(113 days)
The MORCELLEX SIGMA™ Generator is used with the following ETHICON Morcellation Devices: GYNECARE X-TRACT™, GYNECARE MORCELLEX™, and MORCELLEX SIGMA™. The MORCELLEX SIGMA™ Generator is used in conjunction with the ETHICON Morcellation Devices for gynecologic, urologic, and general surgical endoscopic use by trained professionals in hospital environments and ambulatory surgery centers. The MORCELLEX SIGMA™ Generator is used in conjunction with ETHICON Morcellation Devices for cutting, coring, and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.
The MORCELLEX SIGMA™ Generator provides mechanical power to the ETHICON laparoscopic tissue morcellators via the morcellator's Flexible Drive Cable which connects the morcellator to the MORCELLEX SIGMA™ Generator. The MORCELLEX SIGMA™ Generator is equipped with a bi-directional motor that has a user-selectable speed range at which to rotate the ETHICON laparoscopic tissue morcellator. Activation buttons located on the Front Panel of the device allow the user to select the motor rotation direction and the speed of rotation.
The provided text describes the MORCELLEX SIGMA™ Generator, a device used with laparoscopic tissue morcellators, and its 510(k) pre-market notification. The document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study results for novel acceptance criteria.
The acceptance criteria and study information is highly limited to bench testing for performance and electrical safety/EMC.
Here's an breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria. Instead, it describes characteristics that were evaluated and implies that the performance met the requirements for substantial equivalence to the predicate device.
| Characteristic Evaluated | Reported Device Performance |
|---|---|
| Bench Studies: | |
| Device Weight | Evaluated (Implied to be comparable or acceptable for intended use, given it's "same approximate weight" as predicate) |
| Speed | Evaluated (Stated to have "the same operational speed" as the predicate device, with a "user-selectable speed range") |
| Torque Output | Evaluated (Stated to provide "greater maximum torque output compared to the predicate device") |
| Activation/De-activation Pressure | Evaluated |
| Compatibility with ETHICON Laparoscopic Tissue Morcellators | Evaluated (Bench testing conducted to demonstrate compatibility) |
| Electrical Safety and EMC: | |
| Electrical Safety | Conducted in accordance with IEC 60601-1:1988 + A1:1991 + A2:1995 Medical Electrical Equipment - Part 1: General requirements for safety. (Implied compliance with standards) |
| Electromagnetic Compatibility | Conducted in accordance with IEC60601-1-2:2007 Medical electrical equipment – Part 1: General requirements for safety 2. Collateral standard: Electromagnetic compatibility - Requirements and tests. (Implied compliance with standards) |
| Other Comparisons: | |
| Fundamental Technology | Same as predicate device |
| Basic Design | Same as predicate device |
| Principle of Operation | Same as predicate device |
| Bi-directional Motor Rotation | Both the MORCELLEX SIGMA™ Generator and the predicate device provide bi-directional motor rotation. |
| Rated Voltage | Essentially the same as the predicate device. |
| Rated Frequency | Identical to the predicate device. |
| Dimensions | Same as the predicate device. |
| Maximum Power Draw | Greater than the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "bench studies" for performance evaluation and "Electrical safety and electromagnetic compatibility testing." There is no mention of a "test set" in the context of patient data or clinical imaging. These are laboratory-based tests. Therefore, specific sample sizes (e.g., number of devices tested for each characteristic) or data provenance (country of origin, retrospective/prospective) for a clinical test set are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a mechanical generator, and the "ground truth" for its performance is established through engineering and electrical testing against design specifications and relevant standards, not through expert clinical consensus on patient data.
4. Adjudication Method for the Test Set
Not applicable, as there is no human-interpreted "test set" or clinical data mentioned.
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 surgical generator and does not involve AI or human "readers" interpreting output.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is inherent in its mechanical and electrical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is based on:
- Engineering specifications and design requirements: for characteristics like speed, torque, weight, and dimensions.
- International standards: IEC 60601-1 and IEC 60601-1-2 for electrical safety and electromagnetic compatibility.
- Comparison to the predicate device: to establish substantial equivalence in terms of fundamental technology, basic design, principle of operation, and functional characteristics.
8. The sample size for the training set
Not applicable. This is a medical device (generator), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.