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The Ellusa Reusable Bipolar Cable is intended to transfer power from an RF Generator to Bipolar Electrodes.

The subject device, Ellusa Reusable Bipolar Cable is a bipolar accessory designed to transfer the electrosurgical power to the Bipolar electrode. It is connected to a High Frequency Generator via the male end and the female end termination connects to the standard Bipolar instrument. The cable is made of Silicone material and Polypropylene H1500 which is flexible and autoclavable. The length of the cable is 3 meters, and it is provided non-sterile.

This document is a 510(k) summary for the Ellusa Reusable Bipolar Cable. It primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of intended use, technological characteristics, and performance, rather than presenting a study demonstrating that the device meets specific performance acceptance criteria from a clinical or diagnostic standpoint.

Based on the provided text, here's what can be extracted:

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

The document does not specify quantitative acceptance criteria in terms of clinical or diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" are implied by compliance with established medical device standards and demonstrating performance equivalent to the predicate device.

The comparison table on page 4 details the similarities (e.g., Product Code, Device Classification, Functions, Operating principle, Energy Source, Cable Length, Activation Method). |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." Therefore, there is no test set sample size, data provenance, or associated study as typically understood for AI/diagnostic devices. The testing performed was non-clinical (laboratory/engineering) to confirm compliance with safety and performance standards relevant to the device's function as an electrosurgical accessory.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical performance study involving ground truth established by experts was conducted or relied upon.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical performance study involving adjudication of ground truth was conducted or relied upon.

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 device is an electrosurgical cable, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable, as no clinical performance study requiring ground truth was conducted or relied upon. The "ground truth" for this device's performance relies on engineering measurements and compliance with recognized standards (IEC, ISO) for electrical safety, functional performance, and sterilization effectiveness.

8. The sample size for the training set

Not applicable, as this device does not involve a training set (e.g., for machine learning).

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

Not applicable, as this device does not involve a training set.

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The Ellusa Reusable Neutral Plate provides a safe return path for electrosurgical current and is designed for use with Ellusa Generators for minor surgical applications. The Reusable Neutral Plate is provided nonsterile and intended for use only in nonsterile environments.

The Ellusa Reusable Neutral Plates will be provided as a flexible plate made of silicone rubber and will be supplied with a 10-foot cable and is non-sterile. There are no differences in the functionality of a reusable neutral plate as compared to the disposable neutral plate. They are both used to provide a safe return path for electrosurgical current.

This submission is for an Ellusa Reusable Neutral Plate, which is an electrosurgical accessory. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific clinical performance acceptance criteria. Therefore, most of the requested information regarding clinical studies, ground truth, expert consensus, and multi-reader multi-case studies is not applicable to this document.

The acceptance criteria provided here are related to non-clinical testing and engineering standards for the device's safety and performance with respect to its function as an electrosurgical accessory.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided in the document. The document describes non-clinical engineering and biocompatibility testing, which typically uses a specified number of device units or material samples for testing rather than a "test set" in the context of clinical data. The provenance of such testing data is usually from accredited testing laboratories, but specific details are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable as there was no clinical test set requiring expert ground truth establishment for this type of device (electrosurgical neutral plate). The "ground truth" for non-clinical testing is adherence to established engineering and biocompatibility standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable as there was no clinical test set requiring adjudication in this context. The "adjudication" for non-clinical testing involves the interpretation of test results against predefined pass/fail criteria of the standards.

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 applicable. This document is for an electrosurgical neutral plate, which is a hardware accessory, not an AI-enabled diagnostic tool. Therefore, an MRMC study or AI assistance is irrelevant.

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

This information is not applicable. The device is an electrosurgical neutral plate, not an algorithm.

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

The "ground truth" for the non-clinical testing described is based on the pass/fail criteria defined within the referenced international standards (IEC 60601-2-2 and ISO 10993 series). These standards themselves are developed through expert consensus within their respective fields to ensure safety and performance.

8. The sample size for the training set:

This information is not applicable. As a hardware device, there is no "training set" in the context of machine learning. The device design and manufacturing processes are likely informed by engineering principles and previous device experience, but not a dataset used for training an algorithm.

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

This information is not applicable for the reasons stated above.

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The Ellusa Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

The Ellusa Monopolar Tips are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures.

