The Crystal Vision Smoke Evacuator System with Accessories is intended to remove smoke created in surgical procedures.

The Crystal Vision Smoke Evacuator System with Accessories is designed to remove smoke created in surgical procedures. The Crystal Vision Smoke Evacuator System with Accessories can be used to remove smoke produced by lasers, electrosurgical devices, argon beam coagulators, LEEP devices, and other devices that create smoke during surgical procedures.

During internal surgical procedures such as laparoscopy. it helps to maintain the desired internal pressure (pneumoperitoneum). The Crystal Vision Smoke Evacuator System with Accessories removes up to 20 litersper-minute of smoke produced.

The Crystal Vision Smoke Evacuator System with Accessories automatically activates when active (smoke producing) devices that are coupled to the smoke evacuator, with special sensors, are turned on.

The Crystal Vision Smoke Evacuator System with Accessories automatically turns off, at a time predetermined by the operator, after the active device turns off and automatically activates when the high pressure limit is exceeded in the pneumoperitoneum and it remains running to remove smoke, vapors, and gases until the internal pressure returns to levels below the preset maximum.

The Crystal Vision Smoke Evacuator System with Accessories can be used to evacuate CO2 gas from the pneumoperitoneum at the end of laparoscopic procedures.

The Crystal Vision Smoke Evacuator System with Accessories is intended to be used by trained professionals.

The subject device (Crystal Vision Smoke Evacuator System with Accessories) operates under same technologies, same mechanism of actions as the predicate (Crystal Vision (Model 470) and Accessories) and will use same accessories as the predicate device.

The modifications are: increase dimension of the product chassis to partially enclose the Input ULPA filter and the Output Charcoal filter; replace mechanical controls with push buttons; eliminate Stand By switch; replace flow set display, from bargraph display to 3 digits display; expand flow reading from 2 to 3 digits.

Accessories description:

The ULPA Filter & Water Trap:

The ULPA Filter & Water Trap for the Crystal Vision Smoke Evacuator System with Accessories, like the filters for the predicate device, is a replaceable filter that is completely enclosed to protect health care personnel from potential contamination during filter change. The ULPA Filter & Water Trap has a ULPA (Ultra Low Penetration Air) media.

Charcoal Output Filter:

The Charcoal Output Filter for the Crystal Vision Smoke Evacuator System with Accessories, like the one for the predicate device, is a replaceable filter that is completely enclosed and installed on the back of the Crystal Vision Smoke Evacuator System. The filter contains Granular Activated Charcoal from coconut shell and its life is based on the ability of the charcoal to absorb odors.

Sensor:

The Sensor for the Crystal Vision Smoke Evacuator System with Accessories, like the sensor for the predicate device, is an accessory which activates the Crystal Vision Smoke Evacuator automatically, when a cutting, smoke producing device will activate.

Foot Pedal:

The foot pedal is used for end user convenience as to activate the smoke evacuator when needed. The foot pedal shall be connected through same input connector used by sensor(s).

Intra-Abdominal Tubing Set, Sterile and Non-Sterile:

The I/A tubing is used during laparoscopic procedures, to evacuate the smoke produced. It connects to the trocar at one end and to the smoke evacuator to the other end.

Smoke Tubing, Sterile and Non-Sterile:

The smoke tubing may be used during any surgical procedure where there are smoke producing devices that needs smoke evacuation.

Smoke Tubing with In-Line Filter, Non-Sterile:

The smoke tubing may be used during any surgical procedure where there is smoke producing devices that needs smoke evacuation. In addition, the smoke tubing has a HEPA filter

Wand, Sterile and Non-Sterile:

The wand is a hand held device that may be used during any surgical procedure where there is smoke producing devices that needs smoke evacuation.

The provided document is a 510(k) premarket notification for a medical device (Crystal Vision Smoke Evacuator System with Accessories), not a study proving the device meets specific acceptance criteria based on diagnostic performance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through modifications to the form and controls of an existing smoke evacuator system.

