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Sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site. These accessories have applications in general endoscopy and laparoscopy procedures.

AEM instruments incorporate the use of AEM technology and are intended for use with the AEM monitoring system and electrosurgical generators compatible with the AEM system.

AEM Single-Use Suction Irrigation Instruments are
• Electrosurgical accessories, which combine
– Classic active electrode functions of cutting and coagulating tissue with monopolar high-frequency electrical energy
– Shape, size and reach to work laparoscopically or endoscopically
– Elimination of stray-energy emission outside surgeon view provided by AEM shielding and monitoring
– Convenience/peace-of-mind provided by product provided clean and sterile from manufacturer to operating room
– Convenience of providing suction or irrigation to the surgical site without having to swap instruments in and out of the cannula
• Used to ablate, remove, resect, and coagulate soft tissue where associated hemostasis and visualization is required
• For use in open, endoscopic, and laparoscopic surgical procedures

The instruments of this submission are configured to support foot-controlled laparoscopic electrosurgery
• Direct connection from instrument tip to electrosurgical unit foot-switched power outlet via AEM Cord and Monitor
• Suction irrigation channel adapted directly to commercially available suction-irrigation valves
• Working length: 32 cm
• Fits within 5.5 mm diameter cannula

The document describes the AEM Single-Use Suction Irrigation Instrument, a device intended to combine electrosurgical functions (cutting and coagulation) with suction and irrigation capabilities during endoscopic and laparoscopic procedures. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously cleared predicate devices, rather than an independent clinical study proving novel performance.

Here's an analysis of the provided information regarding acceptance criteria and the "study" (bench testing in this case) that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a number of devices or cases in the provided text. The document refers to "production-equivalent units" and "subject instruments" for bench testing. Given this is a 510(k) for substantial equivalence based on bench testing and analogy, a traditional "test set" with a specific number of patient samples is not applicable here.
• Data Provenance: The data comes from bench testing performed internally by Encision, Inc. It is retrospective in the sense that it relies on established data and performance of predicate devices for comparison and analogy. It is not clinical data derived from patients.

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

• This information is not applicable to this 510(k) submission. The "ground truth" for demonstrating substantial equivalence is established through engineering and performance specifications validated via bench testing and direct comparison/analogy to predicate devices, not through expert review of patient data.

4. Adjudication Method for the Test Set

• Not applicable. There is no adjudication method described as this is not a study involving human interpretation of results requiring consensus. The verification and validation were performed "in accordance with Design Control requirements per 21 CFR 820.30 and company quality system procedures."

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, an MRMC comparative effectiveness study was not done. This device is a surgical instrument and accessory, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI" does not apply.

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

• Not applicable. This is a physical electrosurgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc)

• The "ground truth" for the performance claims in this 510(k) is based on engineering and performance specifications derived from the predicate devices and industry standards. For biocompatibility, it's analogy to predicate materials. For sterility and shelf life, it's adherence to relevant standards (ANSI-AAMI-ISO 11137-1:2006) and accelerated/real-time aging studies. No clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient images) was used.

8. The Sample Size for the Training Set

• Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."

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

• Not applicable. There is no training set for this device.

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The EM3 AEM Monitor is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling.

The EM3 AEM Monitor performs two distinct functions:

• Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument.
• End point monitoring is intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation.

The EM3 AEM Monitor is the "nerve center" and interface to the electrosurgical generator and instruments for AEM monitoring, a safety system for minimally-invasive electrosurgery.

• For monopolar electrosurgery. AEM technology prevents unanticipated or undetected burns from stray energy along the instrument outside the surgeon's field of view
• In bipolar electrosurgery, the EM3 displays the measurement of high-frequency current flowing through the instrument and tissue as an aid in determining the endpoint of bipolar desiccation

The EM3 AEM Monitor system comprises two components

• The Monitor or electronic unit.
• A specific or standard ESU Adapter.

An ESU Adapter is an accessory to the Monitor containing cords and connectors, which connect the Monitor to the electrosurgical generator (ESU). Multiple models of ESU Adapters are required due to the wide variety of electrosurgical generators in the marketplace and in use in the hospitals.

