(136 days)
The Aveta Disposable Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Aveta Disposable Hysteroscope is used by physicians in an office or operating room setting. The subject device includes the Aveta Disposable Hysteroscope and Aveta Controller. Like the Aveta Disposable Hysteroscope cleared under K190372, the modified Aveta Disposable Hysteroscope includes a camera and LED light. The Aveta Disposable Hysteroscope is connected to the Aveta Controller to provide the camera and light functions and to process and store the image obtained from the Aveta Disposable Hysteroscope.
For fluid management, the Aveta Disposable Hysteroscope can be used with gravity fed pressurized saline bag or the fluid management system cleared under K190372. For therapeutic procedures, the Aveta Disposable Hysteroscope is used with the cleared Aveta Disposable Resecting Device (K190372). The only functional buttons on the Aveta Disposable Hysteroscope handle are the image capture and the image transfer buttons. For the modified device, when other buttons on the handle are pressed, the Aveta Controller does not take any action.
Other than minor change to the Aveta Controller software to disable fluid management related buttons on the Aveta Disposable Hysteroscope, there is no change to the components of the cleared Aveta System (K190372).
This document is a 510(k) premarket notification for the "Aveta Disposable Hysteroscope" (K192100). The request is a submission to demonstrate substantial equivalence to a legally marketed predicate device (Aveta System, K190372). The provided text describes the device, its intended use, and a comparison to the predicate device. It also briefly mentions non-clinical performance testing.
However, the document does not contain information about acceptance criteria, clinical study design, sample sizes for test or training sets, expert qualifications, ground truth establishment methods, or whether MRMC or standalone performance studies were conducted.
Therefore, I cannot fulfill your request for details on the acceptance criteria and the study that proves the device meets those criteria using only the provided text for the Aveta Disposable Hysteroscope (K192100).
The provided text focuses on demonstrating substantial equivalence through non-clinical performance testing and a comparison of technological characteristics and indications for use to a predicate device. This type of submission (510(k)) typically relies on comparisons to demonstrate safety and efficacy, rather than extensive new clinical studies with detailed acceptance criteria as one might see for a PMA or novel AI/ML device where clinical performance is the primary assessment.
Based on the provided document, the only "study" mentioned is "Non-Clinical Performance Testing," which includes:
- Software verification
- Simulated Use with gravity fed pressurized saline bag: This involved demonstrating regulation of cavity pressure in a model uterine system, flow rate tests, and tissue resection.
Here's what I can extract and what is explicitly missing based on your request categories:
1. A table of acceptance criteria and the reported device performance
- Missing from the document. The document only states that "Results demonstrate the subject device met specifications" for the simulated use testing, but it does not list those specifications or acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing from the document. The non-clinical testing appears to be primarily benchtop and simulated use; therefore, there isn't a "test set" in the context of patient data.
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 from the document. This is a non-clinical evaluation, so expert adjudication of patient data for ground truth is not applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing from the document. Not applicable for this type of non-clinical submission.
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 from the document. This device is a hysteroscope, not an AI/ML diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing from the document. Not applicable, as this is a medical device, not an AI algorithm. Its performance is evaluated in conjunction with human use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing from the document. For non-clinical testing, "ground truth" would typically refer to established engineering and performance specifications validated through physical measurements and simulations, rather than clinical ground truth from patients. The document does not specify these.
8. The sample size for the training set
- Missing from the document. Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Missing from the document. Not applicable.
Summary of available information related to performance:
- Device Name: Aveta Disposable Hysteroscope (K192100)
- Predicate Device: Aveta System (K190372)
- Type of Evaluation: Non-Clinical Performance Testing to demonstrate substantial equivalence to a predicate device.
- Tests Performed:
- Software verification
- Simulated Use with gravity-fed pressurized saline bag (demonstrated: regulation of cavity pressure in a model uterine system, flow rate tests, tissue resection).
- Conclusion: "The results of the non-clinical testing described above demonstrate that the subject device is as safe and effective as the predicate device and support the subject device is substantially equivalent to the predicate device."
To obtain the specific details requested in your prompt, you would need access to the full 510(k) submission (e.g., test reports) which is not typically made public in this summarized format.
§ 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.