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PeriFlux 6000 equipped with PF 6010 is intended for measuring micro-vascular perfusion in skin and muscle in humans. It is also intended for measuring micro-vascular perfusion in all tissues in animals for research purposes. The PF 6010 is also intended for evaluating tissue response in skin to local heating and providing temperature stabilization of skin at blood perfusion measurement.

PeriFlux 6000 equipped with PF 6050 is intended for measuring the pressure cuffs, to simplify simultaneous measurements of perfusion and pressure when used in conjunction with a laser Doppler perfusion monitor. PeriFlux 6000 equipped with PF 6050 is also intended for Pulse Volume Recording (PVR) on human limbs and digits for diagnosis and evaluation of vascular disease in adults. It is not intended for use on neonates and pregnant women.

PeriFlux 6000 equipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia.

The PeriFlux 6000 is a modular multichannel system that offers several tests for diagnosis and evaluation of vascular disease in one instrument. It consists of a Main Unit (PF 6001), which accommodates up to eight different function units of the same type or of different types enabling simultaneous measurements of several parameters. Currently, one type of unit –PF 6040 tcpO2/pCO2 Unit– is available for the US market. Two more units have been developed:

• PF 6010 LDPM/Temp Unit
• PF 6050 Pressure Unit

The PeriFlux 6000 equipped with PF 6010 function units measures microcirculatory blood flow using Laser Doppler technology. In combination with the PF 6050 function unit to inflate blood pressure cuffs and to register the cuff pressure, it enables a range of different tests, including ankle pressure, toe pressure, skin perfusion pressure (SPP), pulse volume recording (PVR), segmental pressures, heat provocations and post-occlusive reactive hyperemia (PORH).

In Laser Doppler Perfusion Monitoring, an optical fibre leads light generated by a laser to the LDPM probe tip, which rests against the tissue. The beam of light will enter the tissue and become scattered. Blood cells moving within the volume illuminated by the beam will cause the light to change frequency. This change in frequency is called a Doppler shift and it is used to calculate the blood flow in the illuminated tissue.

Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on what is present and explicitly stating what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the PeriFlux 6000. Instead, it relies on a comparison to a predicate device (PeriFlux System 5000) and describes general claims of "very good correlation" and "equivalence" between the new device and the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a sample size for the performance tests conducted. It only mentions "tests" in plural, implying more than one data point, but no quantity.
• Data Provenance (country of origin, retrospective/prospective): The document does not specify the country of origin for the test data, nor does it state whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

The document does not mention the use of experts to establish ground truth for the test set. The performance testing described (bench testing of signal correlation) appears to be an objective comparison between device outputs rather than an expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Since experts are not mentioned in establishing ground truth, an adjudication method like 2+1 or 3+1 is not applicable and not described in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No. The device is a "Cardiovascular Blood Flowmeter" and a "Modular multichannel system for diagnosis and evaluation of vascular disease." It is a measurement device, not an AI-assisted diagnostic tool that would involve human readers interpreting output. Therefore, an MRMC study is not applicable and was not performed.
• Effect Size of Human Reader Improvement with/without AI: Not applicable, as there's no AI component or human reader interpretation discussed.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done

The performance testing described ("Bench Testing") for the Laser Doppler Perfusion Monitoring (LDPM) unit (PF 6010) appears to be a form of standalone testing. The document states:
"We have therefore tested how the clinically relevant parameter, blood perfusion, correlates between these two systems. The tests show that the signals correlate very well between the two systems and that they can be regarded as equivalent."

This suggests the device's output (blood perfusion measurement) was compared to the predicate device's output independently, without human interpretation as part of the primary performance evaluation. So, yes, a form of standalone performance was assessed by comparing the device's measurements directly to a predicate device.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing of the PeriFlux 6000's blood perfusion measurement (PF 6010) was the measurement output of the legally marketed predicate device, PeriFlux System 5000 (PF 5010). The document states "how the clinically relevant parameter, blood perfusion, correlates between these two systems."

For the pressure measurement (PF 6050) and temperature measurement and control (PF 6010 and PF 6050 functionalities), the document states: "Temperature and pressure are measured using the same technology and use the same type of sensors in PeriFlux 6000 as in PeriFlux System 5000." This implies the predicate device's established performance serves as the "ground truth" reference.

8. The Sample Size for the Training Set

The document does not mention any "training set." This device is a physiological measurement tool, not an AI/machine learning system that typically requires a training set.

