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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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Lotus Series 4 Ultrasonic Surgical System & Accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. Lotus Series 4 Ultrasonic Surgical System and Accessories may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint)

The SRA Developments Lotus Series 4 Ultrasonic Surgical System and Accessories consists of 3 main components - the power module which generates the ultrasonic energy and provides overall control of the device, the reusable part of the handset (Transducer and waveguide); and the disposable part of the handset (Handpiece). The Lotus Series 4 Ultrasonic Surgical System and Accessories employs torsional mode ultrasound at 35.8-36.6kHz to cut and coagulate soft tissue during laparoscopic or open surgery.

This document describes the 510(k) summary for the Lotus Series 4 Ultrasonic Surgical System & Accessories. It details the device's improvements, its legally marketed predicate device, and the performance testing conducted to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) summary for a medical device (ultrasonic surgical system), the "acceptance criteria" and "device performance" are typically framed in terms of demonstrating equivalence to a predicate device, rather than specific quantitative performance metrics against a defined threshold for AI/diagnostic algorithms. The study conducted here is a series of bench tests to demonstrate this equivalence.

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

• Generator Output Equivalence: The document states "a Transducer was driven by each generator in turn". The exact number of transducers or measurements is not specified.
• New Waveguide Design (Cutting, Hemostasis, Fatigue):
  • Cutting Speed: Tested using "our standard production cutting test". The number of waveguides or tests is not specified.
  • Hemostasis/Bleeding Control: Tested on "porcine tissue". The number of samples or tests is not specified.
  • Fatigue Resistance: Refers to "50 surgical uses" per device. "All devices" suggests more than one, but the exact number of tested waveguides is not specified.
• Handpiece Durability: "The handpieces were subjected to 600 clamping operations... All devices passed the test." The exact number of handpieces tested is not specified, but "all devices" suggests at least multiple.

Data Provenance: The studies were conducted by SRA Developments LTD, based in the United Kingdom. The tests are described as bench testing and in vitro (e.g., porcine tissue for hemostasis), indicating they are prospective tests performed in a controlled laboratory environment for the purpose of this submission. The origin of the tissue (e.g., country for porcine tissue) is not specified.

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

This type of submission for an ultrasonic surgical system does not typically involve "experts establishing ground truth" in the way an AI diagnostic algorithm for image analysis would. The ground truth for performance is established through direct physical measurements (e.g., amplitude, cutting speed, visual assessment of hemostasis, functional testing for durability and fatigue). No human experts or their qualifications are mentioned in this context.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication by experts or a consensus method. Performance is determined by objective physical measurements and functional tests.

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 a 510(k) submission for a surgical instrument, not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is a surgical instrument, not an algorithm, so "standalone" performance in the context of AI is not relevant. The device operates independently of human "reading" or AI interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance tests was based on objective physical measurements and functional parameters such as:

• Amplitude measurements for generator output.
• Measured cutting speed.
• Observed hemostasis (bleeding control) on porcine tissue.
• Continued functionality after simulated usage cycles for fatigue resistance and durability.
• Compliance with electrical safety and EMC standards.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is an ultrasonic surgical system and not an AI/machine learning algorithm.

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

Not applicable, as there is no training set for this type of device.

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The LOTUS Ultrasonic System for Cemented Implant eXtraction System (USCIX) is indicated for the softening of bone cement to facilitate the removal of implants, including pedicle screws and other spinal implants, during revision surgery.

The USCIX consists of a power module which generates the ultrasonic energy and provides overall control of the device, a reusable implant removal handpiece, a reusable acoustic coupler and a range of single use adaptors. USCIX employs longitudinal mode ultrasound at nominally 29kHz (Range 28.00-30.00kHz) to remove cemented implants for revision.

The provided text describes a 510(k) summary for the LOTUS Ultrasonic System for Cemented Implant eXtraction System (USCIX). However, it does not contain details about specific acceptance criteria, a study proving performance against those criteria, or the methodology typically associated with such studies (like sample size, ground truth establishment, expert qualifications, or MRMC studies).

The "Testing" section (G) briefly mentions:

• "Testing to FCC Part 18 has been carried out at EMC Network (SW) Ltd, Devon UK, refer to Section 17 for data."
• "Electrical testing to UL 60601-1 has been successfully carried out by Underwriters Laboratories and the Certificate of Compliance is included in Section 17."