Here's a summary of the acceptance criteria and study information for the EM3 AEM Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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Sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site. These accessories have applications in general endoscopy and laparoscopy procedures.

AEM instruments incorporate the use of AEM technology and are intended for use with the AEM monitoring system and electrosurgical generators compatible with the AEM system.

Single-Use Hand-Control AEM Suction Irrigation Electrodes (DSIE) are electrosurgical accessories that

• . Conduct high-frequency monopolar electrosurgical energy from compatible electrosurgical generators (ESU)
• . Provide suction or irrigation

to a surgical site during laparoscopic and endoscopic procedures.

They combine the classic active electrode functions of cutting and coagulation by monopolar energy with the convenience of being able to provide suction and irrigation without having to swap instruments in and out of trocar, port, or cannula.

They are used during open, endoscopic, and laparoscopic surgical procedures to ablate, remove, resect, and coagulate soft tissue where associated hemostasis is required.

{
  "acceptance_criteria_and_study": {
    "1. A table of acceptance criteria and the reported device performance": null,
    "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": null,
    "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)": null,
    "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": null,
    "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": null,
    "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": null,
    "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": null,
    "8. The sample size for the training set": null,
    "9. How the ground truth for the training set was established": null,
    "Study Summary": "The provided document is a 510(k) summary for a medical device (Single-Use Hand-Control AEM Suction Irrigation Electrodes). This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies typical for new algorithms or AI. \n\nThe conclusion states that the DSIE is 'substantially equivalent to its predicate devices in design and intended use'. It explicitly mentions that 'There are no significant differences between DSIE and the ConMed predicate in electrosurgery or suction/irrigation performance which would raise new issues of safety and effectiveness, performance, function or intended use of the device.' and 'There are no significant differences between DSIE and the Encision predicate in electrosurgery or AEM Monitoring performance which would raise new issues of safety and effectiveness, performance, function or intended use of the device.'\n\n**Based on the available information, the submission does not contain the details typically found in a study designed to prove device performance against a set of acceptance criteria, especially for AI/algorithm-driven devices.** Instead, it relies on demonstrating equivalence to existing, legally marketed predicate devices. Therefore, direct answers to the specific points about acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance are not present in this document."
  }
}

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The Encision AEM Monitoring System is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling.

The AEM Monitoring System consists of two distinct functions:

• . Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument.
• End point monitoring is intended to aid the surgeon in determining the end point . of bipolar electrosurgical desiccation.

The Encision AEM Monitoring System, consisting of the AEM Monitor and accessories, is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. The AEM Monitoring System consists of two distinct functions:

• 1. End point monitoring is intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation.
     The end point monitor displays the electrosurgical current being delivered during bipolar coagulation. At the point where the tissue or vessel is no longer conductive, the meter will display zero or near zero current. An audible indicator of current, presented as a variable click rate, can also be turned on. An optional remote display is also available.

There is no change to the end point monitoring function.

• 2. Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument.
     The active electrode monitoring is performed by measuring the current in the shield of the AEM electrosurgical instrument. The internal conductive shield also diverts capacitivley coupled energy back to the generator, away from the patient. If excessive magnitude or a quality indicative of a sparking condition is detected, an indicator is lit on the monitor front panel and the signal inhibits the ESU (electrosurgical unit) output using the ESU contact quality monitoring circuit.

Connection is made to the ESU contact quality monitoring circuit via a jumper cord. A cord connects the AEM instrument to the monitor and to the ESU output via an adapter. Setup indicators are driven by isolating continuity monitors. These provide checks to ensure the adapters and cable assembly are properly connected.

AEM monitor models, cables and adapters are available for mechanical and electrical compatibility with various ESUs, as well as for footswitching and handswitching monopolar instruments, and bipolar instruments. Minor mechanical and electrical changes may be made to optimize interface with compatible ESUs and instruments, which do not affect the safety and efficacy of the system.

There is no change to the active electrode monitoring function, including the detection circuitry and instrument interface.

Here's a summary of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document describes the AEM Monitoring System and its functions but does not explicitly state specific, quantifiable acceptance criteria or reported device performance metrics in a table format. Instead, it focuses on the device's intended functions and its verification against those functions.