9. How the Ground Truth for the Training Set was Established

Since no training set is mentioned, the method for establishing its ground truth is not applicable and not described.

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PeriFlux 6000 equipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia.

PeriFlux 6000 is a transcutaneous oxygen/carbon dioxide (tcpO2/CO2) monitor, and consists of a main unit, PF 6001, that can be equipped with 1 to 8 PF 6040 function units. An electrode E5250 or E5280 is connected to each function unit and is applied to a patient's skin. Electrode E5250 consists of a Clark sensor and is used for O2 measurement. Electrode E5280 is a combined Clark sensor and Stow-Severinghaus-type sensor, and is used for both O2 and CO2 measurement. Upon measurement, the electrode is heated to make the skin permeable to gas diffusion, which allows O2 and CO2 to diffuse through the skin into the sensor. The instrument is operated from its touch screen interface and allows the users to record, analyze and report top(22 and tcpCO2 values.

The provided document describes the PeriFlux 6000, a transcutaneous oxygen/carbon dioxide monitor, and its 510(k) summary for FDA clearance. The document focuses on establishing substantial equivalence to predicate devices and demonstrating compliance with safety and performance standards. However, it does not contain specific acceptance criteria or a study detailing device performance against such criteria in the way typically expected for an AI/ML device.

The information provided is largely about regulatory compliance, intended use, device description, and comparison to predicate devices, rather than a detailed performance study with quantitative acceptance metrics.

Therefore, I cannot directly extract the full requested information about acceptance criteria and a study proving device performance as it's not present in the provided text. I will address the points that can be inferred or are explicitly stated, and note where information is missing.

Summary of Acceptance Criteria and Device Performance for PeriFlux 6000

The provided document describes the regulatory submission for the PeriFlux 6000, focusing on its substantial equivalence to predicate devices and compliance with relevant safety and performance standards. It does not present specific quantitative acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, the "acceptance criteria" are implied to be adherence to recognized international consensus standards for medical electrical equipment and transcutaneous partial pressure monitoring.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the new device "meets the performance requirements" and "is equipped with the required safety mechanisms," and "fully complies" with the listed international standards. However, it does not provide detailed measurement accuracy, precision, bias, sensitivity, specificity, or similar quantitative performance metrics that would typically be expected from a device study. The provided text is a summary for regulatory clearance, focusing on equivalence and standard compliance rather than a detailed performance report.

2. Sample size used for the test set and the data provenance:

• This information is not provided in the document. The filing focuses on compliance with standards rather than clinical testing with a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the document. Ground truth establishment with experts is generally associated with clinical or image-based diagnostic studies, which is not the type of study described here for a transcutaneous monitor.

4. Adjudication method for the test set:

• This information is not provided in the document. Adjudication methods are typically used in studies involving expert review where consensus on ground truth is required.

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:

• A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted (or at least not reported) as this device is a standalone physiological monitor, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• The PeriFlux 6000 is a standalone device for continuous non-invasive transcutaneous monitoring. The document states it is "a modern transcutaneous oxygen/carbon dioxide monitor that meets the performance requirements." While it doesn't detail a specific "standalone study" with quantitative results beyond compliance with standards, its function is as a standalone measurement device. The performance claims are inherently for the algorithm/device itself.

7. The type of ground truth used:

• For the technical and performance standards, the "ground truth" would be the defined specifications and test methods within the cited international consensus standards (e.g., IEC 60601-1, IEC 60601-2-23). The device's performance is measured against these established engineering and safety benchmarks.
• For the physiological measurements (tcpO2/tcpCO2), traditional ground truth in such devices often involves comparison to arterial blood gas measurements, but the document does not specify if such a comparison was part of the "performance requirements" that were met.

8. The sample size for the training set:

• This information is not applicable as the PeriFlux 6000 is a hardware monitor based on established physiological measurement principles (Clark sensor, Stow-Severinghaus-type sensor), not an AI/ML device 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 for the same reason as point 8.

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The PeriCam PSI is intended for non-invasive two-dimensional imaging of peripheral tissue blood perfusion. This can be used in a wide range of applications and disciplines including dermatology, wound healing, burns assessment etc.

