(394 days)
The Greatbatch Scientific MR Compatible Hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Greatbatch Scientific MR Compatible Hysteroscopes are available in standard and autoclavable 2.0mm and 4.0mm outer diameters with 0° and 30° viewing angles.
The provided text describes the 510(k) summary and FDA clearance letter for the Greatbatch Scientific MR Compatible Hysteroscope. It states that the device was tested for MR compatibility. However, the document does not provide detailed information about the acceptance criteria or the specific study details for proving the device meets those criteria. The information below is limited to what can be extracted from the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| MR Compatibility in a shielded 1.5 Tesla magnet | "was found to be acceptable for use in a shielded 1.5 Tesla magnet" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size or data provenance for the MR compatibility testing.
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)
Not applicable. The testing was for MR compatibility, which typically involves physical measurements rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation of results.
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 device is a medical instrument, not an AI software, and the testing was for MR compatibility, not for diagnostic accuracy that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical instrument, not an AI algorithm. The testing was for the inherent MR compatibility of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for MR compatibility would be established by specific performance standards and physical measurements as defined by applicable medical device standards for MR safety (e.g., ASTM standards for MR compatibility). The document does not explicitly state the specific standards or measurements used.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 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.