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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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The Olympus ESG-400 electrosurgical unit is intended for cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.

The ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. It is intended for cutting and coagulation of tissue in open, laparoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.

The updated ESG-400 allows Olympus Plasma Kinetic (PK) instruments to be connected at the device.

The provided document is a 510(k) premarket notification for an electrosurgical generator, the Olympus ESG-400, detailing its comparison to a predicate device and safety information. It focuses on demonstrating substantial equivalence rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a device to "meet" those criteria in the way a diagnostic or AI-driven device would.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission for an electrosurgical generator.

However, I can extract information related to general performance testing and compliance with standards.

Here's the information that can be extracted, and where applicable, a note that the requested information is not available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Electrosurgical generators are assessed for safety and performance against recognized standards, rather than specific diagnostic accuracy metrics. The "acceptance criteria" here relate to meeting the specifications and safety requirements outlined in the standards and showing equivalence to a predicate device.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of a typical clinical study. Performance testing involved bench tests and validation with representative HF instruments.
• Data Provenance: Not applicable in the sense of patient data. The testing was conducted internally by the manufacturer (Olympus Winter & Ibe GmbH) as bench validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• This information is not applicable and not provided in the document. The testing involved comparing device outputs and functionality against a predicate device and industry standards, not against human expert diagnoses or interpretations.

4. Adjudication Method for the Test Set

• Not applicable. The "test set" here refers to bench testing and comparison against a predicate device, not diagnostic interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done. This type of study is not relevant for an electrosurgical generator, which is a therapeutic device, not an AI-driven diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is an electrosurgical generator, not an algorithm that performs without human involvement. The device itself is the "standalone" component in its intended function.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" for this device's performance is defined by:
  • Compliance with recognized international standards (e.g., IEC, ISO for safety, performance, EMC, software, risk management).
  • Direct comparison of waveform output and power levels to legally marketed predicate devices (Gyrus G400, K081954).
  • Internal engineering specifications and risk analysis based on ISO-14971.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" for this device.

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