These refer to electrical and electromagnetic compatibility (EMC) safety and performance standards, which are general requirements for medical devices but not specific performance or clinical efficacy metrics for the intended use described (softening bone cement). The document states that "performance testing was carried out for some characteristics" due to descriptive characteristics not being "sufficiently precise to assure substantial equivalence" and that "The data from this testing are available and are presented in this 510(k)." However, the actual performance data, acceptance criteria, or the study details are not present in this excerpt.

Therefore, I cannot fully complete the requested table and answer all questions. I can only provide what little is mentioned about testing.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not Available in the Provided Text):

• 2. Sample size used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
• 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 mentioned. This device is an ultrasonic surgical instrument, not an AI-assisted diagnostic tool, so an MRMC study would generally not be applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This refers to typical AI/software performance studies, which are not relevant for this type of physical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• 8. The sample size for the training set: Not mentioned.
• 9. How the ground truth for the training set was established: Not mentioned.

Conclusion based on the provided text:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and general safety/electrical testing. It explicitly states that "performance testing was carried out for some characteristics" to assure substantial equivalence where descriptive characteristics were not sufficient, and that this data is available in the full 510(k) submission. However, this specific excerpt does not detail the nature of this performance testing, the acceptance criteria, or the results, nor does it describe any clinical or comparative efficacy studies.

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Series 3 LOTUS shear & hook are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. LOTUS may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint).

The SRA Developments Series 3 LOTUS Laparoscopic Ultrasound Surgery System consists of the power module which generates the ultrasonic energy and provides overall control of the device, the reusable part of the handset; and the disposable part of the handset. The Series 3 LOTUS system employs torsional mode ultrasound at 35-40kHz to cut and coagulate soft tissue during laparoscopic or open surgery.

The provided text describes the Series 3 LOTUS Laparoscopic Ultrasound Surgery System (K063531). However, the document is a 510(k) summary and not a detailed study report. Therefore, it discusses testing performed but does not provide specific acceptance criteria or the detailed results of a study designed to prove the device meets those criteria in the format requested.

Here's a breakdown of what can be extracted and what information is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary states that "Performance testing was carried out for some characteristics. The data from this testing was available and was presented in this 510(k)." but it does not detail:

• Specific quantitative acceptance criteria (e.g., "device must achieve X % reduction in bleeding").
• The exact results of the performance tests against such criteria.

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

The document mentions three types of testing:

• Animal study: "Performance testing was carried out in an animal study in Portugal".
• Ex-vivo testing: "Ex-vivo testing was also completed both in Portugal and the UK".
• User trials: "User trials were undertaken at a number of UK hospitals."

However, the sample sizes for any of these test sets are not specified. The data provenance states Portugal and the UK, but it does not specify if the studies were retrospective or prospective, though animal and ex-vivo studies are typically prospective. User trials would also typically be prospective.

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

This information is not provided. The document makes no mention of "ground truth" or the use of experts in establishing it for any of the performance tests.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided. Such a study would typically involve human readers interpreting images or data, which is not the primary function of this surgical instrument. The user trials might involve clinicians' feedback on device performance, but not in an MRMC comparative effectiveness study context as typically understood for diagnostic AI.

6. Standalone Performance

The device itself is a surgical instrument (ultrasound shear & hook), not primarily a diagnostic algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not directly applicable in the same way as it would be for an AI diagnostic device. The performance tests described (animal, ex-vivo, user trials) inherently test the device's function directly.

7. Type of Ground Truth Used

This information is not explicitly provided. Since it's a surgical instrument, the 'ground truth' in performance testing would likely relate to objective measures of tissue cutting, coagulation, thermal injury, and functional outcome in the animal and ex-vivo studies. For user trials, it would be subjective feedback from surgeons. The document does not specify how these outcomes were definitively assessed or by whom.

8. Sample Size for the Training Set

This device is a physical surgical instrument and not an AI algorithm that undergoes "training" in the computational sense. Therefore, the concept of a "training set" and its sample size is not applicable.

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

As above, this concept is not applicable to this device.

