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The Carestation 620/650/650c anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics. The systems are intended to be operated by a clinician qualified in the administration of general anesthesia.

The GE Carestation 620/650/650c anesthesia machines (Carestation 600 series) are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult). The anesthesia systems are suitable for use in a patient environment such as hospitals, surgical centers, or clinics. They represent one of the svstems in a long line of products based on the Datex-Ohmeda Aestiva (K000706). Aespire View (K122445) and Avance CS2 (K131945) Anesthesia Systems. The Carestation 600 series anesthesia systems are intended to be operated by a clinician qualified in the administration of general anesthesia.

The Carestation 600 series anesthesia systems supply set flows of medical gases to the breathing system using needle valve flow controlled gas mixing (O2 with Air, O2 with N2O, or O2 with Air and N2O). Gas flows are adjusted by the user using needle valve control knobs on the main system frame, the flows are displayed on the system display unit as numerical digits and as electronic representations of flow meters. Some models (Carestation 650, 650c) also display the flow digits directly above the flow controls. Carestation 600 series systems are also equipped with an integrated pneumatic flow tube that indicates total mixed gas flow from the 2 or 3 needle valves in the gas mixer (prior to the vaporizer manifold). The Carestation 650/650c systems provide an option for auxiliary mixed Oxygen + Air flow delivery where O2 with Air are blended and delivered to an auxiliary port used to support spontaneously breathing patients using a nasal cannula. An optional auxiliary O2 supply includes a separate O2 flow tube and needle valve flow control that delivers O2 flow to an auxiliary port used to support spontaneously breathing patients using a nasal cannula. The gas flow from the optional auxiliary O2 subsystem does not flow through the total flow tube. An optional auxiliary common gas outlet (ACGO) allows the clinician to direct the fresh gas flow of O2. Air, N2O, or anesthetic agent, through the ACGO port on the front of the system. The ACGO may be used to provide fresh gas to an auxiliary manual breathing circuit.

A large selection of frame options include central brake (Carestation 650) or individual caster brakes (Carestation 620), up to 3 breathing gases, optional storage drawers, and vaporizers are available to give the user control of the system configuration. The Carestation 600 series systems are also available in pendant and wall mount (Carestation 650c) models. All Carestation 600 series models have O2 gas and come with one or two additional gases (Air, N2O, or both). Carestation 600 series systems include two vaporizer positions and are available with up to three back-up gas cylinder connections.

The system uses touchscreen technology, hard keys, and a ComWheel to access system functions, menus, and settings on a 15" color display. The display is mounted on an arm on the left side of the machine. It can be rotated via the arm toward, or away from, the system to adjust the horizontal position. An optional arm is available allowing it to be tilted up or down to adjust the vertical viewing angle, or be moved left or right to adjust the horizontal position of the display. The split screen field can be set to show gas trends, Spirometry loops, airway pressure (Paw) gauge, airway compliance, and optional ecoFLOW information. If none is selected, the waveforms expand to fill the split screen area.

The Carestation 600 series systems accept Tec 6 Plus and Tec 7 vaporizers on a 2position Selectatec vaporizer manifold in the same way the Aestiva, Aespire View and Avance CS2 machines use the Tec 6 Plus or Tec 7 vaporizers. Features and devices within the Carestation 600 series systems are designed to decrease the risk of hypoxic mixtures, multiple anesthetic agent mixtures, complete power failure, or sudden gas supply failures. The Carestation 600 series systems are available with optional integrated respiratory gas monitoring which can be physically integrated into the Carestation 600, receive electronic power from the Carestation 600, and communicate measured values to the Carestation 600 for display on the system display unit. When supplied as an option, integrated respiratory gas monitoring is provided via the GE CARESCAPE series (E-sCAiO and E-sCAiOV) respiratory airway modules (K123195) which is identical to the module used on Avance CS2, or the N-CAiO respiratory airway module which was cleared as part of the GE B40 monitor (K133576).

