(47 days)
The Solana Surgical LLC, Metatarsal Decompression Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint.
The device is intended for single use to be used with bone cement or press fit without bone cement.
The Solana Surgical Implant is a one-piece device made of Cobalt Chromium (with titanium plasma spray coated stem) or Titanium, intended to replace the articulating surface of the metatarsal bone at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes to match the geometry of the metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends proximally in the intramedullary canal of the distal metatarsal. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.
The provided text is a 510(k) summary for the Solana Surgical Metatarsal Decompression Implant. It details the device's description, indications for use, and a comparison to predicate devices, ultimately concluding substantial equivalence. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
Therefore, I cannot fulfill your request for that specific information based on the provided text.
The document primarily focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed clinical or performance study results against predefined acceptance criteria.
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.