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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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "mechanical and tissue tests" were performed. However, it does not specify the sample size for these tests (e.g., number of tissue samples, number of test repetitions). The data provenance is also not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided. The core of the submission relies on comparing the new device to the predicate, and leveraging prior testing and standards relevant to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device submission. There is no concept of "ground truth" to be established by experts in the context of electrosurgical device performance demonstration for substantial equivalence. The tests performed are engineering and biological validations, not clinical assessments by experts for diagnostic or treatment efficacy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used in clinical studies or expert reviews of data (e.g., imaging) to establish ground truth or assess agreement, which is not relevant for this device's validation.

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, an MRMC comparative effectiveness study was not done. This device is an electrosurgical tool, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

No, a standalone algorithm-only performance study was not done. This is a physical electrosurgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as presented in your question (expert consensus, pathology, outcomes data) is not applicable to this premarket notification. The "truth" in this context is established through:

• Compliance with recognized standards: IEC 60601, ISO 10993, ISO 11607, ISO 11737.
• Engineering testing: Mechanical, electrical safety, thermal safety.
• Pre-clinical (tissue) testing: To demonstrate equivalent tissue effects, speeds, and forces.
• Biocompatibility testing: Compliance with ISO 10993.
• Sterilization validation: Compliance with ISO 11607 and ISO 11737.

8. The sample size for the training set

This is not applicable. This is a traditional medical device, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This is not applicable. See point 8.

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