(91 days)
The SPY Cystoscopes/Hysteroscopes are intended to provide visualization in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.
The SPY Cystoscope/Hysteroscope is part of Stryker's rigid endoscope product portfolio. The SPY Cystoscope/Hysteroscope is an optical instrument used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Cystoscope/Hysteroscope transmits light in the visible spectrum to illuminate the anatomy, then forms and relays the image of the surgical site to a camera system for image processing and display.
The provided text describes a 510(k) premarket notification for the Stryker Endoscopy SPY Cystoscope/Hysteroscope. It focuses on demonstrating substantial equivalence to a predicate device, rather than a standalone study proving specific clinical performance metrics with a test set, ground truth, or human reader involvement for an AI/ML device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device with details like sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this document.
This document details:
- Device Type: A traditional medical device (optical instrument for visualization in surgery), not explicitly an AI/ML powered device.
- Regulatory Pathway: 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to an existing legally marketed predicate device.
- Performance Testing: Primarily non-clinical bench testing and compliance with recognized voluntary consensus standards.
Here's a breakdown of what is provided, framed as closely as possible to your request, but highlighting the absence of AI/ML specific criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests and their "Pass" results, indicating that the device met the criteria set by the respective standards or comparative testing. The acceptance criteria themselves are implicitly defined by compliance with these standards (e.g., "In accordance with FDA-recognized voluntary consensus standard IEC 60601-1:2020").
| Test Category | Specific Test / Standard | Acceptance Criteria (Implicit from Standard Compliance) | Reported Device Performance |
|---|---|---|---|
| Electrical Safety | IEC 60601-1:2020 (19-49) | Compliance with standard | Pass |
| IEC 60601-2-18:2009 (9-114) | Compliance with standard | Pass | |
| Packaging | ASTM D4169:2022 (14-576) | Compliance with standard | Pass |
| Biocompatibility | ISO 10993-1:2018 (2-258) | Compliance with standard | Pass |
| ISO 10993-5:2009 (2-245) | Compliance with standard | Pass | |
| ISO 10993-10:2021 (2-296) | Compliance with standard | Pass | |
| ISO 10993-23:2021 (2-291) | Compliance with standard | Pass | |
| Cleaning, Disinfection & Sterilization (Reprocessing) | AAMI TIR12:2020 | Compliance with standard | Pass |
| ANSI AAMI ST98:2022 (14-583) | Compliance with standard | Pass | |
| ISO 15883-1:2009 | Compliance with standard | Pass | |
| ANSI AAMI ST79:2017 + A1:2020, A2:2020, A3:2020, A4:2020 (14-562) | Compliance with standard | Pass | |
| ANSI AAMI ST58:2013/(R)2018 (14-432) | Compliance with standard | Pass | |
| ISO 17664-1:2021 (14-578) | Compliance with standard | Pass | |
| ISO 17664-2:2021 (14-579) | Compliance with standard | Pass | |
| ISO 17665-1:2006 (14-333) | Compliance with standard | Pass | |
| ISO 14937:2009 (14-337) | Compliance with standard | Pass | |
| Performance – Bench | Comparative testing to currently legally marketed predicate device: Optical verification, Contrast | Equivalence to predicate device for optical verification and contrast | Pass |
| ISO 8600-1:2015 (9-110) | Compliance with standard | Pass | |
| Hardware compatibility testing | Compatibility with relevant hardware | Pass |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical testing of a physical medical device, not a performance study on a test set of data (e.g., images for an AI algorithm).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant to the described testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. The device is a direct visualization tool, not an AI-assisted diagnostic or interpretative system for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is compliance with established engineering and safety standards, and equivalence to a predicate device's performance.
8. The sample size for the training set: Not applicable. The device does not involve a training set as it's not an AI/ML product.
9. How the ground truth for the training set was established: Not applicable.
§ 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.