(199 days)
The Reflection Constrained Liner is a cemented or uncemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-perative instability and for whom all other options to constrained acetabular components have been considered.
The components subject of this notification are to be used with the Reflection Acetabular System, which is indicated for use with or without cement, and includes single use devices.
The Reflection Constrained Liner is used with existing appropriately sized Reflection Acetabular Shells. The Reflection Constrained Liner can be used with previously implanted femoral components, femoral heads (28 mm only) and Reflection Acetabular Shells such as in a revision case, or it may be used in primary cases and implanted along with the shell, head and stem. Any appropriately sized Reflection Shell may be utilized. Any stem may be used, provided a 28 mm metal femoral heads is used with the femoral component. Ceramic heads or skirted femoral heads of any material should not be used with the Reflection Constrained Liner.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Reflection Constrained Liner) and an FDA clearance letter. These documents attest to the device's substantial equivalence to predicate devices but do not include details about specific performance acceptance criteria or a study designed to demonstrate compliance with such criteria. The document mentions "materials data, and testing results provided within this Abbreviated Notification" to support safety and effectiveness, and refers to several guidance documents, but the specifics of these tests and their results are not detailed in the provided excerpts.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given text.
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”