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NATRELLE INSPIRA® Single Use Sizers are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size breast implant.

NATRELLE INSPIRA® Single Use Sizers are designed for temporary intraoperative placement, to assist in determining the desired breast implant volume. They are used during breast augmentation or reconstruction procedures.

NATRELLE INSPIRA® Single Use Sizers are constructed of a smooth silicone elastomer shell and are filled with responsive gel that contains the colorant cobalt aluminate blue spinel at a concentration of 0.1%. They have been designed to match the dimensions of the NATRELLE INSPIRA® breast implants.

NATRELLE INSPIRA® Single Use Sizers are supplied sterile and are for single patient use, one sizer per breast.

The provided text is an FDA 510(k) clearance letter and summary for a medical device: "NATRELLE INSPIRA® Single Use Sizers." This document does not contain information about an AI/ML-driven device or a study involving human readers or ground truth establishment relevant to AI/ML performance.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (Natrelle® Re-Sterilizable Breast Implant Sizers) through non-clinical performance data, primarily mechanical testing and biocompatibility. The device itself is a physical sizer filled with silicone gel, used by surgeons during breast augmentation procedures.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, including:

• Table of acceptance criteria and reported device performance (for AI/ML): Not applicable. The "performance data" mentioned in the document refers to non-clinical tests like mechanical testing and biocompatibility, not AI performance metrics.
• Sample size and data provenance (for AI/ML test set): Not applicable. There is no AI test set.
• Number of experts and qualifications (for AI/ML ground truth): Not applicable. There is no AI ground truth establishment.
• Adjudication method (for AI/ML test set): Not applicable.
• MRMC comparative effectiveness study: Not applicable. This is a physical medical device, not an AI system.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable. The ground truth for this device's testing relates to physical properties and biocompatibility, not diagnostic or clinical accuracy determined by experts or pathology.
• Sample size for training set (for AI/ML): Not applicable. There is no AI training set.
• How ground truth for training set was established (for AI/ML): Not applicable.

The document explicitly states that "Non-clinical performance data including mechanical testing and biocompatibility data were submitted to support clearance... All pre-established acceptance criteria were met." However, these acceptance criteria and the associated study are not related to the performance of an AI/ML device, human reader improvement, or ground truth for diagnostic accuracy, which are the typical focus of the questions posed.

To summarize, the provided text describes a traditional medical device and its clearance process, not an AI/ML device study.

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