(70 days)
The Aveta System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception.
The modified Aveta System is used by physicians in an office or operating room setting. The Aveta Controller acts as the hub of the system. For diagnostic procedures, the Aveta Fluid Management Accessory, the Aveta Handswitch, the Aveta Scale, the Waste Management Bags, saline bags and an external monitor are all connected to the Aveta Controller. The inflow and outflow of the fluid management accessory are connected to the corresponding ports of a compatible hysteroscope. For therapeutic procedures, the Aveta Reusable Resecting Handset or the Aveta Disposable Resecting Handset are connected to the Aveta Controller for powering the Aveta Disposable Resecting Device.
The provided text is a 510(k) summary for the Meditrina Aveta System (K191958). It describes a device that assists gynecologists in hysteroscopic procedures. This document primarily focuses on demonstrating substantial equivalence to a predicate device (K190372) rather than detailed acceptance criteria and study results for device performance in terms of diagnostic or therapeutic accuracy, as would be expected for an AI/ML powered device.
Therefore, many of the requested items (acceptance criteria for AI performance, sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth details) are not applicable or not provided in this specific 510(k) document, as it concerns a physical medical device and its accessories, not an AI/ML algorithm.
However, I can extract the available information related to the device's functional performance:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Functional) | Reported Device Performance |
|---|---|
| Handswitch controls function as expected (Pressure and Flow Control). | Functional Testing demonstrated Handswitch controls function as expected. |
| Regulation of cavity pressure demonstrated in a model uterine system. | Demonstrated with TruClear 8.0 and Myosure XL hysteroscopes in various operational modes. Results met specifications. |
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to a functional performance test in a model uterine system, not a clinical data set 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, as this was functional testing, not an expert-driven ground truth assessment.
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. This document does not describe an AI-powered device or an MRMC study.
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): For the functional testing, the "ground truth" was likely the expected physical and operational parameters (e.g., maintaining a set pressure, consistent flow control) within the model uterine system.
8. The sample size for the training set: Not applicable. No AI/ML training set is mentioned.
9. How the ground truth for the training set was established: Not applicable.
Summary of the study conducted to prove the device meets acceptance criteria:
The study conducted involved non-clinical performance testing to evaluate the modified Aveta System.
- Study Type: Functional testing and simulated use with a model uterine system.
- Key Tests:
- Functional Testing with Aveta Handswitch: Verified that the Handswitch's pressure control and flow control functions operated as expected.
- Simulated Use with Compatible Hysteroscopes: The device's ability to regulate cavity pressure was demonstrated using two commercially available hysteroscopes (Hologic MyoSure XL and Covidien TruClear 8.0) within a model uterine system. This was performed across various operational modes (diagnostic, therapeutic).
- Results: The results of these tests demonstrated that the subject device met its specifications.
- Conclusion: The non-clinical performance testing confirmed that the differences in the modified Aveta System (inclusion of Aveta Handswitch and compatibility with third-party hysteroscopes) did not raise new questions of safety and effectiveness, and the device performs as safely and effectively as its predicate.
§ 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.