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The AirSurgN Insufflator is intended for use during diagnostic and/or therapeutic laparoscopic procedures to distend the abdominal cavity and maintain pneumoperitoneum by filling it with carbon dioxide (CO2) gas. The AirSurgN Insufflator provides user-selectable variable CO2 gas flow and pressure rates.

The AirSurgN Insufflator is intended for use during diagnostic and/or therapeutic laparoscopic procedures to distend the peritoneal cavity and maintain pneumoperitoneum by filling the cavity with carbon dioxide (CO2) gas and to evacuate surgical smoke. The device helps establish and maintain a path of entry for laparoscopic instruments. The AirSurgN Insufflator is intended to be used in a hospital setting on the adult population of 22 years and older.

The AirSurgN Insufflator is a microprocessor-based CO2 insufflator, controlling pneumatic valves, vacuum pump, and pressure sensors. User input to an LCD touchscreen graphical user interface (GUI) initiates the selected pressure, flow rate, and displays the output. Feedback control loop manages pneumoperitoneum. If smoke evacuation is desired, the user can activate this vacuum function for a fixed time period before shutting off automatically.

The device is reusable. It is not intended to be used in the sterile field and cannot be sterilized.

The provided FDA 510(k) clearance letter for the AirSurgN Insufflator mentions performance testing in general terms but does not include specific acceptance criteria or detailed study results for each test. For medical devices like insufflators, performance testing typically involves evaluating aspects such as pressure accuracy, flow rate stability, volume delivery, and response to various physiological conditions.

Here's an interpretation based on the standard information expected for such a clearance, noting that the specific numerical data and detailed methodology for the "acceptance criteria" and "reported device performance" are not explicitly present in the provided document. The document primarily focuses on what tests were done and that they met the criteria, without listing the criteria themselves or the exact results.

Description of Acceptance Criteria and Study Proving Device Meets Criteria

The AirSurgN Insufflator's performance was evaluated through a series of non-clinical/bench tests to demonstrate its safety and substantial equivalence to the predicate device (PNEUMOCLEAR, K170784). While the document states that "The results met the predetermined acceptance criteria," it does not explicitly list these criteria or the numerical results for the AirSurgN Insufflator. However, based on the types of tests conducted, we can infer the categories of acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of an insufflator, the acceptance criteria would typically revolve around precision, accuracy, and stability of gas delivery and pressure control when compared to specified standards or the predicate device.

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The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit, and (2) a disposable tube set.

The laparoscopic tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 25 mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supply the pneumatic circuitry for insufflation and smoke evacuation respectively.

This appears to be a 510(k) premarket notification summary for a medical device, the EVA15 insufflator with an AutoEvac accessory. The document describes the device, its intended use, technological characteristics, and a comparison to a predicate device, as well as non-clinical testing performed.

However, the provided text does not contain information related to an AI/ML driven device study, nor does it detail acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.

The EVA15 insufflator is a physical medical device (a laparoscopic insufflator) with a new accessory (AutoEvac) that automatically activates/deactivates smoke evacuation based on sensing surgical energy. The core technology involves gas insufflation and venturi-based smoke evacuation, not AI/ML algorithms that require complex efficacy studies based on ground truth, expert readers, or MRMC studies.

Therefore, I cannot extract the information requested in your prompt because it is not present in the provided document. The questions you've asked (e.g., sample size for test/training set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth) are typically relevant for AI/ML medical devices, especially those for diagnostic or prognostic purposes, which this device is not.

The "Non-clinical Testing" section mentions:

• "Performance testing of the insufflator has demonstrated the ability to activate and de-activate smoke evacuation when electrosurgical energy is switched on and off."
• "including testing to IEC 60601-1:2005/AMD1:2012 / AMD 2:2020 (Edition 3.2) - Medical Electrical Equipment - Part 1: General Requirements For Safety"
• "and IEC 60601-1-2:2014 / A1:2020 (Edition 4.1) – Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests."

These are standard electrical safety and EMC (Electromagnetic Compatibility) tests for medical devices, which are functional performance tests, not AI/ML model validation studies.

In summary, the provided text describes a traditional medical device modification for which the acceptance criteria and study described in your prompt are not applicable.

