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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.

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.

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