(315 days)
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation aand 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 document (K012634) is a 510(k) Pre-Market Notification for "Reprocessed External Fixation Devices" by Alliance Medical Corporation. This type of submission is for "reprocessed" medical devices, meaning devices that were originally intended for single use but are being re-used after cleaning, sterilization, and sometimes repair. The testing described focuses on demonstrating that the reprocessed devices perform as intended, similar to their original, new counterparts, and that the reprocessing method is effective.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance (Safety and Effectiveness) | Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness). |
| Biocompatibility | Validation of reprocessing included biocompatibility testing. |
| Validation of Reprocessing | Validation of reprocessing (methods for cleaning, sterilization, etc.) was performed. |
| Original Intended Performance Maintained | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
Note: The document states that the reprocessed devices are identical in design, materials, and intended use as the predicate devices, implying that the acceptance criteria are met if these characteristics and the performance benchmarks are maintained after reprocessing. The specific quantitative acceptance criteria values (e.g., specific tensile strength, fatigue life, or sterilization sterility assurance levels) are not detailed in this summary, but are generally part of the underlying bench and laboratory testing reports.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly state the sample size used for the test set in the performance, biocompatibility, or reprocessing validation studies. It only mentions "Bench and laboratory testing."
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) for reprocessed devices, the data would typically be derived from controlled laboratory studies and possibly prior clinical use data of the original devices or reprocessed devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission for reprocessed devices typically relies on engineering and scientific experts to establish test protocols, analyze performance, and validate reprocessing methods, rather than clinical experts establishing a "ground truth" for a diagnostic or AI device. The document does not specify the number or qualifications of such experts involved in establishing the testing parameters or reviewing the results.
4. Adjudication Method for the Test Set
The concept of "adjudication method" (like 2+1, 3+1) is not applicable to this type of device submission. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reading images) where disagreement needs to be resolved to establish ground truth. For reprocessed external fixation devices, performance is assessed through objective physical, mechanical, and chemical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images. External fixation devices are physical medical instruments, and their effectiveness is not assessed through human reader interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. This concept applies to AI/ML algorithms that operate independently. The device here is a physical external fixation device.
7. The Type of Ground Truth Used
For this device, the "ground truth" is established by objective engineering specifications, material properties, and sterility standards for external fixation devices. For instance:
- Mechanical Integrity: The reprocessed devices must meet the same mechanical strength, fatigue, and other performance characteristics as new, predicate devices.
- Biocompatibility: The materials must remain biocompatible after reprocessing.
- Sterility: The reprocessing must render the devices sterile, typically validated to a Sterility Assurance Level (SAL) of 10^-6.
- Cleaning Effectiveness: The devices must be effectively cleaned to remove biological and other foreign material.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of device. Training sets are used in machine learning for AI algorithms. This submission is for reprocessed physical medical devices, not an AI/ML product.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" is not applicable to this 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.