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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 Insufflator (OPTO-IFL1000) is intended to generate and maintain pneumoperitoneum by filling the abdominal cavity with gas to distend it during diagnostic or therapeutic laparoscopic procedures.

Insufflator (OPTO-IFL1000) is a CO2 insufflation device for creating and maintaining a pneumoperitoneum during laparoscopic examinations and operations. It is capable of establishing the surgical field of view and operating space. CO2 gas can be injected into abdominal cavity by the device, and the gas separates the abdominal wall from the internal organs of the abdominal cavity, forming a space for the operation and visual field. The device is to be used with the following insufflation tubes:

• 1. OPTO-T1000H (with heating function)
• 2. OPTO-T1000 (without heating function)

The provided document is a 510(k) summary for the Insufflator (OPTO-IFL1000) from Guangdong OptoMedic Technologies, Inc. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain the detailed information required to answer many of the specific questions about the device's acceptance criteria and the study proving it meets those criteria, particularly for an AI/ML-based medical device.

The document states: "Performance testing were also conducted and demonstrate that the proposed system performs according to specifications and functions as intended. And the test result shows that the preset acceptance criteria are met." It then lists several performance tests, but it does not specify what those "preset acceptance criteria" are numerically, nor does it provide the reported device performance values against these criteria. Furthermore, it does not describe a study involving "human readers" or "AI assistance," as this is an insufflator, not an imaging analysis AI.

Therefore, many of the questions cannot be answered from the provided text. I will answer what is available and indicate where information is missing.

Acceptance Criteria and Study for Insufflator (OPTO-IFL1000)

Based on the provided document, the device is an Insufflator (OPTO-IFL1000), which is a physical medical device designed to create and maintain pneumoperitoneum during laparoscopic procedures, not an AI/ML-based diagnostic or imaging device. Therefore, questions related to AI performance, human readers, ground truth establishment by experts, and training/test set sample sizes for AI models are not applicable to the information presented for this specific device.

The document discusses "Performance data" and lists various tests conducted to verify the device met all design specifications and is substantially equivalent to a predicate device. The "acceptance criteria" are generally implied to be satisfaction of these test specifications and compliance with relevant standards.

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

The document lists performance tests but does not provide a table with specific numerical acceptance criteria or the numerically reported device performance for these tests. It only states that "the preset acceptance criteria are met."

Below is a table of the performance tests mentioned, with the understanding that specific numerical criteria and results are not detailed in the provided text.

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

For a physical device like an insufflator, "test set" and "data provenance" (country of origin, retrospective/prospective) are typically not relevant in the same way they are for AI/ML models using patient data. The "test set" would refer to the specific Insufflator (OPTO-IFL1000) unit(s) used for the described performance and safety testing. The document does not specify the number of units tested. The provenance of the testing itself is implied to be conducted by the manufacturer, Guangdong OptoMedic Technologies, Inc., in China.

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

This question is applicable to AI/ML devices that interpret data (e.g., medical images) where expert consensus is used to establish ground truth. For a physical device like an insufflator, "ground truth" pertains to its functional performance characteristics, which are measured using validated test methods and equipment, not by human expert interpretation of device output in the same way. Therefore, this information is not applicable and not provided.

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

Not applicable for a physical device performance test.

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 insufflator, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This device is not an algorithm. Its performance is inherent to its physical and software functionality.

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

For this physical device, "ground truth" would be established by:

• Compliance with recognized standards: Such as ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, AAMI TIR 30, AAMI TIR 12.
• Engineering specifications and measurements: Direct measurement of pressure, flow, temperature, alarm triggers, etc., against predefined engineering tolerances and clinical requirements.
• Software verification and validation: Testing to ensure the software functions as intended to control the device and its safety features.

The document states that "The software verification and validation testing were conducted and the test results demonstrated the software function met the requirements. The software for this device was considered a 'Major' level of concern." This indicates that software functionality, which dictates much of the device's "ground truth" operation, was rigorously tested.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable.

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The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

The subject device consists of an insufflator, a high pressure tube and a pneumoperitoneum tube. The insufflator is a microprocessor-controlled CO2 insufflator that consists of the following major components and features: housing, power supply, pressure reducers, venting system, fluid sensor, gas heater, various setting keys and display elements. The insufflator is not intended to enter the field and cannot be sterilized. The pneumoperitoneum tube shall be cleaned, disinfected, and sterilized prior to subsequent use.

