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This product is indicated for use in minimally invasive procedures for removing smoke generated by electrocautery and small amount of fluids when used in conjunction with an effective suction equipment.

The smoke evacuator has two parts - the exhaust tube and the control valve. The product can be installed on 5mm surgical electrode/high-energy instrument in minimally invasive surgery. The product is connected with the vacuum suction system, using negative pressure to extract smoke, small amount of blood and water from the tip of the surgical instrument.

This document is a 510(k) clearance letter for a medical device, the "Vigeon" Laparoscopic Universal Smoke Evacuator (VG003). It demonstrates substantial equivalence to predicate devices. For devices cleared through the 510(k) pathway for substantial equivalence, the focus is on showing similarity to existing cleared devices rather than establishing novel clinical effectiveness or "proving" performance against specific acceptance criteria for an AI/software as a medical device (SaMD).

Therefore, this document does not contain the information requested regarding acceptance criteria for an AI/SaMD, nor does it detail a study proving such a device meets these criteria. The "performance testing" mentioned (phantom experiment, suction function, safety distance, operational safety) are typical for a physical medical device to ensure its mechanical and safety properties, not performance metrics for an AI/SaMD.

Here's why the requested information is absent:

• Device Type: The "Vigeon" Laparoscopic Universal Smoke Evacuator (VG003) is a physical, accessory device used in surgery, not an AI or software-as-a-medical-device (SaMD).
• Regulatory Pathway: The 510(k) pathway for substantial equivalence often relies on comparative testing to predicates for physical performance and safety, not on the rigorous statistical validation against ground truth that AI/SaMD products require.
• "Performance Testing" Description: The description of performance testing ("Phantom experiment, performance testing of suction function, safety testing of the safety distance and operational safety testing") clearly indicates physical testing of the device's mechanical and operational functions, not evaluation of an AI algorithm's diagnostic or predictive capabilities.

In summary, as this is a physical medical device (a smoke evacuator) and not an AI/SaMD, the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI algorithm's performance are not applicable to the provided document.

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The PhotonBlade 3 is a monopolar radiofrequency (RF) device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, and breast procedures (including mastectomy and lumpectomy).

The PhotonBlade 3 Smoke Evacuation device is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, and breast procedures (including mastectomy and lumpectomy), and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The PhotonBlade 3 (Model No: 0730-101-000) and PhotonBlade 3 Smoke Evacuation (Model No: 0730-102-000) devices are sterile, single use, electrosurgical devices have a monopolar electrode at the distal end, which delivers radiofrequency (RF) energy for cutting and coagulation of tissue. The electrode is located at the distal end of a rotatable and extendable shaft. The devices have integrated LED-based illumination. In addition, the PhotonBlade 3 Smoke Evacuation features integrated smoke evacuation tubing for removal of smoke generated by electrosurgery when connected to a smoke evacuation universal connector attaches the device to an IEC 60601 compliant electrosurgical generator.

The provided text is a 510(k) Summary for the Stryker Instruments PhotonBlade 3 and PhotonBlade 3 Smoke Evacuation devices. It discusses the regulatory clearance process and comparison to predicate devices, but does not contain the detailed information required to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria.

While it mentions "pre-defined acceptance criteria for the above tests were met" in the "Performance Testing" section, it does not explicitly state what those acceptance criteria were for each test, nor does it provide a detailed study design or results from such a study.

Therefore, I cannot extract the information requested. The document primarily focuses on establishing "substantial equivalence" to a predicate device based on similar indications for use and technological characteristics, and by referencing compliance with various standards and general performance testing without providing the specific details of a study that directly proves the device meets predefined acceptance criteria for its performance metrics.

