(86 days)
The Extrafix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone ( foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for:
- Temporary stabilization of open or closed acute fractures with soft tissue injuries; .
- Definitive stabilization of open or closed fractures where open or alternative closed # treatment is undesirable or otherwise contraindicated;
- Stabilization of fractures in the context of polytrauma; .
- Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries;
- Arthrodesis and osteotomies with associated soft tissue problems; .
- Stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for . infection or other failure;
- Neutralization of fractures stabilized with limited internal fixation; .
- Stabilization of non-unions; and
- Intraoperative temporary stabilization tool to assist with indirect reduction.
The Extrafix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Extrafix External Fixation System, focusing on the requested information.
It's important to preface this by stating that the provided document K091258 is a 510(k) summary for a medical device that is not an AI/ML powered device. It's a traditional mechanical medical device (external fixation system). Therefore, several of the requested categories related to AI/ML performance studies, ground truth, experts, and training sets will not be applicable or present in this type of submission.
Acceptance Criteria and Study for Extrafix External Fixation System (K091258)
As the Extrafix External Fixation System is a mechanical device, its "acceptance criteria" are related to its physical and functional performance and safety, rather than diagnostic or prognostic accuracy metrics typical of AI/ML devices. The "study" proving it meets these criteria is a characterization and evaluation against recognized standards and guidance documents for external fixation devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria & Test Standard | Reported Device Performance | Comments |
|---|---|---|
| Mechanical Performance: | ||
| ASTM F1541-02 (2007) | Demonstrated compliance | This standard specifies requirements and test methods for external fixation devices, covering aspects like static mechanical properties (e.g., stiffness), cyclic mechanical properties (e.g., fatigue), and material biocompatibility. The summary indicates the device was "characterized and evaluated according to the requirements outlined in ASTM F1541-02 (2007)". No specific numerical performance values are given in this summary document, but compliance implies meeting the standard's thresholds. |
| Material/Biocompatibility: | Demonstrated compliance | Included implicitly within ASTM F1541-02, which covers material requirements. |
| Design/Manufacture: | Demonstrated compliance | Follows Good Manufacturing Practices (GMP) implicitly required by FDA. |
| Intended Use: | Meets stated indications | The device is deemed suitable for the specified indications for use, which are broad and cover various fracture types and scenarios. |
| Substantial Equivalence: | Substantially Equivalent | The primary "acceptance" for a 510(k) is proving substantial equivalence to predicate devices, meaning it is as safe and effective. This was determined to be met. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of an AI/ML "test set" for performance evaluation. For a mechanical device, the testing is done on physical samples of the device components. The number of samples tested for each part of ASTM F1541-02 is not specified in this summary but would be defined by the standard itself (e.g., n=5 or n=6 for static tests, n=3 for fatigue, etc.).
- Data Provenance: Not applicable in the human data sense. The "data" comes from laboratory testing of the manufactured device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This device is not an AI/ML diagnostic or prognostic system requiring expert-established ground truth from patient data. The "ground truth" for a mechanical device is established by objective physical measurements and adherence to engineering standards. The FDA reviewers are the regulatory experts who assess the submitted data against regulations and standards.
4. Adjudication Method for the Test Set
- Not applicable. There is no expert review or adjudication of interpretive results for this type of device. Performance is objectively measured through physical testing.
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 a mechanical device, not an AI/ML system. Therefore, no MRMC study, human reader improvement metric, or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a mechanical device, not an algorithm.
7. The Type of Ground Truth Used
- For a mechanical medical device, the "ground truth" is based on:
- Engineering specifications and design requirements: Does the device meet its blueprints and material specifications?
- Adherence to recognized standards: Does the device perform as required by ASTM F1541-02?
- Safety and Effectiveness: Is the device proven to be as safe and effective as legally marketed predicate devices? This is the ultimate "ground truth" for a 510(k) submission.
8. The Sample Size for the Training Set
- Not applicable. There are no "training sets" for mechanical devices as understood in machine learning. The design and manufacturing process involves iterative development and testing, but not in the sense of an AI training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set in the AI/ML sense, this question is irrelevant. The "truth" in manufacturing involves quality control checks and compliance with design specifications throughout the production process.
§ 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.