(217 days)
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
The subject INBONE™ Total Ankle System, INFINITY™ Total Ankle System and INVISION™ Total Ankle Revision System are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. The systems include three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis.
This is a 510(k) summary for a medical device (an ankle replacement system), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is largely not applicable in the context of AI/ML performance evaluation.
However, I can extract the information that is present regarding the non-clinical performance and a general conclusion of equivalency:
Device Name: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
1. A table of acceptance criteria and the reported device performance
The document lists "Applicable Standard" for various non-clinical performance bench tests. The specific acceptance criteria (e.g., minimum tensile strength value) are not explicitly stated within this summary, nor are the reported performance values. The study concludes that the device performs "at least as well as the predicate devices," implying it met the standards.
| Non-clinical performance bench testing | Applicable Standard | Reported Device Performance |
|---|---|---|
| Tensile Properties | ASTM F648 | Met (Implied) |
| Percent Crystallinity | ASTM F2625 | Met (Implied) |
| Impact Resistance | ASTM F648 | Met (Implied) |
| Cross-Link Density | ASTM F2214 | Met (Implied) |
| Oxidation Characterization | ASTM F2102 | Met (Implied) |
| Density Characterization | ASTM D1505 | Met (Implied) |
| Fatigue Crack Growth Rate | ASTM E647 | Met (Implied) |
| Free Radical Concentration | No ASTM or ISO standard governing free radical concentration evaluation or acceptance in this submission | Met (Implied) |
| Wear Performance | ISO/DIS 22622 | Met (Implied) |
| Lock Detail Testing | ASTM F2665 | Met (Implied) |
| Articular Shear Stability | ASTM F2665 | Met (Implied) |
| Endotoxin ( |
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.