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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 UHI-4 instrument is intended to insufflate the abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment.

This instrument is intended for controlled CO2 insufflation to create a cavity along the saphenous vein and/or radial artery to facilitate observation during an endoscopic vessel harvesting procedure.

This instrument is used to insufflate the colon to facilitate endoscopic observation, diagnosis and treatment.

The subject device, UHI-4, is intended to insufflate the abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment, and for controlled CO2 insufflation to create a cavity along the saphenous vein and/or radial artery to facilitate observation during an endoscopic vessel harvesting procedure. The subject device is also used to insufflate the colon to facilitate endoscopic observation, diagnosis and treatment.

The subject UHI-4 has the following system functions which are existing features/functions of the predicate device and are not new feature/function.

• Cavity mode
• Adjustment of the cavity pressure
• Adjustment of the gas flow rate
• Display mode
• Relief mode
• Smoke evacuation
• Automatic smoke evacuation
• Pressure sensor failure detection
• Excessive pressure alarm & alarm delay setting

The subject device has the same technological characteristics and design as the applicable predicate devices. There have been no modifications to the device hardware design including performance specifications and physical design requirements, materials, sterilization, shelf life, reprocessing, or packaging.

The only difference between the subject device and the predicate device is the device software, and there are modifications for two existing software functions: "Pressure sensor failure detection" and "Alarm delay setting".

This document is a 510(k) summary for the Olympus High Flow Insufflation Unit (UHI-4), seeking clearance for a software change. It is primarily a comparative analysis against a predicate device (K122180) and does not present a traditional study proving the device meets acceptance criteria through clinical or large-scale performance testing as one might expect for a novel AI/ML-based diagnostic device.

Therefore, many of the specific questions about acceptance criteria (in terms of performance metrics like sensitivity/specificity), sample size for test sets, expert involvement, and ground truth establishment are not applicable to this type of submission. The focus here is on demonstrating substantial equivalence, especially concerning a minor software modification, rather than a de novo performance validation study.

However, I can extract the information relevant to this specific K243527 submission based on the provided text, while indicating where information is not available or not applicable.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Bench Testing)

Since this is a 510(k) for a software change to an existing device, the "acceptance criteria" here are primarily demonstrated through showing the new device maintains the same performance and safety characteristics as the predicate device, validated by bench testing focused on the changed functions.

Table of Acceptance Criteria and Reported Device Performance

Here's a breakdown of the other requested information:

1. A table of acceptance criteria and the reported device performance: This is provided above.

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

   • Sample Size: Not applicable in the context of a clinical test set with patient data for this submission. The tests performed ("Overpressure Testing," "Tube Obstruction Testing," "CO2 Suction Control Testing," "Hardware Abnormality Testing," "Communication of Failure Detail Testing," "Software Testing," and "Cybersecurity Testing") were bench tests. These tests typically involve a specific number of units/simulations/iterations as defined by internal validation protocols, but not a "sample size" in the sense of a patient cohort. The document does not specify the number of units tested or the number of test runs for each bench test.
   • Data Provenance: Not applicable as there is no patient data or clinical data for this specific submission. The tests were laboratory/bench-based. The submitter is Olympus Medical Systems Corporation, located in Tokyo, Japan.

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

   • Not applicable. No external experts were used to establish a ground truth for a test set in the conventional sense (e.g., diagnosis of images). The "ground truth" for these bench tests is defined by engineering specifications, safety standards, and the expected functional behavior of the device described by the manufacturer. The tests confirm the device meets these pre-defined engineering criteria.

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

   • Not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments. Bench testing does not involve such methods; results are typically derived from automated measurements or predefined pass/fail 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:

   • No, not done. This device is an insufflation unit, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant to its clearance.

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

   • Not applicable. This is a hardware device with embedded software controlling its functions, not a standalone algorithm. The "software testing" assessed the embedded software's performance within the device.

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

   • Engineering Specifications and Safety Standards. The ground truth for the performance of this device is defined by its intended function, the engineering specifications it must meet (e.g., pressure output, flow rate, alarm thresholds), and established safety standards for medical devices of this class. The "truth" is whether the device performs within its defined parameters and safety limits when subjected to various conditions (normal operation, overpressure, obstruction, hardware faults).

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense. The software modifications enhance existing functions and were presumably developed and verified through standard software development life cycle (SDLC) processes, including unit testing, integration testing, and system testing. The document refers to "Software Testing" and "Cybersecurity Testing" which are validation steps for the finished software, not a training phase for a learning algorithm.

