(266 days)
The Hysteroscopy System is indicated for rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy. It has an additional feature of visualization.
The Hysteroscopy System is designed to visualize the uterus and to facilitate physicians in the procedure of vacuum aspiration of the uterine cavity during the first trimester of pregnancy. Components of the Hysteroscopy System include an EOsterilized single-use cannula and reusable image processing unit. The Hysteroscopy System is available in five sizes that differ in length and width. Each cannula includes an internal channel to draw vacuum or negative pressure up to 500 mmHg. The optical system, which includes a CMOS image sensor, lens, and 40 mW LED, is located at the distal end of the cannula. A lens cover shields the electronics from bodily fluids. The Hysteroscopy System has two connectors: one is an electrical/data connection and the second connection is for vacuum. The cannula is not indicated for use with any other accessories. The patient-contacting materials are medical grade stainless steel, polycarbonate, medical glue, and medical nylon.
This document does not contain an acceptance criteria table or a detailed study of device performance to meet such criteria. It is a 510(k) summary for a Hysteroscopy System. While it lists various performance tests conducted, it does not provide quantitative acceptance criteria or the specific results demonstrating compliance.
Here's a breakdown of what is available based on your request, and what is missing:
1. A table of acceptance criteria and the reported device performance
Missing. The document lists performance tests but does not define acceptance criteria (e.g., minimum tensile strength, maximum leak rate, specific image resolution targets) nor does it present the numerical results from these tests against any defined criteria. It only states, "The protocol and results of all performance testing were acceptable."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing. The document mentions various performance tests (e.g., biocompatibility, electrical safety, mechanical performance, image quality) but does not provide details on:
* The sample sizes used for any of these tests.
* The provenance of the data (e.g., country of origin, retrospective or prospective nature). These tests appear to be bench testing or material-level assessments, not clinical trials on human subjects.
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)
Missing. This type of information would typically be relevant for studies involving diagnostic accuracy or clinical interpretation. The performance tests described are largely engineering and safety evaluations (e.g., tensile strength, vacuum integrity, electrical safety, biocompatibility, image quality parameters like field of view, resolution). There's no indication of any expert-based ground truth establishment in the context usually meant by this question (e.g., for image interpretation or diagnosis).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing. Adjudication methods are typically used in clinical studies where multiple observers or methods are used to establish a definitive diagnosis or outcome. The performance tests listed are technical validations, not clinical outcome adjudications.
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
Missing. An MRMC study is not mentioned. The device is a "Hysteroscopy System" used for visualization and vacuum aspiration. There is no mention of AI or human-in-the-loop performance improvement in this document, as it describes a medical device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing. Not applicable, as this document describes a physical medical device (Hysteroscopy System), not an algorithm or AI software requiring standalone performance testing in that context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing. As noted above, the performance tests described are largely technical/engineering validations. For example, for "image quality testing," the ground truth would be objectively measured parameters such as actual field of view, photometric measurements for illumination, and resolution targets. For "mechanical performance testing," ground truth would be defined by engineering specifications (e.g., expected tensile strength, vacuum pressure). There's no mention of clinical "ground truth" derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Missing. This is not an AI device, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Missing. Not applicable, as there is no training set for an AI algorithm.
§ 884.5070 Vacuum abortion system.
(a)
Identification. A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.(b)
Classification. Class II (performance standards).