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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.

Ask a specific question about this device

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 or 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 is designed for adult, pediatric, infant, and neonatal patients requiring invasive or noninvasive 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: The following new feature for adult, pediatric, infant and neonatal patient group: cFlow

Based on the provided text, the acceptance criteria and study information for the HAMILTON-G5 ventilator are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample size" for the test set in terms of patient data or case numbers. It refers to "bench testing of the device" and "comparison testing with legally marketed devices" for the cFlow feature.

The data provenance is implied to be retrospective in the sense that the device is being compared against already marketed devices (both predicate and reference devices) and established standards. There is no indication of prospective clinical trials in this 510(k) summary. The testing appears to be primarily laboratory/bench-based and validation of software and device performance against technical standards.

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

This information is not provided in the document. The document mentions "properly trained personnel under the direct supervision of a licensed physician" for its intended use, but not for the establishment of ground truth during testing. The "ground truth" for this device appears to be defined by adherence to recognized international technical standards and comparison to previously cleared devices.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the testing described (compliance with technical standards, bench testing, software validation, and comparison to predicate/reference devices), a formal adjudication method like 2+1 or 3+1 typically used in image-based diagnostic AI studies is not applicable or mentioned.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not applicable to this device described. The HAMILTON-G5 is a medical ventilator, not an AI-assisted diagnostic tool for human readers.

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

This concept is not directly applicable as this is a medical ventilator. The device itself operates as a standalone system (an "algorithm only" analogy here would be the ventilator's internal software controlling ventilation parameters). The "human-in-the-loop" is the healthcare professional operating and monitoring the ventilator, as per its indications for use. The performance data refers to the device's technical compliance and functional equivalence.

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

The ground truth used for this submission is primarily:

• Compliance with recognized international technical standards (e.g., ISO, IEC, ANSI/AAMI standards for medical electrical equipment and ventilators).
• Functional equivalence to legally marketed predicate and reference devices (HAMILTON-G5 K131774 and Nihon Kohden NKV-550 Series Ventilator System K181695).
• Intended operation as designed as demonstrated through software design and validation processes and bench testing.

8. The sample size for the training set

The concept of a "training set" in the context of machine learning or AI is not applicable here. The HAMILTON-G5 is a traditional medical device (ventilator) with added features, not an AI/ML-driven model that undergoes training on a dataset. The software itself is validated, but not "trained" in the AI sense.

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

As explained above, there is no "training set" in the AI/ML context for this device. The verification and validation activities were based on established engineering principles, regulatory standards, and comparison to existing cleared devices.

Ask a specific question about this device

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 or hospital type facility provided compressed gas is supplied.

The device is not to be used in the presence of flammable anesthetic agents or other iqnition 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 is an electronically controlled pneumatic intensive care ventilator ventilation system. It uses oxygen and air or heliox to ventilate adults, pediatrics, infants, and neonates. It is powered by AC, and with battery backup in order to protect against power failure or unstable power and to facilitate intra-hospital transport. The HAMILTON-G5's pneumatics deliver gas -- while its electrical systems controls pneumatics, monitors alarms and distributes power. The user interface consists of a LCD-display with touch screen, keys, and a press-and- turn knob.

The HAMILTON-G5's new software version 2.30, includes a pulse oximetry function for continuous, non-invasive oxygen saturation monitoring (SpO2).

Volume targeting in the HAMILTON-G5 is now supported by a new ventilation mode, called the Volume Support mode (VS). It is a flow-cycled, volume targeted, and pressure-regulated mode.

The Volume Support (VS) mode is designed for spontaneously breathing patients. It provides support to patient-initiated breaths so as to deliver the desired tidal volume (V+), at a level appropriate to the patient's efforts. This mode allows the ventilator to change the support in response to changing patient conditions and inspiratory effort levels. To achieve this volume, the device decreases support when the patient's breathing activity increases or, conversely, increases support when the patient's inspiratory effort decreases.

Here's an analysis of the acceptance criteria and study information for the HAMILTON-G5 device, based on the provided document:

The document is a 510(k) summary for the HAMILTON-G5 ventilator, specifically for an updated version (SW 2.30) that includes a pulse oximetry function and a new Volume Support (VS) ventilation mode. It focuses on demonstrating substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly present a typical "acceptance criteria" table with specific quantitative thresholds. Instead, it describes compliance with recognized standards and uses qualitative statements of "substantial equivalence" for the new features.

