.