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The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, incision, and hemostasis in soft tissue surgical procedures.

The subject device Soniquence Reusable 3 Button Fingerswitch Wand is an accessory to the Soniquence SmoothWave RF Generator. It is connected to a High Frequency Generator via the male end, and the female end termination connects to the Monopolar Electrode. This device will be provided non-sterile and is intended to be used with Soniquence Monopolar Electrodes. The 3-Button Fingerswitch Wand includes access to all three monopolar waveforms without unit manipulation. This patented, unique handpiece is utilized to activate CUT, BLEND, and HEMO modes via finqerswitch for general surqical procedures. The depressed button function will be the actual output function and disregards the front display settings. The fingerswitch operational features are as follows: a) The CUT button will activate CUT mode. When depressed, the vellow indicator (CUT) illuminates. b) The BLEND button will activate BLEND mode. When depressed, the yellow indicator (BLEND) illuminates. c) The HEMO button will activate the HEMO mode. When depressed, the blue indicator (HEMO) illuminates.

The provided document is a 510(k) summary for the Soniquence Reusable 3 Button Fingerswitch Wand. It does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML product.

Instead, this document describes a traditional medical device (an electrosurgical accessory) and its substantial equivalence to a predicate device. The "acceptance criteria" discussed are related to electrical safety, biocompatibility, and sterilization validation for this hardware device, not performance metrics for an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, study details (test/training set size, data provenance, expert consensus, adjudication, MRMC studies, standalone performance, ground truth establishment) as this document does not pertain to an AI/ML device.

The document indicates "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence," further confirming that it's not a performance study for an AI/ML algorithm.

However, I can extract the specific non-clinical testing performed for the Soniquence Reusable 3 Button Fingerswitch Wand, which serve as its "acceptance criteria" and the "study" proving it meets them:

1. A table of acceptance criteria and the 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 as these are non-clinical hardware tests, not data-driven performance studies.

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 provided as the tests are based on established engineering and biological standards, not expert medical opinion for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as this is not an expert-driven ground truth assessment for an AI/ML product.

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 a hardware accessory, not an AI/ML product designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable; this is a hardware device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for these tests are the pass/fail criteria defined by the listed international and industry standards (e.g., ISO, IEC, ASTM, AAMI).

8. The sample size for the training set:
Not applicable; this is not an AI/ML product that utilizes a training set.

9. How the ground truth for the training set was established:
Not applicable.

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

The Soniquence 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 the reusable neutral plate as compared to the disposable neutral plate. They are both used to provide a safe return path for electrosurgical current.

Acceptance Criteria and Study for Soniquence Reusable Neutral Plate

This document describes the acceptance criteria and the study performed to demonstrate that the Soniquence Reusable Neutral Plate meets these criteria, as derived from the provided 510(k) summary.

The Soniquence Reusable Neutral Plate is an electrosurgical accessory, not a diagnostic AI/ML device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of device and its regulatory clearance process. The primary method for demonstrating safety and effectiveness for such a device is through non-clinical performance and biocompatibility testing against recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Soniquence Reusable Neutral Plate are based on compliance with an recognized international standard (IEC 60601-2-2) and biocompatibility standards (ISO 10993-5:2010 and ISO 10993-10:2010), demonstrating its safety and performance aspects.

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

For electrosurgical accessories like the Soniquence Reusable Neutral Plate, the "test set" typically refers to the manufactured units or representative samples of the device undergoing non-clinical bench testing. The 510(k) summary does not specify the exact number of devices tested for compliance with IEC 60601-2-2 and ISO 10993 standards. However, industry practice for such testing involves a sufficient number of samples to ensure robust and representative results, often dictated by the specific test protocol requirements within the standards. The data provenance is from non-clinical bench testing rather than human subject data, and thus there is no country of origin or retrospective/prospective distinction in the context of clinical data.

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

This category is not applicable as the device is not an AI/ML diagnostic tool. Ground truth for an electrosurgical neutral plate is established through objective physical and electrical measurements and chemical analyses conducted according to international standards for safety and biocompatibility. The "experts" involved would be qualified test engineers and laboratory personnel with expertise in electrosurgical device testing and biocompatibility assessment, following the methodologies prescribed by IEC and ISO standards.

4. Adjudication Method for the Test Set

This category is not applicable as the clearance is based on objective, quantifiable non-clinical and biocompatibility test results, not subjective interpretations by experts that would require adjudication.

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 category is not applicable. The Soniquence Reusable Neutral Plate is an electrosurgical accessory, not an AI/ML algorithm or a device that assists human readers in medical image interpretation.