To specifically address your questions, the following would need to be present in the document:

1. A table of acceptance criteria and reported device performance: This would require a table explicitly listing criteria (e.g., "minimum lumen output 50 lumens") and the actual measured performance (e.g., "Device A measured 65 lumens").
2. Sample size and data provenance for the test set: The document vaguely mentions "simulated use life testing," "coag verification test," etc., but no sample sizes or origin of data (e.g., animal, human, in vitro, country).
3. Number and qualifications of experts for ground truth: This type of information is usually relevant for studies involving subjective assessment (e.g., image interpretation). For a device like an electrosurgical unit, ground truth often comes from objective measurements or established physical/biological parameters. The document does not provide this.
4. Adjudication method for the test set: Not applicable based on the type of device and testing described.
5. MRMC comparative effectiveness study: Not conducted or mentioned. This type of study is typically for diagnostic aids involving human interpretation.
6. Standalone performance: The described "performance testing" implies standalone testing of the device's physical and electrical characteristics, but the specific metrics and study details are missing.
7. Type of ground truth used: Ground truth would be based on objective measurements against established engineering, physical, and biological standards (e.g., thermal spread in porcine tissue). The document describes what was tested but not the specific "ground truth" values used for comparison or how they were established.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How ground truth for the training set was established: Not applicable.

The closest the document comes to providing performance data related to "acceptance criteria" is under "Performance Testing," which states: "All pre-defined acceptance criteria for the above tests were met. Results from the the subject devices perform as intended and support a determination of substantial equivalence to the predicate." However, it fails to specify what those acceptance criteria were or the actual results that met them.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model ISS000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gyneologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use.

It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Contraindication:

Use of the force feedback needle driver is contraindicated in hysterectomy and myomectorny due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

The da Vinci Insufflator with compatible tube sets is intended for use in diagnostic and/or therapeutic endoscopic and thoracoscopic procedures to distend a cavity by filling it with gas. Intended cavities for this device include abdominal and thoracic cavities in adult and bariatric patients.

The Intuitive da Vinci® 5 endoscope tray is intended for use to encase and protect compatible da Vinci endoscopes for sterilization in any of the following sterilization machines and cycles:

• · STERRAD 100NX sterilization system using the Flex, Express, and DUO cycles
• · STERIS V-PRO maX 2 using the Non Lumen, Flexible, or Lumen cycles
• · STERIS V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
• · STERIS V-PRO 1 Plus using the Non Lumen or Lumen cycles
• · STERIS V-PRO 1 using the V-PRO/Lumen cycle

da Vinci Surgical System, Model IS5000:

The da Vinci Surgical System Model IS5000/Gen5 is a software-controlled, electromechanical system designed for surgeons to perform minimally invasive surgery. It consists of a Surgeon Side Console (Console), a Patient Side Cart (Robot), and a Vision System Cart (Tower) and is used with an Endoscope, EndoWrist Instruments, and Accessories.

The da Vinci Surgical System Model IS5000/Gen5 is a modification to the da Vinci Xi Surgical System Model IS4000 with the same core features. The IS5000 System further integrates supporting surgical devices, such as an updated electrosurgical generator (E-200) and an integrated insufflator. The instruments and accessories compatible with the IS4000 System are also compatible with the IS5000 System, with an additional set of force feedback instruments designed specifically for the IS5000 System. These Force Feedback instruments (including Large Needle Driver, MegaSutureCut Needle Driver, Cadiere Graspers, Fenestrated Bipolar Forceps, and Maryland Bipolar Forceps) are similar to the Xi instruments with the addition of a sensor that translates directional forces at the instrument back to the surgeon through the hand controls on the Console.

da Vinci Insufflator

The da Vinci Insufflator is a pneumatic device, integrated into the system Tower, which connects to house or tank CO2 gas through the Tower insufflation manifold. It is operated through controls and indicators on each of the Tower, Console, or Robot touchscreens.

Endoscope Tray

The endoscope tray is a stainless steel sterilization tray to encase and protect da Vinci endoscopes during reprocessing.