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

• Test Set Sample Size: The document does not specify a "sample size" in terms of patient data or a number of test cases. The testing appears to be primarily bench testing (waveform performance, communication integrity) and compliance with standards rather than clinical trials with patient populations.
• Data Provenance: Not applicable as it's not a clinical study involving patient data. The testing mentioned (waveform testing per ASTM F1100-90, software V&V) is likely performed in a lab or simulate environment. The country of origin of the device manufacturer is Switzerland.

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

• This information is not provided in the document. The document describes compliance with engineered performance standards and internal verification/validation, not the establishment of ground truth by human experts for a test set.

4. Adjudication Method for the Test Set:

• This information is not provided as the testing described does not involve expert adjudication of a test set in the way a clinical study or diagnostic imaging study would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No, an MRMC comparative effectiveness study was not done. This document is for a medical device (ventilator) seeking 510(k) clearance, which typically relies on
  bench testing and substantial equivalence to predicates, not comparative effectiveness studies of human readers with vs. without AI assistance. The device itself is not an AI diagnostic tool.

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

• This question is not directly applicable in the context of this device. The HAMILTON-G5 is a ventilator, a physical device with embedded software and functions. The new features (VS mode, SpO2) are integrated functionalities of the device. The "standalone performance" of these functions (e.g., the SpO2 calculation itself) is established by using previously cleared OEM components and by verifying their integration into the HAMILTON-G5, not as a separate, algorithm-only performance assessment like that for a diagnostic AI.

7. The Type of Ground Truth Used:

• The "ground truth" for the new functionalities would be established by:
  • Engineering Specifications / Reference Devices: For the Volume Support mode, the "ground truth" for its performance is derived from the established performance characteristics and waveforms defined by the ASTM F1100-90 standard and comparison to the MAQUET Servo-i predicate device.
  • Calibration & Known Standards: For the SpO2 function, the "ground truth" for oxygen saturation and pulse rate values would come from the calibrated performance of the OEM pulse oximeter systems (Masimo, Nihon Kohden) and ensuring these values are accurately transmitted and displayed by the HAMILTON-G5.
  • Regulatory Standards: Overall safety and electromagnetic compatibility ("ground truth" for compliance) are established by fulfilling the requirements of the cited IEC standards.

8. The Sample Size for the Training Set:

• Not applicable. This document describes a medical device undergoing 510(k) clearance, not an AI or machine learning model that requires a "training set" in the conventional sense. The device's software (SW 2.30) is developed and verified through engineering processes, not by training on a dataset.

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

• Not applicable, as there is no "training set." The software development and verification process would involve testing against validated specifications and expected outputs based on engineering principles and regulatory standards.

Ask a specific question about this device

The HAMILTON-G5 ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally to infant and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside for intra-facility transport, provided compressed gas is supplied. The device is not intended for transportation outside the hospital or for use in the home environment.

The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system. It uses oxygen and air or heliox to ventilate adults, pediatrics, infants, and neonates. It is powered by ac with battery backup to protect against power failure or unstable power and to facilitate intrahospital transport. The HAMILTON-G5's pneumatics deliver gas, and its electrical systems control pneumatics, monitor alarms, and distribute power. The user interface consists of a LCD-display with touch screen, keys, and a press-and-turn knob. The new nebulization function with AERONEB nebulizers is for use with mechanically ventilated patients to aerosolize physician prescribed medications for inhalation. The new cuff pressure controller implemented in the HAMILTON-G5 is for continuous monitoring and adjustment of the cuff pressure of a tracheal or tracheostomy tube. nCPAP-PS is a new ventilation mode which applies nCPAP with additional pressure support by nasal interfaces with reduced dead space on neonates. NIV-ST is a new mode available for adult and pediatric patients. It delivers pressure-controlled, time-cycled mandatory breaths and pressure-supported, flow-cycled spontaneous breaths by a mask or other noninvasive patient interface.

The provided text describes the HAMILTON-G5 ventilator and its comparison to predicate devices, but it does not contain acceptance criteria or a study that proves the device meets specific performance acceptance criteria.

Instead, the document details a 510(k) premarket notification for a medical device. This process focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving performance against pre-defined acceptance criteria through a specific study as would be seen in a clinical trial or a performance validation study for a novel device.

Here's a breakdown of what is and is not in the document, based on your request:

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

• Not provided. The document states "Technological characteristics and performance specifications of the HAMILTON-G5 ventilator are substantially equivalent to those of the predicate devices." It also mentions "wave-form performance testing as described in the standard ASTM F1100-90," with results shown to be "substantially equivalent to a legally marketed device." However, no specific quantitative acceptance criteria or detailed performance data are presented.

