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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 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 is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the G400 generator. It is available in an 88mm x 227mm loop size. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10-6.

The provided text describes a Special 510(k) Notification for the Gyrus ACMI PKS™ BiLL™ (Bipolar Laparoscopic Loop). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than a de novo clinical study establishing new performance metrics. Therefore, the information requested about acceptance criteria and a study proving device performance in the context of AI-driven diagnostics is not fully applicable. However, I will extract and present the available information regarding performance and evaluation, interpreting "acceptance criteria" as successful completion of the described evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • Pre-clinical Evaluation: Three (3) physicians participated in the pre-clinical evaluation. The evaluation used "extirpated tissue (Human Uterine)." While the number of tissue samples isn't explicitly stated, the context implies mock procedures were performed.
  • Other tests (Bench, Biocompatibility, Electrical): These tests typically involve discrete units of the device or its components. Specific sample sizes are not provided but are generally determined by established engineering and regulatory standards for each test type (e.g., a certain number of devices for electrical safety, specific material samples for biocompatibility).
• Data Provenance: Not explicitly stated, but the submission is from "Olympus Surgical Technologies of America · Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772" (USA) and "Gyrus Medical, Ltd. Fortran Road, St. Mellons Cardiff CF3 OLT" (ERN: 9617070, indicating UK/European entity). Given the submission to the FDA, it is processed for the US market. The tissue used was "Human Uterine" but the exact source (country, hospital) is not specified. The study is retrospective in the sense that it evaluates a device not intended to gather new diagnostic insights but to confirm its performance against a predicate.

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

• Number of Experts: Three (3) physicians.
• Qualifications of Experts: Their specific qualifications (e.g., years of experience, specialty) are not detailed beyond being described as "Physicians." They were involved in the pre-clinical evaluation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the traditional sense of diagnostic interpretation or a consensus-building process for ground truth. In the pre-clinical evaluation, each of the three physicians individually completed 32 questions after a mock procedure. The "adjudication" or decision on user acceptance was based on the collective positive feedback: "All three physicians were happy with the proposed device and felt it met their needs and performed to their expectations." There's no indication of a formal 2+1 or 3+1 adjudication for conflicting opinions as would be seen in a diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 submission is for an electrosurgical device, not an AI-driven diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device's evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is an electrosurgical device, not an algorithm. There is no "standalone" algorithmic performance to evaluate. The device itself is a tool operated by a human.

7. The Type of Ground Truth Used

• Pre-clinical Evaluation: The ground truth for the user acceptance aspect of the pre-clinical evaluation was the individual and collective professional opinion/satisfaction of the three evaluating physicians. For the device performance within the mock procedure, it was based on the physicians' subjective assessment against their expectations and needs.
• Other Tests (Bench, Biocompatibility, Electrical): The "ground truth" for these tests is defined by established engineering standards, regulatory requirements (e.g., IEC 60601, ISO 10993), and the device's own pre-defined product specifications and user requirements. Successful adherence to these standards and specifications serves as the "ground truth."

8. The Sample Size for the Training Set

• Not applicable. This device itself is not an AI algorithm that requires a training set. The "training set" concept does not apply here.

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

• Not applicable. As there is no training set for an AI algorithm, determining its ground truth is not relevant here.

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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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