(277 days)
The ViKY UP device is indicated for computer-controlled laparoscopic hysterectomies (such as da Vinci-assisted laparoscopic hysterectomies) for the purpose of holding and controlling the movement of a uterine manipulator.
ViKY UP is a motorized uterine manipulator positioner for computer-controlled laparoscopic hysterectomies. ViKY UP holds and moves the uterine manipulator in three directions according to surgeon orders by means of either a foot controller or a voice controller. Use of the ViKY UP allows surgeon to remotely gain control on uterine manipulator positioning from his operating position. The ViKY UP includes two attachment mechanisms: one at its first end for mounting the system to the operating room table and the other at the second end for securely grasping a uterine manipulator. The ViKY UP remains external to the patient's body at all times and can be steam sterilized.
The provided text describes the ViKY UP device, a motorized uterine manipulator positioner, and its submission for 510(k) clearance. However, the document does not contain a typical "acceptance criteria" table with specific metrics (like sensitivity, specificity, accuracy) and corresponding performance targets, nor does it detail a study designed to prove the device meets such criteria in a quantitative, statistical sense.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through design analysis, bench testing, and a clinical study assessing safety and effectiveness.
Here's a breakdown of the information that can be extracted, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, a formal table of quantitative acceptance criteria and corresponding performance metrics is not provided in this document. The "acceptance criteria" are implied by the overall goal of demonstrating safety and effectiveness for its intended use and substantial equivalence to predicate devices.
The reported device performance is qualitative:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety | "No adverse effects or complication were observed during the study." "did not create new risk" |
| Effectiveness | "The results showed safety and effectiveness of the device for computer-controlled laparoscopic hysterectomies." |
| Usability/Ergonomy | "These tests validated usability and ergonomy of the ViKY UP device." |
| Compliance with Marketing System Requirements | "confirmed that basic functional characteristics are in compliance with marketing system requirements." |
| Meeting Design Input Requirements | "design output meets the design input requirements." |
| Substantial Equivalence | "The ViKY UP device is substantially equivalent to Probe Holder System (K071405) and has the same technological characteristics as the ViKY EP device (K082233)." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 30 patients
- Data Provenance: Prospective clinical study, conducted in France (based on submitter's address and lack of other indications).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth. The clinical study evaluated the device's performance in actual surgical procedures by surgeons, implying an assessment by the treating surgeons. There is no mention of an independent panel or formal "ground truth" establishment outside of the surgical outcomes.
4. Adjudication Method for the Test Set
The document does not specify any formal adjudication method (e.g., 2+1, 3+1, none) for the clinical study's observations. The reporting of "no adverse effects or complication" and "safety and effectiveness" suggests that the clinical outcomes were observed and reported without a described multi-reviewer adjudication process.
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 done. This device is a surgical manipulator, not an imaging or diagnostic device typically evaluated with MRMC studies. The study assessed the device's performance during surgery, not human reader interpretation of data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the ViKY UP device. The ViKY UP is a motorized surgical assistant (a hardware device), not an algorithm or AI system that operates in a "standalone" mode without human interaction inherent in surgical procedures. It is explicitly described as "computer-controlled" by a "surgeon" using a foot/voice controller, so human-in-the-loop operation is its only mode.
7. The Type of Ground Truth Used
The "ground truth" for the clinical study was based on clinical outcomes and observations during laparoscopic hysterectomies. This includes:
- Absence of adverse effects or complications.
- Confirmation that the device could safely and effectively manipulate the uterine manipulator.
- Observations regarding set-up time and overall procedural impact.
Essentially, the "ground truth" was derived from the real-world performance and clinical judgment of the surgical team using the device in a clinical setting.
8. The Sample Size for the Training Set
The document does not mention a training set in the context of an algorithm or AI. The "training" for a hardware device development would typically involve engineering tests and design iterations, not a data-based training set as understood for AI/ML.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no mention of a training set for an algorithm described in the document. The "ground truth" for the development of such a device would instead be engineering specifications met through bench testing, and design validation processes.
§ 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.