Search Results

The Valleylab™ SM Smoke Management Pencil and accessories are designed for general electrosurqical applications, including cutting and coagulation, and for removing surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The Valleylab™ SM Smoke Management Pencils are monopolar electrosurgical smoke evacuation pencils intended for cutting and coagulation of tissue while simultaneously removing surgical smoke. The pencils are designed to capture surgical smoke and improve visibility to target tissues, while reducing staff and patient exposure to the hazards of surgical plume. The Valleylab™ SM Smoke Management Extended Nozzle accessories are for use with longer electrodes for deeper access procedures. The predicate device is the Valleylab™ Smoke Evacuation Rocker Switch Pencil cleared under K182772.

The proposed devices are compatible with Covidien electrosurgical generators at a maximum peak voltage 4500 Vpk having a 3-prong connector and smoke evacuators having a 3/8" port. Electrode compatibility includes use with standard 3/32" diameter hex and non-hex electrodes. The pencils are available in 10' and 15' tubing/cable lengths models.

This document pertains to the 510(k) premarket notification for the Valleylab™ SM Smoke Management Pencil and accessories. It's important to note that this device is a physical electrosurgical tool and does not contain an AI component. Therefore, much of the requested information regarding acceptance criteria and studies for AI-driven devices (like sample sizes for test sets, ground truth establishment for AI, MRMC studies, standalone algorithm performance, and training set details) is not applicable here.

However, I can extract and present the acceptance criteria and performance testing conducted for this device, which are relevant to its substantial equivalence determination.

Acceptance Criteria and Reported Device Performance

The substantial equivalence determination for the Valleylab™ SM Smoke Management Pencil and accessories is based on meeting various performance standards and demonstrating safety and efficacy comparable to its predicate device (Valleylab™ Smoke Evacuation Rocker Switch Pencil cleared under K182772).

Here's a summary of the performance testing and their acceptance criteria, as reported in the 510(k) summary:

Study Details Regarding Acceptance Criteria (as applicable to a non-AI medical device)

Given that this is a 510(k) submission for an electrosurgical pencil and accessories, and not an AI-driven device, the detailed questions regarding AI study methodology are largely not applicable. However, I will address what is known from the provided text for each point:

1. A table of acceptance criteria and the reported device performance: See the table above.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   • The document does not specify exact sample sizes for each test (e.g., number of units tested for sterilization, biocompatibility, electrical safety, or bench performance).
   • The data provenance is not explicitly stated in terms of country of origin but is from Covidien LLC, a Medtronic company. The tests would be prospective in nature, as they involve testing the actual device prototypes or production samples against established standards.
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 for this type of device testing. Ground truth (e.g., sterility, electrical safety, mechanical integrity) is established by adherence to recognized international and national standards, not expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Device performance against technical standards is typically assessed through objective measurements, not human 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: Not applicable, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, "ground truth" refers to the objective, measurable parameters defined by recognized international and national standards (e.g., ISO for sterilization and biocompatibility, IEC for electrical safety and EMC, ASTM for packaging and shelf-life).
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In conclusion, the Valleylab™ SM Smoke Management Pencil and accessories have undergone rigorous non-clinical performance evaluations against established medical device standards to demonstrate substantial equivalence to a predicate device. The nature of this product as a physical electrosurgical tool means that many of the AI-specific questions are not relevant.

Ask a specific question about this device

The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

The Jiangsu Rong Fu Kang Medical Instruments Co. Ltd (here and after RFK) Electrosurgical Pencils and Electrodes are handheld instruments that are used for cutting and coagulation of soft tissue. They consist of a plastic handle, a connecting cable and plug, control buttons, internal PCB, and either a stainless steel uncoated or non-stick electrode tip. The Electrosurgical Pencils and electrodes are disposable and are supplied sterile.

