(223 days)
The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. Specifically, the system is intended for:
- Stabilization of open or closed fractures, typically in the context of polytrauma or o where open or alternative closed treatment is undesirable or otherwise contraindicated;
- Arthrodesis and osteotomies with associated soft tissue problems; o
- Stabilization of limbs after removal of total joint arthroplasty for infection or other 0 failure;
- Stabilization of non-unions; and 0
- Intraoperative temporary stabilization tool to assist with indirect reduction. 0
The XtraFix External Fixation System includes various elements designed to build a fixator construct. The line additions include new clamps and half pins.
The provided document describes the 510(k) summary for the XtraFix External Fixation System Line Additions, focusing on its substantial equivalence to predicate devices rather than a de novo study with acceptance criteria and performance data. Therefore, many of the requested sections regarding user studies, ground truth, and sample sizes for AI/algorithm performance cannot be extracted directly from this document.
However, based on the information provided, here's what can be stated:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for line additions to an existing device, the acceptance criteria are primarily defined by "substantial equivalence" to predicate devices and adherence to relevant industry standards. The performance is demonstrated through mechanical testing.
| Acceptance Criteria Type | Acceptance Criteria Description | Reported Device Performance |
|---|---|---|
| Substantial Equivalence to Predicate Devices | The new line additions (clamps and half pins) should have similar indications for use and incorporate similar technological characteristics to legally marketed predicate devices. | All evaluations determined that the XtraFix External Fixation System (including the line additions) is substantially equivalent to the predicate devices (XtraFix External Fixation System K091258 and K111155, Synthes Large External Fixation Clamps- MS K031428, and Smith & Nephew Jet-X Unilateral Fixator K994143). |
| Mechanical Performance (External Fixation Devices) | Characterization and evaluation according to the requirements outlined in ASTM F1541-02 (2007): Standard Specification and Test Methods for External Fixation Devices and the FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices. This typically involves criteria related to strength, stiffness, fatigue, and other biomechanical properties. | The system was characterized and evaluated according to the requirements outlined in the specified ASTM standard and FDA guidance. The document states that the principles of operation are the same as for the predicates, implying that the performance meets the established benchmarks for external fixation devices. Specific performance values (e.g., stiffness values, failure loads) are not provided in this summary. |
| MR Safety and Compatibility | Characterization and evaluation according to the requirements outlined in FDA Guidance document, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." This typically involves assessing magnetic fields, RF heating, and image artifact. | Testing confirmed the devices can be used in an MR environment under predetermined conditions. The term "MR Conditional" can be used to describe the system in accordance with the guidance document, meaning it meets the acceptance criteria for safe use in an MR environment under specific conditions. |
Regarding the remaining questions, the provided 510(k) summary does not contain information about:
- 2. Sample size used for the test set and the data provenance: This document describes mechanical and MR compatibility testing, not clinical or AI/algorithm performance studies with test sets of patient data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical images/data requiring human interpretation for ground truth were part of this 510(k) submission's evidence.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical or MR compatibility 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 medical device (external fixation system), not an AI algorithm for diagnostic assistance.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical and MR testing, "ground truth" would be established by the physical properties measured against the standard specifications. This is not comparable to clinical ground truth.
- 8. The sample size for the training set: Not applicable. No AI/algorithm training set was used.
- 9. How the ground truth for the training set was established: Not applicable. No AI/algorithm training set was used.
Summary of what the document implies for the study:
The study referenced is not a clinical efficacy study involving patient data, but rather benchtop mechanical testing and MR compatibility testing. The primary method for demonstrating "device meets acceptance criteria" is via adherence to established ASTM standards and FDA guidance documents for external fixation devices and MR safety, coupled with successfully proving substantial equivalence to existing predicate devices.
§ 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.