The provided document is a 510(k) summary for an Insufflator (K222812), intended to facilitate the use of a laparoscope by distending the peritoneal cavity with gas. It primarily focuses on demonstrating substantial equivalence to a predicate device (K030837) and a reference device (K153513) through non-clinical performance testing.

Based on the provided information, here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" for specific performance metrics in a pass/fail format alongside the device's reported performance. Instead, it lists the standards and the types of comparative non-clinical performance testing performed, implying that meeting these standards and showing comparable performance to the predicate device would be the acceptance criteria.

However, we can infer some criteria from the "General Comparison" table (Table 2) and the "Performance Specifications" in Table 3 (which is incomplete in the provided text).

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

The document mentions "non clinical tests were conducted" and "comparative performance testing was also conducted on the subject and predicate devices." However, it does not specify the sample sizes used for these tests. The tests are non-clinical, meaning they involve lab testing of the devices themselves, not patient data. Therefore, questions of country of origin of data or retrospective/prospective are not applicable for this non-clinical submission.

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

This information is not applicable as the studies are entirely non-clinical performance and safety tests of a medical device (insufflator). There is no "ground truth" to be established by clinical experts for a test set in the context of this 510(k) submission.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as above. Non-clinical engineering tests do not involve expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (insufflator) and relies on non-clinical performance and safety testing. There are no human readers or cases involved in the presented studies.

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

This question is not applicable in the traditional sense for this device. The device is hardware with embedded software, not an AI algorithm performing diagnostic or therapeutic functions needing standalone performance evaluation in the context of AI/ML. The software verification and validation were performed as an integral part of the device's functionality.

7. The Type of Ground Truth Used:

As the studies are non-clinical performance tests, the "ground truth" would be established by:

• Engineering specifications and standards: Adherence to standards like IEC 60601-1, IEC 60601-1-2, ASTM D4169, AAMI TIR 30, AAMI TIR 12, ISO 15883-2, ISO 17665-1, ISO 14971, and IEC 60601-2-18.
• Expected physical and functional performance: Measured parameters like flow rate, pressure accuracy, temperature, and warning thresholds are compared against design specifications and the performance of the predicate device.

8. The Sample Size for the Training Set:

This information is not applicable. The device is an insufflator, not a machine learning or AI model that requires a training set of data. The software within the device is likely deterministic control software, subject to standard software verification and validation, not machine learning model training.

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

This information is not applicable as there is no training set mentioned or implied for this device.

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The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity, so as to generate and maintain pneumoperitoneum, expand the surgical field and keep sufficient space during diagnostic and therapeutic laparoscopic procedures.

The subject device is composed of Gas Insufflator Unit (Model GVS100) and accessories Highpressure Gas Pipe, Insufflation Tubing Set (Model GI-S001), and power adapter). The Insufflation Tubing Set is provided sterile and disposable. The Gas Insufflator Unit is nonsterile, reusable, and AC-powered (100 - 240 VAC, 50/60 Hz, 200 W).

The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity to generate and maintain pneumoperitoneum during laparoscopic diagnosis and/or surgical treatment. The Gas Insufflator controls gas pressure and flow rate by the solenoid valve. The touchscreen displays the gas pressure and flow output. The Gas Insufflator is insufflate CO2 to a body cavity up to 30 mmHg/40 LPM for Adult mode and 15 mmHg/15 LPM for Child mode.

The Gas Insufflator is for professional healthcare environment use.

The provided text describes the acceptance criteria and the study conducted for the Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Gas Insufflator (K221995).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing rather than specific "acceptance criteria" in a tabular format with corresponding reported performance. However, the "Comparison of the technological characteristics" table (Table 1) acts as a de-facto acceptance criteria by demonstrating similarity or equivalence to the predicate device. The "Bench Performance testing" section lists tests conducted to demonstrate performance and safety features.

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The EVA5 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas.

