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The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates.
Intended areas of use:
• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
• During transfer of ventilated patients within the hospital
The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-C3 is designed for adult, pediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation.
The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-C3:
• Therapy type: HiFlowO2

The provided document is a 510(k) summary for the Hamilton-C3 ventilator, seeking to add a "HiFlowO2" therapy type. This document does not describe acceptance criteria for a device's performance in a diagnostic or predictive capacity, nor does it detail a study that proves a device meets such criteria in the way a clinical trial for an AI diagnostic might. Instead, it describes compliance with regulatory standards and a bench test to show equivalence for a new feature.

Therefore, many of the requested elements for describing acceptance criteria and a study (like sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not available within this regulatory submission.

However, I can extract information related to the device's technical specifications and how the new feature was evaluated for substantial equivalence.

Here's the closest representation of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the HiFlowO2 feature in a quantitative form with specific thresholds (e.g., "accuracy > X%"). Instead, the acceptance criterion for the new HiFlowO2 therapy type is substantial equivalence to the reference device (HAMILTON-G5) regarding its flow and oxygen values.

• Neonatal: HAMILTON-C3 (2 to 12 l/min) vs. HAMILTON-G5 (1 to 12 l/min) — Similar
• Adult/Pediatric: HAMILTON-C3 (2 to 60 l/min) vs. HAMILTON-G5 (1 to 60 l/min) — Similar

HiFlowO2 Default Settings (Comparison to HAMILTON-G5):

• Flow Adult/Pediatric: HAMILTON-C3 (15 l/min) vs. HAMILTON-G5 (15 l/min) — Same
• Flow Neonatal: HAMILTON-C3 (2 l/min) vs. HAMILTON-G5 (1 l/min) — Similar
• Oxygen Adult/Pediatric: HAMILTON-C3 (50%) vs. HAMILTON-G5 (50%) — Same
• Oxygen Neonatal: HAMILTON-C3 (40%) vs. HAMILTON-G5 (40%) — Same

"The data provided from this test was shown to be substantially equivalent to the legally marketed predicate device [referring to the reference device for HiFlowO2]." |

The "predicate device" and "reference device" mentioned in the document are already legally marketed and cleared devices. The Hamilton-C3, with the new HiFlowO2 feature, is being compared to these existing devices to demonstrate that it is "substantially equivalent" and therefore safe and effective.

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

• Sample size: Not specified in terms of patient or case numbers. The evaluation of the HiFlowO2 feature was conducted via a bench test. Bench tests typically involve testing the physical device's performance under simulated conditions, not using patient data.
• Data provenance: Not applicable in the context of patient data, as the testing was non-clinical (bench testing).

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

• Not applicable. The ground truth for a bench test typically involves calibrated measurement equipment and engineering standards, not expert human interpretation of medical cases.

4. Adjudication method for the test set

• Not applicable. This type of testing does not involve human adjudication of medical findings.

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 a submission for a ventilator with a new therapy type, not an AI diagnostic device.

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

• Not applicable. This is for a medical device (ventilator), not an algorithm that performs a diagnostic or predictive function. The "study" mentioned is a bench test to verify the physical performance of the ventilator with its new feature.

7. The type of ground truth used

• For the bench test of the HiFlowO2 feature: The "ground truth" would be the measured physical outputs (flow rates and oxygen concentrations) from the Hamilton-C3 device, compared against the specifications and expected performance based on the reference device (HAMILTON-G5) and engineering principles. This is not medical ground truth like pathology or expert consensus.
• For software validation and overall device compliance: The "ground truth" is adherence to established international standards (e.g., IEC 60601 series, ISO 80601 series, IEC 62304) and internal design specifications.

8. The sample size for the training set

• Not applicable. There is no AI model or algorithm being "trained" in the context of this regulatory submission based on the provided text.

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

• Not applicable, as there is no training set.

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The HAMILTON-C6 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates.

Intended areas of use:

• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room

• During transfer of ventilated patients within the hospital

The HAMILTON-C6 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-C6 is designed for adult, pediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation.

The HAMILTON-H900 and IntelliCuff control options for the HAMILTON-C6 allow the remote control of the HAMILTON-H900 humidifier and IntelliCuff cuff pressure controller through the HAMILTON-C6 ventilator.

This document is a 510(k) summary for the Hamilton-C6 continuous ventilator. It focuses on demonstrating substantial equivalence to a predicate device (Hamilton-C3) and a reference device (Hamilton-G5), rather than providing details of an AI-based system. Therefore, much of the requested information regarding acceptance criteria and a study proving an AI device's performance cannot be extracted directly from this document.

However, I can provide information about the general performance criteria that were referenced for the device in question, a continuous ventilator.

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

The document does not provide specific numerical acceptance criteria (e.g., accuracy, sensitivity, specificity) with corresponding reported device performance values. Instead, it states that:

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

The document does not specify a "test set" in the context of an AI algorithm, nor does it provide details about sample sizes, data provenance, or whether data was retrospective or prospective. The testing mentioned appears to be general device performance and safety testing.

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)

This information is not applicable to the type of device and testing described in the document. Ground truth for an AI algorithm is not mentioned as this is not an AI device submission.

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

This information is not applicable to the type of device and testing described in the document.

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 MRMC comparative effectiveness study was done as the HAMILTON-C6 is a continuous ventilator, not an AI-assisted diagnostic or interpretive device. There is no mention of human readers or AI assistance in this context.

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

This information is not applicable. The HAMILTON-C6 is a physical medical device (ventilator), not a standalone algorithm.

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

The concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not applied in this document, as it is a submission for a continuous ventilator, not an AI diagnostic/interpretive system. The "ground truth" used for performance testing of the ventilator would have been based on established engineering standards and validated physical measurements against expected device outputs.