Therefore, the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test sets, expert involvement, MRMC studies, standalone performance, and ground truth establishment for a diagnostic AI/device cannot be extracted from this document, as it is not relevant to the type of device and submission described.

The document discusses performance bench testing against electrical safety and electromagnetic compatibility standards (ANSI/AAMI/ES 60601-1 and IEC 60601-1-2), stating that the device met "Acceptance criteria on all applicable clauses of above mention standards." However, it does not provide a table of these specific acceptance criteria or the reported performance in measurable terms like sensitivity, specificity, or AUC, as these are not relevant for a smoke evacuator's function. No clinical testing (which would involve human or real-world performance data typically associated with diagnostic or AI devices) was performed or required for this submission.

Summary of what can be inferred for this specific device/submission based on the provided text:

• Acceptance Criteria & Reported Performance: The document states the device met acceptance criteria for electrical safety and electromagnetic compatibility standards (ANSI/AAMI/ES 60601-1 and IEC 60601-1-2). No specific numerical thresholds or results beyond "met" are provided. This is typical for predicate device submissions focused on substantial equivalence for physical devices, not diagnostic software.
• Sample Size for Test Set & Data Provenance: Not applicable, as no diagnostic "test set" in the AI sense was used. Performance was assessed via bench testing on the device itself.
• Number of Experts & Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No. The device is a physical smoke evacuator, not an AI or diagnostic tool where MRMC studies would be relevant.
• Standalone Performance: Not applicable.
• Type of Ground Truth: Not applicable.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

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The PenEvac® is intended to be used as the active Monopolar electrosurgery generator system and to facilitate the removal of smoke that is generated during procedures.

The Non-Telescopic PenEvac is defined as monopolar electrosurgical pencil with smoke evacuation capabilities. The device 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 Non-Telescopic PenEvac is intended to be used by trained professionals and will be marketed as a single use device, having different configuration as far as: type of electrode, length of tubing and end connector.

The proposed device is the same as the predicate Telescoping PenEvac. The only modification is a change in the telescopic tip, as the Non-Telescopic PenEvac does not have the telescope capability.

The provided text describes a 510(k) premarket notification for a medical device called "Non-Telescopic PenEvac." This document focuses on demonstrating the device's substantial equivalence to a predicate device, the "Telescoping PenEvac" (K954088), rather than presenting a performance study with detailed acceptance criteria and results in the way typically seen for novel devices or AI/software.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The acceptance criteria are not specified with numerical thresholds in this document, but rather refer to compliance with internationally recognized medical device safety and performance standards (IEC 60601 series). The reported performance is a general statement that the device met these criteria. This type of presentation is common for 510(k) submissions where the device is a modification of an already cleared product and the primary goal is to show "substantial equivalence."

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

The provided text only mentions "Performance Testing-Bench" and explicitly states there was no clinical testing required. Therefore, there is no sample size for an in-human test set or data provenance related to clinical data. The bench testing would have involved physical samples of the device, but the number of units tested is not specified.

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

Not applicable. Since no clinical testing was performed and the study focused on bench testing against IEC standards, there was no need for expert ground truthing of clinical data.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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

No. An MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical testing required." This type of study is relevant for diagnostic devices or AI systems where human reader performance is being evaluated or compared, which is not the case here.

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

Yes, in a sense. The "Performance Testing-Bench" described is a standalone evaluation of the device's physical and electrical characteristics against predefined standards, without human interaction beyond operating the device for the test. However, this is not an "algorithm-only" performance as the device itself is a physical electrosurgical pencil, not primarily software/AI.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" was established by the requirements and acceptance criteria defined within the IEC 60601 series of standards. These standards stipulate acceptable ranges for electrical safety, electromagnetic compatibility, and specific performance characteristics of high-frequency surgical equipment.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.

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

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

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The I.C. Medical SI Controller Model SI 500 is intended to control the flow of irrigation fluids and vacuum to suction/irrigation and multifunction accessories having compatible suction/irrigation features during wound care and closed surgical procedures. When used with appropriate accessories the SI Controller may be used for hydro-dissection.