Acceptance Criteria and Device Performance for da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation, and da Vinci Endoscope Tray

This document describes the acceptance criteria and supporting studies for the Intuitive Surgical da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation, and da Vinci Endoscope Tray.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria or detailed reported device performance in a summary table. However, it outlines the types of testing conducted to demonstrate substantial equivalence to predicate devices and overall safety and effectiveness. Based on the "Performance Data" section, the implicit acceptance criteria are that the devices meet design input requirements, perform as intended, and are safe and effective for their intended uses.

• Devices perform as intended.
• Compatibility with existing instruments and accessories (for IS5000).
• Integrated features (e.g., insufflator, ESU) function correctly. | - Bench testing demonstrated that design output meets design input requirements and devices perform as intended.
• Mechanical and functional verification were conducted.
• Simulated use in animal and cadaver models showed intended performance.
• IS5000 compatible with a subset of IS4000 instruments and accessories.
• Force Feedback instruments are designed specifically for IS5000.
• IS5000 includes new integrated insufflator and ESU. |
  | Safety - Electrical & Electromagnetic | - Compliance with relevant electrical safety and electromagnetic compatibility standards. | - Electrical Safety and Electromagnetic Compatibility testing conducted in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-2, and IEC 60825-1. |
  | Software | - Software verification and validation performed following established processes and methodologies.
• Compliance with FDA guidance for device software functions.
• Cybersecurity compliance. | - Software verification and validation testing performed following the same processes and test methodology as for the predicate device.
• Software documentation classified as "Enhanced" and provided as recommended by FDA guidance.
• Cybersecurity information demonstrating compliance with Section 524B of the FD&C Act and FDA guidance was provided. |
  | Usability & Human Factors | - Safe and effective use by intended users (surgeons, OR staff) in intended use environments.
• No use errors leading to serious patient or user harm. | - Human Factors data assessed use-safety and effectiveness for intended uses, user groups, and environments.
• Surgeon and OR Staff participants safely completed simulated surgical tasks and high-risk use scenarios.
• Results showed no use errors resulting in serious patient or user harm.
• Confirmed safety, effectiveness, and usability for robotic-assisted surgical procedures. |
  | Clinical Performance (Safety & Effectiveness) | - Comparable safety and performance to predicate device in a clinical setting.
• Acceptable adverse event rates.
• No remarkable differences in outcomes compared to predicate (except for specific contraindication).
• Specific finding: Acknowledge and address any identified risks, such as increased unplanned hospital readmission due to vaginal bleeding with force feedback needle driver in specific procedures. | - Clinical Investigation: 53 subjects across 4 specialties followed for 30 days.
• Qualitatively compared to a retrospective review of robotic cases using the predicate device.
• Identified increase in unplanned hospital readmission due to vaginal bleeding when using the force feedback needle driver in hysterectomy and myomectomy (leading to a contraindication).
• No other remarkable differences between the data from the two groups were observed.
• Clinical results show low numbers of adverse events, conversions, deaths, readmissions (2 in gynecology, related to vaginal bleeding), and re-operations. |
  | Sterilization (for Endoscope Tray) | - Ability to encase and protect compatible endoscopes for sterilization in specified sterilization machines and cycles.
• Compatibility with specific sterilization wraps. | - Intended for use with STERRAD 100NX (Flex, Express, DUO cycles) and STERIS V-PRO maX 2, maX, and 1 Plus/1 (Non Lumen, Flexible, or Lumen cycles).
• Intended to be used with legally-marketed, validated, FDA-cleared STERRAD and STERIS V-PRO compatible sterilization wrap.
• Maximum product load: one da Vinci 5 endoscope.
• Maximum weight of tray and endoscope: 13 lbs. |

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

The primary clinical test set information is from a prospective, multi-center, single-arm confirmatory clinical investigation.

• Sample Size: 53 subjects.
  • General Surgery: 20 subjects
  • Thoracic: 6 subjects
  • Urology: 6 subjects
  • Gynecology: 21 subjects
• Data Provenance: The document does not explicitly state the country of origin. Given the FDA submission, it is likely the data was collected in the United States, but this is not explicitly confirmed. The study was prospective, as stated.
• Bench and Pre-clinical studies: Involved animal (canine or porcine) and cadaver models, but specific sample sizes for these are not detailed.

