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HPR45i electrosurgical electrode is intended to conduct radio frequency (RF) current for coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures. The device is a prescription use (Rx) device.

Device Description

HPR45i is a monopolar electrosurgical electrode intended to remove tissue and control bleeding using radio frequency electrical current. It is a prescription use device which is intended to be used by a licensed doctors or specialist in the healthcare facility/ hospital.

The HPR45i is supplied sterile (Sterilized by EO Sterilization) and is not intended to be reused. It consists of 3 different parts such as HPR45i handle, output cable and stainless-steel tube. The stainless-steel tube is insulated over most of its exposed length, and it is connected to the stainless steel (AISI316L) tip at the end. The material of insulation is PTFE. The stainless steel (AISI316L) tip and PTFE insulation are the direct patient contacting parts of the device. It is an external communicating device with limited duration (

AI/ML Overview

The provided text is a 510(k) summary for the HPR45i electrosurgical electrode. It details the device's characteristics, intended use, and a comparison to a predicate device, along with non-clinical and a lack of clinical study data.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria in a table format with corresponding device performance metrics for diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are met by demonstrating compliance with recognized standards and passing various non-clinical performance tests.

Acceptance Criterion Type	Specific Acceptance Criteria (Implied)	Reported Device Performance
Non-Clinical Performance Testing
ESU Testing	Defined performance specifications for electrosurgical units (details not provided).	Pass
Active Components/Accessories Testing	Defined performance specifications for active components/accessories (details not provided).	Pass
Neutral Electrode Testing	Defined performance specifications for neutral electrodes (details not provided).	Pass
Miscellaneous Components/Accessories Testing	Defined performance specifications for miscellaneous components/accessories (details not provided).	Pass
Capacitive Coupling Testing	Verification that capacitive coupling is within acceptable limits (details not provided).	Pass
Electrical Safety and Electromagnetic Compatibility	Compliance with IEC 60601-1 and IEC 60601-1-2 standards.	Pass
Thermal Effect on Tissue	Acceptable thermal effects on tissue, indicating proper function for coagulation (details not provided).	Pass
Sterilization & Packaging
Sterility Assurance Level (SAL)	10^-6 in accordance with ISO 11135.	Validated to SAL 10^-6
Packaging Integrity	Maintenance of sterile barrier and physical integrity (details not provided).	Performed and supports proposed shelf life.
Accelerated Aging Test	Demonstration that device maintains performance over its projected shelf life (details not provided).	Performed and supports proposed shelf life.
Biocompatibility	Compliance with various ISO 10993 standards (1, 3, 4, 5, 10, 11, 18).	All relevant biocompatibility tests were performed and passed (implied by "All non-clinical tests met the acceptance criteria specified in the standards").
Substantial Equivalence	Device is as safe and effective as the predicate device (E-Z Clean Electrosurgical Electrode, K081791) regarding intended use, technology, and performance.	Determined to be Substantially Equivalent (SE).

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

The provided document describes non-clinical performance tests only. It does not refer to a "test set" in the context of clinical data or diagnostic accuracy. Therefore, there is no information on:

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

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

Since no clinical "test set" was used for diagnostic accuracy, there is no information on the number or qualifications of experts used to establish ground truth. The non-clinical tests rely on established engineering and safety standards.

4. Adjudication Method for the Test Set

As no clinical "test set" was used for diagnostic accuracy, there is no information on any adjudication method.

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 MRMC comparative effectiveness study was done or reported. The device is an electrosurgical electrode, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. This device is a medical instrument used by a human surgeon, not an independent algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" implicitly refers to:

Compliance with international and FDA-recognized consensus standards: such as IEC 60601-2-2, IEC 60601-1, IEC 60601-1-2, and various ISO 10993 standards.
Engineering specifications and validated processes: for electrosurgical unit performance, component testing, and sterilization.

There is no clinical ground truth (e.g., expert consensus, pathology, outcomes data) presented as no clinical studies were performed.

8. The Sample Size for the Training Set

Not Applicable. This device is an electrosurgical electrode and does not involve machine learning algorithms that require a "training set."

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

Not Applicable. (See point 8).

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