Implicit Acceptance Criteria (Derived from Intended Use and Device Description):

Study Information

The provided document is a 510(k) Summary for a modified device, leveraging prior clearances and focusing on compatibility. It does not describe a full clinical study with detailed statistical results as would typically be found for a novel device. The "Non-clinical Performance Testing" section is brief and general.

Here's the breakdown based on the available text:

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

   • Sample Size: Not specified with a numerical value. The document mentions "representative electrosurgical units and with an instrument representative of the worst case criteria for AEM technology." This implies a limited, selected set of test cases, but the exact number is not provided.
   • Data Provenance: Not specified. Likely internal company testing.
   • Retrospective or Prospective: Not specified, but given it's "non-clinical performance testing," it would be an engineered test setting rather than testing on patients.

2. 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 this is described as "non-clinical performance testing," it would not involve human expert interpretation of results in the way a diagnostic AI study would. Ground truth would be established through engineering measurements and known physical principles.

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

   • Not Applicable. Adjudication methods like 2+1 are used in studies involving human interpretation and disagreement. This was "non-clinical performance testing."

4. 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. An MRMC study was not done. The device is not an AI diagnostic assistant for human readers. It is an electrosurgical monitoring system.

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

   • Yes, in spirit. The "Non-clinical Performance Testing" focused on the system's inherent performance. While the end-point monitoring aids a surgeon, the core active electrode monitoring function is described as an automated system that "detects" and "inhibits" without direct human interpretation for its primary safety function. The testing described would primarily be a standalone assessment of the system's technical capabilities.

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

   • Engineering Measurements/Physical Principles: For active electrode monitoring, the ground truth would be the actual stray energy/sparking conditions created in a controlled environment, measured by calibrated equipment. For end-point monitoring, the ground truth would be the known conductivity changes in tissue models or actual tissue, correlated with measured current values by the device.

7. The sample size for the training set:

   • Not Applicable/Not Specified. The document does not describe the use of an algorithm that requires a "training set" in the context of machine learning or deep learning. This device appears to be based on established electrosurgical physics and engineering principles rather than a data-driven learning model.

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

   • Not Applicable/Not Specified. As there's no mention of a training set, the establishment of its ground truth is not discussed.

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Encision's Suction Irrigation Electrodes and Adapters are intended for evacuation of body fluids and to cut and coagulate tissue through a trocar cannula for various general surgical laparoscopic procedures.

The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The AEM Monitoring System, with compatible electrosurgical instruments, is designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode. The electrode has a stainless electrode tip welded onto the distal ID of the active tube. The active tube acts as the suction and irrigation path. The tube assembly has primary and secondary insulation layers which separate the inner active tube from the outer shield tube. The device has a molded body that interfaces with the 30 party trumpet valves or luer valves via the appropriate adapter. The Adapters (sold separately) are attached to the body of the electrode to make a compatible connection with selected suppliers of trumpet valve/tube sets. There is an electrical connector on the body capable of accepting Encision AEM cords, which carry the active and AEM shield conductors. The electrode has various fixed tips at the distal end for surgical manipulation and delivery of electrosurgical energy to the patient. All tip styles are insulated from the end of the active tube to the working portion of the tip. There is a sliding sheath outside of the tube assembly. The sheath in the extended position minimizes risk of injury to tissue from tips when the electrode is inserted into a trocar cannula or reoriented. Holes in the distal end of the tube facilitate suction when the sheath is extended. When the sheath is retracted the electrode tip is exposed for delivery of electrosurgical energy. The sheath can be locked into place in the extended position, and has tactile stops in both the extended and retracted positions. The sheath is required for full protection from stray energy.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Suction Irrigation Electrodes, structured according to your request:

