(504 days)
The Morce Power Plus morcellator is intended for use in operative laparoscopy, including laparoscopic general surgical procedures and laparoscopic gyrocological procedures to morcellate and remove tissue.
The VarioCarve morcellator is intended for morcellating and extracting tissue (e.g. removing myomata or the uterus) during laparoscopic procedures in general surgery and gynecology.
The Morce Power Plus / VarioCarve is the drive control unit for the morcellator. With a cutting blade on the distal end, a rotating cylindrical tube is inserted in the abdominal cavity.
This document is a 510(k) summary for the NOUVAG AG Morcellator (Morce Power Plus / VarioCarve). The device is a surgical morcellator used in laparoscopic procedures.
Here's an analysis of the provided text in relation to acceptance criteria and device performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no specific quantitative acceptance criteria or reported device performance metrics explicitly stated for the NOUVAG AG Morcellator. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against predefined criteria.
The general statement regarding performance is:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety & Effectiveness | "The Morcellator has been designed and tested to applicable safety standards. The Morcellator does not raise any new issues of safety, effectiveness, or performance of the product." (Implicitly, it meets the safety, effectiveness, and performance standards of the predicate devices based on substantial equivalence.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe any specific test set or clinical study with a defined sample size. The substantial equivalence claim is made based on the device's technological characteristics being similar to already legally marketed devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as there is no described test set requiring ground truth establishment by experts.
4. Adjudication Method for the Test Set
This information is not applicable as there is no described test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on substantial equivalence based on technical characteristics and intended use, not on comparative effectiveness with or without AI assistance (which is not relevant to this type of device).
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone (algorithm-only) performance study was not conducted or reported. This device is a mechanical surgical instrument, not an AI or diagnostic algorithm, so this type of study is not relevant.
7. The Type of Ground Truth Used
This information is not applicable as there is no described test set requiring ground truth. The basis for clearance is substantial equivalence to predicate devices, implying that the established safety and effectiveness of the predicates serve as a "ground truth" for the new device's similar characteristics and intended use.
8. The Sample Size for the Training Set
There is no mention of a training set in this 510(k) summary. This type of device (surgical instrument) does not typically involve AI models that require training sets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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.