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

   • Not applicable. See point 8.

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The TauTona Pneumoperitoneum Assist Device (TPAD) is intended for use with the Veress Needle for the establishment of a pneumoperitoneum during laparoscopic procedures.

The TauTona Pneumoperitoneum Assist Device (TPAD) is a single use device used during laparoscopic surgical procedures. The device consists of a pad which contains an array of suction cups on one side; a port that attaches to a standard hospital vacuum line; a button to control vacuum to the suction cups; and a handle to allow user to manipulate the device. Suction is applied to the device to allow the user to manipulate (hold and pull on) the tissue around the Veress needle insertion site. The device is crescent in shape to allow removal of the device after use while the Veress needle remains in the patient.

The provided text does not contain detailed acceptance criteria for a specific device. Instead, it is a 510(k) summary for the TauTona Pneumoperitoneum Assist Device (TPAD), which focuses on demonstrating substantial equivalence to a predicate device.

The document highlights the clinical study performed to support this substantial equivalence. Below is an interpretation of the study and what can be inferred about "acceptance criteria" through the lens of equivalence:

Interpretation of Acceptance Criteria and Study Performance

The acceptance criteria, while not explicitly stated as numerical targets for performance metrics like sensitivity, specificity, or specific time thresholds, are implicitly based on demonstrating that the subject device is as safe and effective as the predicate device and does not introduce new questions of safety or effectiveness. This is a common approach for 510(k) submissions.

Implicit Acceptance Criteria:

• Non-inferiority in surgeon satisfaction: The average surgeon questionnaire scoring for TPAD should not be significantly worse than for Standard of Care (SOC).
• Non-inferiority in patient satisfaction: The average patient questionnaire scoring for TPAD should not be significantly worse than for SOC.
• Non-inferiority in procedural timing: The average time from incision to Veress needle insertion and from incision to insufflation for TPAD should not be significantly different from SOC.
• Safety: No Severe or Moderate Adverse Events related to TPAD.

Reported Device Performance (against implicit criteria):

• Surgeon Satisfaction: "The primary endpoint of the average surgeon questionnaire scoring was not significantly different for SOC and TPAD across all responses."
• Patient Satisfaction: "The average patient questionnaire scoring was not significantly different for SOC and TPAD across all responses."
• Procedural Timing: "The average timing measurements from the incision to Veress Needle Insertion, as well as time from incision to insufflation, were not significantly different between SOC and TPAD for both timing durations."
• Safety: "No Severe or Moderate Adverse Events related to the TPAD were observed."

Study Details:

Given the nature of the device (a physical assist device, not an AI/software device or diagnostic imaging tool), many of the specific questions related to AI performance metrics (like MRMC studies, standalone algorithm performance, number of experts for ground truth, adjudication methods) are not applicable or detailed in this 510(k) summary.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set (Clinical Study) Sample Size: The clinical study was done in two phases, totaling 30 patients.
  • Phase 1: 20 patients
  • Phase 2: 10 patients
• Data Provenance: The document does not explicitly state the country of origin. It is a clinical study (prospective), comparing the subject device (TPAD) to Standard of Care (SOC).

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable in the traditional sense for this type of device. The study assessed "surgeon satisfaction" and "patient satisfaction" via questionnaires and "timing measurements." These are direct measures from the users and procedures, not "ground truth" established by experts in the sense of image interpretation or diagnosis. The "experts" involved would be the surgeons using the device.

4. Adjudication Method for the Test Set:

• Not applicable. This study is not about subjective interpretation or diagnosis that would require adjudication. It's about direct measurements (time) and subjective feedback via questionnaires (satisfaction).

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

• No. An MRMC study is typically for evaluating diagnostic imaging devices where multiple readers interpret cases with and without AI assistance. This device is a physical assist device for a surgical procedure, not an imaging or diagnostic AI tool.

6. Standalone (Algorithm Only) Performance:

• Not applicable. The TPAD is a physical assist device, not an algorithm or software that operates in a standalone manner. The "performance" is inherently tied to its use by a human.

7. Type of Ground Truth Used:

• The "ground truth" for this study was primarily:
  • Direct procedural time measurements: Objective data like "time from incision to Veress Needle Insertion."
  • User (Surgeon) Reported Experience: Subjective feedback from surgeon questionnaires.
  • Patient Reported Experience: Subjective feedback from patient questionnaires.
  • Observed clinical outcomes: Lack of severe/moderate adverse events.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. As above, no training set for this device.

