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The NORTECH IntraMyst Humidification System is indicated for use as a means of supplying humidity within the intra-abdominal cavity during diagnostic and/or operative laparoscopic procedures.

Nortech's IntraMyst Humidification System incorporates front panel controls that are similar to Northgate's current Insufflators. The system is designed to provide continuous or on demand humidification to the laparoscopic environment. This may reduce the incidence of postoperative pain, diminish the likelihood of adhesion formation and reduce laparoscope lens fogging. The controller will contain the appropriate pneumatics for supplying and controlling the gas to the catheter at 100 PSI and 5 LPM. In addition, the controller will have displays for indicating abdominal pressure, overpressure, gas supply low, mist active, active pressure sense and amount of fluid dispensed.

The Nortech IntraMyst Humidification System is a Class II device designed to provide continuous or on-demand humidification to the laparoscopic environment. The provided SSS document acts as a 510(k) premarket notification, which is a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. Therefore, the "acceptance criteria" and "device performance" in this context refer to the demonstration of substantial equivalence, rather than specific performance metrics from a dedicated clinical study for this device.

Here's an analysis based on the provided document:

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

• Front Panel Controls: Similar to Northgate's current insufflators.
• Controller Functionality: Contains appropriate pneumatics for gas supply and control (100 PSI, 5 LPM), with displays for abdominal pressure, overpressure, gas supply low, mist active, active pressure sense, and fluid dispensed.
• Standards Compliance: Will meet UL-2601-1, CAN/CSA-C22.2 No. 601.1, EN 60601-1, EN 60601-1-2. Microbiological testing to meet ISO 10993-X. |
  | Safety and Effectiveness: When compared to predicate devices, the new device must not raise different questions of safety and effectiveness. | The document implicitly asserts this by claiming "substantial equivalence in materials, and intended use to numerous currently marketed devices." The compliance with recognized standards (UL, CAN/CSA, EN, ISO) suggests the device's safety and effectiveness will be comparable. |

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

The document does not describe a clinical "test set" in the traditional sense for evaluating device performance against pre-defined criteria. This is a 510(k) submission focused on substantial equivalence, which primarily relies on direct comparison to predicate devices, engineering testing (to meet standards), and possibly bench testing. Therefore:

• Sample Size for Test Set: Not applicable in the context of a clinical performance study. The evaluation likely involved engineering tests and potentially bench tests, but no specific human clinical test set is described.
• Data Provenance: Not applicable in the context of a clinical performance study. The information provided is about the device's design, materials, intended use, and its assertion of substantial equivalence to predicate devices, rather than clinical data from a new study.

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

Not applicable. As this is a 510(k) submission focusing on substantial equivalence, there is no mention of a human-in-the-loop clinical test set requiring expert consensus for ground truth.

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

Not applicable. No clinical test set requiring adjudication is described.

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

Not applicable. This device is a laparoscopic insufflator and humidification system, not an AI-based diagnostic or assistive technology for human readers.

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

Not applicable. This is a medical device, not an algorithm. Its performance would be evaluated through engineering specifications, bench testing, and compliance with standards, not as a standalone algorithm.

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

Not applicable. For a 510(k) submission of this type of device, "ground truth" isn't typically established in the sense of clinical outcomes or expert labels. Instead, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective, and the new device demonstrates equivalence to them through design, materials, and intended use. Performance is implicitly demonstrated by meeting recognized safety and performance standards.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product developed using a training set.

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

Not applicable. This device is not an AI/ML product developed using a training set.

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