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The PSD-60 has been designed to be used with OLYMPUS endoscope (fiberscope, videoscope and rigid scope) compatible with electrosurgical accessories and other ancillary equipment for general, laparoscopic and endoscopic electrosurgery ( cutting, coagulation, including soft tissue coagulation).

The argon plasma coagulation unit has been designed to be used with the electrosurgical unit, OLYMPUS PSD-60 for argon plasma coagulation (APC) of living tissues in treatment using OLYMPUS endoscope compatible with electrosurgery, argon plasma coagulation accessories and other ancillary equipment for endoscopic electrosurgery (coagulation).

The PSD-60 is an Electrosurgery unit and is used in conjunction with a OLYMPUS ENDO-PLASMA, or can be used alone. The PSD-60 has a 7-segment LCD (Liquid Crystal Display) that provides the user with an on-screen setting and operational information. The unit has various cutting and coagulation modes with defined effect levels to provide the physician flexibility in applications (i.e. Its ability is to generate the HF current.). The system has automatic start and stop features. When activated, the device has an alarm as well as a visual error system (i.e. malfunctions or user errors are detected with medical personnel being alerted visually and/or by sound with, in some cases, no energy being delivered.). Upon activation, energy delivered from the PSD-60 to the tissue is displayed in watts on the 7-segment display. Also, the unit can be used in association with an OLYMPUS compatible ENDOPLASMA Argon plasma coagulator. The unit is non-sterile and is reusable.

The OLYMPUS ENDOPLASMA is an Argon plasma coagulation system and is used in conjunction with an OLYMPUS PSD-60. The PSD-60 provides high frequency (HF) voltage to electrically charge Argon gas from the ENDOPLASMA to form plasma in the gas stream when in close proximity to tissue. Current density concentrates at the tissue surface from ENDOPLASMA (probe) causes coagulation. The ENDOPLASMA with the PSD-60 has a 7-segment LCD (Liquid Crystal Display) that provides the user with an on-screen setting operational information. Software in the PSD-60 controls the microprocessor chip in an ENDOPLASMA. The PSD-60/ENDOPLASMA are programmable and have error monitoring features. There is a communications bus cable for the PSD-60 to communicate with an ENDOPLASMA. A pressure reducer with sensor is provided to regulate the Argon gas going into the ENDOPLASMA. The ENDOPLASMA and its accessory are supplied non-sterile and are reusable. Cleaning/ disinfection, and sterilization (as applicable) are provided in the respective user manual. The ENDOPLASMA membrane filter is also a part of the system. The filter is disposable single-use. The filter is connected between the ENDOPLASMA (at the Argon gas port) and connector hose. The filter creates a barrier to protect the ENDOPLASMA from potential contamination. Filters are supplied sterile by means of ethylene oxide and are disposable (single use). They are sterilized by the manufacturer and the sterilization cycle has been validated.

Accessories include: Footswitch, P-cord, APC-cable, APC-probe, Irrigation adapter, Pressure reducer, S-cord.

The provided text is a 510(k) summary for an Electrosurgical Unit, and it explicitly states that clinical data is not necessary for evaluation of safety and efficacy because the device is substantially equivalent to legally marketed predicate devices. This means there isn't a study proving the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or improvement over human readers.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document as such studies were not deemed necessary for this type of submission.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided as clinical performance data or specific acceptance criteria (e.g., sensitivity, specificity) derived from such data are not presented in this 510(k) summary. The submission relies on substantial equivalence to predicate devices, implying that their performance is acceptable, and this new device performs similarly.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be provided. No test set or clinical study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Cannot be provided. No clinical ground truth establishment is described or deemed necessary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Cannot be provided. No test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC study was NOT done. This device is an electrosurgical unit, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is hardware (an electrosurgical unit), not an algorithm. Performance is assessed through compliance with voluntary standards and comparison to predicate physical devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable for clinical performance. The "ground truth" for this device's safety and effectiveness essentially relies on documented compliance with recognized voluntary standards (e.g., IEC, UL, EN, AAMI/ANSI) and the established safe and effective use of its predicate devices. The document implies that engineering and performance testing (e.g., HF current generation, alarm systems, communication protocols) demonstrating compliance with these standards serves as the "ground truth" for its functional and safety claims.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would have a "training set."

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/machine learning device.

Summary of Device Acceptance (based on the provided text):

The Electrosurgical Unit PSD-60, ENDOPLASMA, and Accessories were accepted by the FDA based on a demonstration of substantial equivalence to legally marketed predicate devices and compliance with recognized voluntary standards.

The 510(k) summary explicitly states: "When compared to the predicate devices, PSD-60 and ENDOPLASMA do not incorporate any significant changes in the intended use, method of operation, materials, or design that could affect safety and effectiveness. Therefore, clinical data is not necessary for evaluation of safety and efficacy."

Key points for acceptance:

• Substantial Equivalence: The device was compared to predicate devices like ERBE VIO300D, OLYMPUS UES-20, ERBE VIO APC2, and ERBE APC300.
• Compliance with Voluntary Standards: The device was designed to comply with a list of IEC, UL, EN, and AAMI/ANSI standards, including:
  • IEC 60601-1-1
  • IEC 60601-1-4
  • UL2601-1
  • IEC 60601-1-2 (EMC)
  • EN60529
  • AAMI/ANSI HF-18
  • IEC 60601-2-2
  • IEC 60601-2-18
  • IEC 60601-1
• No significant changes: The manufacturer asserted that there were no significant changes in intended use, method of operation, materials, or design compared to predicate devices that would impact safety and effectiveness.

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