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510(k) Data Aggregation
(90 days)
Unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality. For the XFIX® DFS® Rail System the indications are unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, acute or gradual correction and other bone conditions amendable to treatment by use of the external fixation modality.
The Systems consist of external fixation components and implantable bone screws. The system is utilized in the following manner: bone screws are inserted through the patients skin and soft tissue into bone. The fixator frame of the system is attached the shanks of the bone screws.
The provided text is a 510(k) summary for a medical device (Lower Extremity External Fixation) and the associated FDA clearance letter. It explicitly states that no clinical testing was performed as a basis for substantial equivalence.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be found in this document. The device's clearance was based on its similarity to legally marketed predicate devices, and non-clinical laboratory testing.
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(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.
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(64 days)
The EBI® XFIX® DFS® System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
The system consists of external fixation components and implantable bone screws. The EBI® XFIX® DFS® System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. This submission is for a labeling change to reflect that the EBI® XFIX® DFS® Standard Fixator may be reused twice when the Central Body Component is replaced between each reuse.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. This document is a 510(k) Summary for an external fixation device (EBI® XFIX® DFS® System) seeking clearance for a labeling change to allow reuse of a component.
The document focuses on:
- Device Description: An external fixation system that includes components and implantable bone screws, used for bone conditions.
- Intended Use: Treatment of bone conditions such as leg lengthening, osteotomies, arthrodesis, and fracture fixation.
- Predicate Device Comparison: States that there are no significant differences between the device and other marketed external fixation systems in terms of intended use, materials, and function, concluding substantial equivalence to prior predicate devices (K953406).
- Labeling Change: The specific purpose of this 510(k) is a labeling change to reflect that the EBI® XFIX® DFS® Standard Fixator may be reused twice when the Central Body Component is replaced between each reuse.
Therefore, the requested information regarding acceptance criteria, device performance results, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not available in the provided text. The document is a regulatory submission for substantial equivalence based on existing predicate devices and a specific labeling change, not a performance study report with predefined acceptance criteria.
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