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GEM™ BIOVER disposable microvascular clamps are instruments which are used for all microsurgical procedures. They are used to occlude vessels during anastomosis, which is necessary as a result of vessel damage or thrombosis.

The GEM™ Biover Microvascular Clamps (Clamps) are arterial and venous clamps in both single and double clamp configurations, available in varying sizes. The clamps are sterile, disposable clamps for single use. The clamps are used in microsurgery, plastic surgery, and hand surgery for the temporary occlusion of blood vessels during an anastomosis.

The clamps are available for arteries and veins. The clamping force is higher for the arterial clamps than for the veinous clamps. The clamps are identified by a product reference code and by the color of the clamp. The clamps for veins are green, and the clamps for arteries are yellow.

The clamps are packaged individually in two Tyvek pouches (double pouched). The devices in the Tyvek pouches are gamma sterilized and are placed in cartons of 10. The clamps are used once and are disposed of after use.

This document is a 510(k) summary for the GEM™ Biover Microvascular Clamps, asserting their substantial equivalence to a previously cleared predicate device. This type of submission generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria in a robust statistical study.

Based on the provided text, the device is not an AI/ML powered device, nor is it a diagnostic device that requires high-level performance metrics, such as sensitivity, specificity, or AUC. The submission is for a physical medical device (microvascular clamps). Therefore, the information requested in the prompt regarding AI/ML performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment is not applicable to this document.

The document states:

• "The GEM Biover microvascular clamps remain unchanged from the predicate device."
• "There are no engineering or performance changes to the device or its packaging."

The "performance data" section mentions:

• "The label design change and the outer carton sales unit design change were assessed and validated in a Packaging Summative Human Factors/Usability Study."
• "Historical complaint data were reviewed and indicate no use-related concerns, thus, there are no use-related risks or complaints that trigger a need for further Human Factors validation."

This indicates that the "performance" considered for this submission relates to packaging and user interface (labeling/carton design), and the study conducted was a human factors/usability study, not a clinical performance study measuring accuracy or efficacy of a medical algorithm.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, AI/ML performance, and ground truth for a diagnostic or AI-powered device, as these details are not present and are not relevant to this type of device submission.

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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 GEM FLOW COUPLER System is designed for the detection of blood flow in vessels. The GEM FLOW COUPLER System consists of components as described below:

1. FLOW COUPLER Device (Product Code MVR) - single-use implantable rings used to secure anastomosis of small vessels. This includes a 20MHz ultrasonic Doppler transducer (probe) which attaches to one of the FLOW COUPLER rings, and an external lead.
2. FLOW COUPLER Monitor (Product Code DPW) - portable monitor that provides the audible output of the FLOW COUPLER Device's pulsed Doppler ultrasound signal. A varying audible signal is produced when the FLOW COUPLER Device (probe) detects flow.

The medical device in question is the GEM FLOW COUPLER Monitor (GEM1020M-2).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for each specific test set (e.g., how many monitors were tested for cleaning, how many for audio quality). However, the tests described are primarily non-clinical performance tests of the device's hardware, firmware, and cleaning protocols. Therefore, the "data provenance" is typically within a controlled laboratory or manufacturing environment, rather than clinical patient data. There is no information regarding country of origin of data or whether it was retrospective or prospective, as these are not relevant to these types of engineering/performance tests.

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

For the types of tests conducted (e.g., cleaning, design, audio quality, EMC), the "ground truth" is established by industry standards (e.g., IEC 60601-1:2005, IEC 60601-1-2 Edition 4.1: 2020, 47 CFR, Part 15:2022) and the manufacturer's internal design and functional specifications. These are objective measures rather than subjective expert consensus. Therefore, the concept of "experts establishing ground truth" in the manner of medical image interpretation is not directly applicable here. The "experts" would be the engineers and technicians performing the tests and verifying compliance with the established standards and specifications. Their qualifications are implicitly in their ability to perform such tests and interpret the standards.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for non-clinical performance and engineering tests. The tests are designed with objective acceptance criteria, and the results (e.g., measured values, pass/fail based on a threshold) are typically directly compared against these criteria.

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

No. This document describes a 510(k) Pre-market Notification for modifications to an existing device, the GEM FLOW COUPLER Monitor. The changes are primarily hardware and firmware updates (power management, power button, audio system, remote monitoring disabling) and labeling updates (cleaning solutions). The device itself (a cardiovascular blood flowmeter) provides audible output to a human user to detect blood flow and confirm vessel patency. It does not involve AI or image interpretation, and therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not applicable.

