(28 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 a 510(k) premarket notification for "Alliance Medical Corporation Reprocessed External Fixation Devices." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics for a novel device.
Therefore, many of the requested elements for a detailed study description are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text, addressing what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria. Instead, it relies on demonstrating that the reprocessed devices "perform as originally intended" and are "safe and effective and substantially equivalent" to the predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Performance as "originally intended" (i.e., equivalent to new) | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
| Safety and Effectiveness (equivalent to predicate) | Alliance Medical Corporation concludes that the modified device (the Reprocessed External Fixation Device) is safe, effective and substantially equivalent to the predicate devices. |
| Reprocessing Validation | Validation of reprocessing performed. |
| Functionality | Function Testing performed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the performance testing of the reprocessed devices. Details on data provenance (e.g., country of origin, retrospective/prospective) are also not provided. It is implied that the testing was conducted internally as part of the reprocessing validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not available in the provided text. The document refers to "bench and laboratory testing" rather than clinical expert evaluation for ground truth.
4. Adjudication Method for the Test Set:
Not applicable. The performance data described is based on bench and laboratory testing, not human-read interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through bench and laboratory testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a medical device (external fixation devices), not an AI algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance was established through bench and laboratory testing. This would involve comparing the mechanical and material properties and functional performance of the reprocessed devices against the specifications and expected performance of new, equivalent devices (the predicate).
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of reprocessed physical medical devices as described here. This concept is relevant for AI/ML models.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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.