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The Laser Speckle Imaging System (RFLSI CZW) is intended for blood flow measurements in the micro-circulation. This device is intended for clinical research use.

The Laser Speckle Imaging System (RFLSI CZW) is intended for blood flow measurements in the micro-circulation. This device is intended for clinical research use. It is a measurement tool based on the laser speckle contrast analysis technology and provides real-time blood perfusion information of tissue and organs in a visual and quantitative way. The device is non-patient contacting and does not require the use of contrast agents.

The provided text describes the 510(k) premarket notification for the Laser Speckle Imaging System (RFLSI CZW) and its comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria, particularly in the context of clinical performance or diagnostic accuracy. The document focuses on technological comparison, electrical safety, EMC, and laser safety testing.

Here's a breakdown of the information that is available and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

The document provides the following performance parameters for the subject device:

Note: The document states that "Differences in device parameters do not raise new concerns regarding safety and effectiveness" and that "Verification and validation testing for the subject device demonstrate safety and effectiveness." It also mentions "Comparison tests to verify the substantial performance of the device and the predicate device were conducted... and the results conclude that the device shows comparable performance, safety, and effectiveness to the predicate device." However, specific numerical acceptance criteria for comparability in these comparison tests are not explicitly stated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size:
  • For the "laboratory testing model 'Flow Model' using a fluid simulator," the sample size is not specified.
  • For the "volunteer test on the human body using post-occlusive reactive hyperemia method," the sample size is not specified.
• Data Provenance: Not specified. The document indicates the applicant and correspondent are in China, but it doesn't state where the testing data originated.
• Retrospective or Prospective: Not specified.

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)

This information is not provided in the document. The performance tests described (flow model and volunteer test) likely use objective physical measurements rather than expert assessment for ground truth, but the details are missing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

This type of study is not mentioned in the document. The device is a Laser Speckle Imaging System for blood flow measurement, which typically outputs quantitative data directly, rather than images requiring human interpretation that AI might assist.

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

The performance testing described ("test with laboratory testing model 'Flow Model' using a fluid simulator" and "volunteer test on the human body") appears to evaluate the device's standalone performance in measuring blood flow. The document states that the testing demonstrated that "the device performs its intended purpose, and it meets the specified requirements and standards" and showed "comparable performance, safety, and effectiveness to the predicate device."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the "Flow Model" testing, the ground truth would likely be the known flow rates or parameters of the fluid simulator.
• For the "volunteer test on the human body using post-occlusive reactive hyperemia method," the ground truth would be established by the physiological changes induced by the post-occlusive reactive hyperemia method, which creates a temporary blood flow cessation followed by a reactive increase. The device's measurements would be compared against the expected physiological response. The precise method of establishing 'ground truth' for comparison during these physiological tests is not detailed, but it's not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic accuracy.

8. The sample size for the training set

This information is not applicable/not provided. The device described is a measurement system and not an AI/ML device that typically requires a large training set in the way a diagnostic imaging algorithm might. The document does not mention any machine learning components that would necessitate training data.

9. How the ground truth for the training set was established

This information is not applicable/not provided for the reasons stated in point 8.

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