(184 days)
As a spacemaking device used in guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation.
As a spacemaking device used in cranio-facial guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation. Not to be used in load-bearing areas.
Immix™ is a DL-polylactide resorbable polymer material intended for use by itself or in combination with other materials to create space for bone regeneration. The material is packaged individually in various amounts and supplied sterile.
The provided text describes a 510(k) premarket notification for a medical device called "Immix™ Bone Graft Extender." It outlines the device's purpose, comparison to a predicate device, and the FDA's decision regarding its substantial equivalence. However, the document does not contain any information about acceptance criteria, detailed study designs, performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.
The 510(k) summary focuses on establishing substantial equivalence to a legally marketed predicate device (HTR Polymer, U. S. Surgical). This process typically relies on demonstrating that the new device has the same intended use, technological characteristics, and performs at least as safely and effectively as the predicate, often through comparisons to existing data or general performance characteristics rather than new, extensive clinical trials with specific acceptance criteria as might be seen for novel devices requiring PMA approval.
Here's a breakdown of why the requested information cannot be extracted from this document:
- Table of Acceptance Criteria and Reported Device Performance: This information is completely absent. The document states "The results of performance and biocompatibility testing show that the Immix™ polymer material is safe and effective for its intended use and performs at least as well as legally marketed predicate devices," but it does not specify what those performance criteria were or the actual results.
- Sample Size and Data Provenance for Test Set: Not mentioned. It's unclear if any specific "test set" in the context of AI model evaluation was used, as this is a medical device, not an AI algorithm.
- Number and Qualifications of Experts for Ground Truth: Not mentioned.
- Adjudication Method: Not mentioned.
- MRMC Comparative Effectiveness Study: Not mentioned. The device is a "bone graft extender," not an imaging or diagnostic AI tool that would typically involve human readers.
- Standalone Performance Study (Algorithm Only): Not applicable, as this is a physical medical device, not an algorithm.
- Type of Ground Truth Used: Not mentioned. As it's a physical implant, "ground truth" would likely refer to clinical outcomes, histological analysis, or imaging results from biocompatibility and performance studies, but these details are not provided.
- Sample Size for Training Set: Not applicable/not mentioned. This is not an AI model requiring a training set.
- How Ground Truth for Training Set was Established: Not applicable/not mentioned.
In summary, the provided 510(k) document is a regulatory submission for a physical medical device and does not contain the type of detailed performance study information, especially related to AI model evaluation, that your request specifies. The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to a predicate device, meaning it performs "at least as well" as the predicate based on unspecified performance and biocompatibility testing.
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.