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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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The Gyrus ACMI Inc. PKS Omni Instrument is intended for electrosurgical coagulation, mechanical grasping, and dissection of tissue, and sealing of vessels up to 3mm, during the performance of laparoscopic and general (open) surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation.

The PKS Omni Instrument is a single-use device with a classic laparoscopic so layout, with a 5mm shaft available in several lengths from 15 to 45cm, supporting symmetrically opening steel jaws. These are curved in a manner similar to Maryland forceps and other laparoscopic graspers, and contain bipolar electrosurgical elements that allow coagulation, cutting and vessel sealing. It is intended for use with the Gyrus ACMI G400 workstation

The provided text describes a 510(k) premarket notification for the Gyrus ACMI Inc. PKS Omni Instrument. This is for an electrosurgical device, and the information provided focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study with detailed performance metrics against acceptance criteria. Therefore, most of the requested information (acceptance criteria table, sample sizes, expert details, adjudication, MRMC study, standalone performance, ground truth types, training set details) is not available in the provided text.

Here's a summary of what can be extracted based on the nature of a 510(k) submission for this type of device:

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

This information is not provided in a traditional clinical study format. For electrosurgical devices, acceptance criteria are generally established through bench testing (e.g., burst pressure for vessel sealing, energy delivery consistency, mechanical strength, biocompatibility), and performance is demonstrated against these engineering specifications. The 510(k) summary focuses on "substantial equivalence" to predicate devices rather than direct clinical performance metrics.

2. Sample size used for the test set and the data provenance:

Not applicable in the context of this 510(k) summary. This submission doesn't describe a clinical "test set" in the way one would for an AI/diagnostic device. Performance is typically established through bench validation, and for a 510(k), this involves comparing the new device's technical characteristics to those of predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is not an AI/diagnostic tool requiring expert-established ground truth for a test set. Its safety and effectiveness are established through engineering and performance testing.

4. Adjudication method for the test set:

Not applicable.

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:

Not applicable. This is an electrosurgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable.

7. The type of ground truth used:

For this type of device, "ground truth" would relate to validated engineering specifications and performance benchmarks (e.g., vessel sealing strength measured in ex vivo tissues, cutting efficiency, heat dissipation, biocompatibility testing results). The document does not detail these specific "ground truths."

8. The sample size for the training set:

Not applicable. This device is not an AI system that undergoes "training."

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

Not applicable.

Summary based on the provided document:

The 510(k) notification for the Gyrus ACMI Inc. PKS Omni Instrument focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This is a common pathway for medical devices that are similar in intended use, technological characteristics, and principles of operation to devices already on the market.

The key arguments for substantial equivalence are:

• Intended Use: The device is intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 3mm, in laparoscopic and general (open) surgical procedures, used with the Gyrus ACMI G400 workstation. This intended use is stated to be similar to the predicate devices.
• Technological Characteristics: The device is described as a single-use device with a classic laparoscopic layout, 5mm shaft, symmetrically opening steel jaws, and bipolar electrosurgical elements for coagulation, cutting, and vessel sealing. It utilizes Gyrus's PlasmaKinetic (PK) technology, relying on simultaneous contact of both active and return electrodes with tissue.
• Principles of Operation: The device induces cutting or coagulating/sealing tissue effects when the applicable generator mode is actuated, similar to its predicate devices.
• Materials: Constructed of similar materials as other Gyrus ACMI electrosurgical devices.

The document explicitly states: "The Gyrus ACMI Inc. PKS Omni Instrument, as described in this submission, is substantially equivalent to the predicates in intended use, principles of operation and fundamental scientific technology and raises no new issues of safety and effectiveness."

Predicate Devices cited:

• Gyrus Medical Inc. Zip Wing Cutting Dissector (K023493)
• Gyrus Medical Open Forceps (K024286)
• Gyrus Medical Plasma Seal (K061975)
• Gyrus Medical Plasmacision and Plasmablend Electrodes (K050460)
• Valleylab Ligasure Sealing System/ Ligasure V (K031011)
• Gyrus General Purpose Electrosurgical Generator (K050550)

The FDA's decision letter confirms that the device is "substantially equivalent" to the referenced predicate devices, allowing it to be marketed. This regulatory pathway does not typically involve the type of clinical performance studies with detailed acceptance criteria, sample sizes, and ground truth establishment that would be associated with novel diagnostic algorithms or AI devices. Performance is inferred through similarity to devices already proven safe and effective.

