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510(k) Data Aggregation
(29 days)
GEM Flow COUPLER Device and System
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 System consists of a Flow COUPLER Device and a Flow COUPLER Monitor. The Flow COUPLER Device is a sterile, single-use implantable pair of rings molded out of high density polyethylene with stainless steel pins on each ring. The Flow COUPLER Device is designed to serve as a mechanical, sutureless device for connecting veins or arteries. A probe-holder feature is molded on one Flow COUPLER ring and serves as the press-fit point of attachment for a pre-attached 20 MHz Doppler probe. The Doppler probe connects to the Flow COUPLER Monitor unit, via the external lead.
The Flow COUPLER Monitor and Doppler probe is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels. An audible ultrasonic signal is produced when the Doppler probe detects blood flow.
The Flow COUPLER Device and System has been specifically designed for use in end-to-end anastomosis of blood vessels and the detection of blood flow at the anastomotic site. On an as needed basis, blood flow can be detected for up to 7 days. The Flow COUPLER rings are intended to be a permanent implant. The Flow COUPLER probe is not intended to be a permanent implant; the probe should be removed, by gentle traction on the external lead, 3 to 14 days post-operatively.
The provided document is a 510(k) Premarket Notification from the FDA for the GEM™ Flow COUPLER™ Device and System. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics of a new device.
Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, and expert involvement are not explicitly present in the provided text. The document states that the modified Flow Coupler device is considered substantially equivalent to its own predicate (K142609), which is the GEM Flow COUPLER Device and System.
Here's an attempt to answer the questions based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with quantitative acceptance criteria and reported device performance in the way a clinical study or performance verification study for a new device might. Instead, it states that "functional specifications were not affected by the line extension" for the 4.0mm Flow COUPLER. The acceptance criteria would broadly be that the modified device performs equivalently to the predicate device across the listed tests.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional specifications not affected by size range extension | "functional specifications were not affected by the line extension" (for 4.0mm Flow COUPLER) |
| Shock and vibration performance maintained | Testing included: "shock and vibration" (implies performance was acceptable/equivalent to predicate) |
| Pin alignment maintained | Testing included: "pin alignment" (implies performance was acceptable/equivalent to predicate) |
| Ring retention maintained | Testing included: "ring retention" (implies performance was acceptable/equivalent to predicate) |
| Probe signal maintained | Testing included: "probe signal" (implies performance was acceptable/equivalent to predicate) |
| Ring separation maintained | Testing included: "ring separation" (implies performance was acceptable/equivalent to predicate) |
| Probe to COUPLER separation force maintained | Testing included: "probe to COUPLER separation force" (implies performance was acceptable/equivalent to predicate) |
| Device is substantially equivalent to predicate device | "The risk assessment and bench testing of this device demonstrate that the device is substantially equivalent to the predicate device." |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench testing on the 4.0mm Flow COUPLER line extension," but it does not specify the sample size for any of these tests. The data provenance is not mentioned, but given it's a submission to the US FDA and the company is based in the US, it's highly likely the testing was conducted in the US. The nature of "bench testing" implies it's a prospective series of tests performed on physical devices.
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. For bench testing of physical properties, "experts" in the clinical sense are typically not involved; rather, engineering and quality assurance personnel conduct the tests against specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are highly relevant for clinical studies or studies involving human interpretation. For bench testing of functional specifications, the results are usually objective measurements against predefined engineering tolerances.
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
There is no mention of an MRMC study or AI assistance in this document. The device is a mechanical coupler with an ultrasonic Doppler probe, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is not an algorithm, but a physical medical device. It has a "standalone" function in the sense that the Doppler probe detects blood flow independently, but it is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench tests, the "ground truth" would be the engineering specifications and established functional parameters of the predicate device or industry standards for similar devices. For example, for "ring retention" or "probe signal," there would be quantifiable metrics and tolerances that the device must meet.
8. The sample size for the training set
There is no mention of a training set. This type of test is for a physical device, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable as there is no training set mentioned.
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(28 days)
GEM Flow COUPLER Device and System
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 intraoperatively 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 System consists of a Flow COUPLER Device and a Flow COUPLER Monitor. The Flow COUPLER Device is a sterile, single-use implantable pair of rings molded out of high density polyethylene with stainless steel pins on each ring. The Flow COUPLER Device is designed to serve as a mechanical, sutureless device for connecting veins or arteries. A probe-holder feature is molded on one Flow COUPLER ring and serves as the press-fit point of attachment for a pre-attached 20 MHz Doppler probe. The Doppler probe connects to the Flow COUPLER Monitor unit, via the external lead.
