(93 days)
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.
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| Draft Reviewer Guidance for Ventilators. 1995. | Met/Exceeded |
| IEC 60601-1 (General Requirements for Safety) | Met/Exceeded |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Met/Exceeded |
| IEC 60601-1-4 (Programmable electrical medical systems) | Met/Exceeded |
| IEC 60601-1-8 (Alarm Systems) | Met/Exceeded |
| IEC 60601-2-12 (Critical Care Ventilators) | Met/Exceeded |
| IEC 62304 (Software life-cycle processes) | Met/Exceeded |
| IEC 62366 (Application of usability engineering to medical devices) | Met/Exceeded |
| ISO 5356-1 (Conical connectors: Part 1: Cones and sockets) | Met/Exceeded |
| AAMI/ANSI HE75 (Human factors engineering. Design of medical devices) | Met/Exceeded |
| EN ISO 14971 (Application of risk management to medical devices) | Met/Exceeded |
| EN ISO 13485 (Medical devices -- Quality management systems) | Met/Exceeded |
| EN ISO 9001 (Quality management systems) | Met/Exceeded |
| EN ISO 5359 (Low-pressure hose assemblies for use with medical gases) | Met/Exceeded |
| EN 794-1 (Particular requirements for critical care ventilators) | Met/Exceeded |
| IEC 62133 (Battery Safety. Non-Spillable) | Met/Exceeded |
| ASTM F1100-90 (Standard Specification for Ventilators Intended for Use in Critical Care) | Met/Exceeded |
| MIL-STD-461E (RS101, CS114 (curve #3), and RE101 (Army 7-cm limit)) | Met/Exceeded (where applicable, for predicate device) |
The document also provides comparisons to the predicate device (HAMILTON-T1) on certain specifications:
| Feature | Predicate (HAMILTON-T1) | Proposed (HAMILTON-C1) | Comment (Performance) |
|---|---|---|---|
| Intended Use | More extensive (includes transport out-of-hospital) | More limited (in-hospital transfer only) | Differences do not affect safety/effectiveness for labeled use. |
| Patient Population | Adults and pediatrics | Adults and pediatrics | Equivalent |
| Max Insp. Flow | 210 l/min | 210 l/min | Equivalent |
| Airworthiness | Yes | No | Not designed for air transport. |
| Water Protection | IPX4 | IPX1 | Lower protection (not designed for harsh transport). |
| Temperature Range | -15 to 40 °C (operating), -15 to 70 °C (storage) | 5 to 40 °C (operating), -20 to 60 °C (storage) | Lower tolerance for temperature extremes (not designed for harsh transport). |
| Software Version | 1.1.2 | 1.1.2 | Equivalent |
| Number of Batteries | 2 | 1 | One less battery. |
| Weight | 6.5 kg | 4.9 kg | Lighter. |
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.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).