The Carestation 600 series Anesthesia Ventilator is used in the Carestation 600 series Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. This version of the GE 7900 ventilator (cleared on K023366) is equipped with a built-in monitoring system for inspired oxygen (using an optional O2 cell or optional integrated gas module), patient airway pressure and exhaled volume. Flow sensors in the breathing circuit are used to monitor and control patient ventilation. This allows for the compensation of gas and tubing compression losses, fresh gas contribution, and small gas leakage from the breathing absorber, bellows and pneumatic system connections. User setting and microprocessor calculations control breathing patterns. The user interface keeps ventilation settings in memory. The user may change settings with a simple ventilation parameter setting sequence. A bellows contains breathing gasses to be delivered to the patient and provides a barrier keeping patient gas separate from the ventilatory drive gas. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward from the patent breathing circuit.

This ventilator comes with a standard ventilation mode as well as optional ventilation modes.

Standard ventilation mode:
VCV (Time Cycled, Volume Controlled ventilation)

Optional ventilation modes:
PCV (Time Cycled, Pressure Controlled ventilation) VCV-SIMV (Synchronized Intermittent Mandatory Ventilation Volume Control) PCV-SIMV (Synchronized Intermittent Mandatory Ventilation Pressure Control) PSVPro (Pressure supported ventilation with apnea backup) PCV-VG (Pressure Controlled ventilation - Volume Guaranteed) PCV-VG-SIMV (Synchronized Intermittent Mandatory Ventilation, Pressure Controlled ventilation - Volume Guaranteed) CPAP+PSV (Continuous Positive Airway Pressure/Pressure Support)

The system can include an internal, factory installed, suction regulator and control visible from the front of the machine. It can mount different monitors using an arm or shelf mounts. The mounting is achieved through a combination of GE Healthcare adapters and other third party mounts, including one that allows for the physical integration of the GE Monitor Series B650 (K102239).

The provided text does not contain information about the acceptance criteria and study specifically for an AI/ML powered device. Instead, it describes a medical device, the Carestation 620/650/650c anesthesia system, and its premarket notification to the FDA. The document focuses on establishing substantial equivalence to a predicate device, the Avance CS2, through non-clinical testing.

Therefore, many of the requested details regarding AI/ML device evaluation criteria, such as sample sizes for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, and training set information, are not available in this document.

However, I can extract the general acceptance criteria for the Carestation 620/650/650c device based on the non-clinical testing performed, which is focused on verifying its safety and functionality and establishing substantial equivalence to a predicate device.

Here's the information that can be extracted or deduced from the provided text:

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

The document broadly states that "Verification and validation testing was performed according to predetermined acceptance criteria." While specific numerical performance metrics are not provided, the types of tests conducted serve as the "acceptance criteria" categories for this device. The reported performance is that the device met these criteria.

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

Not applicable. The testing described is primarily non-clinical verification and validation testing of a hardware/software system, not a study involving a "test set" of patient data for an AI/ML algorithm. No specific sample sizes for these tests are mentioned beyond the implication that sufficient testing was done. The document does not refer to any patient data for testing.

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

Not applicable. This device is not an AI/ML algorithm that requires expert consensus for ground truth. Its functionality is tested against engineering specifications and regulatory standards.

4. Adjudication method for the test set

Not applicable, as there is no "test set" in the context of AI/ML evaluation. Product verification and validation involve testing against predefined specifications and requirements.

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

No. This document describes an anesthesia system, not an AI-assisted diagnostic device. Therefore, no MRMC study or evaluation of human reader improvement with AI is mentioned or relevant.

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

This refers to the performance of the Carestation 620/650/650c as a standalone medical device. The document explicitly states that "Extensive non-clinical testing was performed..." and that "The Carestation 620/650/650c has been thoroughly tested through verification of specifications and validation, including software validation." This means its standalone performance against design specifications was evaluated.

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

The "ground truth" for this device's performance is its compliance with engineering specifications, functional requirements, and relevant voluntary and regulatory standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-2). The testing aims to prove that the device operates as designed for its intended use.

8. The sample size for the training set

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

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

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

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The AV-S Anaesthesia Ventilator is intended to provide continuous mechanical ventilatory support during general anaesthesia. The ventilator is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Respiratory Therapists and Technicians under the direction of a Physician. Specifically the ventilator is indicated for use by both adult and pediatric patients.

The AV-S Ventilator is a software controlled multi-mode ventilator designed for mechanical ventilation of adult and paediatric patients under general anaesthesia. In addition, in spontaneous mode, it can be used to monitor anaesthetised patients. It is designed for use in closed circuit anaesthesia and also to drive a Mapleson D circuit.