The Ellusa Generators are radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device is designed to enable the performance of monopolar and bipolar functions for cutting, coagulation, and hemostasis in conjunction with separately-marketed electrosurgical accessories and ancillary equipment which have been developed for mutually- exclusive use with the Ellusa line of generators.

All selections are effected through push buttons and lamps, which give the operator feedback of status. The power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and /or hand switches.

Ellusa Electrodes are used with the Ellusa Generator. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Ellusa family of electrodes is available in various shapes and sizes depending on the need of the surgeon. The devices are available in classic alloys (Tungsten, brass, stainless steel).

These devices are designed to comply with international safety standards including applicable IEC series electrical safety standards.

The provided text is an FDA 510(k) summary for a medical device (Ellusa Generator and Monopolar Tips). It demonstrates substantial equivalence to a predicate device rather than presenting a study of its own for novel acceptance criteria.

Therefore, the information required to directly answer the request (acceptance criteria and a study proving the device meets them, especially in the context of AI/human reader performance) is not present in the provided document.

The document states that:

• The device is "substantially equivalent" to a predicate device (Soniquence RF Generator & Monopolar Electrodes, K183611).
• "There are no technological differences between the subject device as compared to the predicate devices, and the indications for use are identical to the predicate devices."
• "The only difference between the subject devices of this 510k and the predicate devices is a rebranding with the Ellusa name. The technology remains the same."

This type of submission focuses on demonstrating that the new device operates fundamentally the same as a device already on the market, by comparing technological characteristics and showing compliance with relevant safety and performance standards. It does not involve AI or human reader studies.

However, I can extract information regarding the non-clinical testing performed to demonstrate safety and performance equivalence, which acts as the "proof" for this type of submission.

Here's an interpretation of the "acceptance criteria" and "study" based on the provided document, framed within the context of a 510(k) submission for substantial equivalence:

Acceptance Criteria and Demonstrating Equivalence (as per a 510(k) submission):

The acceptance criteria for a 510(k) are not typically expressed as specific performance metrics of a novel AI algorithm or human reader improvement. Instead, they revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. For this device (an electrosurgical generator and tips), the "acceptance criteria" are implicitly met by:

• Identical Intended Use: The device performs the same functions for the same purposes as the predicate.
• Substantially Equivalent Technological Characteristics: No new questions of safety or effectiveness are raised compared to the predicate. Minor differences are shown not to affect safety or performance.
• Compliance with Recognized Standards: The device meets relevant international safety, performance, biocompatibility, and sterilization standards.
• Successful Non-Clinical Testing: Specific tests confirm the device's electrical output, thermal effects, and general functionality are comparable and within acceptable limits.

The "Study" Proving the Device Meets Acceptance Criteria (Non-Clinical Testing):

The "study" in this context is the Non-Clinical Testing section, which provides the technical evidence for substantial equivalence.

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

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

• Sample Size for Test Set: The document mentions "ex-vivo bovine tissue" for thermal effect comparison, but does not specify a quantitative sample size (e.g., number of tissue samples or test runs). For electrical safety and other standard compliance tests, the "sample" would be the device units tested, but a specific number is not provided, though it would be standard practice to test a representative number of units.
• Data Provenance: The tests are "non-clinical verification and validation activities" conducted by the submitter (Ellusa, LLC). The data provenance would be internal laboratory testing.
• Retrospective or Prospective: These tests are prospective, conducted specifically to support the 510(k) submission.
• Country of Origin of Data: Not explicitly stated, but assumed to be the testing facilities used by Ellusa, LLC (US-based).

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

• This question is not applicable to this type of device and submission. "Ground truth" in the context of AI or diagnostic imaging usually refers to clinical diagnoses or pathology results established by medical experts used to train and validate algorithms. For an electrosurgical device, performance is evaluated against engineering specifications and physical measurements, not expert clinical interpretations of images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are used in studies involving human readers or AI output where there might be disagreements in interpretation (e.g., diagnosis from medical images). This document describes engineering validation and verification 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:

• No. This is an electrosurgical device, not an AI or diagnostic imaging product designed to assist human readers. Therefore, an MRMC study was not performed.

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

• No. This device is hardware (generator and tips) for surgical procedures. It does not have an AI algorithm for standalone performance.

