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FLOW NOW is intended for monitoring blood flow in vessels.

FLOW NOW is indicated for monitoring blood flow in peripheral vessels during and following reconstructive microvascular procedures, re-implantation, and free flap transfers. Postoperatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW NOW Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days postoperatively.

The GEM FLOW NOW (FLOW NOW) device is comprised of an implantable non-active silicone vessel sleeve (Figure 2), a 20 MHz ultrasonic Doppler transducer (probe) and probe wire, suture sleeve, probe connector, and an external lead that connects to a monitor. FLOW NOW has a soft, pliable silicone "vessel sleeve" that retains the Doppler probe via press-fit into a silicone bore. The device comes with vessel sleeve and probe already assembled.

The FLOW NOW Device is intended for monitoring blood flow in vessels. It is indicated for monitoring blood flow in peripheral vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW NOW Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively. The FLOW NOW device is intended for use with both currently cleared FLOW COUPLER Monitors (GEM1020M and GEM1020M-2).

The probe is removed from the patient 3 to 14 days after implantation, once monitoring is complete. The probe is separated from the vessel sleeve and removed from the patient's body. non-invasively, by the surgeon pulling on the probe wire outside the patient's body. The silicone vessel sleeve remains permanently implanted. The FLOW NOW device can be used to monitor blood flow through veins and arteries ranging from 2.0 to 4.0 mm in outside diameter.

The provided text is a 510(k) Summary for the GEM FLOW NOW (GEM2770-FN) device. It details the device's technical characteristics and claims of substantial equivalence to a predicate device but does not contain information about the acceptance criteria or a study proving device performance against those criteria in the context of human reader improvement with AI assistance (MRMC study) or standalone algorithm performance.

The document primarily focuses on non-clinical bench testing to demonstrate that the GEM FLOW NOW met defined specifications and comparable performance to its predicate device. It explicitly states that "Clinical performance testing was not required for the GEM FLOW NOW device."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance in those specific contexts, sample sizes for test sets, data provenance, expert details, adjudication methods, MRMC study effect sizes, or standalone algorithm performance.

Here's what I can extract based on the provided text, focusing on the available performance data:

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

The document mentions that "Pre-determined performance specifications were tested, and verification and validation activities were conducted to demonstrate that the GEM FLOW NOW met the defined criteria." However, the specific quantitative acceptance criteria and the detailed reported device performance are not provided in this document. It only states a general conclusion: "The GEM FLOW NOW met acceptance criteria and demonstrated comparable performance to the predicate device for the equivalent indications for use."

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

This information is not provided as the performance data described is non-clinical bench testing, not a clinical study with a test set of patient data.

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 applicable/provided. The document discusses non-clinical bench testing, not studies requiring expert review of patient data for ground truth establishment.

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

This information is not applicable/provided. No clinical test set requiring adjudication is described.

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 done. The document explicitly states: "Clinical performance testing was not required for the GEM FLOW NOW device." This means no study involving human readers or AI assistance was conducted or reported here.

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

A standalone algorithm performance study was not done. The device is a physical diagnostic tool (ultrasonic pulsed doppler imaging system) and not an AI algorithm.

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

For the non-clinical bench testing, the ground truth would be based on engineering specifications and measurements from the physical device. Specific details are not provided.

8. The sample size for the training set

This information is not applicable/provided. The device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable/provided. The device is not an AI/ML algorithm that requires a training set.

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