(90 days)
The OTI Unicondular Interpositional Spacer is intended for use in the Osteoarthritic knee, where substantial amounts of articular cartlige have been lost as a result of the disease.
The prostheses will be used in indications for uncemented treatment of the Tibia articulating surfaces (Medial and Lateral) of the following:
Moderate degeneration of the Medial and/or Lateral compartment of the knee (grade II-IV chondromalicia ) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral components.
OTI Unicondular Interpositional Spacer System
This is an FDA Premarket Notification (510(k)) letter for a medical device called the "OTI Unicondular Interpositional Spacer System." This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and grants permission to market the device.
This document does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.
510(k) clearances typically do not include:
- A table of acceptance criteria and reported device performance from a specific study. The substantial equivalence determination is often based on design similarities, material properties, and sometimes limited bench or preclinical testing, rather than extensive clinical efficacy studies with predefined acceptance criteria as might be seen for a PMA (Premarket Approval) or De Novo pathway.
- Details about sample size, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance. These are more relevant to AI/ML-driven device evaluations or devices requiring clinical trials to demonstrate efficacy.
- Specifics on how ground truth was established for training or testing sets.
To reiterate, the provided text does not contain the information requested in your prompt. It solely outlines the FDA's decision to clear the device for marketing based on substantial equivalence.
§ 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
(a)
Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).(b)
Classification. Class II.