The AV-S Ventilator is also available with a remote display screen unit that can be affixed to an anaesthesia machine and be located remotely from the ventilator control unit. The display screen is affixed to the anaesthesia ventilator by a swivel mounting arm. An interconnecting cable is provided to transmit data between the control unit and the remote display screen unit.

The provided document is a 510(k) summary for the AV-S Anaesthesia Ventilator. It focuses on demonstrating substantial equivalence to predicate devices and outlines the device's technical characteristics and intended use. Crucially, this document does not contain information on acceptance criteria, a study proving device performance against such criteria, or details regarding ground truth establishment, sample sizes, or expert adjudication for performance evaluation studies.

The text consistently refers to the device as an "Anaesthesia Ventilator" and its purpose is for "continuous mechanical ventilatory support during general anaesthesia." It emphasizes the similarities with predicate devices (Penlon Limited AV800 Anaesthesia Ventilator and Datex-Ohmeda 7900 Anaesthesia Ventilator) in terms of software control, multi-mode functionality, and indications for use. The only noted technological differences are the incorporation of the Prima Oxygen monitor and additional software for advanced spontaneous breathing support modes.

Since the document does not contain the requested information about acceptance criteria and performance studies, I am unable to populate the table or provide details for points 2 through 9.

Therefore, the response for the requested information is that it is not present in the provided text.

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The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss.

The Aestiva SmartVent MRI Anesthesia System is substantially equivalent to the following currently marketed device: 1. Datex-Ohmeda Aestiva SmartVent MRI Anesthesia System - Class II -21CFR868.5160. The Aestiva/5 MRI provides the functional feature set offered by the conventional Aestiva 3000 (K973896) to the clinician with the added ability to be used in the MR environment (as cleared in K993410). Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent (Including those cleared in K023366) along with the Aestiva breathing circuit. The Aestiva/5 MRI is constructed of primarily non-ferrous materials to help prevent attraction to the cryogenic magnets in the MRI systems. The Aestiva/5 MRI performed to specifications when tested directly next to an MRI device of the field strength listed in the product labeling. Safety features and devices within the Aestiva/5 MRI decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.

The GE Datex-Ohmeda Aestiva/5 MRI Anesthesia System is a gas machine for anesthesia or analgesia, designed to provide the functionalities of a conventional anesthesia system within an MRI environment.

Here's an analysis of its acceptance criteria and the study that supports it:

1. Acceptance Criteria and Reported Device Performance

The "study" evidencing these criteria is described as "rigorous testing" that validated the device, in part, supporting its compliance with the mentioned standards. This testing focused on both functional equivalence to its predicate device (Aestiva 3000) and its specific performance in an MRI environment (non-ferrous nature and specified operation near 1.5T and 3.0T MRI devices within 300 gauss field strength).

Details of the Study:

This submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical trial to prove efficacy or safety from scratch. Therefore, the "study" described is primarily a series of engineering tests and compliance evaluations against recognized standards and predicate device performance.