8. The sample size for the training set

This information is not applicable to the type of device and testing described in the document. There is no training set for an AI algorithm mentioned.

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

This information is not applicable.

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The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician.

The HAMILTON-G5 ventilator may be used for transport within a hospital type facility provided compressed gas is supplied. The device is not to be used in the presence of flammable anesthetic agents or other ignition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment. The device is not intended for transportation outside the hospital or for use in the home environment.

The HAMILTON-G5 ventilator is designed for adults, pediatrics, infants and neonates requiring invasive or non-invasive ventilation support. It covers a range of clinical modes, including invasive ventilation, Adaptive Support Ventilation (ASV), and noninvasive ventilation. The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-G5:

• IntelliSync+, an option that allows the device to dynamically update the inspiratory or cycling trigger
• Operation of the humidifier HAMILTON-H900 via the GUI of the ventilator HAMILTON-G5

This document, an FDA 510(k) summary for the Hamilton-G5 ventilator, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria and results in the way one might typically describe for an AI/ML device. The "performance data" section primarily lists compliance with various medical device standards and general software validation.

Specifically, there is no detailed acceptance criteria table, no sample size for test sets (in the context of clinical performance evaluation), no information on experts, adjudication methods, MRMC studies, or standalone algorithm performance, no specific ground truth establishment methodologies from patient data, and no details regarding training sets.

The document states:

• "Testing of the new feature IntelliSync+ with the HAMILTON-G5 was conducted by waveform performance testing. The data provided from this test was shown to be substantially equivalent to the legally marketed predicate device."

This indicates that the performance evaluation for the new feature was a bench test involving waveform analysis, comparing it to a predicate device's performance characteristics. This is typical for ventilator predicate equivalence submissions, where the "performance" often refers to meeting engineering specifications rather than clinical outcomes studies with human readers.

Therefore, based solely on the provided text, I cannot generate the requested table and detailed study description. The document does not contain the information needed to fill out points 1 through 9 as they typically apply to AI/ML device performance studies.

However, I can extract what is available about the performance, even if it's not in the requested format for an AI/ML device:

Device: Hamilton-G5 Ventilator (with new features IntelliSync+ and HAMILTON-H900 GUI integration)
Study Type: Technical Performance Bench Testing (for the new features) and compliance with industry standards. No clinical trial data is described.

Summary of available information related to performance/acceptance (limited, not in AI/ML performance study context):

1. Table of Acceptance Criteria and Reported Device Performance:

   Criteria Category (Not formal "acceptance criteria" but compliance metrics)	Reported Device Performance/Compliance
   Software Design & Validation	"The software design and validation process, together with the bench testing of the device, demonstrated that the HAMILTON-G5 operates as intended." "Software verification and validation testing was conducted and documentation was provided as recommended by the FDA's 'Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" The software was considered a "major" level of concern.
   IntelliSync+ Trigger Performance	"Testing of the new feature IntelliSync+ with the HAMILTON-G5 was conducted by waveform performance testing. The data provided from this test was shown to be substantially equivalent to the legally marketed predicate device." (Comparison to predicate Respironics V200 Ventilator's Auto-Trak trigger functionality: "The subject device HAMLTON-G5 is compared to the Respironics V200 Ventilator regarding the trigger synchronization algorithm, which resulted in equivalence regarding the trigger features itself and in substantial equivalence regarding the trigger performance.")
   Compliance with Standards	- ANSI/AAMI ES60601-1 (2005/ (R) 2012): Medical electrical equipment General l Requirements for Safety

• IEC 60601-1-2 (2014): Medical electrical equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
• ISO 80601-2-12 (2011): Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
• IEC 60601-1-8 (2006 + Am.1: 2012): Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
• IEC 60601-1-6 (2010 + A1 :2013): Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
• IEC 62366 (2014): Medical devices Application of usability engineering to medical devices
• ANSI/AAMI HE75(2009(R) 2013): Human factors engineering – Design of medical devices
• IEC 62304 (2006): Medical device software - Software life-cycle processes
• ISO 80601-2-55 (2011): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
• ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
  | Biocompatibility | "Since only materials already used in the primary predicate... are used (the new features did not include any material changes, only software adaptions) Hamilton Medical did not conduct any additional biocompatibility testing." |

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

   • No "test set" in the sense of patient data is mentioned. The testing was "waveform performance testing" (a bench test). No information on the number of waveforms or their origin is provided.

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

   • Not applicable; this was a bench test against technical specifications and comparison to a predicate device's technical performance, not a study requiring expert readers to establish ground truth from patient data.

4. Adjudication method for the test set:

   • Not applicable.

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 a ventilator, not an AI diagnostic imaging device that assists human readers.

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

   • The "waveform performance testing" seems to be a standalone technical performance evaluation of the IntelliSync+ algorithm's ability to interpret and respond to waveforms, comparing its output to that of a predicate device. It's not a clinical standalone study as typically understood for AI/ML diagnostics.

7. The type of ground truth used:

   • For IntelliSync+ performance, the "ground truth" seems to be the expected/measured physiological characteristics of waveforms and the performance of the legally marketed predicate device's trigger algorithm (Auto-Trak) in relation to those waveforms. This is a technical/engineering ground truth, not a clinical ground truth from patient outcomes or pathology.

8. The sample size for the training set:

   • Not applicable. The document describes software modifications and integration of features, not a machine learning model that requires a "training set."

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

   • Not applicable.

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The HAMILTON-C1 ventilator is intended to provide positive pressure ventilatory support or continuous flow of respiratory gases to adults and pediatrics, and optionally infants and neonates.

Intended areas of use:

· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room

· During transfer of ventilated patients within the hospital

The HAMILTON-C1 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-T1 ventilator is intended to provide positive pressure ventilatory support or continuous flow of respiratory gases to adults and pediatrics, and optionally infants and neonates.