The connecting cable is plugged into an Electro-Surgical Generator Unit (ESU) which provides the high-frequency energy to be deployed in the surgical procedure. The plastic handle has two buttons: cutting and coagulation. The cutting button activates the CUT mode of the ESU and the coagulation button activates the COAG mode of the ESU.

The electrode tip makes contact with the target tissue and delivers high frequency energy from the ESU to the target organs for the purposes of cutting and coagulation. This energy then passes through the body tissues and returns to the ESU via a return electrode (ground pad).

The provided document is a 510(k) premarket notification from the FDA for a medical device: a Sterile Single Use Electrosurgical Pencil with Non-Coated and Non-Stick Electrode. While it describes the device, its intended use, and substantial equivalence to a predicate device, it does not contain the level of detail typically found in a clinical study report or a submission for an AI/ML-based medical device that would include specific acceptance criteria for algorithm performance, sample sizes for test sets, expert ground truth establishment, or MRMC studies.

The document focuses on "Non-Clinical Bench Testing" to demonstrate substantial equivalence, primarily comparing physical characteristics, energy type, sterilization, and material properties, as well as thermal effects on tissue and electrical safety (EMC).

Therefore, based on the provided text, I cannot extract the information required to answer your prompt about acceptance criteria and a study proving the device meets those criteria, as it would be relevant for an AI/ML-based device. The device in question is a physical instrument, and its performance evaluation relies on different types of testing.

However, I can interpret the available information to frame a response in the context of what is provided for this electrosurgical pencil.

Interpretation Based on Provided Document (Electrosurgical Pencil - Not an AI/ML Device):

This document describes the regulatory submission for a physical medical device, an electrosurgical pencil. The "acceptance criteria" in this context are not for an algorithm's performance (e.g., accuracy, sensitivity, specificity) but rather for the device's physical and functional characteristics demonstrating substantial equivalence to a legally marketed predicate device. The "study" proving acceptance is the non-clinical bench testing performed.

Here's how the information can be mapped:

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

Since this is not an AI/ML device with performance metrics like accuracy or AUC, the "acceptance criteria" are implicitly the functional and safety equivalence to the predicate device. The "reported device performance" are the results of the bench tests confirming this equivalence.

• Energy Type: High-Frequency Monopolar
• Sterilization Type: EO Sterilization
• Single Use
• Electrode Type: Monopolar
• Electrode Material: Stainless Steel
• Standards Applied: IEC 60601-1, IEC 60601-2-2, ISO 11135, ISO 11607
• Biocompatibility: Conforms to ISO 10993
• Labeling: Conforms to 21 CFR Part 801
• Stability and Shelf Life: 3 Years | All characteristics are identical or demonstrably equivalent.
• Electrode non-stick coating: Subject device uses Silicon oxide; predicate uses Teflon. Demonstrated to be "similar" in performance without craters.
• Handle Length: Subject: 145mm; Predicate: 165mm. (Difference noted, but not deemed critical enough to prevent equivalence).
• Total Device Length: Subject: 190mm; Predicate: 210mm. (Difference noted, but not deemed critical enough to prevent equivalence). |
  | Thermal Effects Equivalence: Similar thermal damage zone sizes on ex-vivo tissues (kidney, liver, muscle). | "These tests showed that the thermal effects of our electrode are virtually identical to those shown in the predicate device." |
  | Non-Stick Performance Equivalence: Similar non-stick performance to predicate. | "The non-stick performance of our non-stick electrode was found to be similar to the predicate device but without occurring holes and craters as in the predicate device's non-stick coating." |
  | Electrical Safety (EMC) Compliance: Pass specified electrical tests. | "The device K231405 successfully passed the following electrical tests: Conducted Emissions, Radiated Emissions (30MHz-1GHz, 1GHz-18GHz), Electrostatic Discharge (ESD), Radio frequency electromagnetic field radiation immunity, Power frequency magnetic field." |
  | Package Integrity & Functional Performance for Shelf Life: Maintain integrity and function after aging. | "Subject device package integrity and functional performance tests were performed in-house in our Jiangsu facilities after aging and real-time stability tests to confirm the proposed shelf life." |