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

No. This device is a monitor that provides audible output to a human user (surgeon, nurse) for the detection of blood flow. It is intrinsically a "human-in-the-loop" device in its intended use. It does not operate as a standalone algorithm for diagnosis or decision-making.

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

The ground truth for the performance tests is based on:

• International and Federal Standards: e.g., IEC 60601-1, IEC 60601-1-2, 47 CFR Part 15.
• Manufacturer's Design and Functional Specifications: These are internal objective criteria derived from engineering requirements.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm or a diagnostic tool that requires a "training set" in the machine learning sense. The performance tests are for hardware and software functionality, not for training a model.

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

Not applicable, as there is no training set for this device.

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The VESSEL EVERTER System is indicated for use with the Microvascular Anastomotic COUPLER and FLOW COUPLER Device in the anastomosis of only arteries normally encountered in microsurgical procedures only in the peripheral vascular system. The VESSEL EVERTER System is indicated for use with COUPLER and FLOW COUPLER System sizes from 2.0 to 4.0 mm.

Two accessory devices comprise the Vessel Everter System: Vessel Everter and Sizing Guide. The Vessel Everter system is an accessory device to the GEM FLOWCOUPLER System, a pair of implantable rings that are used for end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures.

The Vessel Everter System are two non-implantable, sterile, single use hand-held devices that facilitate sizing and use of the GEM FLOWCOUPLER System. The Vessel Everter is comprised of a handle with two soft silicone end effectors (tips), one on each end. The instrument handle features two separate silicone end effectors, each of a different size, intended to be used at the surgeon's discretion. The Vessel Everter end effector is designed with a narrowing tip to allow for engagement with multiple sizes of vessels, corresponding with a coupler size of 2.0-4.0 mm rings. The Vessel Everter is used to press vessel tissue onto the GEM FLOWCOUPLER rings. To accomplish this, the surgeon presses the Vessel Everter into the tissue, flaring the tissue onto and over the Coupler locking pins.

The Sizing Guide is a hard, plastic handle featuring holes on either end through which the vessel's outer diameter may be measured. The holes' diameters are intended to match the inner diameters of the various GEM FLOWCOUPLER rings. The holes correlate to vessel diameters of 2.0 mm to 4.0 mm in 0.5 mm increments. The surgeon may use the sizing guide to guide the selection of which coupler they will use for each particular anastomosis. The Sizing Guide is used by placing the vessel on the sizing guide and comparing the vessel diameter to the holes in the Sizing Guide.

The Vessel Everter and Sizing Guide are sterilized by ethylene oxide and are provided sterile for-single-patient use. The Vessel Everter and Sizing Guide are not implantable and are disposed of after single use.

The parent device, GEM FLOWCOUPLER System, remains unchanged and is not addressed in this submission.

The provided text describes a 510(k) premarket notification for the GEM FlowCoupler System accessories (Vessel Everter and Sizing Guide). It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML device. Instead, it details performance testing for a medical device's physical and biological properties.

Therefore, many of the requested fields cannot be filled as they pertain to AI/ML device validation studies. However, I can extract the available information regarding the device's performance testing for the physical accessories.

Here's a breakdown based on the provided text, acknowledging the limitations for AI/ML specific information:

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

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

The text mentions "porcine vessels" for the Intimal Integrity Verification Testing but does not specify the sample size. It does not mention any human data or specific provenance for these tests.

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

Not applicable. The tests performed are physical and biological evaluations of the device's materials and mechanical properties, not an AI/ML diagnosis where expert ground truth is established.

4. Adjudication method for the test set

Not applicable. This concept is relevant for AI/ML performance evaluation against a human-adjudicated ground truth.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for the performance tests outlined typically refers to established standards and measurement techniques for mechanical properties (e.g., force measurements), material characteristics (e.g., cytotoxicity assays), and biological responses (e.g., hemolysis tests). For the intimal integrity test, the "ground truth" would be the observed integrity of the porcine vessel intima after device use.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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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:

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.

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The Microvascular Anastomotic COUPLER is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures.

The device is a sterile (gamma irradiation), single-use, implantable pair of rings molded out of high density polyethylene with six stainless steel pins on each of the ring. A probe-holder feature is molded on each of the paired rings to be a point of attachment for a sensor/probe at the site of anastomosis.

This document is a 510(k) premarket notification for the Microvascular Anastomotic Coupler and does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

The document outlines the device's indications for use, technological comparison to a predicate device (GEM Microvascular Anastomotic Coupler; K861985), and asserts substantial equivalence in terms of biocompatibility, manufacturing, performance, sterilization, shelf life, packaging, safety, and efficacy to the predicate device.

Therefore, I cannot provide the requested information from the given text.

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