The SI Controller is not intended for use in delivering any blood or blood products

The SI Controller Model SI500 controls the flow of fluids and vacuum to suction/irrigation and multifunction accessories used during -wound-eare and-open and closed surgical procedures and may be used for hydrodissection. Also included in this 510(k) application are tubing sets, disposable fluid canisters and accessories used to connect other surgical accessories to the irrigation fluid and vacuum sources. An electrical cable is also provided to accommodate remote sensing from I.C. Medical Crystal Vision smoke evacuators (K932230) in order to automatically activate and deactivate the SI Controller. I.C. Medical recommends that this device be used with the PenEvac SI (K95166) which is a multifunction suction, irrigation, ESU monopolar electrode device.

The provided text is a 510(k) summary for a medical device (SI Controller, Model SI 500) from 1996. This type of document is a premarket submission to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.

Crucially, this document is a summary for regulatory approval, not a scientific study report demonstrating the device meets specific performance acceptance criteria in a research setting.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be found within this document. These types of detailed studies and the specific reporting of acceptance criteria are typical for a device's rigorous clinical validation, which is a different purpose than a 510(k) summary.

The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, primarily by comparing technological characteristics and intended use.

Here's what can be extracted and what cannot:

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

• Cannot be provided. The document does not define specific, quantifiable acceptance criteria (e.g., "flow rate must be within X% of target") nor does it report the device's performance against such criteria. It states that the pump can deliver "continuously variable flows from 0-3.5 gpm" and that "Pressure may also be varied within a pressure range that is comparable to other devices used during laparoscopic procedures." These are descriptions of capabilities, not measurements against predefined acceptance criteria.
• The heat-retaining plate's maximum temperature is stated as "38 degrees centigrade" (a correction from "30 decrees centigrade" earlier in the document, suggesting a typo was corrected or the specification changed). This is a specification, but not tied to a specific acceptance criterion for a study.

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

• Cannot be provided. No "test set" in the context of a performance study is mentioned. The document relies on comparisons to predicate devices and descriptions of functionality, not on a study with a defined test set.

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):

• Cannot be provided. No ground truth establishment by experts is mentioned, as no performance study is detailed with a "test set" requiring ground truth.

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

• Cannot be provided. No adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, this was not done and is not relevant. This device (SI Controller) is a physical medical device for irrigation and suction, not an AI or imaging device that would involve "human readers" or AI assistance in interpretation.

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

• No, this was not applicable/done. This is not an algorithm-based device.

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

• Cannot be provided. No ground truth is established in the context of a performance study. The "truth" for a 510(k) is about demonstrating equivalence to existing, legally marketed devices.

8. The sample size for the training set:

• Cannot be provided. No "training set" is mentioned, as this device does not involve machine learning algorithms.

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

• Cannot be provided. Not applicable.

Summary of available information from the document:

The provided document is a 510(k) summary for the I.C. Medical SI Controller, Model SI 500, from 1996. Its purpose is to demonstrate substantial equivalence to previously cleared predicate devices for regulatory approval, not to present the results of detailed performance studies against specific acceptance criteria.

The document describes the device's functionality, its various modes of operation (irrigation, suction, manual, AUTO 1, AUTO 2, AUTO 3EF), its accessories (tubing sets, ESU sensor), and its intended use. It largely relies on comparing its technological characteristics (e.g., flow range, pressure range, heat plate temperature) to those of the predicate devices rather than presenting specific quantitative performance data or results from clinical validation studies.

Key statements related to "performance" (though not against formal acceptance criteria):

• Flow Rate: "The pump can deliver continuously variable flows from 0-3.5 gpm."
• Pressure: "Pressure may also be varied within a pressure range that is comparable to other devices used during laparoscopic procedures."
• Heat Retaining Plate Temperature: "The heat retaining plate is not meant to heat cold bags of fluids and it has a maximum temperature of 38 degrees centigrade." (Initially stated as 30 degrees Celsius, then corrected to 38 degrees Celsius).
• Tubing Sets: "The materials used in the tubing sets are the same, with the exception of the peristaltic pump tubing, as those used in the predicate devices. The peristaltic pump tubing is suitable for use in these tubing sets."