The Flow COUPLER Monitor and Doppler probe is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels. An audible ultrasonic signal is produced when the Doppler probe detects blood flow.
The Flow COUPLER Device and System has been specifically designed for use in end-to-end anastomosis of blood vessels and the detection of blood flow at the anastomotic site. On an as needed basis, blood flow can be detected for up to 7 days. The Flow COUPLER rings are intended to be a permanent implant. The Flow COUPLER probe is not intended to be a permanent implant; the probe should be removed, by gentle traction on the external lead, 3 to 14 days post-operatively.
The provided text describes the GEM™ Flow COUPLER™ Device and System, which is a medical device for microvascular reconstruction procedures. However, the document is a 510(k) premarket notification decision letter from the FDA, and it focuses on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a clinical study or AI model performance evaluation.
Therefore, the requested information categories regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, adjudication, and MRMC/standalone studies cannot be fully provided based on the given document.
The document indicates that this device is an update to an existing device (K132727 and K093310). The "acceptance criteria" discussed are largely related to ensuring the new version retains the safety and effectiveness of the previous version and that manufacturing and design changes (like an extended size range) do not negatively impact performance.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the context of an AI model or a specific clinical trial outcome (e.g., sensitivity, specificity, AUC). Instead, it discusses the validation of functional specifications for a line extension.
| Acceptance Criteria Category (Implied) | Reported Device Performance/Testing |
|---|---|
| Functional Specifications (3.5mm Flow COUPLER line extension) | Bench testing performed to validate that functional specifications were not affected by the line extension. |
| Shock and Vibration | Tested |
| Pin Alignment (visual) | Tested |
| Ring Retention | Tested |
| Probe Signal | Tested |
| Ring Separation | Tested |
| Probe to COUPLER separation force | Tested |
| Risk Assessment | Design FMEA and Health Hazard Analysis conducted in accordance with EN ISO 14971:2012. |
| Overall Equivalence | Device demonstrated substantial equivalence to the predicate device with respect to biocompatibility, manufacturing process, product performance, indications, sterilization, shelf life, packaging, and safety and efficacy. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document discusses "bench testing" for a device line extension, not a test set for an algorithm or a clinical study. No information on sample size or data provenance in this context is provided.
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)
Not applicable. This is not a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving an adjudicated test set.
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 does not mention an MRMC study or AI models. It pertains to a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not discuss an algorithm or standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" would be the engineering specifications and expected performance benchmarks for each test (e.g., a certain force for probe separation, a clear probe signal). For the risk assessment, it would be the identified hazards and their severities. This is not clinical ground truth.
8. The sample size for the training set
Not applicable. This document does not describe a training set for an AI model.
9. How the ground truth for the training set was established
Not applicable. This document does not describe a training set for an AI model.
In summary: The provided text is a regulatory clearance document for a medical device (GEM™ Flow COUPLER™ Device and System) based on substantial equivalence. It details manufacturing, design, and functional testing to support modifications to an existing device, rather than providing the kind of performance data usually associated with acceptance criteria for a new AI-powered diagnostic or prognostic tool.
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(49 days)
GEM FLOW COUPLER DEVICE AND SYSTEM
The FlowCOUPLER 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 FlowCOUPLER 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 FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Postoperatively, blood flow can be detected on an as needed basis for up to 7 days. The FlowCOUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.
The Flow COUPLER System consists of a Flow COUPLER Device and a Flow COUPLER Monitor. The Flow COUPLER Device is a sterile, single-use implantable pair of rings molded out of high density polyethylene with six stainless steel pins on each ring. The Flow COUPLER Device is designed to serve as a mechanical, sutureless device for connecting veins or arteries. A probe-holder feature is molded on one Flow COUPLER ring and serves as the press-fit point of attachment for a pre-attached 20 MHz Doppler probe. The Doppler probe connects to the Flow COUPLER Monitor unit, via the external lead.
The Flow COUPLER Monitor and Doppler probe is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels. An audible ultrasonic signal is produced when the Doppler probe detects blood flow.