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

• Sample Size: Not explicitly stated as a numerical count of units tested. For the "Thermal Effects on Tissue", it mentions "Ex-vivo kidney, liver, and muscle tissues were used." The quantity of each tissue type or the number of device samples tested is not provided. For electrical testing, it's typically a set number of units for compliance, but not specified here.
• Data Provenance: The thermal effects and package integrity/functional performance tests were conducted "in-house in our Jiangsu facilities." Electrical (EMC) testing was conducted by "Suzhou Yipin Quality Technical Service Co., Ltd." in Suzhou, China. Biocompatibility testing was performed by "Sanitation & Environment Technology Institute, Soochow University" in Suzhou, China. This indicates retrospective testing performed specifically for the 510(k) submission.

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

This concept is not applicable here as the device is a physical instrument, not an AI/ML algorithm requiring expert annotations for ground truth on images or data. The "ground truth" for this device's performance is established by direct physical measurements, electrical tests, and tissue studies.

4. Adjudication method for the test set:

Not applicable for this type of device testing.

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/ML device that assists human readers.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" for this medical device's performance relies on:

• Direct measurements and physical properties: Comparing specifications like dimensions, materials, and sterile status to the predicate device.
• Ex-vivo tissue studies: For thermal effects, the "ground truth" is the empirically measured thermal damage zone size on animal tissues, compared to the predicate device's effects.
• Standardized electrical test results: Compliance with international electrical safety standards.
• Material properties and biocompatibility studies: Compliance with ISO standards for materials and biological safety.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of AI/ML.

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

Not applicable.

Ask a specific question about this device

Intended use: The monopolar electrosurgical pencil with electrode is used to deliver high frequency current to target tissue for cutting and coagulation.

Indication for use: The device is to be used in combination with a standard electrosurgical generator to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

Disposable electrosurgical pencil uses high density and high frequency current on local tissue thermal effect, the tissue or tissue components vaporization or burst, the medical operation so as to achieve the cutting and coagulation. Therefore, it may not only replace surgical knife for a variety of surgical procedures, and obviously reduce the bleeding or no bleeding. This can significantly reduce the labor intensity of the medical staff, and also shorten the operation time, and is good for patient to recover after surgery.

Disposable electrosurgical pencil is the applied parts of high frequency electrosurgical equipment/generator, when the high-frequency generator outputs a certain waveform of highfrequency current, which passes through the electrosurgical electrode and applies to the tissue of patient for cutting or coagulation, then the residual current returns back to the high-frequency generator through a neutral electrode.

The provided document is a 510(k) Summary for a Disposable electrosurgical pencil. It describes the device, its intended use, and a comparison to a predicate device, along with performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study conducted, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for each performance test with corresponding values. Instead, it states compliance with various standards. The "performance data" section describes the types of tests conducted and concludes that the device performed acceptably by meeting the requirements of recognized standards and guidance.

Here's a summary of the performance testing details:

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

• Sample Size for performance testing (Thermal Tissue Effects): The document states "Tissues of porcine kidney and porcine muscle were used for thermal effect testing." The specific number of samples (e.g., how many porcine kidneys or muscle pieces) is not provided.
• Data Provenance: Not explicitly stated. Given that Shenzhen Mecun Medical Supply Co., Ltd. is based in China, it's highly probable the testing was conducted there, but this is not confirmed in the document. The study is presented as performance testing for the subject device to demonstrate substantial equivalence, which implies it's prospective data for this 510(k) submission.

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

• Not Applicable. The described study focuses on the physical performance of the electrosurgical pencil (e.g., thermal effects on tissue). It is a non-clinical performance study rather than a study involving human interpretation of data where "ground truth" would be established by experts (e.g., radiologists interpreting images). The "ground truth" here is the observable physical effect of the device on tissue under controlled conditions, measured instrumentally or visually by qualified personnel involved in the testing, but not explicitly as a panel of "experts" for ground truth establishment in the traditional sense of medical image analysis or diagnostic studies.

