(574 days)
The mJoule RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The mJOULE RF System consists of console and radio frequency delivery accessories. The control console houses the power supply, cooling system and RF delivery system. The treatment parameters are entered via a touchscreen on the console. The user activates RF emission by means of a footswitch.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or clinical outcomes. Instead, it details the FDA 510(k) clearance for the mJOULE RF System, focusing on its substantial equivalence to a predicate device (Potenza K192545) based on technical specifications and safety testing.
However, I can extract the information about the performance testing that was conducted to demonstrate safety and effectiveness for the purpose of regulatory clearance.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical performance study with sensitivity, specificity, or similar metrics. Instead, it describes a series of engineering and safety performance tests designed to show the device operates within specifications and is safe. The "reported device performance" is that the device successfully passed these tests.
| Acceptance Criteria (Implicit from testing) | Reported Device Performance |
|---|---|
| Performance Parameters: | |
| Frequency accuracy (Bipolar at 1MHz) | Tested and confirmed |
| Power measurement accuracy | Tested and confirmed |
| Energy per pin and total energy accuracy | Tested and confirmed |
| Impedance measurement accuracy and range | Tested and confirmed |
| Safety test of various warnings/failsafe mechanisms | Tested and confirmed |
| Needle depth accuracy | Tested and confirmed |
| Motor speed level | Tested and confirmed |
| Biocompatibility: | |
| Acute systemic toxicity | Passed (ISO 10993 compliant) |
| Cytotoxicity | Passed (ISO 10993 compliant) |
| Irritation | Passed (ISO 10993 compliant) |
| Sensitization | Passed (ISO 10993 compliant) |
| Pyrogenicity | Passed (ISO 10993 compliant) |
| Sterilization: | |
| Sterility Assurance Level (SAL) | Achieved at least 10^-6 |
| Electrical Safety & EMC: | |
| IEC 60601-1 compliance | Compliant |
| IEC 60601-1-2 compliance (EMC) | Compliant |
| IEC 60601-2-2 compliance (High-frequency surgical equipment) | Compliant |
| IEC 60601-1-6 compliance | Compliant |
| Software Verification & Validation: | |
| Compliance with FDA Software Guidance | Confirmed |
| Thermal Testing (Efficacy): | |
| Creation of coagulative zones below tissue surface | Successfully created; proportional to energy delivered |
| Safe and effective for specified indications | Concluded to be safe and effective |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a number of patients or cases. For bench testing, it refers to the number of tests performed on the device. For thermal testing, "ex vivo porcine tissue" was used, but the quantity of samples is not given.
- Data Provenance: The bench and thermal testing were conducted by Sciton, Inc. and are therefore considered internal company data. The thermal testing used "ex vivo porcine tissue." This is likely retrospective, as it's part of the development and verification process before submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The "ground truth" for the performance tests is derived from engineering specifications and established scientific standards (e.g., ISO, IEC). For thermal testing, the evaluation of coagulative zones would typically be done by qualified personnel, but their number and specific qualifications are not mentioned.
4. Adjudication Method for the Test Set:
Not applicable or not described for the types of tests mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human evaluators to resolve discrepancies in diagnostic interpretations. These tests are primarily technical performance and safety assessments against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. The device (mJOULE RF System) is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable in the context of this device. This device is a physical instrument for medical procedures, not a standalone algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the tests described is based on:
- Engineering Specifications: For parameters like frequency, power, energy, impedance, needle depth, motor speed, and safety mechanisms.
- International Standards: For biocompatibility (ISO 10993), sterilization (SAL of 10^-6), and electrical safety/EMC (IEC 60601 series).
- FDA Guidance: For software verification and validation, and for thermal testing procedures (Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, March 9, 2020).
- Ex Vivo Observation: For thermal testing, confirming the creation of coagulative zones.
8. The Sample Size for the Training Set:
Not applicable. This device is a hardware system, not a machine learning algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a machine learning algorithm.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.