Intended areas of use:

· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room

• · For emergency medical care
• · During transport within and outside the hospital
• · During transfer by rescue vehicles, fixed wing aircraft, helicopter or ship

The HAMILTON-T1 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-C1 and HAMILTON-T1 ventilators are designed for adults, pediatrics, infants and neonatal patients requiring invasive or non-invasive ventilation support. All ventilators cover a range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and Non-Invasive Ventilation.

The previously cleared ventilators, HAMILTON-C1 and HAMILTON-T1 (both K140939), have been bundled together in this 510(k) submission in order to add the following new features:

A modification to the software allows compatibility with the Nihon Kohden -SpO2 sensors to be used with HAMIILTON-C1 and HAMILTON-T1 ventilators. These ventilators are already compatible and cleared for use with Masimo SpO2 sensors (K140939).

• cFlow was added, which continuously delivers an air/gas mixture.
• -A modification to the software, which allows HAMILTON-C1/T1 ventilators to be compatible for use with speaking valves. A speaking valve allows tracheostomized adult and pediatric patients to communicate verbally.

The provided text describes the Hamilton-C1 and Hamilton-T1 ventilators and their clearance by the FDA. The submission focuses on adding new features to already cleared devices.

Here's an analysis of the provided information regarding acceptance criteria and study details:

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

The document does not explicitly present a table of acceptance criteria for the new features (cFlow, Speaking Valve, and Nihon Kohden SpO2 sensor compatibility) and their reported performance. Instead, it states that "the data provided from these tests was shown to be equivalent to the legally marketed devices." This implies that the acceptance criterion was equivalence to predicate/reference devices, and the reported performance met this criterion.

However, the "SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COMPARISON WITH THE PREDICATED DEVICES" (Table 1 on pages 5-6) compares various parameters of the proposed HAMILTON-C1/T1 with the predicate HAMILTON-C1/T1 (K140939). For all listed parameters (Indications of Use, Control settings, Modes of ventilation, Alarms), the comparison states "Substantially Equivalent" or "Equivalent". While this table doesn't detail performance metrics for the new features, it confirms that the device, with its existing features, is considered equivalent to its predicate.

For the new features, the text mentions:

• cFlow: "cFlow was added, which continuously delivers an air/gas mixture." It later states, "The Nihon Kohden NKV-550 Series Ventilator System is used as a reference device for the proposed HAMILTON-C1/T1 as both the reference device and the proposed device are intensive care ventilators which have the O2 therapy/cFlow feature." This implies the cFlow feature in HAMILTON-C1/T1 is equivalent to that in the Nihon Kohden NKV-550.
• Nihon Kohden SpO2 sensors: "A modification to the software allows compatibility with the Nihon Kohden -SpO2 sensors to be used with HAMIILTON-C1 and HAMILTON-T1 ventilators." The document states, "The HAMILTON-C3 is used as a reference device for the proposed HAMILTON-C1/T1 as both the reference device and the proposed device are intensive care ventilators which can be used with Nihon Kohden SpO2 sensors and accessories." This suggests compatibility and performance with these sensors are equivalent to the HAMILTON-C3.
• Speaking Valve: "A modification to the software, which allows HAMILTON-C1/T1 ventilators to be compatible for use with speaking valves." "The Esprit Ventilator V200 with Speaking mode Option is used as a reference device for the proposed Speaking valve compatibility on the modified HAMILTON-C1/T1..." This indicates equivalence to the Esprit Ventilator V200's speaking mode.

Implicit Acceptance Criteria and Reported Performance for New Features:

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

The document does not specify exact sample sizes (e.g., number of patients, number of test cases) used for the comparison testing of the new features. It only states that "Testing of the modified HAMILTON-C1/T1, with the new features, was conducted."
The provenance of the data (country of origin, retrospective/prospective) is also not mentioned. The non-clinical performance tests are generally bench testing and software validation, not human studies.

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)

This section is not applicable as the document describes non-clinical performance tests for a ventilator, not diagnostic imaging or AI performance where human expert consensus would establish ground truth. The "ground truth" for these tests would be established through engineering specifications, validated test equipment, and established medical device standards.

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

Not applicable. The testing described is non-clinical performance and software validation, not a multi-reader clinical study 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

Not applicable. This is a ventilation device, not a diagnostic AI tool, so no MRMC study or AI assistance improvement for human readers would be relevant.

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

This question is not entirely applicable in the context of a ventilator. However, the software validation and bench testing can be considered "standalone" in the sense that the device's technical performance and software functions were tested independently of a human operator making clinical decisions or interpreting results in a real patient scenario. The tests confirm the device operates as intended according to its design specifications and relevant standards.

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

The "ground truth" for the non-clinical performance tests and software validation would be based on:

• Engineering Specifications: The defined functional requirements and performance limits of the device.
• International and National Standards: Compliance with standards like ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-12, etc. (listed in Section IX) which define acceptable ranges and behaviors for critical care ventilators, electromagnetic compatibility, alarm systems, and usability.
• Predicate/Reference Device Performance: The established, legally marketed performance of the predicate HAMILTON-C1/T1 and the reference devices (Nihon Kohden NKV-550, HAMILTON-C3, Esprit Ventilator V200) for the new features. Equivalence to these cleared devices serves as a form of "ground truth" for substantial equivalence.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning product that requires a training set. The changes described are software modifications for compatibility and feature additions to a pre-existing ventilator design.

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

Not applicable, as there is no training set for this type of medical device submission.

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Intended Use HAMILTON-H900

The HAMILTON-H900 humidifier is intended to add moisture and to warm breathing gases during invasive and non-invasive mechanical ventilation. The intended area of use is the intensive care ward or the recovery room.

The HAMILTON-H900 humidifier is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

Intended Use HAMILTON-BC8010

The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of pediatric and neonatal patients.

