(140 days)
The ConMed VCARE® Retractor/Elevator is indicated for manipulation of the uterus, and iniection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
The modified VCARE® (Vaqinal-Cervical-Ahluwalia's-Retractor-Elevator) ("VCARE") is a disposable, single-use device for manipulation of the uterus and cervix in surgical and diagnostic procedures. The modified VCARE consists of an insulated manipulator tube having an inflatable balloon at its distal [to user] end and an anatomically configured cannula/handle for maintaining proper attitude of the uterus at the proximal end. The insulated manipulator tube is marked with reference graduations from the distal end (centimeters). The graduations are provided as a guide for comparison to a graduated uterine sound. VCARE incorporates a cervical cup to provide manipulation of the uterus, and retraction and elevation of the cervix. There are four (4) size variations of cervical cups - Small (S), Medium (M), Large (L), and Extra-Large (XL). The cervical cups are green and provide a colpotomy quide. Sites for suturing are located on the cervical cup. Differences between the predicate device and the modified VCARE improve device performance and functionality for uterine manipulation during the indicated procedures and are limited to: 1) New occluder design for sealing pneumoperitoneum once colpotomy is performed, 2) Improved handle design, and 3) Revised component retention mechanism and balloon length.
The provided documentation is a 510(k) Summary of Safety and Effectiveness for the ConMed VCARE® (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator). This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a detailed clinical study with a defined ground truth.
Therefore, many of the requested elements about acceptance criteria, study design, expert involvement, and ground truth establishment are not explicitly present in the provided text. The submission focuses on non-clinical performance testing and a comparison to a predicate device.
Here's an analysis of the provided information relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific quantitative targets and corresponding reported device performance. Instead, it broadly states that "Design verification demonstrates devices comply with design specifications and applicable sections" of various ISO and AAMI/ANSI standards. The "performance" is described in qualitative terms or by stating equivalence to the predicate.
The following table summarizes the types of performance aspects tested and the general conclusion, as specific numerical acceptance criteria are not provided.
| Acceptance Criteria Category (Derived from Testing) | Reported Device Performance |
|---|---|
| Design Specifications & Standards Compliance | Complies with design specifications and applicable sections of ISO 11607-1:2006 (Sterilization - Packaging), ISO 11135-1:2007 (Sterilization - Ethylene Oxide), AAMI/ANSI ST67:2011 (Sterilization - EO compatibility), ISO 10993-7:2008 (Biocompatibility - EtO Residuals), ISO 594/1:1986 (Conical Fittings), and ISO 594-2:1998 (Luer Fittings). |
| Component Retention | Product bench testing included component retention. Results demonstrate compliance. |
| Balloon Performance | Product bench testing included balloon performance. Results demonstrate compliance. |
| Sealing of Pneumoperitoneum | Product bench testing included sealing of the pneumoperitoneum. Results demonstrate compliance. This is a specific improvement with the "new occluder design." |
| Material Properties | Product bench testing included material properties. Results demonstrate compliance. |
| Handle Torque | Product bench testing included handle torque. Results demonstrate compliance. |
| Ergonomics & Usability (Human Factors) | Product bench testing included ergonomics and usability. Results demonstrate compliance. Design validation testing in simulated use environments demonstrates conformance to user needs and intended use. The "improved handle design" and "revised component retention mechanism and balloon length" aimed to improve functionality based on user feedback. |
| Biocompatibility | Material analysis and testing demonstrate the patient contacting materials are biocompatible and comply with the requirements of ISO 10993-1:2009. |
| Substantial Equivalence | The modified VCARE is safe and effective and substantially equivalent to the predicate as demonstrated by non-clinical performance testing for the same intended use/indications for use, target population, principles of operation, performance specifications, and standards for sterilization, packaging, and biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document refers to "non-clinical bench and simulated use testing" and "product bench testing," but does not provide specific sample sizes (e.g., number of devices tested).
- Data Provenance: The testing appears to be internal research and development ("design verification," "design validation testing") conducted by ConMed Corporation. The country of origin for the data is implied to be the United States, given that ConMed Corporation is based in Utica, NY. The testing is described as "simulated use environments," indicating prospective testing within a laboratory or controlled setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided. The testing described is primarily engineering and materials performance, not diagnostic performance requiring expert interpretation for ground truth. The document mentions "user review and feedback" as a basis for design improvements, suggesting input from medical professionals indirectly informed the design, but not as part of a formal ground truth establishment for a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication, as the tests described are objective, non-clinical performance assessments (e.g., material strength, sealing ability, compliance with standards).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not an AI/algorithm-based device, nor is it a diagnostic device where MRMC studies are typically performed. The device is a surgical instrument.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This question is not applicable as the device is a physical surgical instrument, not an AI algorithm.
7. The Type of Ground Truth Used
For the non-clinical performance and material testing, the "ground truth" would be the engineering specifications, relevant ISO/AAMI standards, and established physical/chemical properties. For "usability" and "ergonomics," implicit "ground truth" would derive from user feedback and design requirements aimed at surgical efficacy and safety, but not a formally defined ground truth in the context of diagnostic accuracy.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design process involves iterative development, testing, and refinement, but not a formally defined training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.