Summary of available information regarding testing:

While specific acceptance criteria and detailed study results are absent, the document indicates that the following testing was performed to support the device's substantial equivalence:

• Electromagnetic compatibility testing: Successfully carried out to EN 60601-1-2 and FCC Part 18.
• Electrical safety testing: Carried out in-house to EN 60601-1, with plans for UL60601-1 testing before US marketing.
• Biocompatibility issues: Covered by the predicate device's application (K032424).
• Performance testing:
  • Animal study in Portugal (results included in Exhibit 21 of the 510(k)).
  • Ex-vivo testing in Portugal and the UK (results included in Exhibit 21).
  • User trials in a number of UK hospitals (summary included as Exhibit 22).

The 510(k) concludes that based on this testing, the device demonstrates substantial equivalence to predicate devices, implying that its performance is comparable and acceptable for its intended use.

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The LOTUS Laproscopic Ultrasound Surgery System is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important, LOTUS may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecologic, and thoracic surgery.

The LOTUS (Laparosopic Operation by Torsional UltraSound) system consists of the power module, the reusable part of the handset, and the disposable part of the handset. The Lotus system employs torsional mode ultrasound at 36 kHz to cut and coagulate soft tissue during laparoscopic or open surgery.

Here's an analysis of the provided text regarding the LOTUS Laparoscopic Ultrasound Surgery System (K032424) and the requested information about its acceptance criteria and supporting studies.

Based on the provided documents, comprehensive details about specific acceptance criteria and a structured study proving it are largely absent. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through general performance testing rather than against pre-defined quantitative acceptance criteria.

However, I will extract what can be inferred and explicitly stated from the text.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria are not explicitly stated, this table will reflect the general areas of performance testing mentioned and the outcome reported.

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

• Sample Size for Test Set: Not specified in the provided documents. The text mentions "an animal model" and "an experiential clinical study" and "performance testing," but no numbers are given for the number of animals or human subjects, nor the number of cases or procedures performed.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the company (SRA Developments Ltd) is located in Ashburton, Devon, UK, suggesting the studies could have taken place there or in another undisclosed location.
  • Retrospective or Prospective: Not specified. Animal studies are typically prospective, and "experiential clinical study" could be prospective, but no details are provided.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The nature of the device (surgical tool) implies evaluation by surgeons or clinical specialists, but this is an inference, not an explicit statement.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the type of device and testing (surgical performance), it's highly likely that direct observation and assessment by the surgical team or researchers were used, but no formal adjudication process like 2+1 or 3+1 is mentioned.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported. This type of study is more common for diagnostic imaging devices where multiple readers interpret cases. The LOTUS device is a surgical instrument.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is not an AI-assisted diagnostic device, and no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. The LOTUS device is a physical surgical tool that requires human operation. It does not have a standalone algorithmic component that can be evaluated without human interaction.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" for performance seems to be based on direct observation of surgical outcomes in animal models and experiential clinical studies. This would likely include:
  • Assessment of tissue cutting efficacy.
  • Assessment of coagulation effectiveness (hemostasis).
  • Evaluation of minimal thermal injury.
  • Comparison of these outcomes with predicate devices.
  • Biocompatibility testing provided "ground truth" on material safety.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The LOTUS device is a physical surgical instrument, not an AI/ML algorithm that requires a training set. There is no mention of any AI or machine learning components.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary of Device Performance as Reported in the Study

The provided 510(k) summary (K032424) indicates that the LOTUS Laparoscopic Ultrasound Surgery System underwent several types of testing to demonstrate its substantial equivalence to predicate devices:

• Electrical Safety and Electromagnetic Compatibility: "Successfully carried out." This implies compliance with relevant standards.
• Biocompatibility: "Conducted on some patient-contacting parts of the system." The conclusion of substantial equivalence implies these tests were successful.
• Performance Testing:
  • "Performance testing in an animal model was conducted."
  • "Performance was confirmed in an experiential clinical study."
  • The combined results from this performance testing "demonstrate equivalence" to the predicate devices in terms of its ability to cut and coagulate soft tissue, with considerations for bleeding control and minimal thermal injury. The key difference noted is its torsional mode of operation compared to the predicate's longitudinal mode, but this difference was shown not to impact equivalence negatively.

The overall conclusion is that "The data do, in fact, demonstrate equivalence," supporting the substantial equivalence claim.

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