4. Adjudication Method for the Test Set

• Not Applicable. As explained above, this is a non-clinical performance study. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments, which is not applicable here.

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

• No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. The device is a physical electrosurgical pencil, not a software algorithm or an AI system. Therefore, the concept of "standalone (algorithm only)" is not relevant.

7. The Type of Ground Truth Used

• For the performance testing on thermal tissue effects, the "ground truth" would be the physical and observable effects (cutting and coagulation characteristics, extent of thermal damage) on the porcine tissue, measured or observed directly during the test. This is an experimental observation under controlled conditions, not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI/ML algorithm or a software device requiring a training set. The performance testing involves direct physical testing of the electrosurgical pencil.

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

• Not Applicable. As mentioned above, there is no training set for this type of device.

Ask a specific question about this device

The SnapEvac and PenAdapt is an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed. This device is considered an accessory to an electrosurgical unit (ESU). SnapEvac and PenAdapt removes surgical smoke during surgical procedures that use ESU for cutting and cauterizing. This device is used in conjunction with a suction (vacuum) source.

Contraindications: This device should not be used for microsurgery.

The PlumePen® Elite, PlumePen® Ultra, and PlumePen® Pro is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Indicated for use to remove smoke plume from the surgical site and to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect.

The smoke evacuation devices that are the subject of this 510(k) are PlumePen Surgical Smoke Evacuation Pencils (Elite, Pro and Ultra), PenAdapt Electrosurgical Pencil Adapters and Electrosurgical Pencil Adapters. By interfacing with an effective smoke evacuation unit, these devices function as part of the system to remove smoke particles from the point of surgical activity during procedures that use an electrosurgical unit (ESU) for cutting and cauterizing.

PlumePen Smoke Evacuation Pencils: The PlumePen® Elite, Pro, and Ultra family of devices are sterile, single use electrosurgical hand pieces featuring an integrated smoke evacuation channel. The devices, when connected to an electrosurgical generator and smoke evacuation system are designed to remove smoke plume generated during the use of the pencil for electrosurgical procedures.

PenAdapt and SnapEvac Electrosurgical Pencil Adapters: PenAdapt and SnapEvac are sterile, single use pencil adapters which fit over standard electrosurgical pencils while keeping the blade exposed. They enable the capture and removal of smoke generated during the use of the pencil, in procedures that require cutting and cauterization, when connected to an effective smoke evacuation system.

The provided text describes the 510(k) premarket notification for electrosurgical accessories (PlumePen Surgical Smoke Evacuation Pencils, PenAdapt, and SnapEvac Electrosurgical Pencil Adapters). The purpose of this notification is to demonstrate substantial equivalence to legally marketed predicate devices.

However, the request asks for specific details related to acceptance criteria and a study proving a device meets acceptance criteria, specifically in the context of an AI/ML-driven medical device. The provided document details the testing for electrosurgical tools to demonstrate functional equivalence and safety, not the performance of an AI/ML diagnostic or assistive device.

Therefore, the information required to answer the prompt (acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert roles, adjudication methods, MRMC study details, standalone performance, ground truth types, etc.) is not present in the provided text. The document refers to standard medical device testing such as functionality verification (e.g., 90% smoke capture), electrical safety, biocompatibility, sterilization validation, and packaging validation, which are applicable to physical electrosurgical devices, not AI/ML algorithms.

My response will acknowledge that the requested information is not available in the provided document, as it pertains to a different type of medical device evaluation (AI/ML vs. physical electrosurgical tools).

Ask a specific question about this device

The Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dr, OBS-Di, OBS-De) is used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery with an electrosurgical generator. The device is disposable and supplied sterile with an electrode tip.