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The Gyrus ACMI PlasmaKinetic SuperPulse System is intended for use for the ablation, removal, resection, and coagulation of soft tissue, and where associated hemostasis is required in open, endoscopic, and laparoscopic surgical procedures.

The currently marketed Gyrus ACMI PK SuperPulse System is a bipolar RF generator that accepts a variety of disposable hand pieces that utilize a PlasmaKinetic (PK) waveform. The generator face includes two sockets that allow a range of hand pieces to be utilized in a dry field environment, although only one socket may be active at any given time. The Gyrus ACMI PK SuperPulse System General Purpose Electrosurgical Generator employs a system of automatic instrument detection, through a capacitor located in the hand piece connector plug. This ensures that only the allowable range of waveform output and power level can only be applied to the instrument irrespective of the output socket. Accessories presently provided with the Gyrus ACMI PK SuperPulse System include a power cable and a foot switch. This Special 510(k) proposes the addition of a new optional accessory, the Dual Footswitch Connector Cable. The Dual Footswitch Connector Cable allows for easier use of the Gyrus ACMI PK SuperPulse System when multiple surgeons are present. This is achieved by allowing the connection and use of two footswitches on the same generator.

This document is a 510(k) summary for a medical device called the Gyrus ACMI PK SuperPulse System. It's a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document proposes a "Special 510(k)" for the addition of a new accessory, a "Dual Footswitch Connector Cable," to an already cleared device. The core of this submission is to argue that this change does not significantly affect the safety or efficacy of the original device. No new performance studies or clinical trials are presented because the modification is deemed minor.

Therefore, I cannot provide the requested table or information because the provided text is a regulatory filing asserting equivalence, not a scientific study with performance metrics.

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The Gyrus ACMI PKS Plasma Morcellator is intended for cutting, coring, and extracting tissue in various operative laparoscopy procedures, including laparoscopic general surgical procedures, laparoscopic urological procedures, and laparoscopic gynecologic procedures.

The Gyrus ACMI PKS Plasma Morcellator consists of two main elements: a Morcellator that includes a cutting shaft and handle with an integrated electrical cable that connects to a Gyrus Medical generator; and a Grasper that passes through the hollow shaft of the Morcellator, to grasp tissue and retract it toward the cutting element on the Morcellator shaft tip. An obturator may also be used to assist in the introduction of the device in laparoscopic procedures, and like the grasper, is positioned through the shaft of the Morcellator tube when being utilized

The provided text describes a 510(k) submission for the Gyrus ACMI PKS Plasma Morcellator, focusing on substantial equivalence to predicate devices rather than detailed performance studies with specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.

However, I can provide what is available:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document states: "During design verification, the performance of the PKS Plasma Morcellator was compared against the known performance characteristics of the predicate Gynecare Laparoscopic Morcellator using the bipolar tissue cutting technology of the predicate Gyrus PlasmaCision Laparoscopic Spatula. Testing demonstrated that the performance requirements were met, and that the PKS Plasma Morcellator exhibited comparable performance characteristics to both the predicate care Laparoscopic Morcellator and predicate Gyrus PlasmaCision Laparoscopic Spatula."

2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The study described is a "design verification" which compared the new device against predicate devices' known characteristics, implying bench testing and comparison, not clinical trials with human subjects or specific data sets with provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study described does not appear to involve human experts establishing ground truth in the context of diagnostic or interpretive tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. The study described does not appear to involve adjudication of expert readings.

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:
This information is not provided in the document. This is a medical device (morcellator) and not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a medical instrument (morcellator), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" implicitly used for comparison was the "known performance characteristics" of the predicate devices. This would likely stem from previously established performance data, design specifications, and clinical experience with those predicate devices. Formal "ground truth" in the sense of pathology or outcomes data from a prospective study specifically for this device comparison is not mentioned.

8. The sample size for the training set:
This information is not provided in the document. This device does not use machine learning, so a "training set" is not relevant.

9. How the ground truth for the training set was established:
This information is not applicable as the device does not use machine learning, so there is no training set.

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