• 2. Sample size used for the test set and the data provenance:
  • Test Set: Not explicitly stated as a "sample size" in the context of patients or data records. Instead, the testing likely involved a limited number of physical prototype devices.
  • Data Provenance: The testing was conducted by the manufacturer (Datex-Ohmeda, Inc.) as part of the device development and validation process. This would be considered prospective engineering validation and verification testing. The geographical origin of the data is not specified beyond the manufacturer's location in Wisconsin, USA.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
  • Not applicable (N/A): This type of device (Anesthesia System) and submission (510(k) of an MRI-compatible version of an existing device) does not typically involve expert consensus to establish a "ground truth" on a test set of medical data (e.g., images for diagnosis). Instead, performance is assessed against engineering specifications and voluntary standards. Experts would be involved in the design, testing protocols, and interpretation of results (e.g., engineers, medical device specialists, potentially anesthesiologists for functional review), but not in creating a diagnostic ground truth.
• 4. Adjudication method for the test set:
  • N/A: As there's no "ground truth" to adjudicate in the typical sense of diagnostic accuracy, an adjudication method like 2+1 or 3+1 is not applicable. Performance would be determined by meeting predefined engineering criteria and passing standard-specific tests.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
  • No: This is not an AI-enabled diagnostic device and therefore an MRMC study comparing human readers with and without AI assistance is not relevant or performed for this type of submission.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
  • N/A: This is a physical medical device, not a software algorithm, so the concept of standalone performance (without human-in-the-loop) is not applicable in the typical sense of AI/software. Its functionality is inherently tied to human operation and interaction. The "standalone" performance here refers to the device itself operating according to specifications.
• 7. The type of ground truth used:
  • Engineering Specifications and Voluntary Standards: The "ground truth" for this device's performance is its adherence to its own design specifications, the functional features of its predicate device, and the requirements outlined in the cited voluntary standards (EN 740, EN 60601-1, EN 60601-1-2, ISO 5358, ASTM F1208-94) and relevant FDA guidance. For MRI compatibility, the ground truth was "performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss."
• 8. The sample size for the training set:
  • N/A: This is not a machine learning model, so there is no concept of a "training set" of data for an algorithm. The development process would involve iterative design, prototyping, and testing.
• 9. How the ground truth for the training set was established:
  • N/A: See point 8.

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The Fabius GS/Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius GS/Fabius Tiro can be used for spontaneous, manually assisted, automatic, pressure support, or synchronized mandatory intermittent ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.

The Fabius GS/Fabius Tiro is a continuous flow gas anesthesia system.

The provided document is a 510(k) summary for the Fabius GS/Fabius Tiro Anesthesia System, specifically for a software modification to include Synchronized Intermittent Mandatory Ventilation with Pressure Support (SIMV/PS) as an optional ventilation mode.

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

Description of Acceptance Criteria and Reported Device Performance

The document describes the addition of SIMV/PS mode to the existing Fabius GS/Fabius Tiro Anesthesia System. The acceptance criteria are implicitly based on demonstrating substantial equivalence to existing predicate devices (Evita 4 Ventilator K961687 and 7900 Ventilator K023366) with SIMV with Pressure Support ventilation modes. The substantial equivalence is claimed based on functional similarities and that the device "meets" these similarities.

Study Details:

This document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study on the device's performance against specific acceptance criteria. Therefore, many of the requested details typically found in the clinical study report are not explicitly present.

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

   • Test Set Sample Size: Not applicable in the context of this 510(k) submission. No patient-level test set data is mentioned for performance evaluation in the conventional sense. The "test set" here refers to the parameters and functionalities that were verified against the predicate devices.
   • Data Provenance: Not specified. The submission relies on a comparison of technical specifications and features with previously cleared predicate devices.

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

   • Not applicable as this is a comparison against predicate devices' functionalities, not a diagnostic or clinical performance study requiring expert ground truth establishment. The "ground truth" for substantial equivalence is the functionality of the predicate devices.

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

   • Not applicable. There's no clinical data adjudication described in this type of submission.

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:

   • No MRMC study was conducted. This device is an anesthesia system, not an AI-powered diagnostic tool for human readers.

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

   • No standalone algorithm performance study was described. The submission focuses on the integration of a new ventilation mode (software change) into an existing, cleared anesthesia system. Performance claims are based on similarity to predicate devices already cleared for use.

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

   • The "ground truth" for this submission is the established functionality and regulatory clearance of the predicate devices (Evita 4 Ventilator and 7900 Ventilator) regarding their SIMV with Pressure Support ventilation modes. The new device's SIMV/PS mode is deemed substantially equivalent based on matching these functionalities and parameters.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI algorithm in the sense that it requires a training set of data. The "training set" would implicitly be the established engineering and design principles used to develop the software, which are not quantified in terms of sample size here.

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

   • Not applicable for the same reasons as above. The "ground truth" for the development of the SIMV/PS mode would stem from medical knowledge of ventilation, engineering specifications, and the functionality observed in the predicate devices.

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The Fabius GS and Fabius Tiro are indicated as a continuous flow anesthesia systems. The Fabius GS and Fabius Tiro are indicated for spontaneous, manually assisted, automatic or pressure support ventilation; delivery of gases and anesthetic vapor of patients during anesthesia. The Fabius GS and Fabius Tiro can monitor inspired oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. The Fabius GS and Fabius Tiro are to be used only in the order of a physician.