In conclusion, this specific document does not contain the information required to populate the requested table and answer the study-related questions, as it is a regulatory submission for substantial equivalence rather than a clinical or performance study report.

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The Telescoping PenEvac is intended to be used as the active monopolar electrosurgery generator system and to facilitate the removal of smoke that is generated during the procedure.

The Telessoping PenEvac is a combination of an electrosurgery switching handpiece and a smoke evacuation shroud with a telescoping tip that allows the surgeon to adjust the tip length. It includes pushbutton switches to allow the surgeon to select "cut" or "coagulation" operating modes on typical electrosurgery generators.

The device will be marketed in two versions:
As a complete single use sterile product.
As a partially reusable product with the PenEvac body and electrosurgery cord being reusable and the remainder of the device as a sterile single use product.

Electrodes of various lengths and shapes will be available.

This 510(k) summary for the I.C. Medical Telescoping PenEvac does not contain the level of detail typically found in a study demonstrating device performance against specific acceptance criteria. This document is a summary primarily focused on establishing substantial equivalence to predicate devices, rather than a detailed report of performance testing with specified acceptance criteria and outcomes.

Therefore, for your request, I will have to extract what information is present regarding testing and make inferences about "acceptance criteria" where they are not explicitly stated as numerical targets.

Here's the breakdown of the information based on your request:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission details modifications to an existing device (Telescoping PenEvac) and claims substantial equivalence to predicate devices. The "studies" described are primarily non-clinical bench tests and material compatibility tests, not clinical studies with human participants. The acceptance criteria are largely inferred from the statement of equivalence to predicate devices and compliance with industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated with a specific number for each test. The document refers to "samples of all proposed tip materials" for flammability and "the prototype devices" for ANSI/AAMI compliance. For the bench testing of functionality, it mentions "a number of different electrosurgery generators," implying multiple tests but not a precise count of devices or test runs.
• Data Provenance: The tests appear to be retrospective in the sense that they were conducted internally by I.C. Medical, the Chief Engineer, and/or the manufacturer of components, to support the 510(k) submission. There is no mention of external labs or country of origin other than the submitter's address in Glendale, AZ, USA. These are non-clinical tests, so there's no patient data provenance.

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

• Experts: The "Chief Engineer and/or the manufacturer of the cable/connector/switches" are mentioned as having tested the prototype devices for compliance with ANSI/AAMI HF-18.
• Qualifications: "Chief Engineer" implies relevant engineering expertise in electrosurgical devices. The manufacturer of components would also possess expertise related to their specific parts. No further specific qualifications (e.g., years of experience, certifications) are provided.

There is no mention of clinical experts (like radiologists) as these are non-clinical, bench and material tests.

4. Adjudication method for the test set

• Adjudication Method: Not applicable or explicitly stated as there is no mention of multiple raters or consensus-building processes for these types of non-clinical tests. The tests involve direct measurement, observation of functionality, and material testing, rather than subjective interpretations requiring 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

• MRMC Study: No. This device is an electrosurgical pencil and smoke evacuation system, not an AI-based diagnostic tool. Therefore, an MRMC study and discussions of AI assistance are not relevant to this 510(k) submission.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm or AI system. Its performance is inherent to its design and materials, and evaluated through bench testing simulating use conditions, not through an algorithm's standalone output.

7. The type of ground truth used

• Ground Truth: The "ground truth" for these tests is implicitly defined by:
  • Predicate Device Performance: The functional behavior and material properties of the legally marketed predicate devices (I.C. Medical ESU Shroud, Valleylab Disposable/Reusable Handswitching Pencils) serve as a comparative ground truth.
  • Industry Standards: Compliance with "applicable portions of ANSI/AAMI HF-18: 1993 Electrosurgical Device standard" represents a defined ground truth for electrical safety and performance.
  • Material Certifications: "USP Class VI certified" is a specific industry standard for biocompatibility, acting as a ground truth.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This submission concerns a physical medical device, not an AI/machine learning model that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for an AI/machine learning model.

