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Star/VIVA RF Electrode is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

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Based on the provided text, the document is an FDA 510(k) clearance letter for the Star RF Electrode and VIVA RF Electrode. It describes the regulatory classification, indications for use, and general controls applicable to these medical devices.

However, the provided text DOES NOT contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed technical study information requested in your prompt.

The document is purely a regulatory clearance letter and does not include the technical study report that would contain the requested information. Therefore, I cannot generate the table or answer the specific questions about the study design and results from this text.

To answer your prompt, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) submission's performance data section.

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star/VIVA RF Electrode is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

The star/VIVA RF Electrodes are a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The star/VIVA RF Electrodes consists of the tubing set, PC pipe, PC plug and grounding pad. The grounding pad is FDA cleared (K163450).

The star/VIVA RF Electrodes consist of an electrode tip, insulation part, handle and tubing. Patient contacting materials of star RF Electrode are stainless steel 304 and polyester, and patient contacting materials of VIVA RF Electrode are stainless steel 304 and polyimide. Cooling of the electrode is provided by chilled water which is pumped the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient.

The star/VIVA RF Electrodes are available in different lengths, different tip exposures and different thicknesses. The lengths that are available for the star RF Electrode range from 7 cm to 20 cm and VIVA RF Electrode range from 15 cm to 20 cm. The tip exposures available for the star RF Electrode range from 5 mm to 20 mm and VIVA RF Electrode range from 5 mm to 30 mm. The exposed length of the VIVA RF Electrode can be adjusted by the control button on the handle. The diameters available for the star RF Electrode diameters are 17 Gauge. The diameters available for the VIVA RF Electrode diameters are 15 Gauge and 17 Gauge.

Here's an analysis of the provided text regarding the acceptance criteria and study for the STARmed Co., Ltd. RF Electrodes:

It's important to note that this document is a 510(k) summary for a medical device (RF Electrodes), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study on its performance against specific clinical acceptance criteria. Therefore, the information provided below reflects this context.

Acceptance Criteria and Reported Device Performance

The document doesn't present a table of specific numerical acceptance criteria (e.g., a specific percentage of sensitivity or specificity) for clinical performance. Instead, it demonstrates acceptance primarily through comparative testing against a predicate device and compliance with established international and FDA-recognized consensus standards for safety and biocompatibility.

The "reported device performance" is implicitly that the device performs as safely and effectively as the predicate device and meets the requirements of the listed standards.

Table of Acceptance Criteria (as inferred from the document) and Reported Device Performance:

Study Details:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated in numerical terms for each non-clinical test (e.g., how many electrodes were drop-tested, or how many tissue samples were used for ex vivo testing). The tests are described as types of tests performed (e.g., drop test, bending force test, thermal effects test).
   • Data Provenance: The tests are "non-clinical performance tests" and "ex vivo testing." The thermal effects test was performed on liver, kidney, and muscle tissue. The country of origin for the data is implicitly the Republic of Korea, where STARmed Co., Ltd. is based. These are described as retrospective in the sense that they are conducted on manufactured devices/materials in a lab setting, not as part of a prospective clinical trial.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided. For non-clinical, ex vivo, and bench testing, "ground truth" is typically established by objective measurements and standardized protocols rather than expert consensus on individual cases. For example, for thermal effects, the ground truth would be the objectively measured width and depth of tissue damage.

3. Adjudication method for the test set:

   • This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation (e.g., imaging reads) to resolve disagreements among experts. The non-clinical tests described here rely on quantitative measurements and compliance with objective standards.

4. 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 MRMC comparative effectiveness study was performed. This is a device (RF electrode) for direct tissue ablation, not an AI diagnostic or assistance tool for human readers.

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

   • No standalone (algorithm only) performance study was done. This device is an electrosurgical accessory and does not involve an algorithm working independently. It functions in conjunction with an RF generator and is operated by a human.

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

   • Objective Measurements and Compliance with Standards: For the non-clinical tests, the "ground truth" is derived from objective measurements (e.g., physical parameters for drop/bending tests, electrical readings for conduction, temperature measurements, measured dimensions of tissue damage in ex vivo models) and comparison against the quantitative limits and qualitative requirements specified in the international and FDA-recognized consensus standards (IEC 60601-2-2, AAMI HF 18, ISO 10993 series). There is no "pathology" or "outcomes data" in the clinical sense for these validation tests.

7. The sample size for the training set:

   • Not applicable. This document describes a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply here.

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