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

• Not applicable/Not provided. No clinical testing was conducted. Non-clinical testing (IEC standards, ASTM F1100-90, software verification/validation) is mentioned, but details on "samples" (e.g., number of test runs, test conditions) or data provenance are not elaborated upon in this summary.

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

• Not applicable. No ground truth establishment by experts is mentioned, as no clinical testing was performed where such a process would typically occur.

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

• Not applicable. No adjudication method is mentioned, as no clinical testing with human interpretation was conducted.

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 done. This device is a ventilator, not an AI or imaging diagnostic device that would typically involve human "readers" or an MRMC study.

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

• Not applicable. This question pertains to AI/algorithm performance. The device is a ventilator, not an AI diagnostic algorithm. The "standalone" performance here would refer to the ventilator's own mechanical and electronic functions, which were evaluated via non-clinical tests (IEC, ASTM, software V&V) to show equivalence.

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

• Not applicable/Not explicitly stated for non-clinical tests. For non-clinical performance (e.g., waveform testing), the "ground truth" implicitly refers to the specified technical requirements of the relevant standards (IEC, ASTM) and the performance characteristics of the predicate devices. The claim is "substantial equivalence" to these benchmarks.

8. The sample size for the training set

• Not applicable. No training dataset is mentioned, as this is not an AI/machine learning device.

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

• Not applicable. No training dataset or ground truth for training was established.

Summary of what the document does state regarding performance and equivalence:

• Non-Clinical Performance Tests:
  • Safety testing conducted according to IEC60601-1, IEC60601-1-2, IEC 60601-2-12, and other applicable standards.
  • Wave-form performance testing as described in ASTM F1100-90.
  • Software verification and validation testing.
• Results/Conclusions:
  • Test results show the device is safe and effective for its intended use.
  • Data from wave-form tests were shown to be substantially equivalent to a legally marketed device.
  • Software V&V demonstrated that all specified requirements were implemented correctly and completely.
  • The overall conclusion is that the modified HAMILTON-G5 ventilator is "as safe, as effective, and performs as well as or better than the legally marketed devices identified above."
• Clinical Testing:
  • "No clinical testing was conducted or required in support of this premarket clearance notification."

In essence, the document serves as a regulatory submission arguing for "substantial equivalence" based on non-clinical testing and comparison to predicate devices, rather than a report on specific performance acceptance criteria from a dedicated study.

Ask a specific question about this device

The HAMILTON-G5 ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally to infant and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside for intra-facility transport, provided compressed gas is supplied. The device is not intended for transportation outside the hospital or for use in the home environment.

The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system. It uses oxygen and air or (optionally) heliox to ventilate adults, pediatrics, and optionally infants and neonates. It is powered by ac with battery backup to protect against power failure or unstable power and to facilitate intrahospital transport. The HAMILTON-G5's pneumatics deliver gas, and its electrical systems control pneumatics, monitor alarms, and distribute power. The user interface consists of a LCD-display with touch screen, keys, and a press-andturn knob. The CO2 option allows continuous mainstream monitoring of carbon dioxide.

The provided text describes a 510(k) summary for the HAMILTON-G5 continuous ventilator. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding acceptance criteria and study details (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details) is not directly available or applicable in this document because the submission relies on non-clinical performance and equivalence.

However, I can extract the information that is present and explain why other details are missing based on the nature of a 510(k) submission.

Here's a breakdown of the available and missing information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable/not provided. The submission refers to non-clinical performance tests (safety, waveform, software) rather than a clinical test set with patient data.
• Data Provenance: Not applicable. The tests appear to be laboratory-based and engineering evaluations, not involving patient data from specific countries or retrospective/prospective studies.

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

• Not applicable/not provided. Ground truth establishment with experts is typical for diagnostic algorithms, not for physical medical device performance testing in this context. The "ground truth" here is adherence to engineering standards and functional specifications.

4. Adjudication method for the test set

• Not applicable/not provided. Adjudication methods are typically associated with expert consensus in clinical studies, which are not described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is common for diagnostic imaging AI, to evaluate how AI assists human readers. This submission focuses on the safety and performance of a physical ventilator.

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

• The HAMILTON-G5 is a medical device (ventilator), not an algorithm in the AI sense. Its performance is evaluated through engineering tests and comparison to predicate devices, which can be considered "standalone" in that it performs its function without human intervention for the measurement of that function, but it's not an "algorithm-only" performance in the way an AI would be evaluated.

