(190 days)
The iScience Interventional Canaloplasty Microcatheter is indicated for fluid infusion and aspiration during surgery. The iScience Interventional Canaloplasty Microcatheter is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma.
The iScience Interventional Canaloplasty Microcatheter is a flexible microcatheter designed to allow atraumatic catheterization of spaces in the eye for infusion and aspiration of fluids during surgery. The device allows catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. The microcatheter incorporates an optical fiber to allow transmission of light to the microcatheter tip for surgical illumination and guidance. The device is provided sterile and is intended for single use.
The provided text describes the iScience Interventional Canaloplasty Microcatheter and its regulatory clearance. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding acceptance criteria, specific performance metrics, test set details (sample size, provenance, expert qualifications, adjudication), MRMC studies, or training set specifics for an AI/ML device.
This document describes a medical device clearance process for a physical surgical tool, not an AI/ML diagnostic or assistive device. Therefore, many of the questions related to AI/ML evaluation (like ground truth establishment, expert adjudication, MRMC studies, training set size) are not applicable or the information is not present in this type of submission.
Here's a breakdown of what can be extracted and what information is missing:
Acceptance Criteria and Device Performance for iScience Interventional Canaloplasty Microcatheter
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines conformity to established standards and general performance tests. It does not provide specific numerical acceptance criteria (e.g., "tensile strength must be >X Newtons") or corresponding quantitative results. Instead, it states that tests were performed "to ensure that performance requirements were met" and that "performance testing demonstrates that the iScience Interventional Canaloplasty Microcatheter is functionally equivalent to the predicate devices."
| Acceptance Criteria Category | Reported Device Performance / Conformance |
|---|---|
| Sterilization | Conforms to ANSVAAMI/ISO 11137-1995 |
| Biocompatibility | Conforms to ISO 10993-1, -5, -10, -12 |
| Shelf-Life & Packaging | Conforms to ANSI/AAMI/ISO 11607-2000 |
| Risk Management | Conforms to ISO 14971:2000 |
| Dimensional & Mechanical | Passed tests for: |
| - Tensile Strength of Joints | Performance requirements met |
| - Static Burst | Performance requirements met |
| - Fluid Infusion Line Leakage | Performance requirements met |
| - Aspiration | Performance requirements met |
| - Light Transmission | Performance requirements met |
| Functional Equivalence | Functionally equivalent to predicate devices |
Detailed Information Not Available in the Provided Text:
Questions 2, 3, 4, 5, 6, 7, 8, and 9 relate to the evaluation of AI/ML or diagnostic performance, which is not the primary focus of this 510(k) summary for a surgical microcatheter. Therefore, the specific details you requested are not present.
2. Sample size used for the test set and the data provenance:
- Information not available. The document mentions "Ex-vivo studies" and "A multi-center prospective study," but does not provide sample sizes for these studies or specific details on data provenance (e.g., country of origin, retrospective/prospective for test sets). The prospective study is a clinical study for safety and efficacy, not explicitly a "test set" for performance evaluation in the context you've outlined.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Information not available. This is typically relevant for diagnostic AI/ML devices where expert consensus defines ground truth. For a surgical device, "ground truth" relates to functional performance and safety, evaluated through engineering tests and clinical outcomes, rather than expert interpretation of images/data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information not available. Adjudication methods are specific to diagnostic evaluations, especially in AI/ML performance studies. Not applicable here in the way you've framed it.
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 / Information not available. This device is a surgical microcatheter; it's a tool, not an AI assistant meant to improve human reader performance. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Information not available. This is not an algorithm; it's a physical surgical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering/performance tests, ground truth would be established by physical measurements and adherence to engineering specifications.
- For the clinical study, the "ground truth" for efficacy would likely be outcomes data (e.g., reduction in intraocular pressure) and for safety, it would be adverse event reporting. The document doesn't detail the specific outcome measures beyond "reduce intraocular pressure".
8. The sample size for the training set:
- Not applicable / Information not available. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable / Information not available. As there is no AI/ML training set, this question is not relevant.
In summary, the provided document details the regulatory clearance for a physical medical device. While it lists adherence to various standards and types of performance testing, it does not provide the granular data points concerning specific acceptance thresholds, quantitative results, or the detailed methodology of test/training sets, experts, and adjudication that would be required for an AI/ML or diagnostic device evaluation.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.