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The PenEvac SI is a multifunction handpiece that is meant to provide the following optional functions: monopolar electrode handpiece in an electrosurgery generator system, suction, and to facilitate the removal of smoke generated during the procedure. The intended use is the same as the predicate devices.

The PenEvac SI is a multifunction device that optionally features suction, irrigation, electrosurgery "cut" or "coag, " and smoke evacuator functions. The device is intended to be used with an I.C. Medical Suction/Irrigator/Smoke Evacuator and common electrosurgery generators.

The PenEvac SI has a handpiece body that accepts various tips and endpieces to furnish different operating functions. The handpiece body will be available as either a sterile single use device or as a reusable device. The handpiece features two pushbutton switches and an electrosurgery cord and connector. The handpiece bodies are identical to the predicate Telescoping PenEvac bodies.

Changing the tip will change the function of the handpiece. There are three different configurations available: SIE (Suction, Irrigation, monopolar Electrode) Configuration, SI (Suction, Irrigation) 2 Channel, and SI (Suction, Irrigation) 1 Channel.

This 510(k) summary describes a medical device called the "PenEvac SI," which is an electrosurgery, suction, and irrigation handpiece with smoke evacuation. The document focuses on demonstrating that the PenEvac SI is substantially equivalent to existing predicate devices already on the market (the "Telescoping PenEvac" by I.C. Medical and the "Disposable Laparoscopic Handswitch" by Valleylab).

Based on the provided text, there is no acceptance criteria or study that proves device performance in the way typically associated with AI/ML-driven medical devices. The document is a 510(k) summary for a physical surgical handpiece, not a software algorithm. Therefore, many of the requested categories (like sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of device submission.

The "studies" mentioned are non-clinical engineering tests to ensure safety and fundamental operational equivalence to predicate devices, rather than performance metrics for an AI algorithm.

Here's a breakdown based on the categories, with explanations for why some are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device and not an AI/ML algorithm with performance metrics like sensitivity/specificity, acceptance criteria are generally focused on safety, functionality, and equivalence to predicate devices. The document implies that the "acceptance criteria" were met if the PenEvac SI performed similarly in fundamental engineering tests to the predicate devices and complied with relevant standards.

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size in the document for the non-clinical tests. The tests were performed on "samples of all proposed tip materials" and "prototype devices," as well as the PenEvac SI itself. This likely refers to a small number of physical units or components used for engineering verification.
• Data Provenance: The tests were non-clinical bench tests performed by I.C. Medical (the submitter) or its manufacturing partners (Chief Engineer, manufacturer of cable/connector/switches). There's no mention of country of origin of patient data, as no patient data was used. These were laboratory/engineering tests.
• Retrospective or Prospective: These were prospective engineering tests on prototypes and samples.

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

Not applicable. "Ground truth" in the context of AI/ML algorithms refers to expert labels or definitive diagnoses. For this physical device, the "ground truth" for the tests was established by engineering standards (e.g., ANSI/AAMI HF-18), objective measurements (e.g., current flow, flammability observations), and comparison to the known performance of predicate devices. The "experts" involved were likely engineers, technicians, and potentially the Chief Engineer and relevant manufacturers, who defined and executed the tests based on objective criteria.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. Adjudication methods are used to reach consensus on labels for ground truth in clinical data. These were direct engineering measurements and observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

Not applicable. This is a surgical handpiece, not an AI system designed to assist human readers (e.g., radiologists). No such study was performed or is relevant.

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

Not applicable. There is no algorithm to test in a standalone fashion. The device's function is a direct physical action (suction, irrigation, electrosurgery, smoke evacuation) controlled by the surgeon.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for these non-clinical tests was based on:

• Engineering standards: e.g., compliance with ANSI/AAMI HF-18.
• Predicate device performance: establishing that the PenEvac SI performed "the same as" or "virtually identical" to the legally marketed predicate devices, implying the predicate's performance is the accepted benchmark.
• Objective physical measurements/observations: e.g., current flow for capacitive resistance, visual assessment of flammability, functional testing of smoke evacuation and electrocautery.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML algorithm, and therefore no training set.

