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The ActivaPin™ is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

The ActivaPin™ is made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaPin™ gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place within two years thus eliminating the need for implant removal surgery.

The provided document is a 510(k) summary for the Bioretec ActivaPin™. It describes the device, its intended use, and its equivalence to predicate devices. However, the document does not contain any information about acceptance criteria or specific studies proving the device meets those criteria, as typically found in clinical trials or performance testing reports.

Instead, the submission focuses on demonstrating substantial equivalence to already marketed devices (Inion OTPSTM Biodegradable Pin and Bionx Implants Inc., SmartPin™ PDX, PLGA Pin) through non-clinical tests and in vitro-testing. This type of submission relies on comparing the new device's characteristics and performance to those of legally marketed predicate devices, rather than conducting new clinical studies or setting explicit acceptance criteria for novel performance claims.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these details are not present in the provided 510(k) summary.

The document states: "Non-clinical tests and In vitro-testing determined that the ActivaPin™ has substantially similar performance as compared to its predicate devices." This is the core of the proof of meeting acceptance criteria, which in this context means "being substantially equivalent to predicate devices."

In summary, based only on the provided text:

• Acceptance Criteria and Reported Device Performance: Not explicitly stated as numerical criteria or specific performance values. The acceptance criterion is "substantial equivalence" to predicate devices, which was determined through non-clinical and in vitro testing.
• Sample size for the test set and data provenance: No information provided. The testing was non-clinical and in vitro, not on human subjects.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as there was no human-based ground truth establishment described for a test set.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or conducted.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
• Type of ground truth used: Not applicable in the traditional sense of clinical studies. The "ground truth" for the equivalence assessment was the performance of the predicate devices.
• Sample size for the training set: Not applicable, as this is not a machine learning algorithm; it's a physical device.
• How the ground truth for the training set was established: Not applicable.

The 510(k) process for this device relies on demonstrating that it is as safe and effective as a legally marketed device through comparison, rather than establishing de novo performance metrics with new clinical data.

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