(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 the 510(k) summary for a reprocessed external fixation device (K052064). This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and functional testing rather than clinical trials with human subjects. Therefore, many of the typical elements of an AI/ML device study (like sample size for test sets, expert consensus for ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context.
Here's an analysis of the provided information in relation to the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Result) |
|---|---|
| Validation of reprocessing | Not explicitly detailed, but implied to be sufficient to ensure devices are safe and effective after reprocessing. |
| Function Testing (mechanical performance) | "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." (Implies meeting original specs) |
| Safety & Effectiveness (overall) | Concluded to be "safe, effective and substantially equivalent to the predicate devices." |
Explanation: The acceptance criteria for a reprocessed device primarily revolve around demonstrating that the reprocessing does not degrade the device's original performance characteristics or safety. The performance data provided is high-level, stating that testing was conducted and that the reprocessed devices perform as originally intended. Specific pass/fail thresholds for individual tests are not detailed in this summary.
2. Sample Size Used for the Test Set and the Data Provenance
This is not applicable to this 510(k) submission. No test set involving human data or images was used. The evaluation was based on bench and laboratory testing of the reprocessed devices themselves.
The data provenance is from laboratory and bench testing, presumably conducted by Alliance Medical Corporation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable. The "ground truth" for a reprocessed medical device in this context is its ability to perform identically to virgin devices according to established mechanical and functional standards. This is determined through engineering tests directly on the devices, not by expert interpretation of data.
4. Adjudication Method for the Test Set
This is not applicable. There was no "test set" in the sense of clinical data requiring 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 is not applicable. This submission is for a reprocessed physical medical device, not an AI/ML-powered diagnostic tool. Therefore, no MRMC studies or human reader performance analyses were conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For this device, the "ground truth" for performance is established by the original design specifications and performance characteristics of the predicate (virgin) external fixation devices. The reprocessed devices are compared against these established standards through defined bench and laboratory tests to ensure they function equivalently. The "ground truth" is therefore established through engineering specifications and validated testing methods.
8. The Sample Size for the Training Set
This is not applicable. There is no AI/ML algorithm that requires a "training set" in this submission.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
§ 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.