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The VereSee Optical Veres Needle System is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic surgery.

The VereSee Optical Veres Needle System is comprised two components: 1) Optical Veres Needle, and 2) Camera Control Unit. The Optical Veres Needle consists of a series of three concentric, stainless steel cannulas with a handle and an umbilical cable to connect it to the VereSee Camera Control Unit. The device is provided sterile for single-patient use. The Outer Cannula provides a luer fitting for connection of insufflation tubing with an integral flow control stopcock and a set of seals to prevent leakage of insufflation gas. The Central Cannula consists of a stainless steel hypo tube with a clear, point tip for penetration and visualization during abdomen penetration. The Inner Cannula is composed of a stainless steel hypo tube with a CMOS camera surrounded by light fibers at its tip. The light fibers carry the light from an integral LED which is mounted to a heat sink to distribute heat from the LED. The VereSee Camera Control Unit connects the CMOS camera in the Optical Veres Needle to HDMI compatible monitors to provide an image for laparoscopic procedures. The VereSee Camera Control Unit (CCU) includes an LED driver to power the LED. The CCU connects to the Optical Veres Needle via an umbilical cable. The VereSee Camera Control Unit converts signals from the CMOS camera in the Optical Veres Needle to a format compatible with HDMI display input requirements.

The provided text is a 510(k) summary for the VereSee Optical Veres Needle System and does not contain information about the acceptance criteria or a specific study proving the device meets those criteria in the context of an AI/human comparative effectiveness study or standalone algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (LaproLight Veress Needle) by comparing its intended use, technological characteristics, and performance data related to:

• Sterilization
• Transit Simulation and Shelf-Life
• Biocompatibility
• Electrical Safety and EMC Testing
• Bench and Functional Performance Testing (including optical performance, physical characteristics, mechanical testing like flow and leakage, spring obturator, and needle penetration tip force).

The "510(k) summary" confirms that the VereSee Optical Veres Needle Optical System had comparable performance to the legally marketed veres needles in mechanical testing. However, it does not provide details of acceptance criteria in a table format with reported performance for device safety or effectiveness (e.g., specific thresholds for flow rate, leakage, or optical clarity). It also does not discuss any AI components or their performance.

Therefore, I cannot extract the requested information (points 1-9) as it is not present in the provided text.

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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 TauTona Pneumoperitoneum Assist Device (TPAD) is intended for use in the upper left quadrant of the abdominal wall (i.e., Palmer's Point) with a Veress needle for the establishment of a pneumoperitoneum during laparoscopic procedures.

The TauTona Pneumoperitoneum Assist Device (TPAD) is a single use device used during laparoscopic surgical procedures. The device consists of a pad which contains an array of suction cups on one side; a port that attaches to a standard hospital vacuum line; a button to control vacuum to the suction cups; and a handle to allow user to manipulate the device. Suction is applied to the device to allow the user to manipulate (hold and pull on) the tissue around the Veress needle insertion site. The device is crescent in shape to allow removal of the device after use while the Veress needle remains in the patient.

The provided text is a 510(k) summary for the TauTona Pneumoperitoneum Assist Device (TPAD). It outlines the device's purpose, comparison to a predicate device, and the non-clinical and clinical performance testing performed.

However, the 510(k) summary does not include a formal table of acceptance criteria for the device performance or detailed information about the specific "study that proves the device meets the acceptance criteria" in the format requested. It describes a clinical study to evaluate safety, effectiveness, and ease of use, but doesn't explicitly link specific metrics to predefined acceptance thresholds.

Given the information available, I will extract and infer as much as possible to address your request, acknowledging where information is not explicitly stated.

Here's an attempt to answer your questions based on the provided text:

The provided 510(k) summary describes a clinical study to demonstrate the safety, effectiveness, and ease of use of the TauTona Pneumoperitoneum Assist Device (TPAD). While formal, quantitative "acceptance criteria" for metrics are not explicitly presented in a table format with corresponding reported performance, the summary describes the outcomes of the study.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical thresholds are not provided in the document, this table is constructed based on the described study outcomes and implied "acceptance" as demonstrated by the findings.

Note: The "Acceptance Criteria" provided above are inferred from the study's discussion of "primary endpoint," "secondary endpoints," and "statistical significance" compared to standard of care or theoretical medians, rather than explicit pre-defined numerical thresholds in an acceptance criteria table.

