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The Bipolar Laparoscopic Loop is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Olympus Electrosurgical Generator ESG-400.

The Bipolar Laparoscopic Loop is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Olympus Electrosurgical Generator ESG-400. It is available in an 88mm x 227mm loop size. The device is sterilized by ethylene.

This document describes the premarket notification (510(k)) for the PK Lap Loop, a bipolar electrosurgical device. The submission focuses on demonstrating substantial equivalence to a predicate device (PKS BiLL) rather than presenting a standalone study with defined acceptance criteria and performance metrics in the typical sense of AI/algorithmic device evaluation.

Here's an analysis based on the provided text, addressing your points where applicable:

1. A table of acceptance criteria and the reported device performance

The concept of specific "acceptance criteria" for performance metrics like sensitivity, specificity, or F1-score, as seen in AI/ML device submissions, is not directly applicable here. This document is for a traditional medical device (electrosurgical loop) and focuses on demonstrating substantial equivalence to an already cleared predicate device. The "performance" is implicitly tied to demonstrating that the new device functions equivalently and safely to the predicate.

The closest to acceptance criteria are the characteristics compared between the PK Lap Loop and the predicate PKS BiLL. The reported device performance is that these characteristics are identical or similar to the predicate, implying they meet the predicate's established performance and safety profile.

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