Acceptance Criteria and Device Performance

• Shield circuit: Continuity between shield connector and distal end of shield tube is to be ≤ 2 Ohms. | * Active circuit: The device was found to have an active circuit resistance ≤ 1.618 ohms using a 95% confidence interval with 99% reliability. Pass
• Shield circuit: The device was found to have a shield circuit resistance ≤ 0.830 ohms for a 95% confidence interval with 99% reliability. Pass |
  | Capacitance | Capacitance between active connector and shield connector is ≤ 130 pF @ 100 kHz. | The device was found to have a capacitance ≤ 121.49 pF @ 100 kHz using a 95% confidence interval with 95% reliability. Pass |
  | Energy Transmission | The device must transmit the full range of HF energy, from 30 to 60 watts of power in all modes from any approved ESU with less than 10% change in voltage. | The device was subjected to all 7 modes on the Conmed System 5000 ESU (4 cut modes, 3 coag modes). For every mode, at each of the 3 different power settings, the device transmitted the full range of high frequency energy with less than 10% change in voltage. Pass |
  | Flow | Flow rate from the proximal to distal end of the lumen must be a minimum of 580 mL/min when tested with a fluid head height of 57". | The flow rate was found to be greater than 689.7 mL/min using a 95% confidence interval with 95% reliability. Pass |
  | Safety (Standards) | Satisfactory results for all applicable clauses of:
• IEC 60601-2-2:2006 (Medical electrical equipment – Part 2-2: Particular requirements for the safety of high frequency surgical equipment.)
• IEC 60601-1:1988 with amendments (Medical Electrical Equipment - Part 1: General Requirements for Safety.)
• AAMI ANSI/ISO 10993-1:2003 (Biological evaluation of medical devices - Part 1: Evaluation and testing). | Satisfactory results for all applicable clauses. |
  | Biocompatibility | Non-cytotoxic (AAMI/ANSI/ISO 10993-5:1999)
  Non-irritating, non-sensitizing (AAMI/ANSI/ISO 10993-10:2002)
  Non-toxic (AAMI/ANSI/ISO 10993-11:2006) | * Tests selected for limited contact external communicating device to tissue.
• Non-cytotoxic.
• Non-irritating, non-sensitizing.
• Non-toxic. |
  | Sterilization | Recommended Cleaning Method and Moist Heat Sterilization for 10⁻⁶ SAL (AAMI/ANSI/ISO 17665-1:2006) was validated. | Recommended Cleaning Method and Moist Heat Sterilization for 10⁻⁶ SAL was validated. |

Study Information

1. Sample Size used for the test set and the data provenance:

   • The document does not explicitly state a sample size ("n") for the device performance tests (continuity, capacitance, energy transmission, flow). It describes the results in terms of confidence intervals (e.g., "using a 95% confidence interval with 99% reliability"), which implies statistical analysis from a sample, but the size of that sample is not provided.
   • Data Provenance: The tests are described as bench testing, meaning they were performed in a laboratory setting. There is no information regarding country of origin for the data or whether it was retrospective or prospective, as it's not clinical data.

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

   • This section is not applicable to the provided document. The study described is non-clinical bench testing for device performance characteristics (electrical, fluid flow, and compliance with general standards) rather than clinical performance requiring expert ground truth.

3. Adjudication method for the test set:

   • This section is not applicable for the same reason as above. Bench testing results are typically evaluated against pre-defined engineering criteria, not through expert adjudication.

4. 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, an MRMC comparative effectiveness study was not done. The device is a surgical instrument (Suction Irrigation Electrode), not an AI-assisted diagnostic or therapeutic tool for which human reader performance with/without AI would be relevant.

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

   • This question is not applicable. The device is an electrosurgical instrument for direct surgical use, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

6. The type of ground truth used:

   • For the non-clinical performance tests, the "ground truth" implicitly refers to the pre-defined engineering test criteria and established industry/international standards (e.g., 4 Ohms max for continuity, 580 mL/min min for flow, specific levels for biocompatibility). The results were compared directly to these objective, quantitative criteria.

7. The sample size for the training set:

   • This section is not applicable as there is no "training set" to speak of. The device is not an AI/ML model requiring a training set. The performance tests are conducted on the final device design.

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

   • This section is not applicable for the same reason as above. There is no training set mentioned in the document.

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AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.

The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

AEM instruments incorporate the use of AEM technology and are intended for use with the Encision AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor.

The AEM Disposable Electrode and the AEM Disposable Handpiece connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The handpiece has foot switching and hand switching versions. The electrodes and handpieces are single use products, which are provided sterile. They are designed not to be re-sterilized.

