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The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation/sectioning of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.

The Bipolar Laparoscopic Loop (PKSTM BiLL™) is-a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Gyrus ACMI G400 Workstation Generator. The PKSTM BiLL™ is a laparoscopic instrument. It is available in an 88mm x 215mm loop. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10°0

Here's an analysis of the provided text regarding the PKS™ BiLL™ device, focusing on the requested acceptance criteria and study information:

PKS™ BiLL™ Device Study Analysis

The provided 510(k) summary for the PKS™ BiLL™ device does not contain detailed acceptance criteria and a specific study proving the device meets those criteria in the typical sense of a clinical trial. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and pre-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria with numerical targets are provided in the document. The performance assessment is primarily qualitative, stating that:

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

The document mentions "Preclinical testing" and "Bench and preclinical testing". It states that this testing was done to validate mechanical design, usability, and software selection, and the performance was compared against the predicate LiNA Loop.

• Sample Size for Test Set: Not specified. The document does not provide a number of devices or subjects used in this testing.
• Data Provenance: The nature of the "preclinical testing" suggests in-house laboratory or animal testing. The country of origin of this data is not explicitly stated, but being a US-based manufacturer, it's reasonable to infer the testing was conducted in the US or by its contracted facilities. The testing is prospective in nature, as it's being conducted to validate the new device.

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

Not applicable. The "preclinical testing" described for this device focuses on engineering performance characteristics (electrical, mechanical, sterilization, biocompatibility, and functional "cut and user performance requirements") rather than diagnostic accuracy or clinical outcomes that would typically involve expert ground truth establishment for a test set. There's no mention of experts establishing a ground truth for this type of performance testing.

4. Adjudication Method

Not applicable. As the "preclinical testing" primarily involves engineering and functional performance, clinical adjudication methods like 2+1 or 3+1 for ground truth are not relevant to the described studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The evaluation focuses on substantial equivalence based on technological features and in-vitro/pre-clinical performance compared to predicates, not on the improvement of human readers with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable/Not relevant. This device is an electrosurgical instrument, not an AI algorithm. Its performance is inherent to its design and how it interacts with the G400 Workstation Generator, meaning "standalone" performance without human interaction (as in, no one is operating the laparoscopic loop) is not a practical concept for this device type. The "cut and user performance requirements" inherently involve human interaction for usability.

7. Type of Ground Truth Used

For the described preclinical testing, the "ground truth" implicitly refers to:

• Engineering specifications and regulatory standards: (e.g., IEC 60601, ISO 10993, ISO 11607, ISO 11137).
• Performance characteristics of the predicate device (LiNA Loop): The new device's performance was "compared against the performance characteristics of the predicate LiNA Loop" and found to "exhibit comparable performance characteristics."

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its function is based on established electrosurgical principles and mechanical design.

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

Not applicable. See point 8.

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