(98 days)
The Smith & Nephew IUR Morcellation System is intended for use in gynecological procedures by trained professional gynecologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.
The IUR Reciprocating Morcellator is a disposable, sterile, reciprocating morcellator used in conjunction with the currently cleared Smith & Nephew IUR Morcellation System (K031787), to remove submucous myomas and endometrial polyps from the uterus. The reciprocating design utilizes both a rotational and reciprocating cutting mechanisms. The predicate design utilizes a rotational cutting mechanism only.
The provided text describes a 510(k) premarket notification for a medical device, the Smith & Nephew IUR Reciprocating Morcellator. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or safety through extensive clinical trials as would be required for a novel device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Target) | Reported Device Performance |
|---|---|---|
| Safety and Performance | Does not impact safety and performance compared to the predicate device. | "In vitro testing of the IUR Reciprocating Morcellator demonstrates that the addition of new materials and the proposed design modifications does not impact the safety and performance of the proposed device." |
Explanation: In the context of a 510(k) submission, the "acceptance criteria" for the new device often revolve around demonstrating that it is as safe and effective as a previously cleared predicate device. For this specific device, the primary acceptance criterion was that its design modifications (reciprocating vs. rotational cutting) and new materials did not negatively impact its safety and performance when compared to the predicate IUR Rotary Morcellator (K031787). The reported device performance, based on in vitro testing, affirmed that this criterion was met.
Study Details
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Sample size used for the test set and the data provenance:
- The document mentions "in vitro testing." This suggests that the test set consisted of samples used in a laboratory setting (e.g., excised tissue, phantom materials) rather than human subjects.
- The specific sample size (e.g., number of tissue samples, number of test runs) is not specified in the provided text.
- The data provenance is not explicitly stated beyond being "in vitro testing." There is no mention of country of origin or whether it was retrospective or prospective in a human clinical sense. Being "in vitro" typically implies a controlled laboratory environment.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide any information regarding experts used to establish ground truth. In vitro testing typically relies on standardized measurements and objective outcomes rather than expert interpretation of results, unless the "safety and performance" criteria involve expert assessment of tissue quality post-morcellation, which is not detailed here.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not mention any adjudication method. This is consistent with in vitro testing where objective measurements are usually the primary endpoints, reducing the need for human adjudication of subjective findings.
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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, an MRMC comparative effectiveness study was not done. This device is a surgical instrument (morcellator), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical tool and does not involve algorithms or AI. It inherently requires human-in-the-loop operation. The "standalone" performance here refers to the device's functional characteristics (e.g., cutting ability, structural integrity) as measured in vitro.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For in vitro testing of a mechanical device, the "ground truth" would likely be based on:
- Objective physical measurements: such as cutting efficiency, tissue fragmentation size, power consumption, blade sharpness retention, or structural integrity under stress.
- Comparison to predicate device performance: confirming that the new device performs within the same range or better than the predicate's known performance characteristics.
- The text does not specify the exact parameters measured, but it implies that the "safety and performance" were assessed against objective criteria through "in vitro testing."
- For in vitro testing of a mechanical device, the "ground truth" would likely be based on:
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the context of algorithm development. The in vitro testing performed is for validation, not AI training.
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How the ground truth for the training set was established:
- Not applicable. As there is no AI or machine learning involved, there is no training set and thus no ground truth to be established for it.
§ 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.