The AEM Monitoring System, including the electrodes and handpieces, are designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode.

The electrodes, which consist of an insulated tip, shaft with locking knob, and AEM shield assembly, are available in various tip styles. The material of the molded tip insulation has been changed. The electrode has an inner insulation between the active conductor and shield tube, as well as a secondary outer insulation on the outside of the electrode shaft.

The electrodes snap into the handpiece. The electrodes may be removed from the handpiece and replaced with another electrode within the sterile field.

The electrode can rotate freely or be locked in one of multiple orientations relative to the handpiece, as preferred by the surgeon.

This document is a 510(k) summary for AEM Disposable Electrodes and AEM Disposable Handpieces. It primarily focuses on demonstrating substantial equivalence to a predicate device due to a change in the tip insulation material. Therefore, it does not describe a study proving the device meets acceptance criteria in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity or specificity.

Instead, the "acceptance criteria" here refer to the requirements for demonstrating the safety and effectiveness of the new material and the devices' continued substantial equivalence. The "study" refers to the non-clinical performance testing conducted to support these claims.

Here's a breakdown of the requested information based on the provided text, acknowledging that some fields may not be directly applicable to this type of submission which focuses on material change and substantial equivalence rather than novel device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the biocompatibility or sterilization validation testing. The document states "Suitability of the new material..." and "Sterilization Validation has been performed...", implying tests were conducted, but specific sample sizes are not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal or performed by a third-party lab as part of the manufacturer's regulatory submission process. It is non-clinical, likely laboratory-based.

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

• Not applicable. This submission relies on standardized testing (ISO 10993-1, AAMI/ANSI/ISO 11737-1 and -2) and engineering assessments rather than expert-established ground truth in a clinical or diagnostic context.

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

• Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here.

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-enabled device and no MRMC study was conducted.

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. The testing described is for the physical device components and materials.

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

• The "ground truth" for the non-clinical testing comprises internationally recognized standards and specifications (ISO 10993-1 for biocompatibility, AAMI/ANSI/ISO 11737-1 and -2 for sterilization validation) which define acceptable parameters for these properties. The device's performance is compared against these predetermined standards.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable. No training set is involved.

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The Encision Disposable Handle Assemblies are used for minimally invasive surgical, laparoscopic and endoscopic procedures performed in general surgery, obstetrics/gynecology and gastroenterology/urology.

The DH0100 series and DH0500 series Disposable Handle Assemblies are fully disposable surgical instruments which are packaged for use without additional setup. The instruments fit standard 5.5mm cannulas. The Disposable Handle Assemblies are available in various operative lengths and styles. Tip styles include scissors, and double action and single action forceps and jaws for dissection or grasping. The handle and trigger open and close the working tip of the instrument. The rotation knob turns to allow 360°orientation of the tip as the surgeon prefers. This device does not transmit electrosurgical energy. There is no connection for monopolar or bipolar output from a generator. However, the shaft is insulated, in the event the instrument comes into contact with an active instrument, to prevent stray energy burns. The assembly is supplied sterile and is not intended for more than one use.

The Encision Disposable Handle Assemblies are surgical instruments designed for minimally invasive, laparoscopic, and endoscopic procedures. The device's safety and effectiveness were primarily demonstrated through a declaration of substantial equivalence to predicate devices, supported by non-clinical performance testing.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified. The performance verification was conducted through "bench testing."
• Data Provenance: Not specified, but generally, bench testing for medical devices is performed in a laboratory setting, likely within the manufacturer's facilities or a contracted testing lab. The data is retrospective in the sense that it's gathered specifically for regulatory submission.

3. Number, Qualifications, and Adjudication Method of Experts for Ground Truth

This information is not applicable as the study described is a non-clinical, bench testing program for device functionality and material properties, not a study involving human subjects or expert assessment of clinical images/data. The "ground truth" was based on established engineering specifications, safety standards, and performance metrics for surgical instruments.

4. Adjudication Method

Not applicable, as no expert consensus or adjudication process was involved.

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

No MRMC study was performed. The device's performance was evaluated through bench testing and comparison to predicate devices, not through a study involving human readers or AI assistance. Therefore, there is no effect size of human readers improving with or without AI.

