(37 days)
The Cook Vascular Blood Flow Monitor - Model DP-M350 is intended for monitoring blood flow in vessels intraoperatively, and following micro-vascular procedures, re-implantation, and free-flap transfers. The Swartz Doppler Flow Probe is supplied sterile and is intended for one-time use.
The proposed device is monitor unit that generates a (20 MHz) signal and conducts it to an attached probe that contains a piezo-electric crystal which transmits and then receives Doppler frequency sound waves. The returning signal is amplified and projected via the proposed monitoring unit as an audible output. The monitor unit has two input channels and also provides an adjunct visible (LED) indicator that is used as a complimentary information source to the primary audible indicator. The predicate device was submitted as a system, the proposed device is only the monitoring unit.
The Cook Vascular, Inc. Blood Flow Monitor - Model DP-M350 is a monitoring unit that generates a 20 MHz signal and transmits and receives Doppler frequency sound waves via an attached probe. The returning signal is amplified and projected as an audible output. The monitor unit also features two input channels and a visible LED indicator as a complementary information source.
Here's an analysis of the provided information regarding the device's acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the device's acceptance criteria are demonstrated through a series of engineering and performance tests, rather than a clinical performance study with statistical metrics like sensitivity or specificity. The "acceptance criteria" are implied by the successful completion of these tests.
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Electrical Safety | Electrical Safety Testing | Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor. |
| Power/Battery | Battery Testing | Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor. |
| Electromagnetic Compatibility | EMC Testing | Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor. |
| Software Functionality | Software Validation | Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor. |
| Durability/Reliability | Shock/Vibration Testing | Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor. |
| Mechanical Integrity | Mechanical Validation | Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor. |
| Packaging Integrity | Packaging Testing | Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify sample sizes for any of the tests conducted. The studies appear to be engineering and performance verification tests of the device itself, rather than studies involving patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective nature for a clinical test set is not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests described are engineering validations, not studies requiring expert interpretation of clinical data to establish ground truth.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable given the nature of the tests described (engineering and performance validation).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study described focuses on the technical performance and safety of the device itself, not on its impact on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a blood flow monitor that provides an audible and visual output to a human user; it is not an algorithm that operates standalone without human involvement in the diagnostic or monitoring process. Therefore, the concept of a "standalone" algorithm performance study as typically understood in AI/imaging is not applicable to this device. The tests performed are for the device's technical functionality, which is its standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed would be the engineering specifications, regulatory standards (e.g., electrical safety standards, EMC standards), and design requirements for each test category. For instance, for "Electrical Safety Testing," the ground truth is compliance with relevant electrical safety standards. For "Software Validation," the ground truth is that the software performs according to its design specifications. There is no mention of expert consensus, pathology, or outcomes data as ground truth.
8. The Sample Size for the Training Set
This information is not applicable. The Cook Vascular, Inc. Blood Flow Monitor - Model DP-M350 is a hardware device with associated software, not an AI/machine learning algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI/machine learning algorithm. The "ground truth" for the device's development would be its design specifications and validated engineering principles.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).