(256 days)
AlloX2 Tissue Expanders are intended for temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in treatment of soft tissue deformities.
Additionally, the AlloX2 Tissue Expanders contain a silicone drain component which allows access to and drainage of latent fluids from the periprosthetic space. This drain component does nort-term, immediate, intraoperatively placed drains.
The AlloX2 Tissue Expanders are constructed as a unit from silicone elastomer and consist of a smooth or textured expansion envelope with an integral magnetic injection port. Specialty Surgical Products is proposing that an integral or remote (connected by tubing) drain port be integrated into the predicate device to facilitate the drainage of fluid in the periprosthetic pocket. The port design and magnetic technology/concept are the same as those of the predicate injection ports. The principles of operation of the subject device methodology are identical to that of the primary predicate Silicone Tissue Expander and the additional predicate Closed Wound Drain.
This document is a 510(k) premarket notification for a medical device called "AlloX2 Tissue Expanders." It doesn't describe an AI/ML-driven medical device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details the physical and functional characteristics of the tissue expanders and compares them to existing predicate devices to demonstrate substantial equivalence for FDA clearance.
Therefore, I cannot provide the information requested in the prompt, as it is designed for studies proving the performance of AI/ML diagnostic devices. The document concerns a physical medical device (tissue expanders) and its mechanical/material performance, not a diagnostic algorithm.
Specifically, the document does not include:
- Acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, AUC).
- A test set, training set, or data provenance in the context of an AI/ML model.
- Expert involvement for establishing ground truth for diagnostic images.
- Adjudication methods for diagnostic interpretations.
- Multi-reader multi-case (MRMC) studies or effect sizes of AI assistance on human readers.
- Standalone algorithm performance.
- Ground truth based on expert consensus, pathology, or outcomes data for diagnostic accuracy.
The "testing" mentioned in the document refers to engineering specifications and mechanical/material performance tests for the physical device (e.g., tube shell junction, overexpansion, strength), aligning with ASTM F1441-03, a standard for soft-tissue expander devices.
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