(100 days)
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
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence to Predicate Device | - Identical Indications for Use. | The proposed PKS™ BiLL™ has the identical Indications for Use as the predicate PKS™ BiLL™. |
| - Connects to the same electrosurgical generator (G400). | The bipolar PKS™ BiLL™ connects to the same electrosurgical generator, G400. | |
| - Uses Bipolar PK (Plasma Kinetic) technology with an identification capacitor recognized by the generator for optimal power output. | The PKS™ BiLL™ uses Bipolar PK (Plasma Kinetic) technology and contains an identification capacitor embedded in the single use connector cable will be recognized by the generator to set default optimal power output parameters for the subject instrument. This remained unchanged and identical to the predicate. | |
| - Mechanical design features similar to the predicate. | The mechanical design features of the PKS™ BiLL™ are similar to that of the predicate PKS™ BiLL™. | |
| Electrical Safety | - Compliance to electrical standards (specifically applicable sections of IEC 60601 incorporating electrical, thermal safety and Electromagnetic Interference). | The PKS™ BiLL™ instrument is compliant to electrical standards specifically to those applicable sections of IEC 60601 incorporating electrical, thermal safety and Electromagnetic Interference. Electrical testing was also carried out to IEC 60601 and passed as well. |
| Biocompatibility | - Materials used are well-established and used in other FDA-cleared medical devices. | The PKS™ BiLL™ instrument uses materials that are well established and used in other GYRUS ACMI FDA cleared medical devices. |
| - Biocompatibility testing on all patient contacting parts performed in compliance with ISO-10993. | Biocompatibility testing on all patient contacting parts has been performed in compliance to the relevant requirements of ISO-10993. In addition the representative final product was tested to and passed ISO-10993-1. The product has been determined to be biocompatible. | |
| Sterilization & Packaging | - Packaged and sterilized as a sterile single use device. | The PKS™ BiLL™ instrument is packaged and sterilized as a sterile single use device (sterilized by gamma irradiation to an SAL of 10-6). |
| Design Verification & Validation (Bench Test) | - Device meets product specifications (design verification). | Design verification testing was carried out to ensure the device meets the product specifications, and design validation was carried out to ensure the product meets the user requirements. All testing was completed successfully. |
| - Product meets user requirements (design validation). | Design verification testing was carried out to ensure the device meets the product specifications, and design validation was carried out to ensure the product meets the user requirements. All testing was completed successfully. | |
| Pre-clinical Evaluation (User Acceptance) | - Physicians' satisfaction with ease of understanding the Instructions for Use (IFU). | All three physicians were happy with the proposed device and felt it met their needs and performed to their expectations regarding their experience after a mock procedure and answering 32 questions, which included questions about the ease of understanding the IFU. |
| - Physicians' satisfaction with performance related questions specific to the procedure (e.g., meeting needs, performing to expectations). | All three physicians were happy with the proposed device and felt it met their needs and performed to their expectations after they carried out a mock procedure using the proposed device and answered 32 questions, which included performance-related questions. |
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.
§ 884.4150 Bipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and
(iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),”
(2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,”
(3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,”
(4) Labeling:
(i) Indication: For female tubal sterilization, and
(ii) Instructions for use:
(A) Destroy at least 2 centimeters of the fallopian tubes,
(B) Use a cut or undampened sinusoidal waveform,
(C) Use a minimum power of 25 watts, and
(D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction.