(108 days)
The Neptune S Waste Management System is indicated for use in procedures where collecting and disposing of fluid waste and capturing suctioned tissue specimens is desired. It is intended to be used in operating rooms, pathology, surgical centers, procedure rooms, and for endoscopic procedures, such as colonoscopies, esophagogastroduodenoscopies (EGDs), and bronchoscopies.
The Neptune S Waste Management System includes subject devices Neptune S Rover and V2 Manifolds, previously 510k cleared Neptune 2 Docker, and supporting accessories.
Neptune S Rover is a mobile device, plugged into a standard 15A hospital-grade AC power outlet and is used to suction and collect waste fluids during surgical or nonsurgical procedures. It can also be used to collect tissue specimens suctioned during these procedures. The Rover provides fluid waste management, fluid volume measurement and contains features designed to specifically aid with tissue specimen collection, including an array of lighting features and a flat worksurface. It was designed with a smaller footprint to accommodate smaller operating rooms or procedure rooms, particularly endoscopy suites.
The manifolds are non-sterile, single-use disposables, that act as an interface between the Rover canister and standard medical grade suction tubing. They facilitate the collection of surgical tissue and the removal of fluid waste.
The provided text describes the non-clinical and clinical tests performed for the Neptune S Waste Management System to establish its safety and effectiveness.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics with corresponding reported device performance values for non-clinical tests. Instead, it generally states that "All requirements were met and no new issues of safety or effectiveness were raised" for various non-clinical test items like intended use/user needs, safety, general requirements and performance, software, electrical/mechanical/thermal safety, electromagnetic compatibility, and shipping.
However, for the clinical test (PMCF survey), specific performance rates are provided:
| Acceptance Criteria / Performance Metric | Reported Device Performance (from PMCF of Predicate Device) |
|---|---|
| Success rate of all waste fluid and debris removed | 98.3% |
| Success rate of removing waste fluid and debris without removing excess fluid | 94.7% |
| No adverse events observed (related to use in colonoscopies, EGDs, bronchoscopies) | Achieved (stated "no adverse event observed") |
| No safety issues or adverse events related to clinical procedures | Achieved (stated "no safety issues or adverse events") |
2. Sample size used for the test set and the data provenance
- Sample size for the clinical test set: Not explicitly stated as a number of patients or procedures. It refers to "retrospective clinical data collected through Post Market Clinical Follow-up (PMCF) survey of predicate device." Without further detail, the exact sample size cannot be determined from this document.
- Data provenance:
- Country of origin: Not specified.
- Retrospective or prospective: Retrospective ("retrospective clinical data collected through Post Market Clinical Follow-up (PMCF) survey").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The clinical data used was a PMCF survey of a predicate device, which implies real-world usage rather than a controlled study with expert ground truth establishment for a test set in the context of AI/ML performance evaluation.
4. Adjudication method for the test set
This information is not applicable as the clinical data was a PMCF survey, not a study involving human readers and AI for ground truth adjudication.
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
There is no indication that an MRMC comparative effectiveness study was performed or that the device involves AI assistance for human readers. The device is a waste management system, not an imaging or diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical device (waste management system) and not an algorithm or AI product.
7. The type of ground truth used
For the non-clinical tests, the ground truth was based on design specifications, risk analysis, and conformance to standards (e.g., IEC 60601-1, IEC 62304).
For the clinical data (PMCF survey), the "ground truth" was based on observed operational performance of the predicate device in real-world clinical procedures, specifically looking at waste fluid and debris removal success rates and the occurrence of adverse events. It is outcome-based, related to the device's functional performance in a clinical setting.
8. The sample size for the training set
This is not applicable. The device is a physical medical device, not an AI/ML model that undergoes training with a dataset.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for an AI/ML model mentioned.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.