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

• For the performance tests (e.g., energy output, thermal effect), the "ground truth" is established by physical measurements and engineering specifications, often compared against the predicate device's known performance or against established scientific principles of energy delivery and tissue interaction. For example, for "Energy output verification," the ground truth is the expected power output for a given setting, measured by calibrated equipment. For "Thermal effect comparison," the ground truth involves measuring the actual thermal spread in tissue and comparing it to expected or predicate device behavior.

8. The sample size for the training set:

• Not applicable. This device is not an AI system that requires a "training set."

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

• Not applicable. As above, no AI training set is involved.

In summary, the provided document details a 510(k) submission for substantial equivalence of an electrosurgical device based on engineering and safety testing, not on AI or human-in-the-loop performance studies.

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The Ellusa Bipolar Wands are intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed.

The Ellusa Bipolar Wand family is a line of disposable bipolar electrosurgical devices which is intended for use by a physician familiar with electrosurgery in bipolar coagulation for general surgery where coagulation of soft tissue is needed. The basic design of the Ellusa Bipolar Wands is a plastic handle, an elongated, insulated electrode shaft, a bipolar electrode tip, and an integrated cable and plug which is designed to connect exclusively to the Ellusa line of highfrequency RF energy sources. The operational principle of the device is common to all active bipolar electrosurgical devices; the active tip of the Ellusa Bipolar Wand emits RF energy generated according to settings established on the Ellusa Generator which emits high frequency, low temperature radiowaves directed to the electrode tip. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. This energy is capable of cutting or coagulating target tissue depending on the waveform associated with the mode and power setting of the generator. The devices are disposable and intended for single use only. The devices are intended for transient contact with the patient and are provided sterilized by ethylene oxide and has a shelf life of three years from the date of sterilization.

This document describes the Ellusa Bipolar Wands, an electrosurgical device, and its acceptance criteria as part of its 510(k) submission (K202558) to the FDA. The submission aims to demonstrate substantial equivalence to a predicate device, the Soniquence Bipolar Electrodes (K190336).

1. Table of Acceptance Criteria and Reported Device Performance

The device is assessed against a predicate device, the Soniquence Bipolar Electrodes (K190336). The acceptance criterion is that the Ellusa Bipolar Wands are "Identical to predicate" across a range of technological characteristics.

The study demonstrates that the Ellusa Bipolar Wands meet these acceptance criteria by asserting that they are "identical in technological characteristics to the Soniquence Bipolar Electrodes (K190336) based on a comparison of physical and performance characteristics."

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

The document does not explicitly specify a sample size for a "test set" in the context of an AI/algorithm-based device as this is a medical device (electrosurgical wands) that relies on physical and performance testing for substantial equivalence, not algorithmic performance. The testing involved ex vivo tissue (liver, kidney, and muscle tissue) for performance bench tests. The quantity of tissue samples used is not provided. The data provenance is derived from these bench tests and adherence to various ISO and IEC standards. The data would be prospective, generated during the verification and validation activities for the Ellusa Bipolar Wands.

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

Not applicable. This is not an AI/algorithm-based device requiring expert ground truth establishment for a test set. The substantial equivalence is determined by comparing physical and performance characteristics against a predicate device and adherence to recognized standards.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/algorithm-based device requiring an adjudication method. The assessment is based on objective measurements and compliance with standards.

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 not an AI-assisted device.

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

Not applicable. This is not an algorithm-only device. It is a physical electrosurgical instrument.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Predicate Device Characteristics: The known, legally marketed predicate device (Soniquence Bipolar Electrodes, K190336) serves as the benchmark for technological characteristics and intended use.
• Industry Standards: Adherence to recognized national and international standards (IEC 60601-1, IEC 60601-1-6, IEC 62366, IEC 60601-1-2, IEC 60601-2-2 for electrical safety and performance; ISO 11135, ISO 11737-1, ISO 11737-2, ISO 11138-1, ISO 11138-2 for sterilization; ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11 for biocompatibility; ASTM F1886/F1886M, ASTM F1929, ASTM F1980 for shelf life). This implies that meeting these standards constitutes acceptable performance and safety.
• Bench Test Results: Direct measurements of thermal effects on ex vivo tissue and temperature profiles during simulated use to demonstrate safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that uses a "training set."

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

Not applicable. No training set was used.

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