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Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications.

The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in saline irrigation fluid.

Specific indications:

• transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
• lysis of intrauterine septa
• endometrial ablation .

The Olympus Resection Electrodes that are subject to this submission are for application in saline. Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporization and cutting.

The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft).

The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, rollers, needles or buttons.

All subject Resection Electrodes are single-use electrodes and are delivered sterile and are used in combination with a reusable HF cable (the HF cable is not subject to this submission).

This device is a set of Resection Electrodes for gynecological applications. The submission states that the subject device is identical in design and manufacturing to the predicate device (K152092), and therefore, the current submission relies on performance testing, sterilization, and packaging validation testing previously reviewed and deemed acceptable in K152092.

As such, without access to the K152092 submission, I cannot provide details on the specific acceptance criteria, study design, sample sizes, expert qualifications, or ground truth methods. The provided document for K161600 only states that the performance data for K161600 is based on the performance data of K152092 without re-presenting the actual data for K152092.

However, based solely on the information provided in the K161600 document, I can infer the following about what would have been implicitly accepted given the "identical" claim:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in K161600 as it defers to K152092. It would typically include metrics related to electrosurgical performance (e.g., cutting efficiency, coagulation effectiveness, impedance characteristics, thermal spread, mechanical stability of the electrodes under stress, durability during use, material biocompatibility, and electrical safety).

2. Sample sizes used for the test set and data provenance: Not explicitly stated in K161600. These would have been part of the studies for predicate device K152092.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not explicitly stated in K161600. If clinical studies were part of K152092, expert evaluation would have been involved, likely by urologists (for the predicate device's original indication) or potentially other surgeons if generalized tissue effects were assessed.

4. Adjudication method for the test set: Not explicitly stated in K161600.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is more common for diagnostic imaging AI devices, not electrosurgical electrodes.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical tool, not an AI algorithm. Its performance is always in conjunction with human use.

7. The type of ground truth used: Not explicitly stated in K161600. For electrosurgical devices, ground truth might involve objective measurements of tissue effect (e.g., depth of coagulation, width of cut, histological analysis post-ablation), electrical parameters, and mechanical testing results, rather than expert consensus on diagnostic images.

8. The sample size for the training set: Not applicable. This device is an electrosurgical tool, not an AI/ML algorithm that relies on a training set.

9. How the ground truth for the training set was established: Not applicable.

However, the document does contain information about the regulatory review and basis for substantial equivalence:

Summary of Acceptance Criteria and Study (Implicitly from K152092):

Since K161600 claims identical design and manufacturing to K152092 and relies on K152092's performance data, the acceptance criteria and study would have been related to demonstrating the safe and effective performance of electrodes for electrosurgical cutting and coagulation.

Key Performance Data Categories (Inferred from industry standards for electrosurgical devices):

• Electrical Performance: Power output, impedance matching, current distribution, absence of arcing.
• Thermal Performance: Controlled tissue heating, minimal collateral thermal damage, effective coagulation/cutting.
• Mechanical Integrity: Durability of the electrode tip, insulation, and shaft during simulated use; resistance to bending and fracturing.
• Biocompatibility: Confirmation that materials are biocompatible (typically by testing or established use).
• Sterilization Validation: Ensuring the device can be consistently sterilized.
• Packaging Validation: Ensuring sterility is maintained until use and transit integrity.

How the Device Meets Acceptance Criteria:

The device meets the acceptance criteria by being identical in design and manufacturing to the previously cleared predicate device K152092, whose performance data was already deemed acceptable by the FDA for urological indications. The K161600 submission argues that despite different indications (gynecological vs. urological), the "intended use" is the same (electrosurgery in saline) and there is an "extensive knowledge base regarding the use of bipolar electrosurgery for gynecological applications." This implies that the fundamental performance characteristics demonstrated in K152092 are transferable and acceptable for the new indications.

The document explicitly states:

• "The subject device is identical in design and manufacturing to the predicate device (K152092). Therefore, the current submission relies on performance testing previously reviewed and deemed acceptable in K152092."
• "Sterilization is performed according to ISO 11135 and packaging conforms with ISO 11607-1. Since the subject device is identical in design and manufacturing to the predicate device, the current submission relies on sterilization and packaging validation testing previously reviewed and deemed acceptable in K152092."

Therefore, the "study that proves the device meets the acceptance criteria" is the original set of studies performed for the K152092 submission, which are not detailed in this document.

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