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

The document does not explicitly provide details on the number or qualifications of experts used to establish a "ground truth" for the clinical test set in the sense of independent adjudication of outcomes.

For the pre-clinical surgical equivalence studies, veterinary pathologists were involved in the review of histology from excised tissue. Their specific qualifications (e.g., years of experience) are not mentioned.

For the human factors study, Surgeon and OR Staff participants were observed, implying their expertise was leveraged, but they were the users being studied, not necessarily establishing a separate "ground truth".

The clinical investigation involved surgeons with a range of experience performing procedures, and outcomes were tracked. The document doesn't indicate a separate panel of experts for post-hoc ground truth establishment for clinical events. Adverse events, readmissions, etc., would typically be derived directly from patient records and assessed by the study investigators/clinicians.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth for the clinical outcomes. Adverse events, readmissions, surgeries, etc., appear to be directly measured results from the clinical investigation. The document mentions "clinical assessments" and "qualitative comparison" to retrospective data, suggesting a direct observation and comparison approach rather than a multi-expert adjudication of each case for a specific "ground truth."

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done based on the provided text. The device described, the da Vinci Surgical System, Insufflator, and Endoscope Tray, are surgical tools, not AI-driven diagnostic or assistive technologies that would typically involve "human readers" to interpret data (like images) with or without AI assistance. The clinical study compares the new system to a predicate system (IS4000) based on surgical outcomes.

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

This question is not applicable to the device described. The da Vinci Surgical System is an instrument control system that assists surgeons; it is not a standalone algorithm performing tasks independently. While it is software-controlled, its performance is always in conjunction with a human surgeon. Bench testing and pre-clinical studies evaluate the device's technical performance and safety aspects without direct human patient involvement, which could be considered "standalone" in that context, but this isn't an "algorithm-only" performance evaluation.

7. The Type of Ground Truth Used

• Clinical Investigation: Clinical outcomes (e.g., adverse events, conversions, deaths, readmissions, re-operations) observed directly from patient follow-up data. The identified issue with the force feedback needle driver in specific procedures resulting in vaginal bleeding was likely a direct observation within the study data.
• Pre-clinical Studies: Veterinary pathologists' review of histology from excised tissue to assess surgical safety and performance in animal models.
• Bench Testing: Engineering measurements, mechanical and functional verification against design input requirements.
• Human Factors: Observation of user performance and subjective feedback from surgeons and OR staff.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning or AI models being developed for the device's core functionality. The da Vinci Surgical System as described is a robotic surgical platform, not an AI diagnostic or predictive tool that would undergo a typical machine learning training and testing paradigm. "Training set" might refer to data used during software development, but it's not specified.

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

As there is no explicit mention of an "AI training set" for the device's core surgical assistance function, the method for establishing its ground truth is not provided. Any software development would rely on traditional software verification and validation processes against specified requirements, rather than a machine learning ground truth establishment.

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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).

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1. Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954)
   The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.

2. Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955)
   The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.

3. Single Use Hand Switch Monopolar Forceps (CD956)
   The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.

4. Single Use Hand Switch Bipolar Forceps (CD957)
   The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.

Modern Medical Electrosurgical Monopolar Forceps and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (monopolar or bipolar) to the specified output terminal of an electrosurgical generator. The forceps are intended for use with rated accessory voltage of 2.0kVp. The forceps are offered sterile (EtQ) and either as with or without smoke evacuation system which include four models, such as CD954, CD955, CD956 and CD957.

The provided document is a 510(k) premarket notification from the FDA for Monopolar and Bipolar Forceps. It details the device's characteristics and its substantial equivalence to previously cleared predicate devices. Crucially, this document is for electrosurgical cutting and coagulation devices and accessories, not an AI/ML-driven medical device. Therefore, the concepts of acceptance criteria for AI models, such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set information, are not applicable to this submission.

