(64 days)
Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-Pro® Sterilizer Systems.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 year post sterilization. The products are for single use only.
Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERIS® V-Pro® Sterilization Cycles: Lumen Cycle Non Lumen Cycle Flexible Cycle
Device lumen dimensions:
Flexible Cycle: 1 lumen max and 1 mm min ID x 1050 mm max length for all pouch sizes.
Lumen Cycle: 1 lumen max for all pouch sizes.
1 mm min ID for pouch sizes: 130 x 380 mm, 130 x 270 mm, 90 x 250 mm, 90 x 200 mm 2 mm min ID for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm 125 mm max length for pouch sizes: 130 x 380 mm, 130 x 250 mm, 90 x 250 mm, 90 x 200 mm 250 mm max length for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm
Max Weights: 1.234 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 300 x 450 mm 250 x 400 mm 190 x 330 mm
.122 pounds for pouch sizes below (Flexible and Lumen Cycles) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm
.204 pounds for pouch sizes below (Non-Lumen Cycle) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm
Pouch Sizes: 300 x 450 mm 250 x 400 mm
Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-Pro® Sterilizer Systems.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 year post sterilization. The products are for single use only.
Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERIS® V-Pro® Sterilization Cycles: Lumen Cycle Non Lumen Cycle Flexible Cycle
Device lumen dimensions:
Flexible Cycle: 1 lumen max and 1 mm min ID x 1050 mm max length for all pouch sizes.
Lumen Cycle: 1 lumen max for all pouch sizes.
1 mm min ID for pouch sizes: 130 x 380 mm, 130 x 270 mm, 90 x 250 mm, 90 x 200 mm 2 mm min ID for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm 125 mm max length for pouch sizes: 130 x 380 mm, 130 x 250 mm, 90 x 250 mm, 90 x 200 mm 250 mm max length for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm
Max Weights: 1.234 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 300 x 450 mm 250 x 400 mm 190 x 330 mm
.122 pounds for pouch sizes below (Flexible and Lumen Cycles) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm
.204 pounds for pouch sizes below (Non-Lumen Cycle) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm
Pouch Sizes: 300 x 450 mm 250 x 400 mm
This document is an FDA 510(k) clearance letter for a medical device: "Steriking® LT-Blueline Pouches with Tyvek®". It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is a regulatory approval for a physical medical device (sterilization pouches), not an AI/ML diagnostic or therapeutic device.
Therefore, I cannot answer your specific questions regarding acceptance criteria and performance studies for an AI/ML device based on the input provided. The requested information (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) is relevant for AI/ML device submissions, but this document pertains to a physical sterilization product.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).