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

• Sample Size (Clinical Study): 20 individuals total, split into two arms:
  • TPAD arm: 10 patients
  • Standard of Care (SOC) arm: 10 patients
• Data Provenance:
  • Country of Origin: United States (U.S.). The study was performed at an academic center in the U.S.
  • Retrospective or Prospective: Prospective (described as a "randomized clinical study").

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

The document does not explicitly state the "number of experts used to establish the ground truth" in the sense of independent expert review of cases for accuracy. Instead, the "ground truth" or device performance was assessed by:

• Surgeons: who performed the procedures and completed questionnaires on device feasibility/ease of use. Their specific qualifications (e.g., years of experience, specialty) are not detailed beyond "surgeon."
• Patients: who completed surveys to assess patient satisfaction.
• Study Staff: who likely monitored adverse events, collected time metrics, and captured photographs.

Therefore, the "experts" are the performing surgeons and the patients themselves providing direct feedback on their experience.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the context of expert review (e.g., 2+1, 3+1). The primary endpoint (surgeon questionnaire) was completed by the performing surgeon, not an independent panel, and secondary outcomes were objective measurements (time, adverse events) or patient self-reported.

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 performed. This device is not an AI-based diagnostic or assistive software for image interpretation, but rather a physical surgical assist device. Therefore, the concept of "human readers improving with AI assistance" is not applicable here. The clinical study compared the use of the TPAD device (a physical assist device) against the Standard of Care.

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

This question is not applicable. The device is a physical surgical assist device and does not involve AI algorithms or standalone performance. It is used with a human surgeon.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was established through:

• Direct observation and measurement: Time metrics (time to obtain laparoscopic access, time to complete insufflation).
• Surgeon feedback: Questionnaires on feasibility/ease of use, reflecting the practical aspects of the device during actual use.
• Patient outcomes: Adverse event monitoring (bruising resolution) and patient reported satisfaction via surveys and photographs.

This can be categorized as a combination of objective clinical measurements, direct user (surgeon) assessment, and patient-reported outcomes. It is not based on expert consensus of reviewed cases, pathology, or large-scale outcomes data in the traditional sense of diagnostic accuracy studies.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical device and contains no software/AI that would require a "training set."

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

This information is not applicable as the device is a physical medical device and contains no software/AI that would require a "training set."

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The Disposable Veress Needles are intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars opic procedures.

The Disposable Veress Needles are composed of needle, inner core, handle and made of medical grade stainless steel, PC, PE, ABS, and Model II has a silicone sleeve on the handle. The device is packed in Tyvek dialysis bag with 4058B Tyvek dialysis paper and ESE film. The contact duration is less than 24 hours. The device is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures. The device is sterilized by EO and is intended for single-use only. The proposed device is available in a variety of needle lengths. There are two models for Disposable Veress needles: I, II. The difference between the two models is that the model II has a blue silicone sleeve outside the handle.

The provided text describes a 510(k) premarket notification for a medical device called "Disposable Veress Needles." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, the requested information about acceptance criteria and a study proving device performance (especially points relevant to AI/ML such as test set size, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment) cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.

The document primarily discusses non-clinical testing for physical properties, biocompatibility, sterilization, and shelf-life of a physical medical instrument (a Veress needle), not an AI/ML diagnostic or predictive tool.

Here's a breakdown of what can be extracted, and where the requested information is absent:

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

• Acceptance Criteria: The document states, "The tests listed below have demonstrated that the subject device performs as well as the predicate device based on the acceptance criteria." However, the specific numerical or qualitative acceptance criteria (e.g., "puncture force must be within X to Y Newtons") are not explicitly detailed in the provided text. Instead, categories of tests are listed.
• Reported Device Performance: The document only states that the device "performs as well as the predicate device" after these tests. No specific performance results (e.g., actual measured tip pull force, switch operation timing, etc.) are provided.

Regarding points 2-9, which are highly relevant for AI/ML device evaluations, the information is not present in this document because it describes a physical medical device, not an AI/ML algorithm.

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

• Not applicable / Not provided. This document does not describe a study involving data sets for an AI/ML algorithm. The "test set" here refers to physical units of the device subjected to non-clinical tests. The number of samples for each physical test (e.g., how many needles were tested for tip pull) is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. Ground truth definition by experts is not relevant for the non-clinical physical and biological tests described for a Veress needle.

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

• Not applicable / Not provided. Adjudication methods are relevant for expert consensus on AI/ML ground truth, not for physical device testing.

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

• Not applicable / Not provided. This is explicitly for AI-assisted diagnostic devices and does not apply to a standalone physical surgical instrument like a Veress needle.

