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510(k) Data Aggregation
(109 days)
Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterlized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterilization Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.
Sterilization methods and configurations - Sterrad NX Standard Sterilization Cycle
Lumen claims for Sterrad NX Standard Sterilization Cycle
| Summit Cassette Model | Minimum Inside Diameter | Maximum Length | Number of Lumens |
|---|---|---|---|
| IN-2681 | 1 mm | 65 mm | 1 |
| IN-2681 | 3 mm | 200 mm | 1 |
| IN-8987-S | 1 mm | 500 mm | 5 |
| IN-8615 | 2.3 mm | 210 mm | 5 |
| IN-6105 | 4 mm | 235 mm | 1 |
The worst case validated load by vent-to-volume calculation is the IN-2681 tray.
Summit Medical Inc. InstruSafe Instrument Protection System are cassettes / trays used to enclose and hold surgical instruments and instrument accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes / trays do not have direct patient contact. The cassettes / trays by themselves do not maintain sterility.
The cassettes / trays are different sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes / trays have perforations to allow sterilant penetration. The cassettes / trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical instruments within the cassette / tray during the sterilization process and subsequent storage and transportation.
InstruSafe Instrument Protection System cassettes include
- perforated base
- perforated cover
- silicone inserts (hold-it / hold down)
- Handles
- Latches
- Feet
- Posts (optional)
- Divider (optional)
- Shelf (optional)
The cassette contains components made of anodized aluminum, stainless steel, blue silicone, black silicone, polyester, ultem™ 1000
The provided document is a 510(k) premarket notification for the InstruSafe® Instrument Protection System. It describes the device, its intended use, and a comparison to a predicate device, focusing on sterilization methods.
However, the document does not contain information typically associated with acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device. This document is for a non-AI medical device and primarily focuses on demonstrating substantial equivalence to a predicate device, particularly regarding a new sterilization cycle. Therefore, I cannot extract the requested information as it is not present.
Specifically, the document does NOT contain information on:
- A table of acceptance criteria and reported device performance for an AI/ML algorithm.
- Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set sample size related to an AI/ML device.
The information provided pertains to the physical and functional characteristics of instrument protection cassettes and their compatibility with a specific sterilization cycle. The "performance data" mentioned refers to sterilization validation testing, not AI algorithm performance.
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