(261 days)
The HOPKINS Telescopes when used with sheaths are intended to be used to permit viewing of the cervical and uterine cavity for the purpose of performing diagnostic and surgical procedures.
The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 12° and 30° direction of view, 2mm, 2.9mm, 4mm diameter and 26cm, 30cm, 36cm working lengths.
The provided text is a 510(k) Summary for the HOPKINS Telescopes, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria for a novel AI/software component.
Therefore, the provided document does not contain the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/software performance.
The document states:
- "Clinical studies were not required to demonstrate substantial equivalence to the predicate device." (Page 9)
- "The conclusions drawn from the nonclinical test demonstrate that the subject device is as safe and effective as the predicate device to support a substantial equivalence determination." (Page 9)
This means the submission relies on bench testing and comparison of technological characteristics to a legally marketed predicate device, not on a clinical performance study with defined acceptance criteria and human readers (or AI algorithms) in the way your prompt describes.
To directly answer your questions based only on the provided text, the answer is that this information is not present for the HOPKINS Telescopes device.
If this were an AI/software device and the information was present, here's how I would answer each point:
- Table of acceptance criteria and reported device performance: This would be a table detailing metrics like sensitivity, specificity, AUC, or agreement rates, with specific target thresholds (acceptance criteria) and the actual performance achieved in the study.
- Sample size and data provenance: This would specify the number of cases/patients in the test set (distinct from training data), whether the data was collected retrospectively or prospectively, and from which countries or institutions.
- Number of experts and qualifications: This would state how many experts (e.g., radiologists, pathologists) were involved in establishing ground truth and their relevant experience (e.g., board-certified, years of experience, subspecialty).
- Adjudication method: This would describe how discordant readings or interpretations among experts were resolved (e.g., 2+1 means two initial readers, with a third if they disagree; 3+1 means three initial readers, with a fourth for adjudication if necessary).
- Multi-reader multi-case (MRMC) comparative effectiveness study: If conducted, this would provide details on how the AI system impacted human reader performance, including statistical metrics like the effect size (e.g., mean increase in AUC, sensitivity, or specificity when AI assistance was used compared to no AI assistance).
- Standalone performance: This would report the performance of the algorithm itself, without any human interaction, against the ground truth.
- Type of ground truth: This would specify the reference standard used (e.g., expert consensus, pathology results, follow-up clinical outcomes, surgical findings).
- Sample size for training set: This would state the number of unique cases/patients used to train the AI model.
- Ground truth for training set: This would explain the methodology used to label or establish the ground truth for the data utilized during the training phase of the algorithm.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.