Intended Use HAMILTON-BC4010

The HAMILTON-BC4010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of pediatric and neonatal patients.

HAMILTON-H900

The HAMILTON-H900 respiratory gas humidifier is designed to add heat and moisture to respiratory gases, which are then administered to patients who need invasive or noninvasive ventilation. The breathing gas is passed through a humidifier chamber, where the gas is heated and humidified using an external heat source.

The HAMILTON-H900 humidifier uses breathing circuits that are recognized automatically when connected to the humidifier. The humidifier uses two heating systems as heat sources:

• -A heating plate that has contact with the metal plate of a special humidifier chamber inserted into the base of the humidifier prior to application, thus heating the water contained inside the chamber.
• -The controlled heating within the breathing circuits.

The respiratory gas exiting the humidifier chamber is continuously monitored using temperature sensors that are integrated into the humidifier base. Additionally, a temperature probe inside the breathing tube is used to measure the temperature of the gas delivered to the patient airway.

The design of the breathing tubes offers heating performance over the entire length by providing constant heating of the entire tube wall, from the chamber exit to the patient connection. A float mechanism, together with detection of the water level inside the humidifier chamber and the autofill mechanism, keeps a constant water level.

HAMILTON-BC8010

The HAMILTON-BC8010 is a single-use, dual-limb breathing circuit comprising heated inspiratory and heated expiratory tubes. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.

HAMILTON-BC4010

The HAMILTON-BC4010 is a single-imb breathing circuit comprising a heated inspiratory tube. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.

HAMILTON-HC322/HC310

The HAMILTON-HC322/HC310 are single-use humidifier chambers with a float mechanism to keep a constant water level inside the auto-feed chamber. The HAMILTON-HC322 humidifier chamber is part of the HAMILTON-BC8022/BC4022 breathing sets and the HAMILTON-HC310 humidifier chamber is part of the HAMILTON-BC8010/BC4010 breathing sets, as cleared in K152029.

This is a 510(k) summary for a medical device (respiratory gas humidifier and breathing circuits), not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, and ground truth establishment, which are typical for AI/ML device submissions, are not primarily available or applicable in the provided text.

The document discusses substantial equivalence to predicate devices based on technological characteristics and performance, focusing on non-clinical data. It does not describe an AI/ML algorithm that predicts or diagnoses based on medical images or other data, nor does it detail a study that evaluates the performance of such an algorithm against a ground truth established by experts.

However, I can provide the acceptance criteria and performance as described for this specific device, based on the provided text, recognizing that it's not in the context of an AI/ML model.

Here's an analysis of the provided text, focusing on the closest equivalents to your requested information, understanding the context is a medical device, not an AI/ML diagnostic:

The provided text is a 510(k) summary for the Hamilton-H900 Humidifier and Hamilton-BC series breathing circuits. This document outlines the rationale for the device's substantial equivalence to previously cleared predicate devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and performance specifications and non-clinical testing, rather than the type of clinical performance study typically conducted for AI/ML diagnostic or predictive devices.

Therefore, many of the requested points (e.g., number of experts for ground truth, adjudication methods, MRMC study, standalone performance for an algorithm) are not applicable to this type of device submission.

Here is the information extractable from the document, focusing on performance characteristics and non-clinical testing rather than AI/ML specific criteria:

Acceptance Criteria and Reported Device Performance (Non-AI/ML Context)

The acceptance criteria are implied by the "Characteristic used for comparison" and the "HAMILTON-H900 (Subject device)" column in Table 1 for the humidifier and Table 2 for the breathing circuits. The "reported device performance" is the statement that the subject device meets these established characteristics, which are largely identical to the predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

For HAMILTON-H900 (Humidifier):

For HAMILTON-BC8010 / BC4010 (Breathing Circuits):

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The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates.

Intended areas of use:

· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room

· During transfer of ventilated patients within the hospital

The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-C3 is designed for adult, paediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation.

The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-C3:

• The following two new ventilation modes for adult / pediatric patient group: ● (S)CMV and SIMV
• SpO2 monitoring option

This section describes the acceptance criteria and the study proving the device meets those criteria, based on the provided text.

1. Table of acceptance criteria and reported device performance:

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

The provided text focuses on device performance testing against regulatory standards and software validation. It mentions "waveform performance testing" for the new ventilation modes. However, it does not specify the sample size for any test sets used in performance testing, nor does it detail the data provenance (e.g., country of origin, retrospective/prospective nature of data).

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):

This information is not provided in the document. The testing described is primarily technical compliance and performance against established engineering standards and validated software functionality, rather than a clinical study requiring expert ground truth for interpretation of outcomes.

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

This information is not provided. The text describes bench testing and software validation, not a study design involving adjudication of human interpretations.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the provided text. The device is a ventilator, and the testing described is related to its technical performance and safety, not a diagnostic or interpretive AI system that human readers would use.

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

The document describes "Software Design and Validation" processes, "bench testing of the device," and "waveform performance testing" for the new ventilation modes. These types of tests are inherently "standalone" in that they evaluate the device's algorithmic and mechanical performance directly against engineering specifications and expected outputs, without direct human intervention as part of the core performance measurement, other than operating the test equipment. So, yes, standalone algorithm performance was assessed though not explicitly called out as such.

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

The "ground truth" for the device's technical performance and safety is derived from the international and national standards and guidelines listed (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-12). For the new ventilation modes, "waveform performance testing" was conducted, implying that the ground truth for correct operation were the expected waveform characteristics and parameters as defined by the ventilator's design specifications and the algorithms derived from the predicate HAMILTON-G5.

8. The sample size for the training set:

A "training set" is typically associated with machine learning or artificial intelligence models. As this document describes a medical device (ventilator) and its compliance with technical standards and software validation, there is no mention of a training set in the context of machine learning. The "training" for such a device would refer to its design, development, and engineering phases.

