(425 days)
The Gyrus ACMI Inc. BiCoag Hemostasis Probe is intended for coagulation of active bleeding lesions in the upper or lower gastrointestinal tract during endoscopic procedures. The device also can be used for irrigation.
The BiCoag Hemostasis Probe is intended to be used for coagulation of active bleeding lesions in the upper or lower gastrointestinal tract when used with a bipolar high frequency generator. It contains a central irrigation port. The probe is to be available in 10 Fr and 7 Fr (3.3mm and 2.3mm respectively) outer diameter configurations to allow its use through a minimum 3.7mm and 2.8mm endoscope working channel, respectively.
The provided text describes a 510(k) premarket notification for the Gyrus ACMI Inc. BiCoag Hemostasis Probe. This document focuses on demonstrating substantial equivalence to predicate devices for a medical device rather than presenting a study demonstrating performance against specific acceptance criteria for a new AI or diagnostic device.
Therefore, many of the requested elements (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are not applicable to this type of regulatory submission and are not found in the provided text.
The submission aims to show that the Gyrus ACMI Inc. BiCoag Hemostasis Probe is substantially equivalent to already legally marketed predicate devices, thereby not raising new questions of safety and effectiveness.
Here's an attempt to fill in the table and address the questions based on the available information, noting where information is not present:
Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)
Since this is a 510(k) submission for substantial equivalence rather than a detailed performance study against novel acceptance criteria, the concept of specific "acceptance criteria" for performance metrics like sensitivity or specificity, and the "reported device performance" against those, is not directly addressed in the provided document.
Instead, the "acceptance criteria" for this submission would implicitly be that the device is substantially equivalent in intended use, materials, principles of operation, and fundamental scientific technology to predicate devices, and raises no new issues of safety and effectiveness. The "reported device performance" is effectively that it meets this standard of substantial equivalence.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Implicit for Substantial Equivalence) |
|---|---|
| Device is substantially equivalent to predicate devices in intended use, materials, principles of operation, and fundamental scientific technology. | The Gyrus ACMI Inc. BiCoag Hemostasis Probe is substantially equivalent to the predicates in intended use, materials, principles of operation, and fundamental scientific technology. |
| Device raises no new issues of safety and effectiveness. | The device raises no new issues of safety and effectiveness. |
Detailed Study Information (Not Applicable to this 510(k) Summary)
The provided text does not describe a study that proves the device meets specific acceptance criteria in the manner of an AI or diagnostic performance study. Instead, it's a regulatory summary relying on substantial equivalence to existing predicate devices. Consequently, most of the following questions cannot be answered from the provided text.
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A table of acceptance criteria and the reported device performance:
- As explained above, specific performance metrics are not given. The acceptance criteria are implicit in the substantial equivalence argument, and the "reported performance" is that it meets this.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document does not describe a clinical study with a test set of patient data.
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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 / Not provided. Ground truth establishment by experts for a test set is not mentioned as part of this substantial equivalence submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No adjudication method is mentioned as there is no described test set.
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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 / Not done. This device is an electrosurgical probe, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI assistance effect size are not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not done. This is a physical medical device, not an algorithm. Standalone algorithm performance is not relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. Since no specific performance study is detailed, no ground truth type is mentioned.
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The sample size for the training set:
- Not applicable / Not provided. The device is not an AI/ML model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable / Not provided. As there's no training set, no ground truth establishment for it is mentioned.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).