The Fabius GS and Fabius Tiro are continuous flow gas anesthesia systems.

The provided document does not contain specific acceptance criteria or a detailed study description for the Fabius GS and Fabius Tiro Anesthesia Systems' Apnea Ventilation feature in the same way one would expect for a machine learning or AI-driven device.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on a hazard analysis, system-level qualification, and verification/validation tests. The Apnea Ventilation feature is described as a software change.

Therefore, many of the requested details (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or not provided in this type of regulatory submission, which predates the common expectations for AI/ML device descriptions.

However, I can extract the available information and indicate where details are not provided.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a software change to an existing device, the "acceptance criteria" are framed in terms of maintaining safety and effectiveness and demonstrating substantial equivalence to predicates. Performance is described functionally rather than with quantitative metrics typically found in AI/ML performance tables.

• User Alert: All three devices (Fabius GS/Tiro, Evita 4, 7900 Ventilator) alert the user to the apnea condition.
• User Disablement: The Apnea Ventilation feature can be disabled by the user, similar to the predicate devices.
• Backup Function: Intended as a short-term backup to prevent apnea if spontaneous effort fails.
• Core Functionality: Basic infrastructure, operating principle, alarm strategies, fault detection circuitry, and mechanical/pneumatic subassemblies remain unchanged. |
  | Hazard Analysis & Qualification Success | Qualification included hazard analysis, system level qualification, and verification/validation tests were performed, implying successful completion. (Specific results or metrics from these tests are not detailed in this summary). |
  | Functional Equivalence | - All devices are triggered if a user-selected time elapses without a spontaneous breath during pressure support ventilation.
• All prevent an apnea condition.
• All alert the user to the condition.
• All can be disabled by the user. |
  | (Implied) No adverse impact on existing device features | The document states the change is "software only" and that the "basic infrastructure... remain unchanged," implying functionality not related to the Apnea Ventilation feature is unaffected. |

Study Details:

The document describes the evidence for substantial equivalence, which primarily constituted a comparison to predicate devices and internal qualification processes.

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 submission focuses on a software change to an existing device and its substantial equivalence to predicate devices. There is no mention of a "test set" in the context of patient data or algorithm performance used in a way that generates sample sizes for statistical analysis relevant to AI/ML. The "test" here refers to verification and validation of the software feature itself and its integration into the system.

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

• Not Applicable / Not Provided: Ground truth in the context of patient data adjudicated by experts is not described for this type of submission. The "ground truth" here would relate to the functional correctness of the software and its ability to prevent apnea as designed, which is established through engineering and clinical validation rather than expert labeling of empirical patient data.

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

• Not Applicable / Not Provided: As no "test set" requiring expert adjudication is described, no adjudication method is mentioned.

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

• Not Applicable / Not Provided: This device is an anesthesia system with an apnea detection and response feature, not a diagnostic AI/ML tool designed to assist human readers (e.g., radiologists). Therefore, an MRMC study is irrelevant to this submission.

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

• Partially Applicable / Implicitly Done: The "Apnea Ventilation feature" is a software algorithm that operates autonomously when triggered by the absence of spontaneous breaths. The "system level qualification, and verification/validation tests" would have evaluated its standalone (algorithm-only) performance within the device infrastructure. However, specific performance metrics or a detailed description of these tests (e.g., how apnea was simulated and how the system responded) are not provided in this summary. The device's overall use involves a human operator, but the apnea feature itself is an automated response.

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

• Functional/Design Specification Ground Truth: The "ground truth" for this device's feature would be its adherence to engineering specifications for detecting apnea conditions and successfully delivering a pressure support breath as designed, and its equivalence to the functional behavior of the predicate devices. This would be established through bench testing, simulated scenarios, and potentially animal or human studies to confirm physiological response, though details are not supplied in this specific summary.

8. The sample size for the training set

• Not Applicable / Not Provided: This is a deterministic software feature, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" here would refer to software development and debugging.

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

• Not Applicable / Not Provided: As there is no "training set" for an AI/ML model, this question is not relevant. The ground truth for the device's design and function comes from established medical standards for ventilation and anesthesia, engineering principles, and the functional behavior of predicate devices.

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