(102 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 bory 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 is a 510(k) summary for the Alliance Medical Corporation's Reprocessed External Fixation Devices. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical or performance study for a novel AI/medical imaging device would.
Instead, the submission for these reprocessed devices focuses on demonstrating that they perform "as originally intended" and are substantially equivalent to the original predicate devices. This is a crucial distinction. For reprocessed devices, the "acceptance criteria" are primarily centered around ensuring the reprocessing does not compromise the device's functional integrity, sterility, and material properties compared to new devices.
Therefore, the information for some of your requested points is not present in this type of submission. I will answer based on the information provided and note when information is not available due to the nature of this 510(k) for reprocessed external fixation devices.
Description of Acceptance Criteria and Study
The acceptance criteria for the Reprocessed External Fixation Devices are implicit in demonstrating that the reprocessed devices are safe, effective, and substantially equivalent to the predicate devices and perform "as originally intended." The study conducted was a series of bench and laboratory tests designed to validate the reprocessing methods and ensure the device's original performance characteristics are maintained.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs as originally intended, exhibiting the same mechanical design, materials, shapes, and sizes as predicate devices. | "The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices. 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." "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." |
| Material Integrity: Reprocessing does not compromise the material properties. | Implied by the statement that "design, materials, and intended use... are identical to the predicate devices" and "performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." (No specific material property tests mentioned beyond functional tests for reprocessing) |
| Sterility: If provided sterile, the reprocessed device meets sterility requirements. | "Sterilization Validation (for sterile devices)" was conducted. |
| Safety and Effectiveness: Reprocessed devices maintain safety and effectiveness comparable to predicate devices. | "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed External Fixation Devices. This included the following tests: Validation of reprocessing, Sterilization Validation (for sterile devices), Function test(s)." "Alliance Medical Corporation concludes that the modified devices (Reprocessed External Fixation Device) are safe, effective, and substantially equivalent to the predicate devices as described herein." |
| Reprocessing Validation: The reprocessing procedure effectively cleans and prepares the device for re-use without degradation. | "Validation of reprocessing" was conducted. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The 510(k) summary only states "Bench and laboratory testing was conducted," implying that a sample of reprocessed devices would have been tested, but the exact number is not disclosed.
- Data Provenance: The document does not specify the country of origin of the data. Given it's a US submission, it's highly probable the testing occurred in the USA. The tests were likely conducted prospectively as part of the reprocessing validation process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. The "ground truth" for proving substantial equivalence of reprocessed mechanical devices primarily relies on objective engineering and scientific measurements from bench and laboratory tests, rather than expert clinical assessment of images or patient outcomes. The "ground truth" would be the engineering specifications and performance characteristics of the original predicate devices.
4. Adjudication method for the test set:
- This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation (e.g., radiologists, pathologists) where there might be inter-reader variability. For bench testing of mechanical properties, results are generally objective measurements that do not require clinical adjudication.
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:
- This information is not applicable and not provided. This device is a reprocessed external fixation device, not an AI-powered diagnostic or therapeutic tool that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable and not provided. This device is a mechanical medical device, not an algorithm or AI system.
7. The type of ground truth used:
- The ground truth used for these tests would be the original manufacturer's specifications and performance data for the predicate (new) external fixation devices. The reprocessed devices are demonstrated to be substantially equivalent if their performance in the bench and lab tests meet these established specifications.
8. The sample size for the training set:
- This information is not applicable and not provided. There is no concept of a "training set" for a reprocessed mechanical device as there would be for an AI algorithm.
9. How the ground truth for the training set was established:
- This information is not applicable and not provided. As explained above, there is no training set for this type of device submission.
§ 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.