(76 days)
The Endoscopic Multi-fire Clip Applier was designed to be used with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis of mucosal and submucosal defects
The InScope Endoscopic Multi-Fire Clip Applier is designed for gastrointestinal endoscopic clipping for marking and hemostasis. It consists of a control handle, an insertion tube, jaws at the distal end for gripping the tissue, and up to 5 clips that can be attached to the tissue individually with each actuation of the device handle. The device is provided sterile and is for one time use only.
The provided document, K013889, is a 510(k) premarket notification for the InScope Endoscopic Multi-Fire Clip Applier. The document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than reporting on a clinical study where acceptance criteria are typically detailed.
Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria is not explicitly available in the provided text. The document describes a comparison to a predicate device, but does not provide a table for acceptance criteria and device performance based on a human-centric or AI-centric study.
However, I can extract the information that is present and indicate what is missing based on your request:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as quantitative acceptance criteria in the document for a performance study. Instead, the document focuses on compliance with standards and technological similarity to a predicate device. | The InScope Endoscopic Multi-Fire Clip Applier was found to be "substantially equivalent to the legally marketed Olympus HX-5/6-1 Endoscopic Clipping Device." This was demonstrated through "bench testing and comparative analysis of features." Bench tests included "scope passage, rotation, clip deliverability, vessel sealing, and minimum and average clip removal force." Specific numerical performance data from these bench tests is not provided. |
Study Details (Based on available information and acknowledging missing data)
Since this is a 510(k) for a medical device cleared via substantial equivalence, the "study" described is primarily bench testing comparing the device to a predicate, not a clinical trial or AI performance study with the specific metrics requested.
- Sample size used for the test set and the data provenance: Not applicable in the context of the provided document. The document refers to "bench testing" which implies in-vitro or simulated use, but does not provide details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a clinical or image-based test set involving expert review is not mentioned, as the reported "study" is bench testing for mechanical equivalence.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to the bench testing described.
- 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 document is for a mechanical medical device (clip applier), not an AI diagnostic or assistive device, so MRMC studies or AI improvement metrics are irrelevant.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the bench testing, the "ground truth" would be the engineered specifications and performance characteristics of the predicate device, against which the InScope device's mechanical performance was compared.
- The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI or machine learning device.
- How the ground truth for the training set was established: Not applicable.
Summary of Performance Data and Substantial Equivalence Basis
The document states that the InScope Endoscopic Multi-Fire Clip Applier is "substantially equivalent to the legally marketed Olympus HX-5/6-1 Endoscopic Clipping Device" based on:
- Compliance with various standards, practices, and guidances: These include standards for sterilization (AAMI TIR 27, ANSI/AAMI/ISO 11137-1994, ISO 10993-7), biological evaluation (ISO 10993-1), and material specifications (ASTM F67-00, ASTM F136-98, ASTM F138-97, ASTM F899-95, ASTM F3063-00).
- Bench testing: This testing assessed "scope passage, rotation, clip deliverability, vessel sealing, and minimum and average clip removal force."
- Comparative analysis of features: Between the InScope device and the predicate Olympus device.
- Material safety: The tissue contact materials have "a long history of safe usage in medical devices."
The conclusion drawn is that "the device is safe and effective and performs as well as or better than the predicate device."
§ 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.