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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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