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Longeviti PorousFit implants are anatomical shapes intended for non-weight bearing augmentation and/or restoration of contour within the craniofacial skeleton.

Longeviti PorousFit implants are single-use, high density polyethylene (HDPE) for permanent implantation to restore the natural contour of the craniofacial skeleton. Devices are molded into various dimensions and shapes based on the area of the craniofacial skeleton requiring reconstruction and/or augmentation. PorousFit implants are provided sterile using ethylene oxide (EO).

The provided documents do not contain any information about acceptance criteria or a study proving that the device meets those criteria, as typically understood in the context of AI/ML-based medical devices or diagnostic tools.

The document is a 510(k) premarket notification for the Longeviti PorousFit implant, which is a physical medical device (an implant for craniofacial reconstruction). The FDA letter and the 510(k) summary pertain to demonstrating substantial equivalence to a predicate device, not to demonstrating performance against specific accuracy metrics for an AI algorithm.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This is not applicable to an implant undergoing a 510(k) for substantial equivalence. The "performance" for such a device is demonstrated through biocompatibility, mechanical testing, and manufacturing consistency, not diagnostic accuracy.
2. Sample sizes used for the test set and data provenance: No "test set" in the context of an AI/ML algorithm exists. Performance is based on material properties and manufacturing processes.
3. Number of experts used to establish ground truth and qualifications: Not applicable. Ground truth for an implant is its physical and biological properties, not a diagnostic read.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance, often with AI assistance.
6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI model evaluation. The "ground truth" for the implant itself relates to its physical and chemical properties and biological response.
8. The sample size for the training set: Not applicable. There is no training set for an AI model.
9. How the ground truth for the training set was established: Not applicable.

What the document does describe regarding "testing" for this implant is:

• Summary of Testing: "Testing completed by Matrix Surgical USA for their OmniPore implants are applicable to the Longeviti PorousFit implants. This includes biocompatibility evaluations (Cytotoxicity, ISO Systemic Toxicity, ISO Intracutaneous Study, USP Pyrogen Study, and ISO Muscle Implantation Study), mechanical evaluations, impact testing, purity testing per USP, and porosity testing."

This type of testing is standard for physical implants to ensure their safety and effectiveness, and the applicant is leveraging testing done for their predicate device due to identical materials and manufacturing processes.

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