The Electrosurgical Pencil (OBS-Dt, OBS-Ds, OBS-Ds, OBS-Da) is used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery with an electrosurgical generator, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Not Found

This FDA clearance document is for an Electrosurgical Pencil and does not contain information about acceptance criteria or a study proving device performance as typically expected for AI/ML-enabled devices. The document is a 510(k) clearance letter, which determines substantial equivalence to a predicate device, rather than providing detailed performance data derived from clinical studies with specific acceptance criteria that would typically be seen for a new technology or diagnostic AI/ML device.

Therefore, I cannot provide the requested information in the format given because the input document does not contain:

1. A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance thresholds.
2. Sample size used for the test set and the data provenance: There is no mention of test sets, data, or their origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no mention of ground truth establishment.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone performance study was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on the regulatory clearance process for a medical device (electrosurgical pencil) based on substantial equivalence to existing products, rather than a detailed performance study for an AI/ML algorithm.

Ask a specific question about this device

The device is to be used in combination with a standard electrosurgical generator to cut and coagniate soft tissus by means of high frequency electrical current during an electrosurgical procedure.

The Single use electrosurgical pencil with electrode is a monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post. It directs high frequency alternating current to heat target tissue thereby bringing about cutting and coagulation during surgical procedures.

The electrosurgical pencil handpiece consists of a plastic handle, electrical cable and a plug. The switching modes are for "CUT" and "COAG" function. A socket in front of the pencil casing is used to allow the insertion of an electrode.

The electrosurgical pencil handpiece is available in 3 models, differing only in their button configuration: Push Button Electrosurgical Pencil (Model #: GDSA), Electrosurgical Rocker Pencil (Model #: GDSB), and Electrosurgical Foot Control (Model #: GDJA).

The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball, needle and dermal tip. The electrode tip is either coated or noncoated. There may or may not be a heat shrink attached. There are 47 different types of electrodes.

The model number of each subjective device "Single use electrosurgical pencil with electrode" consists of two parts: the first four letters representing model number of the pencil, and the second part representing model number of the electrode. For example, model number: GDSA-DA-C66 is for Push Button Electrosurgical Pencil with Standard Blade 2.6". There are 141 different combinations of pencil and electrode.

The diameter of the conductive post is 2.36mm. The pencil with electrode attached is to be connected to a general high frequency electrosurgical generator by means of the electrical cable and is used in conjunction with a patient grounding pad during an electrosurgical procedure.

The switching method of this electrosurgical pencil may be push button, rocker switch or foot switch. The cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug.

The provided text describes a 510(k) premarket notification for a "Single use electrosurgical pencil with electrode". This is a medical device application for a new version of an existing device, aiming to demonstrate substantial equivalence to a previously cleared predicate device.

The document focuses on comparing the proposed device to its predicate, rather than providing a detailed acceptance criterion table with numerical performance metrics and a specific study that proves the device meets those criteria in a typical clinical or diagnostic sense with specificity/sensitivity.

Instead, the "acceptance criteria" here are largely compliance with international standards and equivalence to the predicate device in various performance aspects. The "study" refers to performance and safety testing conducted to ensure this compliance and equivalence.

Here's a breakdown of the requested information based on the provided text:

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

Since this is a substantial equivalence submission for an electrosurgical pencil, the "acceptance criteria" are primarily related to safety, functional performance, and biocompatibility, benchmarked against standards and the predicate device. The "reported device performance" is a statement of compliance with these standards and equivalence to the predicate.

Since this is a 510(k) summary for a relatively straightforward electrosurgical device, the detailed metrics often found in AI/diagnostic device submissions are not present. The "study" mentioned for performance testing is a comparative study, implying the new device's performance was found to be similar to the predicate.

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 primarily describes bench testing and biocompatibility testing.

