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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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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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The HAMILTON-C1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics. Intended areas of use:
• In the intensive care ward 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 is designed for adults and pediatrics requiring invasive or noninvasive ventilation support. The HAMILTON-C1 ventilator covers a full range of clinical requirements: including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and Non-Invasive Ventilation (NIV).
The HAMILTON-C1 is suitable for ICU special-care areas, cardiac surgery recovery rooms, stepdown or sub-acute care units, and long-term care centers. With its IntelliTria technology. the HAMILTON-C1 responds to the changing breathing patterns or circuit leaks found in non-invasive ventilation by automatically varying leaks and adapting sensitivity thresholds for optimal response to the patient's breath.
The HAMILTON-C1's software and ventilation modes are identical to the HAMILTON-T1's software and ventilation modes. One can operate the HAMILTON-C1 with the touchscreen or with a single turn wheel. Hard keys give direct access to the most important functions. In effect, the HAMILTON-C1 is a HAMILTON-T1, but with the features related to transportventilation stripped off.
With the large alarm lamp, a clinician can immediately identify an alarming HAMILTON-C1 ventilator because of the alarm lamp located at the top of the device, even if the clinician is at a long distance away or when several different devices are operating simultaneously in the same room.
Interface for PDMS, patient monitor, and nurse call are available as well. The optional interfaces provide ports for connection to hospital monitors, Patient Data Management Systems (PDMS), and nurse call systems.
The high-performance turbine can deliver up to 210 L/min flow; this relatively high flow rate is potentially helpful when utilizing NIV modes of ventilation.

The provided text describes the HAMILTON-C1 ventilator and asserts its substantial equivalence to a predicate device, the HAMILTON-T1. The demonstration of equivalence is primarily based on non-clinical testing and a comparison of technical specifications, rather than a clinical study evaluating the device's diagnostic or therapeutic performance against specific acceptance criteria.

Therefore, many sections of your request regarding acceptance criteria for device performance in a clinical context, sample sizes for test sets, expert ground truth establishment, adjudication methods, and comparative effectiveness studies cannot be fully answered from the provided document. The document focuses on regulatory compliance through comparison to a predicate device and adherence to recognized standards.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not explicitly present a table of acceptance criteria for device performance in a clinical setting with corresponding reported performance from a study. Instead, it lists standards that the device meets, which function as regulatory acceptance criteria for safety and effectiveness.

The document also provides comparisons to the predicate device (HAMILTON-T1) on certain specifications:

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 explicitly states that the device was cleared based on non-clinical tests and comparison to a predicate device. It does not mention any clinical test sets or patient data. Therefore, this information is not available in the provided text.

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)

No clinical test set or ground truth establishment by experts is described in this document. The clearance is based on technical specifications and adherence to engineering and safety standards.

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

No clinical test set or adjudication method is described in this 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 or comparative effectiveness study involving human readers or AI assistance is mentioned. The HAMILTON-C1 is a continuous ventilator, not a diagnostic AI device.

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

The document does not describe the performance of a standalone algorithm. The device is a medical device, not solely an algorithm.

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

No patient-specific ground truth (expert consensus, pathology, outcomes data) was used for device clearance based on this document. The "ground truth" for the device's substantial equivalence is its performance against established engineering, safety, and performance standards, and comparison to the predicate device's cleared specifications.

8. The sample size for the training set

The document does not describe any training set data, as it focuses on the regulatory clearance of a medical device based on non-clinical testing and substantial equivalence, not a machine learning model's training.

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

Not applicable, as no training set or its ground truth establishment is mentioned in the provided text.

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