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The Inion OTPSTM Biodegradable Pin is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The Inion OTPS™ Biodegradable Pin is indicated for maintenance of alignment and fixation The missi OFF . Breedomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Previously 510(k) cleared Inion OTPS™ Biodegradable Pin (K031712) is manufactured by extrusion followed by grinding and cutting. With this special 510(k) we inform for additional manufacturing method by injection moulding followed by cutting. Injection moulded Inion OTPSTM Biodegradable Pins are identical in all the other aspects with the predicate pins except this manufacturing method. Material recipe with copolymer composition is identical. Only difference is that the molecular weight is slightly higher with the extrusion recipe than with the injection moulding recipe.

The provided text is a Special 510(k) Summary for a medical device called the "Inion OTPS™ Biodegradable Pin." This document describes a modification to the manufacturing method of an already cleared device, not the initial approval of a new device or its performance against acceptance criteria in a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, specifically:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence of a modified manufacturing method (injection molding) to a previously cleared manufacturing method (extrusion). It states that the injection-molded pins are "essentially identical" and "substantially equivalent" to the predicate device, with "no new risks associated with use... as compared to the predicate device." This equivalence is "shown by the verification testing," but details of this testing (specific criteria, results, sample sizes, etc.) are not included in this summary.

The document's purpose is to inform the FDA that a manufacturing change does not alter the device's safety or effectiveness, allowing it to remain on the market. It's not a report of a new clinical or performance study establishing new acceptance criteria or proving their fulfillment.

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