The EVA5 insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. It is indicated to facilitate the introduction of various endoscopic instruments by filling the alimentary canal with gas to distend it. The EVA5 Insufflator is used in an operating room or endoscopic suite. It consists of the following major component (1) a micro-processor-controlled insufflation flow control system.

The EVA5 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate the alimentary canal via an endoscope. The EVA5 is powered by AC and uses a compressed 50 psi CO2 gas supply to supply the pneumatic circuitry for insufflation.

The EVA5 Insufflator is a medical device intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas. The document provides information regarding its non-clinical testing to demonstrate substantial equivalence to its predicate devices.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is non-clinical, focusing on the device's technical specifications.

3. Number of Experts and Qualifications

This information is not provided as the described testing is non-clinical performance testing of the device's mechanical and electronic functions, not human interpretation of medical images or data.

4. Adjudication Method

This information is not applicable as the testing described is non-clinical performance testing, not involving human interpretation or adjudication.

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

No MRMC comparative effectiveness study was mentioned. The EVA5 Insufflator is a mechanical device, and its performance is evaluated based on technical specifications rather than human reader accuracy.

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm (the insufflator's flow control system). The "Non-clinical Testing" section states: "Performance testing of the insufflator demonstrated that the subject device met its acceptance criteria..." This refers to the device's intrinsic mechanical/electronic performance.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance testing would be the precise, calibrated measurements of flow rate and timing. These would be established using validated testing equipment and methodologies.

8. Sample Size for the Training Set

This information is not applicable. The EVA5 Insufflator is a hardware device with a micro-processor-controlled insufflation flow control system. It is not an AI/ML algorithm that is "trained" on a large dataset in the conventional sense. Its "training" or calibration would occur during its manufacturing and quality control processes based on engineering specifications.

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

As noted in point 8, the concept of a "training set" and "ground truth" for a training set is not directly applicable to a hardware device like an insufflator. The device's operational parameters are designed and calibrated based on engineering principles and established medical device standards. The "ground truth" for its performance would be defined by these engineering specifications and validated through rigorous testing against calibrated measuring instruments.

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The EVA 15 Insufflator is intended for use in diagnostic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA 15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set.

The laparoscopic tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 25mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supply the pneumatic circuitry for insufflation and smoke evacuation respectively.

This document describes the 510(k) submission for the EVA15 Insufflator, emphasizing the modifications and the non-clinical testing performed to demonstrate substantial equivalence to its predicate device (K202799 - Palliare EVA15).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the device met its acceptance criteria, which were the "same acceptance criteria as applied to the predicate" (K202799). However, specific numerical acceptance criteria are not detailed for all tests. The performance reported indicates successful completion of these tests.

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

The document does not specify a "test set" in terms of subject data (e.g., patient data for an AI algorithm). The testing described is non-clinical performance testing of the device itself (hardware and software). Therefore, specific sample sizes for a data-driven test set are not applicable here. The provenance of any data used for testing (e.g., country of origin, retrospective/prospective) is not mentioned as the testing focuses on device function.

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

This information is not applicable as the document describes non-clinical performance testing of a medical device (an insufflator), not an AI algorithm that requires expert-established ground truth from images or patient data.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

No MRMC study was performed or mentioned. This type of study focuses on human reader performance with and without AI assistance, which is not relevant for an insufflator device.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of the device was performed in the form of non-clinical testing (static and dynamic conditions). This is not an "algorithm only" study in the typical AI context; rather, it refers to the performance of the integrated device system. The document states: "Performance testing of the insufflator in the revised pressure range demonstrated that the subject device met its acceptance criteria... Testing included: Static condition (Pressure accuracy), Dynamic condition (Simulated leak, Smoke evacuation)."

7. Type of Ground Truth Used

The "ground truth" for this device's performance testing would be the engineering specifications and established functional requirements for insufflators. For example, pressure accuracy would be compared against a calibrated standard, and smoke evacuation effectiveness against predefined thresholds. It's not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

This information is not applicable as the device is a hardware/software system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.

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

This information is not applicable for the same reasons as point 8.

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The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, colon or thoracic cavity with up to 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflation is intended to use in hospital. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set.

There are 3 operating modes:

• Flow Mode (1) delivers a fixed flow, settable between 0 and 15 standard liters per minute (SLPM)
• Pressure Modes (2) -
  • Intermittent Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is capped at 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
  • Continuous Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is capped at 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).

