(87 days)
The Modified Superview is indicated for use in treatment of esophageal varicies utilizing combination ligation /injection therapy. The Modified Superview is indicated for band ligation treatment of anorectal hemorrhoids.
The Microvasive Modified Superview is a Multiple Band Ligator composed of two major components.
- The Ligating Unit: The main component of the ligating unit is a cylinder which fits at the distal end of the endoscope. Elastic bands are stretched around the distal portion of the cylinder.
- Handle Unit with Trip Wire and Scope Fastener: The main component of the Handle Unit is a plastic spool which turns only in the clockwise direction. A trip wire is attached to the plastic spool. When the plastic spool is rotated, the handle will make a distinct "click" sound, and one band will be fired automatically. The Handle Unit also incorporates a scope fastener to secure the handle onto the endoscope. An irrigation valve is located on the side of the Handle Unit.
The provided text is a 510(k) Summary for the Speedband Superview Multiple Band Ligator and does not contain a study comparing the device's performance against specific acceptance criteria. Instead, it aims to demonstrate substantial equivalence to a predicate device. Therefore, I cannot complete a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria.
However, I can extract other relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided. The document focuses on demonstrating substantial equivalence rather than meeting specific performance acceptance criteria.
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. No clinical test set data is described. The submission relies on laboratory testing and biocompatibility assessments, not a clinical study with a test set.
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. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set and thus no adjudication method is described.
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 device is a medical instrument (ligator), not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth data is described for this submission. The submission references "Laboratory testing regarding characteristics was performed on the Modified Superview to verify its safety and performance" and "A biocompatibility assessment was performed... with satisfactory results." These are technical verifications, not clinical ground truth.
8. The sample size for the training set
Not applicable. No training set is described as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. No training set is described.
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.