The PeriCam PSI is a device to perform non-contact imaging of tissue blood perfusion in the microcirculation, for example skin, using Laser Speckle contrast analysis. The full measurement area surface is illuminated with a laser beam resulting in a laser speckle pattern. The pattern is imaged by a CCD camera and image processing of the speckle contrast is used to generate high resolution color code images showing the blood perfusion in the tissue.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PeriCam PSI device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, or a threshold for "similar response"). Instead, the acceptance criteria are implicitly defined by the concept of "substantial equivalence" to predicate devices. The performance data focuses on demonstrating this equivalence through comparative studies.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document repeatedly mentions "Several comparative studies" and "comparative studies" but does not specify the sample size (number of subjects, measurements, or data points) for these studies.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that the manufacturer is Swedish (Perimed AB, Järfälla, Sweden) and the predicate device is also mentioned as being from Perimed (PIM 3 Laser Doppler Perfusion Imager PIM 3), it's highly probable the studies were conducted by the manufacturer, likely in Sweden or a related research setting. The nature of the studies (comparative performance with provocations) suggests prospective data collection in a controlled environment. However, this is an inference, not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The concept of "ground truth" as it's typically understood in diagnostic AI (e.g., pathology, clinical outcome data) is not directly applicable here. This submission is for a medical device (PeriCam PSI) that measures physiological parameters (blood perfusion), not for a diagnostic algorithm that interprets images for disease.

The "ground truth" in this context is the actual blood perfusion measurement from an established, substantially equivalent device. The comparative studies aim to show that the new device's readings match those of the predicate device under various conditions. Therefore, there's no mention of experts establishing a separate "ground truth" to which the device readings are compared. The predicate device itself acts as the reference.

4. Adjudication Method for the Test Set

Not applicable. As described above, the studies involve direct comparison of measurements between devices, not adjudication of interpretations by human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document describes comparative studies of the new device against predicate devices to demonstrate substantial equivalence in measurement output, not a study of human readers using the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the studies described are inherently "standalone" in the sense that they evaluate the device's measurement performance (algorithm + hardware) directly against predicate devices. The PeriCam PSI is a measurement device that generates color-coded flow maps; its performance is evaluated based on the similarity of these measurements to existing technology, not on human interpretation of the output.

7. The Type of Ground Truth Used

The "ground truth" is established by the measurements from the predicate device(s) (PIM Laser Doppler Perfusion Imager K920844, and implicitly moorFLPI Full Field Laser Perfusion Imager K063586). The studies directly compared the absolute measurements and relative responses to provocations (heating, occlusion) between the PeriCam PSI and the predicate device.

8. The Sample Size for the Training Set

Not applicable. The PeriCam PSI is a measurement device based on physical principles (Laser Speckle Contrast Analysis), not a machine learning algorithm that requires a "training set" in the conventional sense. Its "training" or calibration would involve ensuring the physical parameters and algorithms are correctly implemented to yield accurate and consistent measurements, not learning from a labeled dataset.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of a machine learning algorithm. The device's underlying physics and algorithms are designed based on established scientific principles for measuring blood perfusion.

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Use of the PF 5050 Pressure Unit is indicated for non-invasive Pulse Volume waveform Recordings (PVR) on extremities of patients with vascular diseases.

It is also intended to measure and control the pressure in a blood pressure cuff to simplify simultaneous measurements of perfusion and pressure when used in conjunction with a laser Doppler perfusion monitor.

The PF 5050 Pressure Unit is a modular unit that can be installed in the PeriFlux System 5000. The device provides Pulse Volume waveform Recordings (PVR) on various limb and digit extremities made possible through air plethysmography. The PF 5050 Pressure Unit includes a small display where the mean cuff pressure is displayed.

The PVR tracing is accomplished by attaching a standard blood pressure cuff on various areas of the extremities. To provide skin contact, atmospheric air is inflated to approximately 50 - 65 mmHg using the balloon pump supplied with a standard blood pressure gauge. A pressure transducer records the pressure change in the cuff (Pulse Volume waveforms) secondary to change in v the extremity segment under the cuff during repeated cardiac cycles.

The PeriFlux System 5000 is a multi-channel, multi-functional system capable of hosting one, two, three or four function units including for example a PF 5010 LDPM Unit for blood perfusion measurements. The PeriFlux 5001 Main Unit accommodates up to four different function units of the same type or of different types enabling simultaneous measurements of several parameters. There are three different function unit types available at the moment.

PF 5010 LDPM Unit for blood perfusion measurements.

PF 5020 Temp Unit for temperature measurements.

PF 5040 tcpO2 / pCO2 for measurements of transcutaneous O2 and CO2.

The provided text is a 510(k) summary for the PERIMED PF 5050 Pressure Unit, which describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, clinical studies, sample sizes, ground truth establishment, or expert adjudication methods.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided document. The 510(k) summary focuses on demonstrating equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

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