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LOTUS Enhanced Shears are indicated for soft tissue surgical incisions when bleeding control and minimal injury are important. They may be used as an adjunct to or substitute for electrosurgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint).

The Lotus Series 5 is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. It may be used as an adjunct to or substitute for electrosurgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint)

LOTUS Series 4 Enhanced Shears: The LOTUS Series 4 Enhanced Shears consist of a reusable Transducer and a Single use Handpiece and are designed to use torsional ultrasound in the 35.4-36.6kHz range to cut and coagulate soft tissue during laparoscopic, open or bariatric surgery. The 2 types of LOTUS Series 4 Enhanced Shears subject to this application are the ES4-200CT transducer (with DS4-200CD Handpiece) that is designed for use in open surgery and the ES4-500CT transducer (with DS4-500CD Handpiece) that is designed for bariatric surgery. The new LOTUS Series 4 Enhanced Shears transducers have a similar waveguide and blade form to that of the ES4-400CT that was previously cleared as part of the Lotus Series 4 Ultrasonic Surgical System and Accessories (K151101). The LOTUS Series 4 Enhanced shears use an identical transducer stack and casing and the same LG4 generator cleared as part of K151101. The Handpieces are identical in function as those cleared as part of K151101. They are identical to the DS4-200SD and DS4-500SD except that they use the same curved jaw as the DS4-400CD. All of these devices are described in detail in K151101. All Transducers are reusable up to 50 times and the Handpieces are single use and provided sterile.

LOTUS Series 5: The LOTUS Series 5 is a modification to the Lotus Series 4 Ultrasonic Surgical System and Accessories. LOTUS Series 5 consists of new Transducers and Handpieces but are driven by the same generator as in the predicate - the LG4. The Transducers and Handpieces offer the improved feature of 360° rotation, whereas the predicate has rotation limited to 240°. To facilitate this feature, it has been necessary to redesign the transducer so that it sits axially in the plane of the waveguide. It still uses torsional ultrasound in the 35.4-36.6kHz range at the waveguide blade to perform its surgical function. The output at the waveguide blade is substantially equivalent to that of the predicate. The Handpieces of LOTUS Series 5 have had the area where the transducer fits to the Handpiece altered to allow for the 360° rotation, but the outer appearance of the Handpieces remains unchanged from the predicate. All Transducers are reusable up to 50 times and the Handpieces are single use and provided sterile.

The provided text describes two medical devices, LOTUS Series 4 Enhanced Shears and LOTUS Series 5, and their substantial equivalence to a predicate device (Lotus Series 4 Ultrasonic Surgical System and Accessories, K151101). The document details the devices' intended use, technological characteristics, and performance testing, but it does not provide traditional acceptance criteria in the form of numerical thresholds or comparative statistics that are typically found in studies for AI/ML devices or diagnostic tools.

Instead, the acceptance criteria are implicitly defined by demonstrating that the new devices are "substantially equivalent" to an existing predicate device, meaning they perform as safely and effectively. The studies conducted are primarily bench testing to confirm this equivalence in performance.

Here's the breakdown based on your request, focusing on what can be extracted from the document:

LOTUS Series 4 Enhanced Shears & LOTUS Series 5

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit numerical acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, or effect size) are not provided in this regulatory document, the table reflects the comparison points used to establish substantial equivalence. The "Acceptance Criteria" column indicates that the performance should be "Equivalent to Predicate," meaning it must meet or not negatively deviate from the established performance of the legally marketed predicate device (LOTUS Series 4 Ultrasonic Surgical System and Accessories K151101).

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

• Sample Size: Not explicitly stated as a number of samples in the typical sense (e.g., patient cases). The testing involved bench testing of the devices themselves.
  • For LOTUS Series 4 Enhanced Shears: "Performance testing cut times" and "Transducer lifetime" were tested.
  • For LOTUS Series 5: "Acoustic performance cut times, maximum average power and frequency tracking," "Thermal spread in 3 types of tissue (muscle, kidney and liver)," "Length of dissection," and "Transducer lifetime" were tested.
• Data Provenance: The document only mentions "bench testing" and "No animal testing has been undertaken." This suggests testing performed in a laboratory setting on the physical devices or tissue models, rather than clinical data from specific countries or patient populations. The tests were likely conducted by the manufacturer, SRA Developments Ltd (United Kingdom).

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

• Not Applicable. This submission is for surgical instruments, not for diagnostic or AI/ML devices that require ground truth established by human experts. The performance is assessed through objective engineering and biological bench tests (e.g., cut times, thermal spread in tissue).

4. Adjudication Method for the Test Set:

• Not Applicable. As there are no human experts establishing a "ground truth" for diagnostic or AI/ML performance, no adjudication method is relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This device is a surgical instrument (ultrasonic shears), not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant to this submission.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for these devices is established by objective physical measurements and biological effects (e.g., precise timing of cuts, calibrated temperature measurements for thermal spread in animal tissues, mechanical displacement measurements) as compared to the performance of the legally marketed predicate device. It's not expert consensus, pathology, or outcomes data in the typical sense, but rather engineering and pre-clinical performance data.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As there is no training set, there is no ground truth establishment for it.