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

Since there is no mention of a training set in the context of machine learning, this question is not applicable. The "ground truth" for the device's design and functionality is established through engineering principles, medical device regulatory requirements, and the functionalities of predicate devices.

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The HAMILTON-MR1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates.
Intended areas of use:

• In the MRI department
• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
• During transfer of ventilated patients within the hospital
  The HAMILTON-MR1 ventilator is classified as MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners.
  The HAMILTON-MR1 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-MR1 is an MR-Conditional ventilator which increases the availability of appropriate modes of therapy for ventilated hospital patients requiring MR imaging. It is designed for adult, pediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation. It can be used at the gauss line, in the presence of either 1.5T or 3T MRI machines.
With the shielded, MRI-compatible HAMILTON-MR1 ventilation performance and MR image quality is as safe and as effective as the predicate device throughout the MRI procedure. The integrated gaussmeter is programmed to alarm when the clinician is placing the HAMILTON-MR1 too close to the MRI magnet, which helps the clinician to properly position the HAMILTON-MR1 at the 50mT (500 gauss) line or less.
The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-MR1:

• Neonatal patients with a minimum weight of 0.2 kg and a minimal tidal volume of 2 mL
• . The following two new modes for the neonatal patient group: nCPAP and nCPAP-PC
• An increase in the battery duration from 5 hours and 20 minutes to 9 hours and 20 minutes.

The provided document describes a 510(k) submission for the HAMILTON-MR1 ventilator, focusing on its substantial equivalence to previously cleared predicate devices. The submission concerns adding new features, specifically the capability to ventilate neonatal patients and two new ventilation modes (nCPAP and nCPAP-PC).

This document does not include information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven medical device, as it is a ventilator and not an AI/ML diagnostic tool. Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to this type of device submission.

However, I can extract information regarding performance testing and regulatory compliance relevant to this specific device.

Acceptance Criteria and Device Performance (Based on the provided document)

Since this is a ventilation device rather than an AI/ML diagnostic, "acceptance criteria" here refer to compliance with relevant medical device standards and demonstrating functionality for the newly added features.

1. Table of Acceptance Criteria and Reported Device Performance

• ANSI/AAMI ES60601-1 (2005/(R) 2012): Medical electrical equipment General — Requirements for Safety | Compliant: Testing demonstrated compliance with this standard. |
  | - IEC 60601-1-2 (2007): Electromagnetic Compatibility | Compliant: Testing demonstrated compliance with this standard. |
  | - ISO 80601-2-12 (2011): Critical Care Ventilators Specific Requirements | Compliant: Testing demonstrated compliance with this standard. |
  | - IEC 60601-1-8 (2006 + Am.1: 2012): Alarm Systems | Compliant: Testing demonstrated compliance with this standard. |
  | - IEC 60601-1-6 (2010 + A1 :2013): Usability | Compliant: Testing demonstrated compliance with this standard. |
  | - IEC 62366 (2008)+A1(2014): Usability Engineering | Compliant: Testing demonstrated compliance with this standard. |
  | - IEC 62304 (2006): Medical Device Software Life-Cycle Processes | Compliant: Software design and validation process, together with bench testing, demonstrated the device operates as intended. Additional software verification and validation conducted as per FDA guidance. Software classified as "major" level of concern. |
  | - ISO 80601-2-55 (2011): Respiratory Gas Monitors Specific Requirements | Compliant: Testing demonstrated compliance with this standard. |
  | Added Features Functionality:
• Neonatal patient compatibility (min. 0.2 kg, min. 2 mL tidal volume) | Demonstrated Functionality: Covered by the overall testing of modified HAMILTON-MR1. |
  | - New modes nCPAP and nCPAP-PC performance for neonatal use | Functionality Demonstrated & Substantially Equivalent: New ventilation modes subjected to waveform performance testing. Data provided showed substantial equivalence to legally marketed devices (specifically, the HAMILTON-C1/T1 which already has these modes and neonatal capability). |
  | Extended Battery Duration:
• Increase from 5 hours 20 minutes to 9 hours 20 minutes | Demonstrated: Battery duration increased to 9 hours 20 minutes (with typical run time stated as 8 hours). |
  | MR-Conditional Performance:
• Does not generate artifacts in MRI
• Not negatively influenced by magnetic fields (1.5T and 3.0T static magnetic fields) | Verified: MRI environment test for RF-Noise redone to verify no artifacts. System test for magnetic immunity redone to verify no negative influence by magnetic field. The device is classified as MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners, and the integrated gaussmeter alarms when too close to the MRI magnet (50mT line or less). |
  | Material Biocompatibility:
• Biocompatibility of new materials | Confirmed: Only biocompatible materials or materials already used in earlier 510(k)s were introduced; no additional testing conducted (implying prior acceptance). |

Study Details (Contextualized for a Ventilator Submission):

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

• This document does not specify a "test set" in terms of patient data or clinical trials, as it's a 510(k) for a ventilator modification based on bench testing, engineering verification, and comparison to predicate devices, rather than a clinical performance study involving human subjects.
• The data provenance is from bench testing and software verification/validation activities conducted in support of the submission. The company is Hamilton Medical AG, located in Bonaduz, Grisons, Switzerland. The testing is implied to be prospective as it was conducted specifically for this submission.

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

• Not applicable in the context of this 510(k) submission for a ventilator. Ground truth as typically defined for AI/ML diagnostic devices (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's performance is its adherence to engineering specifications and international standards, demonstrated via bench testing and engineering verification.

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

• Not applicable. This relates to clinical study design for image interpretation or diagnosis, which is not part of this ventilator submission.

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 a ventilator, not an imaging device or an AI assistant for human readers. MRMC studies are not relevant to this submission.

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

• Not applicable. The device is a ventilator, a physical machine that provides mechanical ventilation. Its "performance" is its ability to deliver specified ventilation parameters safely and effectively, not an algorithm's diagnostic output.

