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VCARE Dx uterine manipulator/injector cannula is indicated for manipulation of the uterus, and injection of fluids during laparoscopic gynecologic procedures such as laparoscopic supracervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy.

VCARE Dx™ uterine manipulator/injector cannula is a sterile, disposable, single-patient use device which consists of a hollow, rigid, insulated, anatomically curved manipulator tube (OD: 5mm; length: 48cm (19") including handle) with an inflatable PVC intrauterine balloon at the proximal end, graduations (cm) along the shaft measuring distance from the proximal end and a molded handle at the distal end for maintaining proper attitude of the uterus. The graduations on the shaft of the VCARE Dx™ can be used as a guide for comparison to a graduated uterine sound, if one is used. The intrauterine balloon is inflated by passing air via a standard syringe (not included) through the distally located pilot balloon/valve assembly. The internal tip of the manipulator tube is open to allow direct intrauterine introduction of dye/contrast media via the injector port on the rear of the handle, when prescribed. VCARE DxTM incorporates a component that seats against the cervix providing a positive stop from over-penetration of the uterine cavity and counter traction with the intrauterine balloon for effective manipulation. The rear portion of the device is secured at its proper depth with a locking mechanism situated at the rear of the main tube and external to the patient.

The provided K093556 document describes a 510(k) submission for the VCARE Dx uterine manipulator/injector cannula. The regulatory pathway for this device is based on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of substantial equivalence rather than explicit performance targets.

Here's an analysis of the document's information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define quantitative "acceptance criteria" for the VCARE Dx in terms of specific performance metrics or thresholds. Instead, the "acceptance criteria" were implied to be the performance specifications and functional design of the predicate device, VCARE (K955446). The study aimed to demonstrate that the VCARE Dx performed similarly to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "A comparison test was performed between VCARE Dx (subject device) and VCARE (predicate device) to test similar performance specifications."

• Sample Size: The document does not specify the sample size used for this comparison test.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a performance verification test likely conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. Given that the study was a comparison of performance specifications between two devices, it's unlikely that external medical experts were used to "establish ground truth" in the way they would for, say, diagnostic accuracy. The assessment would have been against engineering specifications or functional outputs.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which doesn't appear to be the primary focus of this engineering comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

An MRMC comparative effectiveness study was not performed, nor is it applicable to this device. The VCARE Dx is a physical medical device (uterine manipulator/injector cannula), not an AI algorithm or diagnostic tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

A standalone performance study in the context of an "algorithm only" or "AI" is not applicable to this device. It is a physical medical device. The "performance verification" was a comparison of the device itself to its predicate.

7. The Type of Ground Truth Used:

For the performance verification, the "ground truth" was effectively the established performance specifications and functional design of the legally marketed predicate device (VCARE). The study aimed to show that VCARE Dx met these same functional and specification standards. It was not a diagnostic device where pathology or outcome data would be the ground truth.

8. The Sample Size for the Training Set:

This is not applicable as the VCARE Dx is a physical medical device and does not involve a "training set" in the context of machine learning or AI algorithms.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the reasons stated above.

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