(61 days)
The FLOW COUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FLOW COUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FLOW COUPLER Device is used in conjunction with the FLOW COUPLER Monitor, the FLOW COUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post- operatively.
The FLOW COUPLER Device and System consists of a FLOW COUPLER Device and a FLOW COUPLER Monitor. The FLOW COUPLER Monitor is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels. The FLOW COUPLER Device includes a 20MHz ultrasonic Doppler transducer (probe) attached to one of the FLOW COUPLER rings, and an external lead. The probe via the external lead connects to the monitor and emits a pulsed ultrasonic signal. A varying audible signal is produced when the probe detects flow.
The provided text describes the GEM™FLOW COUPLER™ Monitor (GEM2010M-2), a cardiovascular blood flowmeter, and its substantial equivalence to a predicate device. However, the document does not detail specific acceptance criteria, a study that quantifies device performance against those criteria, or the methodology for ground truth establishment, sample sizes, or multi-reader studies in the manner typically required for AI/algorithm-driven device evaluations. The information provided focuses on the regulatory submission process (510(k)) and comparisons to a predicate device, rather than a detailed performance study with quantifiable metrics.
Based on the provided text, here's what can be extracted and what information is not available:
1. A table of acceptance criteria and the reported device performance
The document states that "The testing was completed with passing results per the pass/fail criteria defined for each test case." However, the exact acceptance criteria (e.g., specific accuracy, sensitivity, specificity thresholds) and the reported device performance for each are not explicitly listed. Instead, it broadly states that the modified monitor "meets the same performance specifications as the predicate device" and that the "performance data described in this submission confirm that the modified monitor meets the same performance specifications." The performance data categories include:
| Test Category | Reported Device Performance (as stated in the document) |
|---|---|
| EMC Testing | Passing results per the pass/fail criteria defined for each test case. |
| Electrical Safety Testing | Passing results per the pass/fail criteria defined for each test case. |
| Acoustic Output Testing | Passing results per the pass/fail criteria defined for each test case. |
| AC Power Continuous Use | Passing results per the pass/fail criteria defined for each test case. |
| Battery Life Testing | Passing results per the pass/fail criteria defined for each test case. |
| User Interface Functional Testing | Passing results per the pass/fail criteria defined for each test case. |
| Flow Velocity Testing | Passing results per the pass/fail criteria defined for each test case. |
| Functional Performance Testing | Passing results per the pass/fail criteria defined for each test case. |
| Packaging Validation Testing | Passing results per the pass/fail criteria defined for each test case. |
| Software Verification | Passing results per the pass/fail criteria defined for each test case. |
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 in the document. The document refers to "bench testing" and "performance data described in this submission" but does not detail the size of any test sets or the origin/nature of the 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 provided in the document. The device is a "pulsed Doppler ultrasound system designed for the detection of blood flow in vessels" that produces an "audible signal" when flow is detected, and the modified monitor "adds a qualitative visual display as a secondary indicator of blood flow." Therefore, the ground truth would likely relate to the presence/absence or characteristics of blood flow, which would typically involve highly specialized experts or direct measurement. However, details of any human expert involvement are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 is not mentioned in the document. The device is a monitor for detecting blood flow, not an AI-driven image interpretation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the "FLOW COUPLER Monitor" as a "pulsed Doppler ultrasound system designed for the detection of blood flow in vessels." While it includes "software for digital filtering of the returned audio signal for noise reduction" and a "qualitative visual display," it is presented as a medical device providing information to a human user (e.g., producing a "varying audible signal" and a "qualitative visual display"). The question of "standalone" algorithm performance in the context of typical AI algorithms is not directly applicable or addressed here, as the device is a measurement tool, not an autonomous diagnostic algorithm. Its function is to detect blood flow, which is then interpreted by a human user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of ground truth used to validate the device's ability to "detect blood flow and confirm vessel patency" is not explicitly stated. Given the nature of a Doppler ultrasound, the ground truth would typically be established through direct physiological measurements or other highly reliable methods for confirming blood flow and vessel patency, rather than expert consensus on images. However, the document does not specify.
8. The sample size for the training set
The document does not describe any training sets for the device. The device is a monitor, not a machine learning model that undergoes training in the typical sense.
9. How the ground truth for the training set was established
Since there is no mention of a training set, this information is not provided.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.