(83 days)
The iBalance AKRxx Medial Opening Wedge Tibial System includes instrumentation, implant, and fixation and is used to provide fixation following Proximal Tibial opening wedge osteotomies. It is intended to be used with adequate post-operative immobilization.
The iBalance AKRFx Medial Opening Wedge Tibial System is comprised of an instrumentation set (AKRFX Medial Instrumentation), a PEEK wedge-like implant (the iFX® Medial PEEK Implant) and PEEK fixation (the iFX® Medial PEEK Cancellous and Cortical Anchors). The system enables surgeons to perform a high tibial opening wedge osteotomy with fixation. The iFX® Medial PEEK Implant is provided in three general sizes; Small (SM), Medium (MD), and Large (LG). Two configurations of implant and anchors exist. The implant and anchors work as a single construct to fixate and support the opening wedge at its corrective angle.
The provided 510(k) summary for the iBalance Medical, Inc.'s AKRyx Medial Opening Wedge Tibial System does not contain detailed acceptance criteria or a comprehensive study report that would allow for a complete description of the device's performance against specific acceptance criteria. The document states that the system meets certain standards and that testing was performed, but it lacks the quantitative results and methodologies typically expected for such a report.
However, based on the information provided, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993-1 standard (for PEEK materials) | "Biomaterials... meet standard ISO 10993-1 standard for biocompatibility" |
| Meet ASTM F 899 (for stainless steel) | "Biomaterials... meet... ASTM F 899 for stainless steel" | |
| Physical Properties | Comparable to the Arthrex System predicate device (based on ASTM F 2077) | "Performance testing according to ASTM F 2077 compared physical properties of the iBalance AKREX System to the Arthex System predicate device." |
| Instrumentation Functionality | Enable proper placement of the iFX implant and anchors | "cadaver studies demonstrated the performance of the AKREx Instrumentation cnables the proper placement of the iFX implant and anchors." |
| Clinical Safety | Differences in design do not raise new safety issues; healing of osteotomy not adversely affected (compared to predicates) | "the company's clinical safety study shows that the differences in the iFX® Medial PEEK Implant System do not raise new safety issues and healing of the osteotomy is not adversely affected by differences in device design as compared to the predicates." |
| Overall Functionality | "functioned as intended" | "In all instances, the iBalance AKRFX Medial Opening Wedge Tibial System functioned as intended and testing results observed were as expected." |
Important Note: The "Reported Device Performance" in the table above paraphrases the statements made in the 510(k) summary. The document does not provide specific data points (e.g., tensile strength values, specific biomechanical outcomes, success rates, complication rates) that would allow for a direct comparison against quantitative acceptance criteria. The statements are general affirmations of compliance or performance.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for any of the studies mentioned.
- Data Provenance:
- Biomaterials: Implied to be laboratory testing against ISO and ASTM standards.
- Physical Properties: Laboratory testing (ASTM F 2077).
- Instrumentation Functionality: "cadaver studies" – suggests prospective, ex-vivo data.
- Clinical Safety: "clinical safety study" – suggests prospective human data. No country of origin is specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the summary. For the cadaver studies, it's implied that surgeons or trained personnel evaluated placement, but no details on their number or qualifications are given. For the clinical safety study, it's not stated how "ground truth" (e.g., successful healing, lack of adverse events) was established or by whom.
4. Adjudication Method for the Test Set
This information is not provided in the summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study is not mentioned. The document describes studies on the device's physical properties, biocompatibility, and clinical safety, but not on human reader performance with or without the device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical medical implant system, not an AI algorithm.
7. The Type of Ground Truth Used
- Biocompatibility/Physical Properties: Ground truth is established by standardized material testing (ISO 10993-1, ASTM F 899, ASTM F 2077) and comparison to predicate device characteristics.
- Instrumentation Functionality: "Proper placement" in cadaver studies would likely be determined by expert observation during and after the procedure using the instrumentation. This could be considered expert consensus/observation in a controlled cadaveric setting.
- Clinical Safety: "No new safety issues" and "healing of the osteotomy is not adversely affected" would be determined through clinical assessments, follow-up imaging, and patient outcomes in a clinical study. The specific methods for establishing this "ground truth" (e.g., radiographic evidence of union, absence of infection, pain scores) are not detailed.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical implant, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above.
§ 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.