(61 days)
The Single Use RF electrode (Needle Type) is a monopolar electrosurgical electrode indicated for coagulation of soft tissue when it used in conjunction with compatible radio frequency electrosurgical device.
Single Use RF Electrode (Needle Type) consists of conductive electrode part, insulation coated part and conductive post part. There are several models (Models: GA-B, GA-C, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A) according to the total size and needle electrode part size. The conductive post of electrode is inserted into the head of the intended handpiece to receive the radio frequency current and delivers the current to a target tissue for coagulation in electrosurgical procedure. This device is a monopolar RF electrosurgical electrode used in conjunction with radio frequency electrosurgical device and a neutral electrode plate which complies with IEC 60601-1 and IEC 60601-2-2. It is intended to be used exclusively with the ESU cleared in K160469, Model: AGNES.
The provided document is a 510(k) summary for a medical device called "Single Use RF electrode (Needle Type)". This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Therefore, it describes tests performed to show safety and effectiveness compared to a predicate device, rather than explicit "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the sense of demonstrating a novel performance claim with specific thresholds.
The studies conducted are primarily focused on ensuring the new device is as safe and effective as existing, legally marketed devices.
Here's an analysis of the information, formatted to address your specific points where applicable, and highlighting what's not present in a 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
As a 510(k) summary, specific numerical "acceptance criteria" and "reported device performance" for novel claims are generally not detailed. Instead, the document states that tests were performed and results "met the requirements" or "supported the safety and effectiveness." The primary acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device, meaning it's as safe and effective.
Here's a summary of the tests performed and their general outcomes:
| Test Category | Specific Tests Performed | Reported Outcome / Acceptance Criterion (Implicit) |
|---|---|---|
| Electrical Safety | IEC 60601-1, IEC 60601-2-2 | Results met electrical safety requirements. (Implicitly, comparable to predicate and standards) |
| EMC Testing | IEC 60601-1-2 | Results met EMC requirements. (Implicitly, comparable to predicate and standards) |
| Performance (Nonclinical) | RF output (IEC 60601-2-2, Clause 201.11 & 201.12) | Results met performance requirements. |
| Biocompatibility | ISO 10993-1, -5, -10, -12 | Tests performed in accordance with standards. (Implicitly, passed biocompatibility) |
| Sterility | ISO 11135, -11138-1, -11138-2, -10993-7 | EO gas sterilization verified and validated in accordance with standards. |
| Packing & Shelf Life | ISO 11607-1, -11607-2, ASTM F1980 | Verified and validated in accordance with standards. (Shelf life 3 years) |
| Mechanical Retention | IEC 60601-2-2, Clause 201.15.4.1.1 02 | Tests performed in accordance with standards. |
| Extractable Substance | pH, Potassium permanganate-reducible substances, Residue on evaporation, UV spectrum, Heavy metals | Tests performed. (Implicitly, within acceptable limits) |
| Measurement Tolerance | Needle length, body length, thickness of specified different sizes | Tests conducted. (Implicitly, within manufacturing specifications) |
| Electrical Current Flow | Through a circuit tester | Test conducted. (Implicitly, showed appropriate current flow characteristics) |
| Animal Study (Acne Coagulation) | 1. Depth of skin penetration (mini pigs). |
- Destroyed sebaceous glands, reduced inflammatory cells, papule, and pustule (rabbit ear model). | 1. Penetration depth "relatively accurate," distinct coagulation.
- Sebaceous glands destroyed, inflammation and lesions "greatly reduced," considered "valid method to prevent reoccurrence." |
2. Sample Size Used for the Test Set and the Data Provenance
- Nonclinical/Benchtop Tests: Sample sizes are not reported in this summary. These tests are typically performed on a limited number of device units.
- Animal Study:
- One part of the animal study used mini pigs to check penetration depth. The number of mini pigs is not specified.
- Another part used a rabbit ear model to assess acne treatment. The number of rabbits is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the non-clinical or animal study data beyond the applicant/submitter being based in South Korea. The animal study appears to be prospective in nature, as it describes inducing acne in rabbits and then treating them.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Nonclinical/Benchtop Tests: For these types of tests, "ground truth" is typically established by recognized standards and engineering specifications rather than expert interpretation of images or other subjective data. No experts are mentioned in this context.
- Animal Study - Macroscopic Assessment: A dermatologist performed macroscopic assessment. The number and specific qualifications (e.g., years of experience) of the dermatologist(s) are not specified. Their role was to assess "damage and safety on the skin surface and inside the corium."
- Animal Study - Histological Assessment: This involved standard pathology techniques (hematoxylin & eosin staining). While a pathologist would interpret these, the document does not specify the number or qualifications of experts for histological interpretation.
- No "ground truth" in the typical sense of human expert consensus for a diagnostic AI study is found here, as this is not an AI diagnostic device.
4. Adjudication Method for the Test Set
- Not applicable in the context of this 510(k) submission. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical studies involving interpretation by multiple readers, especially for AI diagnostic devices. This document is about an electrosurgical electrode and its safety/performance through bench and animal testing.
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. This document pertains to an electrosurgical electrode, not an AI-assisted diagnostic or therapeutic device that would involve human readers interpreting cases with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical electrosurgical electrode, not an algorithm.
7. The Type of Ground Truth Used
- Nonclinical/Benchtop Tests: Ground truth is implicitly based on recognized international and national standards (e.g., IEC, ISO, ASTM) and the device's engineering specifications.
- Animal Study - Macroscopic Assessment: Ground truth for macroscopic assessment was a dermatologist's visual assessment and measurements using a camera and a folliscope magnifying glass, and a 3D measuring instrument (PRIMOS Pico).
- Animal Study - Histological Assessment: Ground truth was established by histological analysis (hematoxylin & eosin staining) of tissue samples.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical electrosurgical electrode, not a machine learning or AI algorithm that requires a training set. The "training set" concept is irrelevant here.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As established in point 8, there is no training set for this device.
§ 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.