(485 days)
Transonic Systems' BLF22 and BLF22A tissue perfusion monitors are intended for use in the measurement of microvascular perfusion.
The BLF22 (single-channel) Tissue Perfusion Monitor reports Flow, Mass or Velocity on its front panel digital display. Housed in a small metal case, the Monitor is equipped with a convenient multi-position handle/stand. It also features: rear panel analog outputs for Flow/Mass/Velocity in 0 - 10 Volts DC; and a USB computer interface.
The BLF22A (single-channel + Indicator Tone) Tissue Perfusion Monitor incorporates all the functionality of the BLF22, plus adjustable Low Flow Indicator Tone circuitry. This will sound an audio signal when tissue perfusion flow drops below a preset level.
The provided document is a 510(k) summary for the Transonic Tissue Perfusion Monitors (Models BLF22 and BLF22A). It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/ML medical device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through bench testing and electrical safety testing.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this document, as they relate to studies for AI/ML device performance validation.
Here's a summary of the information that can be extracted, and an explanation for what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative manner. The performance testing is described qualitatively as demonstrating "functional requirement specifications" and meeting "all required release specifications."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional requirement specifications (including flow values and user messages) | Demonstrated |
| Compliance with electrical safety standard IEC 60601-1 | Complied |
| Measurement of volume flow within specified full range and accuracy (for probe/monitor combination) | Tested and met |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document describes "bench studies" and "testing" but does not specify a "test set" in the context of an AI/ML model or a sample size of patient data. The testing appears to be hardware-focused, evaluating the device's functional and electrical properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth establishment by experts is not described, as the performance testing focused on the device's physical and electrical functioning, not diagnostic accuracy based on expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. No adjudication method is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through bench and electrical safety testing, not assessing human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a monitor measuring microvascular perfusion, not an AI algorithm, so the concept of "standalone performance" for an algorithm is not relevant here. The device itself is standalone in its function as a measurement tool.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing would be the true physical measurements of flow, mass, and velocity under controlled conditions, and compliance with electrical safety standards. This is inherent in bench testing and refers to accurately calibrated equipment and established safety protocols.
8. The Sample Size for the Training Set
Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML algorithm is mentioned.
§ 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).