(29 days)
The Trillium™ Tri-optic Measurement Cell is intended for use in the BioTrend oxygen saturation and hematocrit system.
Indications for Use:
The BioTrend oxygen saturation and hematocrit system measures percent The Blor rond oxygen saturation in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closed chest support and limb perfusion.
The Trillium™ Tri-optic Measurement Cell is a single-use insert designed to be used in the BioTrend Qxygen Saturation and Hematocrit System (K954501). The BioTrend Oxygen Saturation and Hematocrit System measures oxygen saturation and hematocrit by using dual wavelength photometric techniques. The Tri-optic Measurement Cell is an in-line, full flow, sterile and non-pyrogenic fluid path disposable device. The device accommodates the transmission of the light-emitting signal into the blood path and collection of the backscattered light signal.
The provided document is a 510(k) premarket notification for a medical device called the Trillium™ Tri-optic Measurement Cell. This particular submission is a "SPECIAL 510(k)," meaning it's for a modification to an already legally marketed device. The modification involves coating the blood contact surfaces with Trillium™. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics.
Therefore, much of the requested information (like a table of acceptance criteria, specific device performance, sample sizes for test/training sets with provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) is not explicitly available in the provided text.
However, based on what is available, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a quantitative table of acceptance criteria or specific reported device performance metrics in numerical form. Instead, it states that the device was evaluated for its Coating Characteristics, Physical Characteristics, and Performance Characteristics during "in vitro bench testing." The conclusion drawn from these tests is:
| Acceptance Criteria Category | Reported Device Performance (Qualitative) |
|---|---|
| Biocompatibility | Demonstrated that it "does not significantly affect safety and effectiveness" compared to predicate devices. |
| Coating Characteristics | Evaluated (details not provided). |
| Physical Characteristics | Evaluated (details not provided). |
| Performance Characteristics | Evaluated (details not provided). |
| Substantial Equivalence | Demonstrated to be substantially equivalent to other commercially distributed extracorporeal cardiopulmonary devices when compared to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only mentions "in vitro bench testing."
- Data Provenance: The studies were "in vitro bench testing," implying laboratory-based testing. No information on country of origin or whether it was retrospective/prospective is provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable or not specified. Since the testing was "in vitro bench testing" and focused on physical and performance characteristics, human expert ground truth as typically understood in diagnostic studies (e.g., radiologists interpreting images) is not relevant here. The ground truth would be based on validated laboratory measurement methods.
4. Adjudication Method for the Test Set:
Not applicable or not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. An MRMC study is typically for evaluating diagnostic interpretative performance, which is not the focus of this device's evaluation based on the provided text.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device itself is an "in-line, full flow, sterile and non-pyrogenic fluid path disposable device" designed to be used with a BioTrend Oxygen Saturation and Hematocrit System. It's a component, not a standalone diagnostic algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not directly apply here. The "performance data" mentioned refers to the physical and functional performance of the device component.
7. The Type of Ground Truth Used:
The ground truth for the "in vitro bench testing" would be based on objective measurements and validated laboratory standards for coating, physical, and performance characteristics (e.g., material analysis, flow dynamics measurements, optical properties, stability testing etc.). The document indicates "acceptable scientific methods" exist for assessing these characteristics.
8. The Sample Size for the Training Set:
Not applicable. This is a physical device modification, not a machine learning algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as point 8.
§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).