(330 days)
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.
§ 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).