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The HAMILTON-C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants, and neonates.

Intended areas of use:

• In the intensive care ward or in the recovery room.
• During transfer of ventilated patients within the hospital.

The HAMILTON-C2 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-C2 has been designed to ventilate adult and pediatric patients in the critical care environment. With optional support, the HAMILTON-C2 is also able to ventilate infants and neonates. The HAMILTON-C2 ventilator uses the same graphical user interface (GUI) used by the HAMILTON-C2, HAMILTON-G5, and HAMILTON-T1, which features a touchscreen "Ventilation Cockpit". This provides the exact information that the user needs and helps focus on what is important. In addition, the HAMILTON-C2 includes the ASV ventilation mode, which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.

The HAMILTON-C2 has been designed with built-in batteries and a turbine thereby giving the user maximum independence and flexibility to accompany a patient everywhere. The HAMILTON-C2 offers ventilation modes that provide full and partial ventilatory support.

• 1. The HAMILTON-C2 offers all the conventional modes, as well as advanced invasive and non-invasive ventilation modes: ASV, (S)CMV+, SIMV+, PCV+, SPONT, APRV, DuoPAP, NIV, NIV-ST, nCPAP-PS, PSIMV+ with IntelliSync, and PSIMV+ without IntelliSync.
• 2. All 41 monitoring parameters can be trended over 1, 6, 12, 24, and 72 hours.
• 3. The new HAMILTON-C2 offers the mode option of both "PSIMV+ with IntelliSync" and "PSIMV+ without IntelliSync". In the previously cleared version of the HAMILTON-C2, the only version of PSIMV+ that was included had IntelliSync.
• 4. The ability to turn off the Apnea alarm in the nCPAP-PS mode.
• 5. Because some clinicians prefer to set the rate and the inspiration time Ti and other clinicians prefer to set the rate and the inspiration-expiration ratio I:E to define the timing of mandatory breaths in controlled modes. Therefore, both options are available in the proposed HAMILTON-C2

The provided text describes a 510(k) summary for the HAMILTON-C2 ventilator. The document focuses on demonstrating substantial equivalence to predicate devices and detailing the ventilator's features and compliance with relevant standards. It does not contain information about acceptance criteria and a study specifically proving the device meets those criteria in the context of an AI/algorithm.

Therefore, I cannot provide the requested information. The document is for a medical device (ventilator) and does not discuss AI/algorithm performance.

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The HAMILTON-C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants, and neonates. Intended areas of use: • In the intensive care ward or in the recovery room. • During secondary transport from one hospital to another. • During transfer of ventilated patients within the hospital. The HAMILTON-C2 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-C2 is an electronically controlled pneumatic intensive care ventilator. Due to its compact design, a weight of only 9.5 kg, built-in, hot-swappable batteries, and an ultra-quiet turbine, this ventilator can accompany a patient everywhere within a hospital, independently of central gas and power supplies, and during sconnal a transport from one hospital to another. The device offers ventilation modes that provide full and partial ventilatory support. The ventilator's ergonomic design, including a 10.4 in. color touch screen, a press-and-turn knob, and keys, let the user access the ventilator settings and monitored parameters. The graphical user interface can be tilt up to 45°. The HAMILTON-C2 can be customized so that it starts up with institution-defined settings.

This document describes a 510(k) premarket notification for the HAMILTON-C2 continuous ventilator. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than a novel AI algorithm requiring a specific set of acceptance criteria based on diagnostic performance.

Therefore, the requested information regarding AI algorithm performance (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, effect size) is not applicable to this submission. This is a traditional medical device submission for a ventilator, not an AI-powered diagnostic or assistive technology.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them, keeping in mind the device's nature:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable for this type of submission. This is not an AI/diagnostic device that uses a "test set" of patient data in the way an algorithm would be evaluated. The testing described is hardware and software verification/validation against engineering standards and functional performance, not a clinical study on patient data to assess diagnostic accuracy or similar metrics.

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

• Not applicable. The "ground truth" for a ventilator's performance is defined by established engineering and medical device standards (e.g., IEC, ASTM) and its ability to meet specified physical and functional parameters. There's no "expert consensus" on ground truth in the context of diagnostic accuracy for this device.

4. Adjudication Method:

• Not applicable. See point 3.

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

• No. This is not an AI-assisted diagnostic or interpretation device that would involve human readers.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. The device is a ventilator, which is a physical medical device with embedded software, not a standalone algorithm. The software verification and validation were done in the context of the device's overall function.