• Performance Testing (Penetrating thermal tissue effects): The "test set" consisted of "Porcine Liver, Porcine Kidney, Porcine Muscle tissues." The sample size (number of tissue samples or repetitions) is not specified. The data provenance is ex-vivo (animal tissue), likely conducted in a controlled lab environment (implicitly, in China, based on the submitter's location). This type of testing is generally considered prospective in terms of data collection and analysis for the submission, even if it uses ex-vivo samples.
• Biocompatibility Testing: The specific sample sizes for tests like cytotoxicity, sensitization, systemic toxicity, and pyrogen testing are not specified. These tests typically involve in-vitro assays (cytotoxicity) and in-vivo animal models (sensitization, systemic toxicity, pyrogen). The provenance would be from lab testing, likely conducted in China or a contracted lab.

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 type of information is not applicable and not provided for this device. The "ground truth" for electrosurgical pencils involves objective physical/biological measurements (e.g., thermal effect depth, electrical parameters, biocompatibility reactions) rather than expert interpretation of images or clinical data. The standards themselves (IEC, ISO) define the "ground truth" for compliance.

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

Not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in expert assessment (e.g., in radiology studies). This submission relies on objective testing following defined international 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 and not provided. MRMC studies are specific to AI-assisted diagnostic devices involving human readers. This device is an electrosurgical pencil, not a diagnostic AI system.

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

Not applicable and not provided. This is not an AI algorithm. Its performance is assessed through physical, electrical, and biological testing.

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

The "ground truth" for this device's performance and safety is established by objective measurements and adherence to recognized international standards.

• For electrical safety and EMC, the ground truth is defined by the parameters and limits specified in IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
• For biocompatibility, the ground truth is defined by the acceptable limits and biological responses outlined in ISO 10993 series standards.
• For performance (thermal tissue effects), the ground truth is the measured penetrating thermal effect compared to the predicate device's measured effects on porcine tissues. Implicitly, similar or equivalent effects are the "ground truth" for demonstrating equivalence.

8. The sample size for the training set

Not applicable and not provided. This device is not an AI/machine learning model, so there is no concept of a "training set."

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

Not applicable and not provided for the same reason as point 8.

Ask a specific question about this device

The ShinEvac® Smoke Evacuation Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct and electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The ShinEvac® Smoke Evacuation Pencil, model: SW12200-APBCSE36, SW12200-APBCSE36G, SW12200-APBCSE56, SW12200-APBCSE56G, SW12200-APBCSB36 and SW12200-APBCSB56 is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Electro surgical Pencil is one of accessories of HF Electro Surgical Unit generates frequency from 300~600KHz for coagulation and cutting function, power up to 80W and 120W respectively. It is connected with cable conducting electro energy from unit and is holding a detachable tip electrode for the electrosurgery. This device is compatible with the Ø 2.38mm tip electrode and the maximum voltage is 4.5 KV peak. This device can remove surgical smoke when connected to a smoke evacuator.

The provided text describes a medical device, the ShinEvac® Smoke Evacuation Pencil, seeking FDA clearance via a 510(k) submission. This type of submission generally demonstrates substantial equivalence to a predicate device rather than providing extensive de novo clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, the study described here focuses on demonstrating that the new device performs similarly to a legally marketed predicate device, especially regarding safety and functional aspects, rather than setting and meeting specific quantitative clinical performance metrics like sensitivity, specificity, or AUC as one might see for diagnostic AI devices.

However, I can extract information related to performance testing and safety, which serve as the acceptance criteria for this type of device within the context of a 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Performance Testing (Animal Study): The animal study involved evaluating the device in "three different tissues" ("liver, kidney and muscle"). The exact number of animals or trials within each tissue type is not specified.
• Data Provenance: The animal study is prospective (conducted for the purpose of this submission). The country of origin for the animal study is not specified in the provided text.
• Other tests (Safety, Biocompatibility, Sterilization): These are typically laboratory-based tests conducted on device samples. The specific sample sizes for these tests are not provided but would be defined by the respective international standards (e.g., ISO, IEC).