The Flow COUPLER Device and System has been specifically designed for use in end-to-end anastomosis of blood vessels and the detection of blood flow at the anastomotic site. On an as needed basis, blood flow can be detected for up to 7 days. The Flow COUPLER rings are intended to be a permanent implant. The Flow COUPLER probe is not intended to be a permanent implant; the probe should be removed, by gentle traction on the external lead, 3 to 14 days post-operatively.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or a direct performance table. Instead, it focuses on demonstrating substantial equivalence to a predicate device by verifying that modifications did not affect functional specifications and that the device meets relevant standards.
However, based on the types of testing performed, we can infer the performance areas that would have had internal acceptance criteria:
| Performance Area | Inferred Acceptance Criteria (Not explicitly stated, but implied by testing) | Reported Device Performance (Summary from text) |
|---|---|---|
| Doppler Probe Signal Functionality | Signal should be detectable and accurate for blood flow. | Testing included "Doppler probe signal functionality." The submission concludes that "functional specifications were not affected by the modification to the Doppler wire." The system is designed for "detection of blood flow and confirmation of vessel patency." An audible ultrasonic signal is produced when blood flow is detected. The device can detect blood flow for up to 7 days post-operatively. |
| Doppler Probe Wire Tensile Strength | Wire should withstand specified tensile forces without breaking. | Testing included "Doppler probe wire tensile and connection strength testing." The submission concludes that "functional specifications were not affected by the modification to the Doppler wire." |
| Doppler Probe Wire Connection Strength | Connections should remain secure under specified forces. | Testing included "Doppler probe wire tensile and connection strength testing." The submission concludes that "functional specifications were not affected by the modification to the Doppler wire." |
| Electrical Safety (IEC 60601-1 Conformance) | Device should meet all applicable electrical safety standards. | Testing included "electrical testing conformance to IEC 60601-1." The submission indicates this testing was successful in showing functional specifications were not affected. |
| Biocompatibility (ISO 10993-1) | Device materials should not cause adverse biological reactions. | "Biocompatibility testing was performed in accordance to ISO 10993-1." The submission states that "biocompatibility... of this device demonstrates that the device is substantially equivalent to the predicate device." |
| Risk Management (EN ISO 14971:2012) | Risks should be identified, analyzed, and mitigated to acceptable levels. | "A risk assessment of the modifications in the form of a Design FMEA and Health Hazard Analysis has been conducted in accordance with EN ISO 14971: 2012." The successful completion of this indicates risks are managed. |
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 non-clinical testing performed. It refers to "testing" performed to verify functional specifications.
- Data Provenance: The data provenance is not explicitly stated beyond being "non-clinical testing on the modified device." There's no mention of country of origin or whether it was retrospective or prospective, though "non-clinical" usually implies laboratory or bench testing rather than human clinical trials.
3. Number of Experts and Qualifications for Ground Truth
- The document does not refer to experts establishing ground truth for any test set in the context of this 510(k) submission. The testing described is primarily engineering and materials-based to confirm functional specifications and safety, not related to expert interpretation of diagnostic output.
4. Adjudication Method for the Test Set
- Not Applicable: Since no human interpretation or diagnostic ground truth establishment is described, no adjudication method is mentioned or relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
- No: The document does not mention or describe an MRMC comparative effectiveness study. This submission is for a device that detects blood flow, not an imaging or diagnostic algorithm that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
- The device being submitted (GEM Flow COUPLER) is a hardware device (coupler with an integrated Doppler probe and a monitor unit). While the monitor unit processes the Doppler signal, the submission focuses on the device's functional specifications and safety. Therefore, a standalone "algorithm only" performance study, as typically understood for AI/software, is not applicable to this type of device and is not mentioned. The "detection of blood flow" is an inherent function of the Doppler technology, not a distinct AI algorithm.
7. Type of Ground Truth Used
- The ground truth for the non-clinical testing appears to be based on engineering specifications and established regulatory standards. For example, for "Doppler probe signal functionality," the ground truth would be the expected and accurate detection of a simulated or actual blood flow signal. For electrical safety, the ground truth is conformance to IEC 60601-1 standards. For biocompatibility, it's conformance to ISO 10993-1. These are not typically "expert consensus," "pathology," or "outcomes data" in the diagnostic sense.
8. Sample Size for the Training Set
- Not Applicable / Not Mentioned: This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" of the device is through its design, manufacturing to specifications, and calibration, not through data input.
9. How Ground Truth for the Training Set was Established
- Not Applicable / Not Mentioned: As this is not an AI/ML device with a training set, the concept of establishing ground truth for a training set does not apply.
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(102 days)
GEM FLOW COUPLER DEVICE AND SYSTEM
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