(569 days)
The Accuflo™ Electromagnetic Flow System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. The device will function in circuits utilizing centrifugal pump heads as well as circuits utilizing roller pumps. There are no other intended uses for the device. The equivalent device, the Bioprobe, is primarily used with centrifugal pumps.
The Accuflo™ Electromagnetic Flow Monitoring System is composed of three (3) components, a monitor display unit, a transducer and a sterile flow-through probe.
The provided document is a 510(k) summary for the Accuflo™ Electromagnetic Flow Monitoring System, asserting its substantial equivalence to a predicate device, the Biomedicus Bioprobe Electromagnetic Flow System. It does not contain information about a study proving the device meets specific acceptance criteria in the manner of a clinical trial or performance study report. Instead, the "acceptance criteria" appear to be implicit in the comparison table demonstrating similarity to the predicate device. The "reported device performance" refers to the accuracy claim made for the Accuflo™ system within this comparison.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate: Bioprobe System) | Reported Device Performance (Accuflo™ System) |
|---|---|---|
| Components | 3 | 3 |
| Separate Monitor | Yes | Yes |
| Digital Display | Yes | Yes |
| Zero Offset Control | Yes | Yes |
| Electromagnetic Transducer | Yes | Yes |
| Electromagnets | 1 | 2 |
| Disposable Flow Probe | Yes | Yes |
| Construction | Insert Injection Molded | Insert Injection Molded |
| Electrodes | 3 pairs in a row | 3 in a row |
| Inside Diameter | 3/8" | 3/8" |
| Material | Polycarbonate | Polycarbonate |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Accuracy | Accurate within 300 ml | Accurate within 50 ml |
Note: The accuracy claim for the Accuflo™ system (within 50 ml) is presented as an improvement over the predicate device (within 300 ml), not as an "acceptance criterion" that was met in a separate study with a predefined threshold. The "acceptance criteria" here are inferred from the characteristics of the predicate device for demonstrating substantial equivalence.
Regarding a "study that proves the device meets the acceptance criteria":
The document does not describe a study in the traditional sense that would prove the Accuflo™ system meets its own stated accuracy of "within 50 ml" through specific testing methodologies. The accuracy claim is stated as a characteristic within the comparison table, implying it is inherent to the design and operation, potentially demonstrated through internal testing that is not detailed here.
The entire 510(k) submission itself serves as the "study" demonstrating that the Accuflo™ system is substantially equivalent to the predicate device based on design, components, materials, and intended use, with the improved accuracy noted as a difference that does not raise new questions of safety or effectiveness.
Therefore, the following information is largely not available in the provided text:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document is a 510(k) summary, not a detailed study report. It does not mention sample sizes, test sets, or data provenance for performance testing.
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. This type of ground truth establishment is typically for diagnostic imaging or similar devices, not for an electromagnetic flow monitoring system where accuracy would be determined by physical measurements against a known standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to clinical or diagnostic adjudication processes, which are not relevant to the type of device 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 is a medical imaging study type, not relevant to a flow monitoring system. The device does not involve "human readers" or "AI assistance" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly stated as a formal study. The device itself is "standalone" in its function of measuring flow, but the document doesn't describe a specific "standalone performance study" with detailed methodology.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. For a flow monitoring device, ground truth for accuracy would typically be established by in vitro testing against precisely known flow rates using calibrated equipment. This detail is not provided.
8. The sample size for the training set
- Not applicable/Not provided. This is relevant for machine learning models. The Accuflo™ system is a measurement device, not an AI/ML system.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, not relevant for this type of device.
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).