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

• This device is an electrosurgical pencil, not an AI/diagnostic device that typically relies on expert-established ground truth for its performance metrics (like sensitivity/specificity).
• For the animal study, the evaluation of "safety from tissue temperature, tissue cooling time and the extent of tissues' thermal damage" would likely involve veterinary pathologists or researchers with expertise in electrosurgery and tissue histopathology. However, the exact number and qualifications of these experts are not specified in the document.
• For the other tests (safety, biocompatibility, sterilization), the "ground truth" is established by adherence to the objective criteria and protocols defined in the referenced international standards.

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

• Not applicable as this is not a diagnostic AI device requiring expert consensus for ground truth labeling. Performance is assessed against objective engineering and biological 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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools and is not applicable to an electrosurgical pencil. The submission is for a physical medical device, not an AI algorithm assisting human readers.

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

• Not applicable. This device is a physical electrosurgical tool and not an AI algorithm.

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

• For the animal study, the "ground truth" for assessing cutting performance, tissue temperature, cooling time, and thermal damage is established through direct observation, measurement, and potentially pathological examination of a histologist or other experts.
• For safety, biocompatibility, and sterilization tests, the "ground truth" is defined by the objective pass/fail criteria and methodologies stipulated within the referenced IEC and ISO international standards. Compliance with these standards serves as the benchmark.

8. The sample size for the training set

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

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

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

Ask a specific question about this device

The device is used to conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

There are two main series of smoke evacuation pencil.
(1) Smoke Evacuation Fingerswitch (PS947): The device includes the active handle which connects with the active electrode. The diameter of the mating part is 2.36mm+/-0.02mm. The buttons on the active handle control cutting and coagulation, the yellow side activates the cutting function and the blue side activates the coagulation function. The active handle's end is connected to an insulation cord with an active connector. The EVA tubing at the rear of the active handle then leads to a filter and pump system that facilitates the removal of harmful "surgical smoke" from the site of operation. The switching controls are mounted onto an active handle that moves freely up and down the shaft of the device when the device is in vertical position (or moves freely forward and backward when the device is in horizontal position), when the switching control moves freely on the shaft, distance between the front end of the handle and the controls is reduced or increased that works like extending and retracting the suction tip on general smoke evacuation, allowing the surgeon a greater degree of control and removing the need for additional accessories to extend the length of the device when working in cavities and other areas with restrictive access. Furthermore, the electrode can be exchanged with 63.5mm, 69mm and 120mm long electrodes in diameter 2.36±0.2mm with corresponding nosecone for further extending the length of suction tip for smoke evacuation.
(2) Smoke evacuation system with electrosurgical pencil (CE809): The device includes electrosurgical pencil with electrode and smoke evacuation handle connected with EVA tubing with ID22mm tubing connector. Electrosurgical pencil (PD646 or PD631) with 69mm long electrodes in diameter 2.36±0.2mm, can be put into the handle that functions as smoke evacuation pencil.

This document is a 510(k) premarket notification for a medical device and therefore primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in a traditional clinical trial sense. The provided text describes non-clinical performance testing (bench testing) to support substantial equivalence.

Here's an analysis based on the information provided, specifically addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical quantitative AI/software sense (e.g., sensitivity, specificity, AUC thresholds). Instead, it compares the proposed device's characteristics and its tested performance against those of a predicate device to demonstrate substantial equivalence.

The "acceptance criteria" in this context are implicitly defined by the safety and performance standards met by the predicate device and the relevant international and national standards for electrosurgical devices and smoke evacuation systems. The "reported device performance" refers to the results of the bench testing that showed equivalence to the predicate device.