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

• Not applicable / Not provided. This is for AI algorithms, not a physical medical device.

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

• Not applicable / Not provided. The "ground truth" for the physical device tests would be objective measurements against an engineering standard or predicate device performance, not expert consensus on medical findings.

8. The sample size for the training set

• Not applicable / Not provided. There is no AI/ML algorithm, and thus no training set.

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

• Not applicable / Not provided. There is no AI/ML algorithm, and thus no training set or ground truth establishment method for it.

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AirSeal iFS System: The ConMed AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired to facilitate the use of various thoracoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument can also be used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis, and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.

AirSeal dV Solution: The AirSeal Robotic Solution (ARS) is intended for use in diagnostic and/or therapeutic endoscopic procedures in conjunction with the ConMed AirSeal iFS and an Intuitive da Vinci X Cannula and Cannula Seal to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired to facilitate the use of various laparoscopic and thoracoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. The Cannula Cap is indicated for use with or without visualization. The ARS System must be used with the Intuitive da Vinci X 8mm Instrument Cannula, an Intuitive Cannula Seal and the AirSeal iFS in AirSeal mode. When used in AirSeal mode, the Cannula Cap and Bifurcated Tube Set are designed to provide CO2 gas delivery with stable pneumoperitoneum and continuous smoke evacuation during robotic assisted laparoscopic and thoracoscopic procedures using the da Vinci Xi or da Vinci X systems. The Bifurcated Filtered Tube Set is used to connect the Cannula Cap and Cannula Seal to the AirSeal iFS.

The ConMed AirSeal iFS System consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a microprocessor-controlled insufflation, recirculation and filtration unit. The cannula, trocar and tube sets are sterile, single-use products. The AirSeal iFS System is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity. The AirSeal iFS System is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode (Adult and Pediatric); or (c) Smoke Evacuation Mode. The ConMed AirSeal dV Solution (or AirSeal Robotic Solution) consists of the following major components: (1) AirSeal® Cannula Cap with a cannula cap and an obturator (in standard and long lengths), and (2) AirSeal® Bifurcated Filtered Tube Set. The cannula cap, obturator and tube set are sterile, single-use products. The AirSeal dV Solution, in conjunction with Intuitive daVinci XiX Cannula and Cannula Seal, is operated in the Airseal Mode with the AirSeal iFS System to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. The ConMed AirSeal dV Solution is a sterile, single use device, primarily composed of polycarbonate, and stainless steel.

The provided FDA 510(k) summary describes the AirSeal iFS System and AirSeal dV Solution, which are laparoscopic insufflators. This document is a premarket notification for a medical device seeking substantial equivalence to a predicate device. As such, the "acceptance criteria" and "device performance" in this context refer to engineering and regulatory compliance testing rather than clinical performance metrics typically associated with AI/ML algorithms.

Here's an analysis based on the provided text, addressing your questions where applicable and noting when particular information is not present in this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance data categories. The specific quantitative acceptance criteria and detailed reported performance values for each test are not explicitly provided in this summary document. This level of detail is typically found in full test reports submitted to the FDA but is summarized for the 510(k) public abstract.

Study Proving Acceptance Criteria Met:

The study proving the device meets the acceptance criteria consists of benchtop testing and non-clinical testing. The document states:

• "Benchtop testing was completed to support substantial equivalence to the predicate as it relates to safety and effectiveness."
• "The following tests were conducted to support substantial equivalence for the expanded indication..." (followed by the list in the table above).
• "Based upon the findings of non-clinical testing, the differences present no issues of safety and efficacy and the subject AirSeal iFS System and AirSeal dV Solution are substantially equivalent to the predicate PneumoSure (K063367)."

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

This document does not specify sample sizes for individual tests. The testing conducted is primarily engineering verification and validation (V&V) on device prototypes or production units. Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided for these types of engineering tests.

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

This type of information is not relevant to the described studies, as they are engineering performance tests of a physical medical device, not clinical studies involving expert interpretation of data or images. "Ground truth" in this context refers to established engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against predefined engineering specifications and regulatory standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. This device is not an AI/ML algorithm that assists human readers; it is a laparoscopic insufflator.

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

This question is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests described would be established engineering specifications, design requirements, and recognized international standards (e.g., ISO, IEC) to which the device's performance is compared. For example, for "set pressure," the ground truth is the specified pressure values the device is designed to maintain.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm developed with a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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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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