6. Standalone Performance Study

A standalone performance evaluation was conducted in the form of "non-clinical performance testing" and "bench testing." This evaluated the device's articulating functions, shaft insulation, and material biocompatibility against defined engineering and safety standards. This study did not involve human operators in a clinical setting to assess performance, but rather technical performance attributes.

7. Type of Ground Truth Used for Test Set

The ground truth for the test set (bench testing) was based on:

• Established engineering specifications for articulating functions.
• Industry standards for dielectric withstand (for insulation).
• ISO 10993 series of standards for biocompatibility.
• Performance characteristics of the predicate devices for cutting, tissue manipulation, and handle articulation.

Essentially, the "ground truth" was defined by a combination of engineering requirements and the performance of already-approved, substantially equivalent devices.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical surgical instrument, not an AI or machine learning algorithm. Therefore, there is no "training set."

9. How Ground Truth for Training Set was Established

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

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The AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.

The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The AEM Disposable Electrode and the AEM Disposable Handpiece connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The handpiece has foot switching and hand switching versions. The electrodes and handpieces are single use products, which are provided sterile. They are designed not to be re-sterilized.

The AEM Monitoring System, including the electrodes and handpieces, are designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode.

The electrodes, which consist of an insulated tip, shaft with locking knob, and AEM shield assembly, are available in various tip styles. The electrode has an inner insulation between the active conductor and shield tube, as well as a secondary outer insulation on the outside of the clectrode shaft. The electrodes snap into the handpiece.

One version of the handpiece provides switching for the Cut and Coag functions of the ESU. This version has an integral cord. The other version uses foot-switching provided with the electrosurgical generator. The foot-switching handpiece connects to either the existing reusable or disposable AEM Cord from Encision. The electrodes may be removed from the handpiece and replaced with another electrode within the sterile field.

The electrode can rotate freely or be locked in one of multiple orientations relative to the handpiece, as preferred by the surgeon.

The provided text is a 510(k) summary for the ENCISION AEM Disposable Electrodes and AEM Disposable Handpieces. It describes the device, its intended use, and technological characteristics, and declares substantial equivalence to predicate devices based on non-clinical performance testing.

However, the document does not contain the specific information typically found in a clinical study report regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement for a multi-reader or standalone study. The performance testing mentioned is "bench testing consisting of continuity and capacitance measurements, and compatibility testing."

Therefore, based only on the provided text, I cannot complete the requested tables and descriptions for clinical acceptance criteria and study details. The document is a regulatory submission focused on substantial equivalence to predicate devices through non-clinical testing rather than a detailed report of a clinical efficacy or performance study.

Here's what can be extracted and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

MISSING: The document does not specify quantitative acceptance criteria or detailed reported device performance metrics in the format of a clinical study. The testing was non-clinical.

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

MISSING: No information is provided regarding a "test set" in the context of human data. The testing mentioned is "bench testing."

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

MISSING: No experts for establishing ground truth are mentioned, as the testing was non-clinical bench testing, not a clinical study involving interpretation of data by experts.

4. Adjudication Method for the Test Set

MISSING: No adjudication method is mentioned, as there was no test set involving human data or expert interpretation.

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

NO: The document does not describe a MRMC comparative effectiveness study. The testing was non-clinical to confirm safety and effectiveness for substantial equivalence.

6. Standalone Performance Study

NO: The document does not describe a standalone performance study in the context of an algorithm or AI. The performance verified was related to the device's AEM technology and delivery of electrosurgical energy through bench testing.

7. Type of Ground Truth Used

MISSING / NOT APPLICABLE: For bench testing, "ground truth" would relate to engineering specifications and measurements (e.g., continuity, capacitance values) rather than expert consensus, pathology, or outcomes data. These specific "ground truth" details are not provided.

8. Sample Size for the Training Set

MISSING / NOT APPLICABLE: This concept is not relevant to the non-clinical bench testing performed for this device. There is no mention of a "training set" as would be used for AI/ML development.

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

MISSING / NOT APPLICABLE: Not relevant, as there is no training set mentioned.

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