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Seare Biomedical Silicone Rods are intended for use in the cosmetic correction of soft tissue deformities, and are shaped at the surgeon's discretion to create an implant to aid in the reconstruction process. Some uses have been as temporary stents for the formation of new tendon sheaths, as well as other uses in surgical repair procedures demanding a highly inert and flexible rod shaped material as deemed appropriate by the using surgeon.

Seare Biomedical Silicone Rods are made from specially formulated silicone elastomers designed for implantation. The intended use of the Seare Biomenical silicone rod is for forming a finished device by the surgeon for his or her own custom use. Seare Biomedical Silicone Rods are in the cosmetic correction of soft tissue deformities, and are shaped at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The Seare Biomedical Silicone Rods will be provided in 15cm or 30 cm lengtiss, 3FR - 28FR sizes, sterile and nonsterile. The durometers or hardness (Shore A) will range from 5 to 60. The appearance is dear to slightly opaque. Surface characteristics will vary from smooth to varving degrees of texturing and porosity.

The provided document is a 510(k) summary for the Seare Biomedical Silicone Rods. It states "Clinical Tests: None" for the device. Therefore, a study proving the device meets acceptance criteria was not conducted or reported in this document. The device was found substantially equivalent based on material, function, performance, and design to predicate devices already on the market.

Based on the available information, the following questions cannot be answered as no clinical studies were performed or reported:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

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