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

• The "ground truth" for this ventilator device is its compliance with internationally recognized medical device standards (e.g., IEC, ISO, ANSI/AAMI), its engineering specifications, and its demonstrated performance in bench testing (e.g., waveform performance testing for new ventilation modes, magnetic immunity, RF-noise generation). The comparison to predicate devices also serves as a baseline for "truth" in terms of substantial equivalence.

8. The sample size for the training set:

• Not applicable. This device does not use an AI/ML model that requires a training set.

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

• Not applicable. No training set is used for this device.

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The HAMILTON-H900 humidifier is intended to add moisture and to warm breathing gases during invasive and non-invasive mechanical ventilation. The intended area of use is the intensive care ward or the recovery room.
The HAMILTON-H900 humidifier is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications for patients > 10 kg.
The HAMILTON-BC8022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.
The HAMILTON-BC4022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.
The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive mechanical ventilation of infants > 10 kg.
The HAMILTON-BC4010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of infants > 10 kg.

The HAMILTON-H900 respiratory gas humidifier is designed to add heat and moisture to respiratory gases, which are then administered to patients who need invasive or noninvasive ventilation. The breathing gas is passed through a humidifier chamber, where the gas is heated and humidified using an external heat source.
The HAMILTON-H900 humidifier uses breathing circuits that are recognized automatically when connected to the humidifier. The humidifier uses two heating systems as heat sources:

• -A heating plate that has contact with the metal plate of a special humidifier chamber inserted into the base of the humidifier prior to application, thus heating the water contained inside the chamber.
• -The controlled heating within the breathing circuits.
  The respiratory gas exiting the humidifier chamber is continuously monitored using temperature sensors that are integrated into the humidifier base. Additionally, a temperature probe inside the breathing tube is used to measure the temperature of the gas delivered to the patient airway.
  The design of the breathing tubes offers heating performance over the entire length by providing constant heating of the entire tube wall, from the chamber exit to the patient connection. A float mechanism, together with detection of the water level inside the humidifier chamber and the autofill mechanism, keeps a constant water level.
  The HAMILTON-BC8022 and HAMILTON-BC8010 are single-use, dual-limb breathing circuits comprising heated inspiratory and heated expiratory tubes. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.
  The HAMILTON-BC4022 and HAMILTON-BC4010 are single-limb breathing circuits comprising a heated inspiratory tube. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.

This document is a 510(k) Summary for medical device clearance, specifically for the Hamilton-H900 respiratory gas humidifier and associated breathing circuits. It details the device's characteristics and compares them to predicate devices to establish substantial equivalence.

Based on the provided text, the document describes performance data regarding electrical safety, electromagnetic compatibility, mechanical testing, software verification and validation, biocompatibility, and a human factors/usability study. However, it does not contain information about studies involving human readers, ground truth established by experts, or specific acceptance criteria and performance data in a comparative table for an AI/human-in-the-loop system.

The document states:

• "Hamilton Medical has demonstrated the HAMILTON-H900 humidifier and the HAMILTON-BC-series breathing circuits to have adequate performance."
• "The following performance and nonclinical data were provided in support of the substantial equivalence determination."
• It then lists various technical tests meeting industry standards (IEC, ISO).

Therefore, I cannot directly answer your request for a table of acceptance criteria and reported device performance (in the context of an AI/human-in-the-loop system as implied by the prompt's follow-up questions) or any details related to expert ground truth, adjudication, MRMC studies, or multi-reader studies, as these concepts are not mentioned in this regulatory submission for a respiratory humidifier and its circuits. This document focuses on the technical performance and safety of hardware and software components against established engineering standards and predicate devices.

To answer your specific questions based only on the provided text:

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

   • The document provides several comparison tables for "Characteristic used for comparison" (e.g., flow range, accuracy displayed temperature, humidity performance, etc.) against predicate devices (Tables 1, 2, and 3). These characteristics can be interpreted as performance metrics, and the device's reported values are listed. However, explicit "acceptance criteria" for these values are not stated as pass/fail thresholds within these tables, but rather as performance characteristics matched or compared to predicates.
   • For the non-clinical tests (e.g., Electrical Safety, EMC, Mechanical Testing, Software V&V, Biocompatibility, Human Factors), the acceptance criterion is implicitly compliance with the stated industry standards (e.g., IEC 60601-1, ISO 8185, ISO 5367, ISO 5356-1, ISO 10993-1). The reported device performance is that it "complies with" these standards.

   Example (from various sections, not a single explicit table):

   Acceptance Criterion (Implied)	Reported Device Performance	Source Section
   Compliance with IEC 60601-1 (Electrical Safety)	The devices comply with the IEC 60601-1 standard for safety.	Electrical Safety and Electromagnetic Compatibility
   Compliance with ISO 8185 (Respiratory Gas Humidifiers)	The devices comply with the ISO 8185 standard for respiratory gas humidifiers.	Electrical Safety and Electromagnetic Compatibility
   Airway temperature control (Invasive mode)	33°C - 43°C	Table 1
   Humidity performance (Invasive mode)	>33 mg H2O/L at up to 60 L/min flow and 26°C ambient temp.	Table 1
   Software Validation (Level of Concern: Major)	All specified requirements have been implemented correctly and completely.	Software Verification and Validation Testing
   Biocompatibility (following ISO 10993-1)	Testing in accordance with ISO 10993-1 performed, including Cytotoxicity, Sensitization & Irritation, Systemic Toxicity, Genotoxicity, Implantation Testing, Extractables and Leachables.	Biocompatibility
   Compliance with ISO 5367 (Breathing Tubes)	The breathing circuits comply with the ISO 5367 standard for breathing tubes.	Mechanical Testing
   Human Factors / Usability	Conformance with "Applying Human Factors and Usability Engineering to Medical Devices, 2016" guidance.	Human Factors / Usability Study

2. Sample sizes used for the test set and the data provenance: Not specified in the document for the performance studies. The testing appears to be primarily lab-based performance and safety verification of the device hardware and software. It does not mention clinical trial data or patient data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document is not evaluating an AI system against expert consensus or ground truth derived from expert review. It's about a hardware medical device (humidifier) and its compliance with engineering standards.

