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510(k) Data Aggregation
(77 days)
The Smith & Nephew, Inc. External Fixation Instrumentation is intended for use in:
- Post-Traumatic joint contracture which has resulted in loss of range of motion ( not applicable for Smith & Nephew Rail System)
- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- Open and closed fracture fixation
- Pseudoarthrosis of long bones
- Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-X Fixator)
- Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge)
- Correction of segmental bony or soft tissue defects
- Joint arthrodesis (not applicable for Smith & Nephew Rail System)
- Infected fractures or nonunions
- Mini external fixator systems are indicated for the management of comminuted intraarticular fractures of the distal radius (not applicable for Smith & Nephew Rail System)
- Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints. As well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia (not applicable for Smith & Nephew Rail System)
Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. External Fixation Instrumentation. The subject devices are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew External Fixation Systems and their cleared Indications for Use. Smith & Nephew External Fixation Instruments can be organized into instrument families which are categorized as follows: Tightening/Insertion, Alignment, Guides, and Drills.
The provided text is a 510(k) Premarket Notification for the "Smith & Nephew, Inc. External Fixation Instrumentation." This submission is for surgical instruments, not a device that generates performance metrics in the way an AI diagnostic or therapeutic device would.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment is not applicable to this type of regulatory submission.
This 510(k) submission establishes substantial equivalence to legally marketed predicate devices based on similarities in:
- Raw materials
- Manufacturing processes
- Sterilization procedures
- Nature of body contact
- Design and function
The FDA's review for this type of device focuses on ensuring these accessory instruments are safe and effective for their intended use alongside the cleared Smith & Nephew External Fixation Systems, and that they are substantially equivalent to existing predicate instruments. It does not involve a performance study with quantitative acceptance criteria as would be expected for a diagnostic or AI-driven device.
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(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.
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