Here's a reinterpretation of the request based on the available information:

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

• Test Set (for performance testing): The document mentions "bench testing on the subject device and predicate devices by using porcine tissue: kidney, liver, muscle for both Cut mode and Coagulation mode".
  • Sample Size: Not explicitly stated (e.g., number of porcine tissue samples, number of tests performed). It only specifies the types of tissue.
  • Data Provenance: Porcine tissue (an animal model). The country of origin is not specified, but the applicant is based in Hong Kong, China. It is a prospective bench test, not retrospective patient data.

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

This is not applicable as the study described is a non-clinical, bench testing study, not a study evaluating human performance or diagnostic accuracy that would require expert ground truth. The "ground truth" for the non-clinical performance evaluation was laboratory measurements and objective assessments (e.g., thermal zone size measurement, electrical safety compliance, sterilization validation).

4. Adjudication method for the test set

Not applicable. This was a non-clinical bench test. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for establishing expert consensus on patient data.

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 pencil with smoke evacuation, not an AI or imaging device that would involve human readers or diagnostic interpretation.

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

This is not an algorithm-only device. It's a physical medical device. The "performance" evaluated was its physical and electrical characteristics and its ability to perform cutting, coagulation, and smoke evacuation, as operated by a user in a simulated environment.

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

For the bench testing, the "ground truth" was established by:

• Laboratory measurements: Assessing thermal effects and thermal zone sizes on porcine tissue.
• Standard compliance: Verification against international and national standards (e.g., IEC, ISO, ASTM). This involves objective measurements and tests rather than expert consensus on subjective data.

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as it is not an AI/ML algorithm.

Ask a specific question about this device

The Smoke Evacuation Button Switch Pencil and Telescoping Smoke Evacuation Switch Pencil are intended for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The Pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The application devices, the Smoke Evacuation Button Switch Pencil and the Telescopic Smoke Evacuation Button Switch Pencil (referred to hereafter as the Smoke Evaluation Pencils), are a collection of electrosurgical electrodes with an integrated smoke collection tube. The flat blade electrode provided in each pencil can be removed and replaced with a compatible electrode.

New Deantronics is requesting clearance two series Smoke Evacuation Pencils.

The simplified series includes two different housing styles (round and oval) of pencil body design. Each housing style has two different lengths of attached tubing at the proximal end of the pencil body, 10ft and 15ft; thus, there are 4 models in this and the premium series. These 4 simplified series models share the same design elements (functional design, technology design, packaging, sterilization method and process, etc.)

The premium series embodies one of two extender mechanisms. There are 2 smoke nozzle extender/fixation mechanism designs in this series; with and without lock mechanism. Each design includes two lengths of spiral tube and cable, while all the other design elements, such as cosmetic appearance, grip characteristics, construction materials, packaging, sterilization method, etc., are identical in this premium series to the simplified series.

The Smoke Evacuation Pencils are designed to be used with a compatible electrosurgical generator and smoke evacuation system.

These devices are single use and are sold sterile.

The provided text is a 510(k) summary for a medical device (Smoke Evacuation Button Switch Pencil) seeking FDA clearance. It focuses on demonstrating substantial equivalence to a predicate device. This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The document describes the device as an electrosurgical accessory for cutting, coagulation, and smoke evacuation, and its performance is evaluated against engineering standards (e.g., IEC 60601 series, ISO 10993-1) and physical tests (e.g., button activation force, weld integrity). It does not mention any AI or algorithmic components, nor does it describe a study involving human readers or expert consensus for ground truth.

Therefore, I cannot fulfill the request using the provided text. The questions posed in the prompt (regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance) are relevant to the evaluation of AI/ML-based medical devices, which this document is not about.

Ask a specific question about this device

Medline's Smoke Evacuation Pencil is designed for general electrosurgical applications including cutting and coagulating, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a medical device (Medline Smoke Evacuation Pencil). It does not contain any information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth or train AI models.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

The document focuses on the regulatory clearance process for a relatively low-tech electrosurgical device, not on the validation of an AI/ML-based medical device.

Ask a specific question about this device