The tubeset is a sterile, single-use product. The tubeset is made of PVC and polyethylene. The A VA 15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 15mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supplies to supply the pneumatic circuitry for insufflation and smoke evacuation, respectively.

The provided text describes the EVA15 Insufflator, a medical device, and its 510(k) submission to the FDA. However, it does not contain information about a study involving AI assistance for human readers, nor does it detail a study for an AI algorithm's standalone performance. The document focuses on the substantial equivalence of the EVA15 Insufflator to a predicate device (SurgiQuest AirSeal iFS System) based on non-clinical performance testing of mechanical and electrical aspects.

Therefore, many of the requested details, especially those related to AI model evaluation (like sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable or present in this document.

Here's an analysis of the available information based on your request:

Acceptance Criteria and Device Performance (Bench Testing Summary):

The document provides a summary of non-clinical performance testing. The "acceptance criteria" are generally stated as "predefined acceptance criteria" without specific numerical thresholds, and the "reported device performance" is a qualitative statement that the device met these criteria.

Information Not Available in the Document:

1. Sample size used for the test set and the data provenance: The document details bench testing, which implies a test set, but it does not specify the sample size (e.g., number of units tested, number of simulated scenarios). It also does not discuss data provenance in the sense of patient data (e.g., country of origin, retrospective/prospective), as this is a physical device rather than an AI/imaging diagnostic.

2. 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 testing involves objective measurements of pressure, flow, and filtration, not expert human interpretation for establishing ground truth like in medical imaging.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for engineering bench testing.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for a medical device (insufflator) approval, not an AI diagnostic/assistance tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device's performance testing consists of physical measurements against engineering specifications and validated standards (e.g., pressure readings, flow rates, filtration efficiency).

7. The sample size for the training set: Not applicable as this is not an AI/machine learning model that undergoes training.

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

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The AP50/30 Insufflator is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard/High Flow, Pediatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans and minimal invasive surgery.

The Insuflow® Port (5 mm, 8 mm, 10mm and 12mm) devices have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.

The Lexion AP50/30 Insufflator is a microprocessor-controlled CO2 (carbon dioxide) insufflator with multiple operating modes. The insufflator instrumentation is intended for hospital use for Standard/High Flow, Pediatric, and Bariatric laparoscopic procedures used in conjunction with a laparoscope to fill and distend a peritoneal cavity with gas; for trans anal minimal invasive surgery (TAMIS) to fill and distend the rectum and colon using CO2 gas; and for Vessel Harvesting procedures used to create a cavity along the saphenous vein and/or the radial artery during an endoscopic vessel harvesting procedure.

The device incorporates the following major components and features: a metal housing, a world power supply, pressure reducers, a venting system, a gas heater control and a touch screen user interface with various settings and display elements. The software operation includes system checks, user interface, setting adjustments, warning/error messages and service info. The device is equipped with a continuous pressure measurement mode that controls the conformity of the actual pressure in the peritoneal or extraperitoneal cavity with the pre-set nominal pressure. The AP50/30 Insufflator is designed with several alarms/warnings to inform the operator in case of an overpressure or other malfunctions. The device is to be used with specially designed singleuse tubing sets, the Insuflow® Port, in order to utilize the full capabilities of continuous pressure measurement and gas heating and humidification. (The insufflator can also accept other tubing sets for gas deliver only.)

The Insuflow® Port (5, 8, 10, 12 mm) devices are gas conditioning/access port devices that attach to the outlet of the AP50/30 Insufflator and are designed to warm and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow® Port consists of an ethylene oxide sterilized, disposable single use tubing set and a path of entry access port device which contains the pressure sensors, a filter, and gas heater/humidifier. The access port device materials are intended for patient contact of less than 24 hours. The Insuflow® Port is connected to the AP50/30 Insufflator via a plug connector cable, which controls the pressure sensing, gas heating and safety circuits for the system. Regulated CO2 gas from the AP50/30 Insufflator flows into the Insuflow® Port, through the in-line filter, continues along the tubing to enter the path of entry access device that contains the heating element and humidification media, and through the path of entry access device lumen for delivery into the patient's surgical cavity.