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

Not applicable. No training set exists.

In summary: The provided document is a 510(k) summary for a conventional medical device (a surgical handpiece). The "acceptance criteria" and "studies" are focused on demonstrating fundamental safety, functionality, and substantial equivalence to already-cleared predicate devices through non-clinical engineering and bench tests, in line with typical 510(k) requirements for such devices. The questions related to AI/ML performance metrics, clinical studies with human readers, and ground truth establishment for datasets are not relevant to this submission.

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The Telescoping PenEvac ABC is intended to be used only during open surgical procedures as the active handpiece in a combination argon beam coagulator/electrosurgery generator system that uses monopolar electrodes and to facilitate the removal of smoke that is generated.

The Telescoping PenEvac ABC is a combination of an argon beam coagulator pencil and an electrosurgery switching handpiece with a smoke evacuation shroud. It is intended to be used with argon beam generators that include electrosurgery capabilities. The device has push button switches to allow the surgeon to select CUT, COAG, or ARGON functions on the generator. An ARGON ASSIST mode can be selected by sliding the tip of the ABC Telescoping Tip back to expose the monopolar electrode. The device consists of three major components: PenEvac Body, ABC Adapter, and ABC Telescoping Tip. The PenEvac Body contains the pushbutton switches and ESU cord and connector. The ABC Adapter fits into the rear of the PenEvac Body and contains flexible tubing, generator connector, electrical conductor, and a rigid metal tube that fits into the PenEvac Body. The ABC Telescoping Tip is used during open surgical procedures. The tip may be extended or shortened as desired. It also has a sliding tip that can expose, or conceal, the electrode during argon procedures.

This document is a 510(k) summary for a medical device called the "Telescoping PenEvac ABC". It aims to demonstrate that this new device is substantially equivalent to existing, legally marketed predicate devices.

Let's break down the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicitly stated numerical "acceptance criteria" or detailed quantitative "reported device performance" metrics in the way one might expect for a clinical study with quantifiable endpoints (e.g., sensitivity, specificity, accuracy).

Instead, the summary focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical testing. The "acceptance criteria" here are implicitly that the new device functions "the same" as or "comparably" to the predicate devices and does not introduce new safety or effectiveness concerns.

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

• Sample Size for Test Set: Not explicitly stated numerically. The text refers to "Samples of all proposed tip materials" for flammability testing and "a number of different electrosurgery generators and an argon beam coagulator" for bench testing. This suggests a small, representative sample of materials and equipment rather than a statistically powered clinical trial sample.
• Data Provenance: The testing was "bench tested" and "nonclinical." This means the data was generated in a laboratory or engineering environment, not from human subjects. The country of origin is not specified, but the submission is to the FDA (United States). The testing is prospective for this specific device.

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

This type of information is not applicable to this 510(k) summary. The testing described is non-clinical bench testing, not clinical studies involving expert interpretation of medical images or patient outcomes. The "ground truth" for these engineering tests would be derived from physical measurements against established engineering standards or direct comparison to the functional performance of predicate devices. The "Chief Engineer" is mentioned as overseeing some tests, implying engineering expertise.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable to this type of non-clinical bench testing. Adjudication methods are typically used in clinical studies when multiple human observers evaluate data and their interpretations need to be reconciled.

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 handpiece, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and "improvement with AI" are not relevant here.

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

Not applicable. This device is a physical surgical instrument, not an algorithm. Its function inherently involves a human operator (the surgeon).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests described:

• Flammability: Ground truth is based on physical flammability characteristics and established safety standards.
• Functional Performance (smoke evacuation, electrocautery, argon beam coagulation): Ground truth is the observed functional output compared to the specifications and performance of the legally marketed predicate devices. This is a direct comparison to known, accepted performance.
• Electrical/Cable Compliance: Ground truth is established by adherence to the ANSI/AAMI HF-18: 1993 Electrosurgical Device standard.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model, so there is no concept of a "training set" in the context of its development and testing.

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

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

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