(266 days)
The Kronner Side-Kick is intended to assist the surgical staff in mounting, positioning and holding a uterine manipulator during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.
For holding uterine manipulators during laparoscopic or open surgery on female pelvic organs.
The Kronner Side-Kick uterine manipulator holder is used to mount, position and hold in position uterine or vaginal manipulators used in laparoscopic surgical procedures. It is made mostly from aluminum and stainless steel and is mounted to standard operating room tables and locked in position allowing surgical devices to be securely held in position for long periods of time. Use of the Sidek-Kick frees operating room staff for other activities and reduces fatigue associated with manually maintaining a device in position during surgical procedures.
The manipulator is inserted into the patient using standard technique, then the Side-Kick is joined to the manipulator.
With proper adapters the Side-Kick may be used with various manipulators, such as the RUMI, the V-Care and the Arch Koh,
A gas supply module, which can be attached to the operating table rail, transfers nitrogen or compressed air from the wall or a portable tank to the Side-Kick holder through two flexible lines. When the switch is turned on the Side-Kick joints are locked. When the switch is turned off the Side-Kick joints are unlocked.
Pressing a foot pedal releases all the Side-Kick joints for position changes. When the foot pedal is released the joints lock. The foot pedal is connected to the gas supply module through two lines covered by a protective hose.
A branched gas line connects the two luers of the Arm assembly to the gas supply module. A single gas line connects the gas supply module to the main pivot.
The Kronner Side-Kick remains external to the patient's body at all times.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 1. Arch Koh, RUMI, and V care manipulators can be attached to Sidekick adapters satisfactorily and can be used, as required, for the intended use. | Factory tested and confirmed to meet this criterion. |
| 2. Arch Koh, RUMI, and V care manipulators will be able to move the uterus through a range required for the surgery. | Factory tested and confirmed to meet this criterion. |
| 3. Arch Koh, RUMI, and V care manipulators will be held with the strength required for holding the uterus during the surgery. | Factory tested and confirmed to meet this criterion. |
| 4. All Sidekick components will perform as required. | Factory tested and confirmed to meet this criterion. |
| 5. All Sidekick components can be easily assembled in an operating room environment. | Factory tested and confirmed to meet this criterion. |
2. Sample Size and Data Provenance for Test Set
The provided document states "Kronner Sidekick and Sidekick uterine manipulator adapters are factory tested." This implies that all manufactured units undergo this testing. Therefore, the sample size for the test set would be 100% of the production units. The data provenance is prospective, from factory testing conducted by Kronner Prototypes, Inc. The country of origin is not explicitly stated but is implied to be the USA, given the company's address (Roseburg, OR) and submission to the FDA.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not mention the use of external experts to establish ground truth for the factory acceptance testing. The testing appears to be internal to Kronner Prototypes, Inc., and overseen by their design analysis and quality control processes.
4. Adjudication Method (Test Set)
No formal adjudication method (like 2+1 or 3+1) is described for the factory testing. The criteria are likely assessed against predefined specifications by internal personnel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned in the provided document. The device is a physical holder, not an imaging or diagnostic AI tool that would typically involve such a study to compare human reader performance with and without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was conducted in the form of "factory testing." The results of this testing are what is described under the "Reported Device Performance" in the table above. The document emphasizes that "Design analysis and testing has been conducted to confirm that basic functional characteristics of the subject device is substantially equivalent to the predicate device cited, and that design output meets the design input requirements." This pertains to the standalone performance of the device itself.
7. Type of Ground Truth Used
The ground truth used for the factory testing is based on predefined design input requirements and functional specifications for the device. These specifications would dictate what constitutes "satisfactory attachment," "required range of motion," "required strength," and proper performance and assembly.
8. Sample Size for Training Set
The concept of a "training set" is not applicable to this device. The Kronner Side-Kick Uterine Manipulator Holder is a physical medical device, not an AI or machine learning algorithm that requires a dataset for training.
9. How Ground Truth for Training Set Was Established
As there is no training set for a physical device, this question is not applicable.
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. 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.