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The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).

The ManipulatOR PRO is indicated for manipulation of the uterus during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion and diagnostic laparoscopy. The ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.

The ManipulatOR and ManipulatOR PRO are sterile, single-use uterine manipulators indicated for uterine manipulation and preventing loss of pneumoperitoneum during laparoscopic gynecology procedures. The ManipulatOR and ManipulatOR PRO are silicone insulated and anatomically designed stainless steel manipulators with a silicone intrauterine balloon at one end and an external handle at the other end. The balloon is inflated with air using a 20cc syringe that is supplied with the device.

The ManipulatOR and ManipulatOR PRO are designed to improve physician visibility of the uterus and cervix during various medical examinations and procedures. Like many uterine elevators currently in the market place, the ManipulatOR and ManipulatOR PRO are designed for use in surgical procedures requiring cervical uterine motions with elevation and retraction of the vaginal fornices. The ManipulatOR and ManipulatOR PRO can help to create the tension on the tissue to assist in ligament dissection. In the most commonly used procedure, the total laparoscopic hysterectomy, the uterine elevator must expose the fornix and seal the vagina following removal of the uterus.

The provided document is a 510(k) summary for the Gynetech ManipulatOR and ManipulatOR PRO devices. It describes the devices, their intended use, and claims substantial equivalence to previously cleared predicate devices.

However, the document does not contain information about acceptance criteria, detailed study designs, specific device performance metrics, sample sizes for test or training sets, ground truth establishment, or expert involvement for a performance study.

Instead, the document primarily focuses on:

• Indications for Use: What the device is cleared to do.
• Technological Characteristics: How the device is similar to and different from its predicate, largely related to material changes (addition of colorants).
• Performance (mention only): A general statement that the devices were subjected to safety and performance testing for the initial 510(k) review and passed biocompatibility testing. It states this testing "demonstrated the functionality and safety of the device for its intended use."

Therefore, based solely on the provided text, I cannot complete the requested tables and information about acceptance criteria and a study proving device performance in detail.

The document states: "The ManipulatOR and ManipulatOR PRO were subjected to safety and performance testing by the manufacturer for the initial 510(k) review." and "The performance testing undertaken for the initial 510(k) review demonstrated the functionality and safety of the device for its intended use." This is a summary statement, not a detailed report of a performance study. No specific metrics like sensitivity, specificity, accuracy, or other quantitative performance measures are given.

In the context of 510(k) submissions, "performance testing" often refers to engineering and bench testing to ensure the device meets its design specifications and safety requirements, rather than a clinical study evaluating diagnostic accuracy or reader improvement. The described changes (colorants) are material changes, and the associated performance testing would likely be focused on biocompatibility and mechanical property verification, not a clinical study of efficacy.

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The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).
The ManipulatOR PRO is indicated for manipulation of the uterus during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion and diagnostic laparoscopy. The ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.

The ManipulatOR and ManipulatOR PRO are sterile, single-use uterine manipulators indicated for uterine manipulation and preventing loss of pneumoperitoneum during laparoscopic gynecology procedures. The ManipulatOR and ManipulatOR PRO are silicone insulated and anatomically designed stainless steel manipulators with a silicone intrauterine balloon at one end and an external handle at the other end. The balloon is inflated with air using a 20cc syringe that is supplied with the device. The ManipulatOR and ManipulatOR PRO are designed to improve physician visibility of the uterus and cervix during various medical examinations and procedures. Like many uterine elevators currently in the market place, the ManipulatOR and ManipulatOR PRO are designed for use in surgical procedures requiring cervical uterine motions with elevation and retraction of the vaginal fornices. The ManipulatOR and ManipulatOR PRO can help to create the tension on the tissue to assist in ligament dissection. In the most commonly used procedure, the total laparoscopic hysterectomy, the uterine elevator must expose the fornix and seal the vagina following removal of the uterus.

This document is a 510(k) summary for the Gynetech ManipulatOR and ManipulatOR PRO. It details the device's indications for use, its description, and a summary of performance and safety data, as well as a substantial equivalence discussion.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., "device must withstand N newtons of force"). Instead, it lists various performance tests and indicates that they were "successfully completed to confirm the subject device met the user requirements for the proposed intended use." The reported device performance is qualitative, confirming that the tests were passed.

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

The document does not specify the sample sizes for the various performance tests (e.g., number of devices tested for air leak, balloon integrity, etc.). The provenance of the data is from Gynetech Pty Ltd, an Australian company. The studies appear to be prospective bench testing and biocompatibility testing, conducted by the manufacturer to demonstrate device performance. This is not clinical data, but rather engineering and laboratory testing.

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. The performance data is derived from technical bench tests and biocompatibility testing, not from expert review of data that would require "ground truth" establishment in the traditional sense of clinical studies.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are bench tests and biocompatibility assessments, not clinical studies involving expert adjudication of findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes technical performance testing and biocompatibility assessment, not a clinical study involving human readers or AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone performance study of an algorithm was not done. This device is a physical medical instrument, not an AI or software device. The listed studies focus on the physical and material performance of the uterine manipulator.

7. Type of Ground Truth Used

The "ground truth" for the performance studies described would be based on engineering specifications, material science standards (e.g., ISO 10993-1 for biocompatibility), and established test protocols to determine if the device meets its design requirements. This is not clinical "ground truth" like pathology or outcomes data.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, and the described studies are not machine learning or AI-based; therefore, there is no "training set."

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

This information is not applicable for the same reasons as in point 8.

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