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The Senhance Ultrasonic System and accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. The Senhance Ultrasonic Surgical System and accessories are indicated for use with the Senhance Surgical System.

The Senhance Ultrasonic System is an energized instrument system which delivers ultrasonic energy to the tissue of interest for soft tissue incisions. It is designed to be used with the Senhance Surgical System which precisely manipulates laparoscopically based instruments in surgery. The Senhance Ultrasonic System is composed of five components: 1. The Dissector which interfaces with the tissue of interest 2. The Transducer which converts electrical energy into ultrasonic energy 3. The Senhance Adapter which physically attaches the instrument to the Senhance Surgical Robotic System manipulator arm 4. The Ultrasonic Generator which controls the energy settings to be delivered to the tissue 5. The Footswitch

This document describes the Senhance Ultrasonic System, a surgical device designed for soft tissue incisions. The system is intended for use with the Senhance Surgical System, a robotic platform. The 510(k) summary provided outlines the device's characteristics, comparison to a predicate device, and the performance data used to support its substantial equivalence.

Here's a breakdown of the requested information:

1. Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly present a table of "acceptance criteria" against which specific numerical performance metrics are then stated. Instead, the performance testing described aims to demonstrate the safety and effectiveness of the device by showing its compatibility and comparable performance to a predicate and reference device across various characteristics. The ultimate "acceptance criterion" for this submission appears to be demonstrating substantial equivalence, meaning the technological differences do not raise any different questions of safety or effectiveness.

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

• Sample Size for Test Set:
  • Pre-Clinical Design Validation: Four teams (one surgeon and one surgical assistant per team), totaling 8 individuals. These teams performed surgical tasks on a live porcine model.
  • Biological Testing, Cleaning/Sterilization, Bench Testing, Electrical Safety, Software V&V: Specific number of units/samples for these tests are not explicitly stated. The description indicates "testing" was conducted.
• Data Provenance: The pre-clinical design validation was conducted in a "single-center" environment.
  • The "live porcine model" implies prospective data collection using animal subjects for performance evaluation.
  • Other tests (biocompatibility, cleaning, bench, electrical safety, software) would typically involve lab-based prospective testing of the device components.
  • The country of origin for the data is not specified.

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

• Pre-Clinical Design Validation: Four surgeons and four surgical assistants were involved as users in the simulated use validation. These individuals "represented the intended primary user population" and were "trained subjects." Their specific years of experience or formal qualifications (e.g., board-certified) are not explicitly detailed, but their participation in surgery and assistance roles implies relevant medical expertise in gynecological and general surgery. They essentially served as experts evaluating the device's performance against user needs.
• For other tests (e.g., biocompatibility guidance, sterilization standards), the "ground truth" is established by adherence to recognized international standards and FDA guidance, meaning the experts implicit are those who draft and approve such standards and the specialists performing the tests according to those standards.

4. Adjudication Method for the Test Set

• For the pre-clinical design validation, the summary states that "All pre-determined acceptance criteria were met." This suggests a direct evaluation against predefined performance benchmarks. It does not describe an explicit "adjudication method" in the sense of multiple experts independently scoring and then resolving discrepancies (like 2+1 or 3+1). The "trained subjects" (surgeons and assistants) in this simulated environment were likely the evaluators of the system's performance and their assessment contributed to meeting the acceptance criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided 510(k) summary. The study described is a pre-clinical design validation with simulated use, not a study evaluating human reader performance with or without AI assistance.

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

• The Senhance Ultrasonic System is an instrument system for robotic surgery, not an AI-driven diagnostic or image analysis algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not directly apply to this type of device. The system requires human intervention for its operation via the Senhance Surgical System by a surgeon and surgical assistant.

7. The Type of Ground Truth Used

• Pre-Clinical Design Validation: The ground truth for this phase was established by observing and evaluating the device's performance during surgical tasks on a live porcine model. The "pre-determined acceptance criteria" serve as the standard against which performance was measured. In this context, the "ground truth" is based on observed functional performance in a simulated biological environment, representing what is expected of the device in actual surgical use (e.g., effective soft tissue incisions, hemostasis, minimal thermal injury).
• Other Tests (Biocompatibility, Sterilization, Bench Testing, Electrical Safety, Software V&V): The ground truth is adherence to established scientific principles, international standards (ISO, AAMI, IEC), and FDA guidance documents.

8. The Sample Size for the Training Set

• The provided 510(k) summary does not describe a "training set" in the context of machine learning. The device is a surgical instrument and robotic system, not a machine learning algorithm that requires a data training set.

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

• As the device is not a machine learning algorithm, there is no "training set" or corresponding ground truth establishment process for a training set described in this submission.

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