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For laparoscopic assisted vaginal hysterectomy
The Endoscopic Hysterectony instrument set consisting of vaginal tube, mandrin and instrumentation insert is used to support LAVH (lapa-roscopically assisted vaginal hysterectomy).

• The tube is used for visualization of the cervical portio. . The distal section of the vaginal tube can be seen during laparoscopically assisted vaginal hysterectorny, and thus serves the surgeon as a guide and support during cutting. The tube allows pneumoperitoneum to be maintained during cutting and opening of the posterior vaginal vault.
• The mandrin supports the introduction of the vagina. Prior to introduction it is inserted into . the vaginal tube and locked in place.
• The instrumentation insert has two openings instrument ports through which surgical instruments are t inserted into the vaginal tube without loss of gas.
  For the use of the uterus manipulator in endoscopic hysterectomy: Indication:
• Uterus myomatosis
• Abnormal uterine bleeding
  The Uterus Manipulator set, consisting of uterus manipulator and uterus probe is used to support LAVH.

The Endoscopic Hysterectory instruments and Uterus manipulator are designed to remove the uterus through the vagina. The obturator can be introduced into the vagina through the tube. The vaginal tube is gas tight.
The changeable distal tip of the uterus manipulator is deflectible so that the uterus can be moved in optimal operation position. The Jose invith the locking device (17). When the turned manipulator and can be lockly alia dia resea in the docking device (17). When th manipulator and can be locked and released win the deflected angle. When the luer sealing handle is moved clockwise, the used and right a nandle is moved the instrument can be cleaned by rinsing.
The uters manipulator is an instrument with a distally inclinable probe section. The part of the instrument which is inserted in the uterus serves to fix the uterus and change or manipulate its position.

The provided text describes a 510(k) submission for an "Endoscopic Hysterectomy and Uterus Manipulator" and its acceptance criteria, along with the studies (or lack thereof) conducted to demonstrate its performance.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical or diagnostic studies. The "sample sizes" for the mechanical stress tests are:
  • Vaginal tube bayonet locking system: 1 device (tested for 100,000 cycles).
  • Uterus manipulator hinge: 1 device (tested for its mechanical resistance).
  • Sterilization: Not quantifiable as a "sample size" in this context, but implies multiple sterilization cycles were performed.
• Data Provenance: The mechanical and sterilization tests were performed by Richard Wolf Medical Instruments Corporation (the manufacturer). This is internal testing. The document refers to "clinical use" for steam sterilization but does not provide details of specific studies. This is retrospective/internal company data.

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

• Not applicable. The tests performed were mechanical and sterilization tests, not diagnostic or clinical accuracy studies that require expert-established ground truth.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method was mentioned or required for the mechanical performance and sterilization tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. No MRMC comparative effectiveness study was mentioned. The device is a surgical instrument, not an AI or diagnostic tool where such studies would typically be performed to assess human reader improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• No. This is not an AI or algorithmic device; it is a physical surgical instrument. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

• Engineering specifications and standards for mechanical integrity and sterilization efficacy. For the mechanical tests, the ground truth is the absence of failure (e.g., locking system remaining tight, hinge being strong enough). For sterilization, the ground truth is effective sterilization without adverse impact on the device.

8. The Sample Size for the Training Set

• Not applicable. This device is a surgical instrument and does not involve machine learning or AI, so there is no "training set."

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

• Not applicable. As there is no training set, this question is irrelevant.

Additional Notes from the Document:

• Clinical Tests: The document explicitly states: "No clinical tests performed." It references literature (Dr. Reich, "The Role of Laparoscopy in Hysterectomy," 1994) but this is for background or validation of the procedure (LAVH), not a clinical study on the safety and effectiveness of this specific device.
• Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through substantial equivalence to legally marketed predicate devices. This means the new device is compared to existing devices concerning design, materials, intended use, and technological characteristics, arguing that it is as safe and effective as those already on the market.
• Device Type: This submission is for a traditional medical device (surgical instruments), not an advanced diagnostic or AI-driven system. The "acceptance criteria" discussed are primarily related to mechanical durability and material compatibility, typical for this class of device.

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