4. Adjudication method: Not applicable (no expert review process described).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but hardware and embedded software. The software V&V was done, but it's not a standalone AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the functional performance (e.g., temperature, humidity), the "ground truth" would be measurements from calibrated instruments and adherence to the specifications derived from the predicate devices and applicable standards. For other tests like electrical safety, EMC, and biocompatibility, the ground truth is compliance with the specified international standards. No expert consensus, pathology, or outcomes data is mentioned as ground truth.

8. The sample size for the training set: Not applicable. This document is about a finished medical device (hardware and embedded software), not a machine learning model that undergoes a separate training phase.

9. How the ground truth for the training set was established: Not applicable. (See #8).

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The IntelliCuff device is intended to continuously measure and automatically maintain the userset cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation.

The device can be used with any mechanical ventilator, as follows:

• . When used with a non-Hamilton Medical ventilator, IntelliCuff adjusts the cuff pressure to values set on the device.
• When used with a Hamilton Medical ventilator, IntelliCuff adjusts the cuff pressure to values set either on the device or on the ventilator, depending on configuration.

The device is to be used during ventilation of adults, pediatrics, and neonates, who are intubated with ETT or TT, in the following areas:

• In the intensive care ward or in the recovery room ●
• In the operation room during intubation narcosis
• For emergency medical care or primary care ●
• During transport within and outside of the hospital
• . During transfer by rescue vehicles, ship, jet, or helicopter

The IntelliCuff device continuously measures and automatically maintains cuff pressure during mechanical ventilation of adults, pediatrics, and neonates using a cuffed endotracheal tube or tracheostomy tube. It is an integrated and continuous cuff pressure control solution that secures airway management in intensive care units, operating rooms, and during interhospital transport.

When the IntelliCuff device is connected to a Hamilton Medical ventilator, cuff pressure settings can be manually adjusted by either selecting the appropriate values on the ventilator or the cuff pressure controller.

It is designed for immediate use; no calibration or maintenance is required. It operates in the recommended range of desired cuff pressures for various cuffed endotracheal tubes to provide suitable solutions for various clinical patient situations. For inflation, room air is used and no contact to the respiratory gas system of a patient occurs. A large-scale display and convenient and intuitive interaction buttons maximize safe use and visibility of all important data.

The associated accessories include:

• Cuff Pressure Tube with Filter
• Device Mount Solution ●
• USB Power Supply and Car Adapter

The provided text is a 510(k) Summary for the IntelliCuff device, which is an automatic cuff pressure controller for endotracheal and tracheostomy tubes. Unfortunately, the document does not contain a specific study demonstrating acceptance criteria for device performance as it does not report quantitative performance metrics against specific acceptance thresholds.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

• Technological characteristics comparison: Showing that the IntelliCuff shares the same fundamental technological elements with predicate devices (e.g., inflation/deflation, user-controlled set pressure, software control, alarm system).
• Compliance with regulatory standards: Reporting that the device has undergone various electrical safety, electromagnetic compatibility (EMC), mechanical, and software verification and validation testing in accordance with relevant IEC and RTCA standards. These tests confirm the device's safety and functionality within its intended environment.
• Human Factors/Usability Study: Indicating conformance with FDA guidance for optimizing medical device design.

While these are crucial aspects of device clearance, they do not provide quantitative acceptance criteria for the device's primary function (continuously measuring and automatically maintaining cuff pressure) and the results of a study against those criteria. Such data would typically involve metrics like accuracy of pressure measurement, stability of pressure maintenance, response time to pressure deviations, etc., along with predefined acceptable ranges.

Therefore, I cannot fulfill all parts of your request with the information provided. The document states that "The test results show that the device has adequate performance for its intended use" and "the IntelliCuff device was found to have an adequate performance profile that is similar to the predicate devices" but does not quantify this performance or explicitly state acceptance criteria.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be created. The document mentions compliance with general safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, RTCA/DO 160G) but does not provide specific, quantitative acceptance criteria for cuff pressure measurement or maintenance, nor does it report specific performance values against such criteria. It states that "The test results show that the device has adequate performance for its intended use" but without specific metrics.

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

• Not specified for performance testing. The document mentions "Electrical safety and EMC testing," "Mechanical testing," "Software Verification and Validation Testing," and a "Human Factors / Usability Study." While these involve testing, the sample size (e.g., number of devices tested, number of simulated or actual cases) for these tests is not given. The "data provenance" (country of origin, retrospective/prospective) is also not detailed for any specific performance study, as no such study with quantitative performance metrics is described.

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

• Not specified. This information would typically be relevant for studies involving human assessment or interpretation (e.g., image-based diagnostics, clinical outcomes). Since the IntelliCuff is a mechanical/electronic device for pressure control, the concept of "ground truth established by experts" in this context is not directly applicable to its core performance testing as described. For a human factors study, experts (usability engineers, clinicians) might be involved, but their number and qualifications are not listed.

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

• Not applicable/Not specified. Adjudication methods are typically used in studies involving subjective interpretation of data (e.g., by human readers). This type of method is not described for the performance testing of the IntelliCuff device.

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 such study was performed/described. MRMC studies are used for evaluating diagnostic aids, often involving AI, where human readers interpret cases with and without the aid. The IntelliCuff device is an automated pressure controller, not a diagnostic aid for human interpretation, so an MRMC study is not relevant to its function and was not reported.