The provided text is a 510(k) Premarket Notification for a medical device, the AP50/30 Insufflator with Insuflow® Port. It focuses on demonstrating substantial equivalence to predicate devices, particularly for a newly added operating mode (TAMIS).

Important Note: This document describes the acceptance criteria and study for a hardware medical device (insufflator), not an AI/ML-based device. Therefore, many of the requested fields related to AI/ML (e.g., ground truth establishment for training set, MRMC study, sample size for training set, number of experts for ground truth) are not applicable to this type of medical device submission. The study described is an engineering performance verification and validation.

Here's a breakdown based on the provided text, addressing the applicable criteria for this device:

Acceptance Criteria and Device Performance for AP50/30 Insufflator with Insuflow® Port (TAMIS Mode)

This submission focuses on demonstrating substantial equivalence of the modified AP50/30 Insufflator (with the addition of a TAMIS operating mode) to its predicate devices. The acceptance criteria are implicit in matching the performance specifications of the predicate devices for existing modes and ensuring the new TAMIS mode meets appropriate performance targets comparable to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by matching or demonstrating comparable performance to the predicate devices, particularly the PNEUMOCLEAR Insufflator (K170784) for the TAMIS mode. The tables provided in the document serve as the performance data compare to historical predicate performance.

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

• Sample Size: The document refers to "comparative bench testing" and "design verification testing." It does not specify a numerical sample size in terms of "units tested" or "number of unique test scenarios." This type of engineering testing typically involves a set number of test runs or units to demonstrate specifications are met across operational ranges and conditions.
• Data Provenance: The testing was "performed to demonstrate that the performance of the proposed AP50/30 Insufflator is substantially equivalent to that of the predicate devices." This implies that the data is prospective data generated from testing of the new device intended for submission. The location of testing is not specified, but it would have been conducted by the manufacturer (Lexion Medical LLC) or a contracted test facility.

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

• N/A. For a hardware medical device like an insufflator, "ground truth" as it relates to expert consensus on images or clinical outcomes is not applicable. The device's performance is objectively measured against engineering specifications (e.g., flow rate, pressure accuracy, alarm function). Verification and validation testing is conducted by engineers and technicians against established specifications.

4. Adjudication Method for the Test Set

• N/A. Adjudication methods (like 2+1, 3+1) are relevant for subjective assessments, typically in image interpretation or clinical trial endpoints that require expert consensus. For an insufflator, performance is measured against objective, quantifiable engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• N/A. MRMC studies are specific to evaluating the diagnostic performance of imaging devices or algorithms, usually involving human readers interpreting images. This is a hardware device for surgical procedures (insufflation), not an imaging or diagnostic AI/ML device.

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

• N/A. This is not an AI/ML algorithm. The device has software that controls its functions, which was validated ("The software used in the AP50/30 Insufflator was determined to have a major level of concern, and was developed and successfully validated in accordance with the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005."). This software validation assesses the correct functioning of the control algorithms, which operates autonomously to maintain pressure and flow.

7. The Type of Ground Truth Used

• Engineering Specifications / Predicate Device Performance: The "ground truth" for this device's performance is its ability to meet established engineering specifications (e.g., precise control of gas pressure and flow, accurate alarm triggers) and to perform comparably to its legally marketed predicate devices, particularly for the added TAMIS mode. The performance is quantified through direct physical measurements during bench testing.

8. The Sample Size for the Training Set

• N/A. This is not an AI/ML device; there is no "training set." The software is designed and programmed based on engineering principles and requirements, not trained on data.

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

• N/A. As there is no training set for an AI/ML model, this question is not applicable. The software ground truth is derived from design requirements and engineering specifications documented during the device development process.

In summary, the provided document details the regulatory submission for a hardware medical device with specific performance characteristics. The "acceptance criteria" revolve around demonstrating that the modified device (with a new operating mode) performs comparably to its predicates and meets all relevant safety and performance standards. The "study" proving this involves comprehensive bench testing and software validation against objective engineering specifications. The concepts of AI/ML-specific evaluations (like training sets, data provenance for AI models, MRMC studies, or multi-expert adjudication for diagnostic ground truth) do not apply to this type of device submission.

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