(46 days)
The Duette™ Multi-Band Mucosectomy Device is intended for endoscopic mucosal resection in the upper gastrointestinal tract.
The Duette TM Multi-Band Mucosectomy Device has a ligation component consisting of a barrel with latex bands and a Ligator handle. This barrel is attached to the distal end of an endoscope and bands are deployed by actuating the handle. The barrel allows introduction of an electrosurgical snare for endoscopic therapies.
This document describes a medical device called the Duette™ Multi-Band Mucosectomy Device and its 510(k) submission to the FDA. The submission focuses on substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics. Therefore, I cannot provide the requested information in its entirety because the provided text does not contain the specific acceptance criteria, study details, and performance data you've asked for.
Here’s what I can extract and what is missing, based on the provided text:
Missing Information:
The provided text does not contain any information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for either test or training sets.
- Sample size for training sets.
- How ground truth for training set was established.
Information Extracted from the Provided Text:
This 510(k) submission for the Duette™ Multi-Band Mucosectomy Device primarily relies on non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than on clinical studies with performance metrics against acceptance criteria.
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A table of acceptance criteria and the reported device performance:
- Not provided. The document states, "Non-Clinical testing was performed on characteristics and operational functions of the Duette™ Multi-Band Mucosectomy Device deemed necessary to verify safety and performance." However, specific acceptance criteria or performance metrics from these non-clinical tests are not disclosed in this document.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document refers to "non-clinical testing," implying bench or laboratory tests, not clinical human-subject test sets with data provenance.
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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. Since the document only mentions non-clinical testing, there is no mention of human experts defining ground truth for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. As above, no clinical test set is described.
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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 provided. This device is a mechanical Mucosectomy Device, not an AI or imaging diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. This is a mechanical device, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not provided. For the non-clinical testing, ground truth would likely refer to engineering specifications or validated test methods, but details are not given.
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The sample size for the training set:
- Not applicable/Not provided. This is a mechanical device, not an AI or software device that would have a "training set."
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How the ground truth for the training set was established:
- Not applicable/Not provided. As above, a training set is not relevant for this type of device.
Summary of the Device and Submission:
- Device Name: Duette™ Multi-Band Mucosectomy Device
- Intended Use: Endoscopic mucosal resection in the upper gastrointestinal tract.
- Device Description: Ligation component (barrel with latex bands), Ligator handle. Attaches to an endoscope; bands deployed by actuating the handle. Allows introduction of an electrosurgical snare.
- Submission Type: 510(k) Premarket Notification (K050578)
- Basis for Clearance: Substantial Equivalence to predicate devices (Olympus Distal Attachment, K984358).
- Testing Basis: Non-Clinical testing performed on "characteristics and operational functions... deemed necessary to verify safety and performance." No details on these tests, acceptance criteria, or results are provided in this excerpt.
This document is a 510(k) summary, which often provides less granular detail about studies compared to a full 510(k) submission or clinical trial report. The focus of this specific 510(k) is on the substantial equivalence of device design and intended use, supported by non-clinical testing, rather than a detailed clinical performance study with specific acceptance criteria as might be expected for novel diagnostic or AI-driven devices.
§ 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).