(240 days)
AVETA SYSTEM:
Hysteroscopy:
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.
Cystoscopy:
The Aveta System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the system allows the user to perform various diagnostic and therapeutic procedures.
AVETA DISPOSABLE HYSTEROSCOPE (Pearl/Opal/Coral):
The Aveta Disposable Hysteroscope (Pearl/Opal/Coral) is intended to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
AVETA DISPOSABLE CYSTOSCOPE (Coral):
The Aveta Disposable Cystoscope (Coral) is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the Cystoscope allows the user to perform various diagnostic and therapeutic procedures.
The Aveta System is an integrated system which allows for visualization of the intended cavity for the purpose of performing diagnostic and operative procedures (hysteroscopy and cystoscopy). The Aveta System consists of the components listed in Table 1. The system includes a Controller with integrated fluid management which incorporates a dual peristaltic pump design to control the continuous inflow and outflow of saline to provide fluid distention of the cavity. The Controller provides continuous monitoring of the cavity pressure to the set pressure. For hysteroscopy, it also monitors the volume differential between saline inflow from the uterus (fluid deficit). The Controller connects to a sterile, single use disposable Scope (available in various configurations, see below) that allows visualization of the cavity and displays the images obtained from the Scope on a standard monitor. For operative hysteroscopy procedures, the Aveta System includes sterile, mechanical Disposable Resecting Device (available in various configurations, see below) powered by an integrated motor in the device handset or by use of an external Resecting Handset (available in two configurations, as a disposable device or a reusable device). The resecting device is inserted through the working channel of the sterile hysteroscope to resect the target tissue/pathology. For cystoscopy, when combined with accessory instruments the cystoscope is used for diagnostic and therapeutic procedures.
The provided document is a 510(k) Premarket Notification for the Meditrina Aveta System. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch in the same way a PMA (Premarket Approval) would. As such, the information provided focuses on comparative performance and engineering tests, rather than clinical efficacy studies with specific acceptance criteria related to disease detection or treatment outcomes.
Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 as it pertains to acceptance criteria for algorithmic performance, sample sizes for test sets, expert-established ground truth, MRMC studies, or multi-reader studies. The "performance data" section (Section VII) lists various engineering and bench tests, but these are not for the purpose of demonstrating diagnostic or clinical performance in a "study" as implied by the request.
The "study that proves the device meets the acceptance criteria" in this context refers to the bench and engineering tests conducted to demonstrate that the modified Aveta System performs equivalently to its predicate and meets safety standards.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria and reported device performance in the sense of accuracy metrics (e.g., sensitivity, specificity) for a diagnostic AI/ML device. The "performance data" section lists types of tests performed (e.g., "Pressure accuracy and control," "Optical testing," "Motor/Oscillation speed"), but it does not specify the numerical acceptance criteria for these tests nor the exact quantitative results achieved by the device against those criteria. It only states that the tests were performed "per approved test protocols."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information about sample sizes for a clinical "test set" or data provenance (country, retrospective/prospective) is provided. The performance data listed (Section VII) refers to engineering and bench tests on the device's components and system function (e.g., integrity, dimensional inspection, functional testing). These are not data sets for an AI/ML algorithm.
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):
This information is not provided. The study is a 510(k) submission, focused on engineering and functional equivalence rather than clinical diagnostic performance that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/not provided. No clinical test set requiring adjudication is mentioned.
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:
No MRMC study or any study involving human readers with or without AI assistance is mentioned. The device described appears to be an endoscopic system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/not provided. The device is a physical system for visualization and surgical procedures, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable/not provided. The "ground truth" in this context would be the design specifications and functional requirements met by the engineering tests, not a clinical ground truth for diagnostic accuracy.
8. The sample size for the training set:
Not applicable/not provided. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable/not provided. This device is not an AI/ML algorithm that requires a training set with established ground truth.
In summary, the provided document details a 510(k) submission for a medical device (Aveta System, a hysteroscope/cystoscope system). It focuses on demonstrating substantial equivalence to a predicate device through engineering and bench testing, rather than reporting on the performance of an AI/ML model for diagnostic purposes as implied by the structure of your questions.
§ 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.