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The Lac-Mac Ltd. 84E Series Single Ply Wrappers are devices intended to be used to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed medical device for at least 30 days. The Lac-Mac Ltd. 84E Series Single Ply Wrappers are provided nonsterile and must be processed before use. These wrappers may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (prevacuum, 270°F, 4 minutes with 40 minutes drying time).

Lac-Mac Ltd. 84E Series Single Ply Wrapper

This document is a 510(k) clearance letter from the FDA for a medical device called "Lac-Mac Ltd. 84E Series Single Ply Wrapper." It does not contain any information regarding the acceptance criteria or a study proving the device meets that criteria in the context of an AI/ML powered device.

The document grants clearance for a physical product (sterilization wrap) and primarily addresses its substantial equivalence to previously marketed predicate devices under the 510(k) pathway. This regulatory pathway is for conventional medical devices and does not involve AI/ML performance evaluation as would be required for a software-as-a-medical-device (SaMD) or an AI-enabled device.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or how ground truth was established for an AI/ML model.

This document is entirely irrelevant to the query about AI/ML device evaluation.

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