The document focuses on demonstrating that the new device is as safe and effective as its predicate devices, primarily through comparative performance testing data (physical, electrical, and biological properties) rather than algorithmic performance.

Here's a breakdown of the relevant information provided in the document:

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

The document doesn't present acceptance criteria in a formal table with quantitative targets for "performance" as one might expect for an AI/ML model (e.g., accuracy, sensitivity, specificity). Instead, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices across various characteristics. The "reported device performance" is the demonstration that these characteristics are equivalent, or that any differences do not raise new safety or effectiveness concerns.

The tables (e.g., Table 1, Table 2) present a Side-by-Side Comparison (Subject-Predicate Comparison) for different models of the proposed device against their respective predicate devices. The "Result" column indicates "Equivalent" or "Not Equivalent." For items marked "Not Equivalent," an explanation is provided to argue why this difference does not impact safety or effectiveness.

Examples from the tables:

2. Sample size 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 a "test set" in the context of an AI/ML model with a specific sample size of cases (e.g., images). Instead, it refers to performance testing on the physical device:

• "Performance Testing included comparative device use on porcine tissue: kidney, liver and muscle for both Cut mode and Coagulation mode..."
• This indicates prospective in-vitro/ex-vivo testing rather than data from human subjects.
• The origin of the tissue (e.g., country) is not specified.
• The "sample size" would likely refer to the number of porcine tissue samples or the number of tests performed, which is not numerically detailed but implied to be sufficient for the required validation per the referenced FDA guidance.

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 to this type of device submission. Ground truth for an electrosurgical device typically comes from:

• Engineering specifications and measurements: e.g., electrical safety tests, material properties.
• Established biological models: e.g., the observed effect of electrosurgical current on porcine tissue.
• Compliance with recognized consensus standards: e.g., ISO, IEC standards for sterility, biocompatibility, electrical safety.

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

Not applicable. There is no human interpretation or subjective assessment of "cases" that would require an adjudication method. The performance tests are objective measurements (e.g., resistance levels, temperature, visible coagulation effects that meet predefined criteria).

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 medical device, not an AI/ML-driven diagnostic or assistive system.

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

Not applicable. There is no standalone algorithm. The device is a physical instrument.

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

The "ground truth" for this device's performance is established through:

• Compliance with recognized standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 for electrical safety, ISO 11135:2014/AMD 1:2018 for sterility, ISO 10993 series for biocompatibility.
• Comparative functional testing: Performance tests on porcine tissue to demonstrate similar coagulation/cutting effects as the predicate devices.
• Material and design specifications: Data sheets for materials, design drawings, and manufacturing processes ensure the device is constructed as intended and is equivalent to predicates.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device. There is no concept of a "training set."

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

Not applicable. As there is no training set, there is no ground truth for it to establish.

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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.

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Medline's Smoke Evacuation Shroud is a single use, sterile product. Its intended use is as an electrosurgical accessory to attach to a standard cautery pencil. The shroud removes surgical procedures. The product is used inside the sterile field.

Medline's Smoke Evacuation Shroud is a single use, sterile product.

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Medline Smoke Evacuation Shroud" does not contain the information necessary to answer your request about acceptance criteria and a study proving device performance as it relates to AI/machine learning devices.

The document is a standard FDA 510(k) clearance letter for a Class II medical device (a smoke evacuation shroud, which is a physical accessory for electrosurgical pencils) and primarily addresses regulatory compliance and substantial equivalence to predicate devices. It does not discuss:

• Acceptance criteria for an AI/ML algorithm.
• Performance studies involving AI/ML.
• Sample sizes for test or training sets.
• Expert involvement in establishing ground truth.
• Adjudication methods.
• MRMC studies or effect sizes for human readers.
• Stand-alone algorithm performance.
• Types of ground truth.

Therefore, I cannot populate the table or provide any of the requested details based on the given input. This document is not relevant to the kind of AI/ML device performance study you are asking about.

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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.

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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.

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