(175 days)
The Smith & Nephew IUR Morcellation System is intended for use in gynecological procedures by trained professional gynocologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.
The Smith & Nephew IUR Morcellation System is used to perform hysteroscopic surgery for the removal of Submucous myomas and endemontar peopator, a motor drive unit, and a motor drive control unit. Smith & Nephew's IUR Morcellation System uses mechanical resection to remove endometrial polyps and submucous myomas. The Smith & Nephew IUR Morcellation control unit meets UL 2601-1 and IEC 60601-1, electrical safety standards for BF type equipment.
The provided document is a 510(k) summary for the Smith & Nephew IUR Morcellation System. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a detailed study proving performance is not available in this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary focuses on substantial equivalence to predicate devices, not on proving performance against specific quantitative metrics or acceptance criteria through a clinical or performance study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. No specific test set, patient data, or study details are discussed.
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 in the document. No discussion on ground truth establishment or expert involvement in a test set is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method is mentioned as there is no test set or performance evaluation described.
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
This information is not provided in the document. The device described is a mechanical tissue resection system, not an AI-assisted diagnostic tool, so an MRMC study or AI-related considerations are not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. As this is a mechanical device, the concept of "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the document. No ground truth is discussed as there is no performance study.
8. The sample size for the training set
This information is not provided in the document. There is no mention of a "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not provided in the document. As there is no training set, this question is not applicable.
Summary of what the document DOES provide, relevant to its purpose:
The document serves as a 510(k) summary, which aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than a performance study against specific acceptance criteria.
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Predicate Devices: The Smith & Nephew IUR Morcellation System is deemed substantially equivalent in intended use and fundamental technological characteristics to:
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Intended Use: The device is intended for use in gynecological procedures by trained professional gynecologists to resect and remove endometrial tissue for submucous myomas and endometrial polyps.
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Technological Characteristics Comparison: The system is stated to be substantially equivalent in design, materials of construction, function, and/or intended use to the predicate devices. It also mentions meeting electrical safety standards (UL 2601-1 and IEC 60601-1 for BF type equipment).
Conclusion:
The provided document is a regulatory submission for premarket clearance based on substantial equivalence, not a detailed study outlining acceptance criteria and device performance metrics. Therefore, most of the questions related to clinical study design, sample sizes, ground truth establishment, and performance outcomes cannot be answered from this text.
§ 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.