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

This category is not applicable. The Soniquence Reusable Neutral Plate is a physical electrosurgical accessory, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth used for the Soniquence Reusable Neutral Plate is objective physical and electrical measurements and chemical analyses as defined by the referenced international standards:

• IEC 60601-2-2:2017 provides the methodologies and acceptance criteria for electrical safety and performance of electrosurgical equipment and accessories.
• ISO 10993-5:2010 (Cytotoxicity) and ISO 10993-10:2010 (Sensitization and Irritation) provide the methodologies and acceptance criteria for evaluating the biocompatibility of medical devices.

8. The Sample Size for the Training Set

This category is not applicable. The device is not an AI/ML algorithm that requires training data.

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

This category is not applicable. The device is not an AI/ML algorithm and therefore does not have a "training set."

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

The subject device, Soniquence 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.

The provided document is a 510(k) summary for the Soniquence Reusable Bipolar Cable, which is an electrosurgical accessory. It declares substantial equivalence to a predicate device and details non-clinical testing. However, it does not contain the specific information requested about acceptance criteria for device performance, a study proving the device meets these criteria, or any data related to diagnostic accuracy, sample sizes, expert involvement, or ground truth for AI models. The device in question is a cable, not an AI/ML-driven diagnostic tool.

Therefore, most of the requested information cannot be extracted from this document.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly state "acceptance criteria" in the context of specific performance metrics for the device. Instead, it describes compliance with recognized electrical and sterilization standards.

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

Not applicable. The document describes non-clinical engineering and sterilization testing, not a diagnostic test set with patient data.

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

Not applicable. This is not a study involving expert-established ground truth for a diagnostic test.

4. Adjudication method for the test set

Not applicable.

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 document does not pertain to AI/ML devices or MRMC studies.

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

No. This document does not pertain to AI/ML algorithms.

7. The type of ground truth used

Not applicable. The tests performed are compliance tests against established engineering and sterilization standards, not diagnostic performance with a "ground truth" in the clinical sense.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set mentioned.

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

Not applicable.

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

The Soniquence Bipolar Electrodes 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 Soniquence Bipolar Electrodes 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 Soniquence line of high-frequency RF energy sources. The operational principle of the device is common to all active bipolar electrosurgical devices; the active tip of the Soniquence Bipolar Electrode emits RF energy generated according to settings established on the Soniquence RF 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.

The provided text describes a 510(k) summary for the Soniquence Bipolar Electrodes and primarily focuses on non-clinical testing and substantial equivalence to predicate devices. It explicitly states in section "Clinical Testing (807.92(b)(2))" that "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."

Therefore, the input document does not contain the information requested regarding acceptance criteria related to device performance in a clinical setting, a study proving the device meets these criteria, sample sizes for test or training sets, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training data was established. The document focuses on bench testing and material biocompatibility.

Based on the provided text, I am unable to fulfill the request as it pertains to clinical performance evaluation.

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The Soniquence RF 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 Soniquence Electrodes are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures.

The Soniquence RF 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 mutuallyexclusive use with the Soniquence® 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.

Soniquence Electrodes are used with the Soniquence RF 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 Soniquence 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.

This document, an FDA 510(k) submission summary for the Soniquence RF Generator and Soniquence Electrodes, does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance on a test set, expert ground truth establishment, or clinical effectiveness studies with human readers.

The document states:

• "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." (Page 11)
• The non-clinical testing listed primarily focuses on electrical safety, EMC, Usability Engineering, sterilization, biocompatibility, and software verification and validation. It also includes "Energy output verification of each of the five modes and comparison to predicate" and "Thermal effect comparison for representative modes of the subject device and predicate on ex-vivo bovine tissue." (Page 11)

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for AI/algorithm performance characteristics. The device appears to be a traditional electrosurgical unit, not an AI/algorithm-driven diagnostic or therapeutic device.

If you are looking for information about the performance of the Soniquence RF Generator and Soniquence Electrodes, the document primarily relies on substantial equivalence to predicate devices (Surgi-Max® Ultra (K170107), Bovie® IDS-310 Electrosurgical Generator (K134054), Elliquence Electrodes (K142410), and Cobbra RF™ Tissue Dissector (K160041)) based on technological characteristics and intended use.

Here's a summary of the performance testing mentioned, which is non-clinical and geared towards safety and functional equivalence, not AI performance characteristics.

Table of Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Related):

Since the requested information pertains to an AI/algorithm-driven device, and this document describes a traditional electrosurgical unit without AI components, the following points cannot be answered from the provided text:

• Sample size used for the test set and data provenance: No test set (in the AI sense) is mentioned.
• Number of experts used to establish ground truth & qualifications: Not applicable.
• Adjudication method: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

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