7. Type of Ground Truth Used:

• Regulatory/Engineering Standards and Predicate Device Performance: The "ground truth" against which the HAMILTON-C2 performance was evaluated consists of:
  • International Electrotechnical Commission (IEC) Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-12 for electrical safety and specific ventilator requirements.
  • American Society for Testing and Materials (ASTM) Standards: ASTM F1100-90 for wave-form performance testing.
  • Performance of Legally Marketed Predicate Devices: Performance parameters and safety profiles of HAMILTON-G5, HAMILTON GALILEO, Dräger EvitaXL, Dräger SAVINA, and MAQUET Servo-i.

8. Sample Size for the Training Set:

• Not applicable. Ventilators are not "trained" on data in the same way an AI algorithm is. The development process involves design, engineering, and iterative testing/refinement.

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

• Not applicable. See point 8.

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The HAMILTON-C2 ventilator is intended to provide positive pressure ventilatory support to adults and paediatrics. Intended areas of use: · In the intensive care ward or in the recovery room. · During transfer of ventilated patients within the hospital. The HAMILTON-C2 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.

Not Found

I apologize, but the provided text does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device.

The document is an FDA 510(k) clearance letter for the HAMILTON-C2 ventilator, indicating that the device has been found substantially equivalent to a predicate device. It specifies the intended use and regulatory information but does not detail the testing or studies performed to demonstrate performance against specific acceptance criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Information on the number or qualifications of experts for ground truth.
• Details on adjudication methods.
• Information about MRMC comparative effectiveness studies or effect sizes.
• Details on standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample sizes for training sets.
• How ground truth for training sets was established.

Ask a specific question about this device

The HAMILTON-C2 ventilator is intended to provide positive pressure ventilatory support to adults and paediatrics.
Intended areas of use:
• In the intensive care ward or in the recovery room.
• During transfer of ventilated patients within the hospital.
The HAMILTON-C2 ventilator is a restricted 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-C2 is an electronically controlled pneumatic intensive care ventilator. Due to its compact design, a weight of only 9,5 kg, built-in, hot-swappable batteries, and an ultra-quiet turbine, this ventilator can accompany a patient everywhere within a hospital, independently of central gas and power supplies.
The device offers ventilation modes that provide full and partial ventilatory support. The ventilator's ergonomic design, including a 10.4 in. color touch screen, a press-and-turn knob, and keys, let the user access the ventilator settings and monitored parameters. The graphical user interface can be tilt up to 45°. The HAMILTON-C2 can be customized so that it starts up with institution-defined settings.

Here's an analysis of the provided text regarding the HAMILTON-C2 ventilator, focusing on acceptance criteria and supporting studies:

It is important to note that the provided 510(k) summary for the HAMILTON-C2 ventilator (K090468) describes non-clinical performance tests and does not include information about clinical studies, MRMC studies, or specific AI/algorithm performance criteria. This device is a continuous ventilator, which generally undergoes extensive engineering and safety testing rather than clinical performance studies in the same way an AI diagnostic tool would.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the given 510(k) summary. The testing described focuses on engineering and safety standards (IEC, ASTM) rather than clinical data sets. Therefore, concepts like a "test set" in the context of clinical data are not applicable here.

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

This information is not provided and is not applicable to the type of testing described (engineering, safety, and performance standards for a ventilator). Ground truth based on expert consensus is typically relevant for diagnostic devices or AI algorithms that interpret medical images or data.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, especially those incorporating AI, where the performance of human readers with and without AI assistance is evaluated. The HAMILTON-C2 is a ventilator, a life-support device, and its evaluation focuses on its technical safety and performance, not on human interpretation or diagnostic accuracy.

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

This is not explicitly stated in a manner relevant to AI algorithms. The HAMILTON-C2 is an electronically controlled ventilator, and its "performance" is inherently "standalone" in how it delivers ventilation based on its internal programming and user settings. The software verification and validation ensure its internal logic performs as designed, which is analogous to "standalone" performance for its specific function. However, it's not an AI algorithm acting independently in a diagnostic capacity.

7. The Type of Ground Truth Used

The "ground truth" for the HAMILTON-C2 ventilator's performance is established by:

• Engineering Standards: Adherence to international and industry standards like IEC60601-1, IEC60601-1-2, IEC 60601-2-12 for safety and ASTM F1100-90 for waveform performance.
• Predicate Device Performance: The functional performance, especially related to waveform, is compared against legally marketed predicate devices to demonstrate substantial equivalence.
• Software Specifications: The software's "ground truth" is its design specifications, validated through verification and validation testing.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device is not described as involving machine learning or AI that would require a "training set" of data in the typical sense.

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

This information is not provided and is not applicable, as there is no mention of a training set for machine learning or AI.

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