7. The type of ground truth used

• The "ground truth" for this ventilator device primarily constitutes:
  • Compliance with International Standards: IEC60601-1, IEC60601-1-2, IEC 60601-2-12, ASTM F1100-90.
  • Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (HAMILTON-G5 K070513, MAQUET Servo-i K041223, Viasys AVEA ventilator K062093, Datex-Ohmeda Engström Carestation K062710, Dräger EvitaXL with NeoFlow Option K051263, K983219).
  • Software Requirements: The specified requirements for the device's software.

8. The sample size for the training set

• Not applicable/not provided. The document describes a medical device, not a machine learning model that requires a training set.

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

• Not applicable/not provided for the same reason as point 8.

Ask a specific question about this device

The HAMILTON-G5 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, and optionally infants. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside for intra-facility transport, provided compressed gas is supplied. The device is not intended for transportation outside the hospital or for use in the home environment.

The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system. It uses oxygen and air to ventilate adult, pediatric and optionally infant patients. It is powered by ac with battery backup to protect against power failure or unstable power and to facilitate intrahospital transport.

The HAMILTON-G5's pneumatics deliver gas, and its electrical systems control pneumatics, monitor alarms, and distribute power.

The user interface consists of a LCD-display with touch screen, keys, and a press-andturn knob.

The HAMILTON-G5 provides audible and visual patient- and ventilator-related alarms.

The provided 510(k) summary for the HAMILTON-G5 ventilator focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics in the format usually associated with AI/ML device evaluations.

Here's a breakdown of the available information based on your request, along with explanations for missing sections:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical acceptance criteria or present performance data in a quantitative table. The evaluation relies on demonstrating that the HAMILTON-G5 ventilator "conforms to the FDA recognized standards for safety and performance issues with lung ventilators" and that "the test results indicated that the device performed as specified." This implies that the device met pre-established engineering and regulatory standards, but these are not explicitly listed as "acceptance criteria" with corresponding "reported device performance" values in the document.

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

This information is not provided in the document. The submission states "Performance tests were performed," but does not detail the nature of these tests, the number of devices or scenarios tested, or the origin of any data (e.g., country of origin, retrospective/prospective). This is typical for a traditional medical device submission where the focus is on engineering and safety standards rather than clinical data sets.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/not provided. The HAMILTON-G5 is a continuous ventilator, not an AI/ML diagnostic or predictive device that would require expert-established ground truth for its performance evaluation in the context of this 510(k) summary. Its performance would be assessed against technical specifications and safety standards for ventilation.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As explained above, the device's performance is not evaluated based on expert adjudication of "ground truth" data in this context.

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

This information is not applicable/not provided. The HAMILTON-G5 is a standalone medical device, not an AI-assisted diagnostic or decision support tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable/not provided. The HAMILTON-G5 is a physical ventilator, not an algorithm. Its performance is inherent to its mechanical and electronic design and operation, not a software algorithm that can be evaluated in isolation.

7. Type of Ground Truth Used

This information is not applicable/not provided. The concept of "ground truth" (e.g., pathology, outcomes data) usually applies to diagnostic or predictive devices being evaluated against a definitive standard. For a ventilator, performance is typically assessed against engineering specifications, safety standards, and physiological parameters (e.g., delivered tidal volume accuracy, pressure control, alarm thresholds) that are measurable and verifiable.

8. Sample Size for the Training Set

This information is not applicable/not provided. The HAMILTON-G5 is a hardware medical device with embedded software, not a machine learning model that undergoes a "training" phase with a dataset in the conventional sense. Its development involves engineering design, testing, and validation according to established medical device development processes.

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

This information is not applicable/not provided for the same reasons as #8.

In summary:

The provided 510(k) summary for the HAMILTON-G5 ventilator demonstrates substantial equivalence to predicate devices based on technological characteristics and performance specifications. It states that "performance tests were performed, and the test results indicated that the device performed as specified," and that the device "conforms to the FDA recognized standards for safety and performance issues with lung ventilators." However, it does not contain the detailed, quantitative acceptance criteria, study methodologies, or data provenance typically found in submissions for AI/ML-driven devices. The nature of the device (a continuous ventilator) means many of the requested categories (e.g., expert-established ground truth, MRMC studies, training sets) are not relevant to its 510(k) clearance process.

Ask a specific question about this device