(195 days)
The PeriFlux System 5000 is indicated for use in measuring microvascular perfusion, in skin and muscle, in humans. It is also indicated for use in measuring microvascular perfusion in all tissues in animals.
The PeriFlux System 5000 Modular Laser Doppler Flowmeter System 5000 consists of a PF 5001 Main Unit, which can accommodate up to four Function Units. The first available Function Unit is the PF 5010 LDPM (Laser Doppler Perfusion Monitor) Unit. A PF 5990 Blank Panel takes the place of a Function Unit if less than four Units are required. Probes are attached to collect the information, which is analysed, using the PeriSoft analysis program.
Here's an analysis of the provided text regarding the PeriFlux System 5000 Modular Laser Doppler Flowmeter, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary letter from the FDA. It does not contain detailed information about specific acceptance criteria, study designs, or performance metrics. It primarily establishes substantial equivalence to a predicate device. Therefore, many of the requested details cannot be extracted directly from this document.
1. Table of Acceptance Criteria and Reported Device Performance
As the provided document is a 510(k) summary for substantial equivalence, it does not specify explicit acceptance criteria or report detailed device performance metrics in the way a clinical study report would. The primary "acceptance criterion" met here is the FDA's determination of substantial equivalence to the predicate device, the PeriFlux System 4000. This implies that the performance characteristics are considered comparable.
| Acceptance Criterion (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Substantial Equivalence to Predicate Device (PeriFlux System 4000) | Technological Characteristics: "The technology is the same but the design has been modified to simplify use... and allow customers to more easily choose the number of channels they need." |
| Functionality: "The PeriFlux System 5000 presents only Perfusion and TB (CMBC and Velocity are measured by the instrument to calculate Perfusion)." (Predicate presented CMBC and Velocity directly) | |
| Probe Compatibility: "The probes... are identical in every way with those used for the PeriFlux System 4000 laser Doppler Flowmeter - they are interchangeable between the two systems." | |
| Safety | Implicitly deemed safe through substantial equivalence to a legally marketed device and compliance with general controls. |
| Effectiveness | Implicitly deemed effective for its stated intended use through substantial equivalence to a legally marketed device. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The document focuses on technological comparison rather than a formal clinical or performance testing study with a defined test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. As there's no mention of a formal clinical test set or ground truth establishment, this detail is absent.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of an MRMC comparative effectiveness study is present in this 510(k) summary. Given the nature of the device (a Laser Doppler Flowmeter measuring microvascular perfusion, not an imaging diagnostic device that typically involves human interpretation), such a study would be highly unlikely and generally not relevant for this type of device.
6. Standalone (Algorithm Only) Performance Study
This is not applicable and not mentioned. The PeriFlux System 5000 is a measurement device, not an algorithm that operates independently without human interaction or a physical sensor. Its "performance" would relate to the accuracy and precision of its measurements, not to algorithm-only operation in the context of interpretation.
7. Type of Ground Truth Used
Given that this is a 510(k) submission primarily focused on demonstrating substantial equivalence based on technological characteristics and intended use, there is no explicit mention of a 'ground truth' in the context of a performance study. For a measurement device like a flowmeter, "ground truth" would typically refer to a validated reference method for measuring microvascular perfusion against which the device's measurements are compared for accuracy and precision. This document does not detail such a comparison study.
8. Sample Size for the Training Set
This information is not provided. Laser Doppler Flowmeters are typically based on established physical principles for blood flow measurement, not on machine learning algorithms that require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as the device does not appear to be an AI/ML-based system requiring a training set with established ground truth.
§ 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).