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

• Implied, but not explicitly detailed. The various compliance tests (electrical safety, EMC, mechanical, software V&V) are essentially standalone tests of the device's functionality and safety. The entire document describes the device (the algorithm and hardware) as a standalone system for continuous pressure maintenance. However, specific standalone performance metrics for things like pressure accuracy or response time are not given in the summary.

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

• Not explicitly stated for core performance, but implied by standards. For compliance with standards like IEC 60601-1 (safety) or RTCA/DO 160G (mechanical), the "ground truth" would be the specified limits and test methodologies defined by those standards. For software verification and validation, the "ground truth" would be the documented software requirements. For a human factors study, the "ground truth" relates to usability objectives and error rates, often compared against benchmarks or user feedback. However, for direct performance metrics like pressure accuracy, the "ground truth" would typically come from highly accurate reference measurement equipment. This is not detailed in the summary.

8. The sample size for the training set:

• Not applicable. The IntelliCuff device is described as a cuff pressure controller. The provided text does not indicate that it uses machine learning or AI models that require a "training set" in the conventional sense (e.g., for image recognition or predictive analytics). Its functionality appears to be based on control system algorithms rather than learned models.

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

• Not applicable. As no training set is mentioned or implied for a machine learning model, this question is not relevant based on the provided text.

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The HAMILTON-T1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates.
Intended areas of use:

• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
• For emergency medical care
• During transport within and outside the hospital
• During transfer by rescue vehicles, fixed wing aircraft, helicopter or ship
  The HAMILTON-T1 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-C1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates.
Intended areas of use:

• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
• During transfer of ventilated patients within the hospital
  The HAMILTON-C1 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-C1 and HAMILTON-T1 are designed for adults, pediatrics, infants and neonatal patients requiring invasive or non-invasive ventilation support. Both ventilators cover a full range of clinical requirements: including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and non-invasive ventilation.
The two previously cleared ventilators, the HAMILTON-T1 and the HAMILTON-C1, have been bundled together in this 510(k) submission, in order to add the following new features to both ventilators:
Neonatal patients with a minimum weight of 0.2 kg and a minimal tidal volume of 2 mL. The following two new modes for the neonatal patient group: nCPAP and nCPAP-PC; SpO2 monitoring with MASIMO PULSE OXIMETERS;
An increase in the battery duration from 5.5 hours on the HAMILTON-T1, to 9.25 hours (maximum) instead and an increased battery duration from 2 hours to 4.30 hours on the HAMILTON-C1.
Increased temperature range for the HAMILTON-T1 to 50°C [122°F] for adult and pediatric patients. Increased altitude operating condition for the HAMILTON-T1 from 15.091 ft to 25.000 ft for adult and pediatric patients.

This document is a 510(k) summary for the Hamilton-T1 and Hamilton-C1 ventilators, detailing their substantial equivalence to predicate devices and the performance data supporting this claim.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding reported device performance for specific features. However, it implies that the devices meet a set of performance and safety standards, and that their performance on new features (neonatal ventilation, improved battery life, increased temperature/altitude range, SpO2 monitoring, and new modes) has been demonstrated to be "substantially equivalent" to legally marketed predicate devices.

The "Difference Status" column in the comparison tables (Table 1 for HAMILTON-T1 and Table 2 for HAMILTON-C1) implicitly acts as a form of "acceptance criteria met" by referencing substantial equivalence to specific predicate devices for each new or changed feature.

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

The document extensively references "bench testing" and "waveform performance testing" for the new ventilation modes as described in ASTM F1100-90. It also mentions "gas sample analysis" for VOC and particulate matter.

• Sample Size: The document does not specify the sample size for the test sets used in these bench tests.
• Data Provenance: The data appears to be from bench testing conducted by the manufacturer, Hamilton Medical AG, located in Bonaduz, Grisons, Switzerland. The nature of these tests (laboratory-based performance evaluation) suggests they are prospective in relation to the submission.

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)

This information is not provided in the document. The testing described (bench testing, waveform performance testing, gas sample analysis) is focused on technical performance metrics against specified standards and predicate devices, rather than clinical ground truth established by medical experts for a diagnostic or treatment outcome.

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

This information is not applicable and therefore not provided in the document. The tests described are objective engineering and performance evaluations, not subjective assessments requiring adjudication of ground truth by multiple human reviewers.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This document is for a ventilator, not an AI-assisted diagnostic or therapeutic device requiring human interpretation of output. Therefore, information on differences in human reader improvement with or without AI assistance is not applicable and not provided.

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

The device is a ventilator, which is a therapeutic medical device, not an algorithm for diagnosis or interpretation. The document describes the performance of the integrated device and its new features. Therefore, the concept of "standalone (algorithm only)" performance as typically applied to AI/ML devices is not directly applicable here. The performance data presented refers to the functionality of the device itself.

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

For the technical performance evaluations, the "ground truth" implicitly refers to the established standards (e.g., ASTM F1100-90), technical specifications, and the performance characteristics of the identified predicate devices. For example, for waveform performance, the waveforms generated by the new modes would be compared against expected waveforms defined by the standard and/or predicate device performance. For VOC and particulate matter, the ground truth is the "requirements for allowable levels" of these substances. This is not clinical ground truth derived from human subjects or pathology.

8. The sample size for the training set

The document describes a mechanical ventilator with hardware and embedded software, not a machine learning or AI algorithm that typically has a "training set." Therefore, the concept of a "training set sample size" is not applicable and not provided. The software mentioned (considered "major" level of concern) undergoes verification and validation, but this is distinct from machine learning model training.

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

As the concept of a "training set" for an AI/ML algorithm is not applicable to this device, the method for establishing its "ground truth" is also not relevant and not provided. The software verification and validation would follow established software engineering principles and regulatory guidance, ensuring the software performs its intended functions correctly and safely.

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