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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.

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