(321 days)
AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a hand-piece, Single use RF electrodes (needle type). Disposable neutral electrode pad and a footswitch.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the AGNES device.
It's important to note that the provided document is a 510(k) Summary, which establishes substantial equivalence to a predicate device. It demonstrates that the new device is as safe and effective as a legally marketed device and does not necessarily involve establishing new acceptance criteria or conducting a comprehensive "study that proves the device meets the acceptance criteria" in the same way a PMA (Premarket Approval) submission would. Instead, the focus is on showing equivalence through comparing specifications, adherence to recognized standards, and preclinical/animal testing to address differences.
Therefore, some of the requested information (like human reader MRMC studies or specific acceptance criteria for a novel AI algorithm's performance) is not applicable or present in this type of FDA submission.
Acceptance Criteria and Device Performance for AGNES (K160469)
The "acceptance criteria" for this 510(k) submission are primarily rooted in demonstrating that the AGNES device is substantially equivalent to its predicate devices (HR-5000 and INTRAcel Premium Fractional RF Micro Needle System) and that any differences do not raise new questions of safety or effectiveness. This is achieved by conforming to recognized electrical safety and performance standards, and, for specific functional aspects, through preclinical and animal studies.
The document does not present a table of quantitative acceptance criteria for its overall performance and compare it to reported device performance in a clinical efficacy context. Instead, it demonstrates compliance with safety and engineering standards and addresses the biological effects of its differences through testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Category / Aspect | Acceptance Criteria (from recognized standards or equivalence to predicate) | Reported Device Performance (as demonstrated by studies) |
|---|---|---|
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2 standards. | Device passed all tests for electrical safety and electromagnetic compatibility according to the specified standards. |
| RF Output Power | Compliance with IEC 60601-2-2, Clause 201.11 & 201.12. Output power range (2-46 W) shown not to raise safety/effectiveness concerns compared to predicate (12.5-50W at 200 ohm). | Tests demonstrated compliance with IEC 60601-2-2. The output power range was shown to be safe and effective, analogous to predicate. |
| Active Component (RF Electrode) | Compliance with IEC 60601-2-2 (Clause 201.8, 201.13, 201.15) for mechanical, electrical, and insulation integrity. | Mechanical, electrical performance, and insulation integrity tests were performed and complied with IEC 60601-2-2. |
| Biocompatibility | Compliance with ISO 10993-1, -5, -10 standards. | Tests demonstrated biological compatibility according to ISO 10993 series. |
| Sterility & Packaging | Compliance with ISO 11135, ISO 11138-2, ISO 10993-7, ISO 11607-1, ASTM F1980-07. | Sterility and packaging validation confirmed compliance with the specified ISO and ASTM standards. |
| Neutral Electrode Pad (K102372) | Compliance with IEC 60601-2-2, Sub-clause 201.15.101 for thermal performance, contact impedance, and adhesion. | Tests confirmed compliance with IEC 60601-2-2 for thermal performance, contact impedance, and adhesion. (Note: Pad itself has prior 510(k) clearance K102372). |
| Foot Switch | Compliance with IEC 60601-2-2, Sub-clause 201.8.10.4, 201.11.6.5, and 201.12.2. | Tests confirmed compliance with IEC 60601-2-2. |
| Thermal Effect/Penetration Depth (Animal Study) | Demonstration that differences in electrode dimensions and output power do not raise new safety concerns and achieve intended effect (electrocoagulation and hemostasis). | Macroscopic Assessment (Dermatologist): Damage and safety on skin surface/corium, reduction of acne lesions observed. |
| Microscopic Assessment (Histological): Accurate penetration depth, distinct coagulation in mini pigs; destruction of sebaceous glands, reduction of inflammatory cells, papule, and pustule in rabbit acne model. "Valid method to prevent reoccurrence" of acne. |
2. Sample Size Used for the Test Set and Data Provenance
- Engineering/Safety Tests (Electrical, Biocompatibility, Sterility): The document refers to compliance with recognized standards (IEC, ISO, ASTM). These standards typically define the sample sizes and procedures for testing components and the overall device. For example, biocompatibility tests (ISO 10993) would involve specific numbers of cell cultures, animals, or material samples. The exact sample sizes for each specific engineering test are not detailed in this 510(k) summary but are inherent to the standard methods. Data provenance is implied to be laboratory testing by the manufacturer or accredited labs.
- Animal Study: The study used "mini pigs" for penetration depth and coagulation assessment, and a "rabbit's ear model" for acne treatment. Specific numbers of animals are not provided in the summary. The provenance is preclinical testing, likely conducted by or for the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Engineering/Safety Tests: "Experts" in this context are the qualified personnel in test laboratories who perform and interpret the results of the standard tests (e.g., electrical engineers for IEC 60601, toxicologists/biologists for ISO 10993, microbiologists for sterility tests). Their specific number and qualifications are not detailed in the summary but are presumed to meet the requirements of the standards.
- Animal Study (Macroscopic Assessment): A "dermatologist" performed macroscopic assessment on damage and safety. The number of dermatologists and their specific years of experience are not specified.
- Animal Study (Histological Assessment): The histological assessments would typically be performed by a veterinary pathologist or a pathologist with experience in animal tissue, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Engineering/Safety Tests: Adjudication is generally not applicable in the same way as clinical imaging studies. Compliance is determined by whether the device's performance meets the quantitative thresholds defined by each standard (e.g., leakage current within limits, tensile strength exceeding a value).
- Animal Study:
- Macroscopic Assessment: A "dermatologist" assessed damage and safety. It's unclear if this was a single dermatologist, or if a consensus/adjudication process was used if multiple assessors were involved.
- Microscopic Assessment: The histological assessment involves objective staining and observation. While interpretation requires expertise, a formal adjudication process between multiple experts for "ground truth" establishment in this specific context is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly mentioned or performed as part of this 510(k) submission. This type of study is more common for diagnostic devices (e.g., AI for radiology reading) to compare human performance with and without AI assistance. The AGNES device is a therapeutic electrosurgical device; its primary function is to perform a physical action (electrocoagulation and hemostasis) and treat conditions like acne, not to provide diagnostic readings. The "effectiveness" is shown through its functional performance and biological effect, not by improving human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
- Not applicable. The AGNES device is a physical electrosurgical device operated by a human. It is not an AI algorithm designed to operate autonomously or provide outputs without human interaction.
7. Type of Ground Truth Used
- Engineering/Safety Tests: The "ground truth" is defined by the objective pass/fail criteria established by the international and national standards (IEC, ISO, ASTM).
- Animal Study: The "ground truth" for the animal study was based on:
- Clinical Assessment (Photo Assessment): Macroscopic observations by a dermatologist and photographic evidence.
- Histological Pathology Analyses: Microscopic examination of tissue samples stained with hematoxylin & eosin, assessing sebaceous gland destruction, inflammatory cells, etc. This is considered objective biological evidence.
- 3D Measuring Instrument (PRIMOS Pico): For assessing reduction of acne lesions, providing quantitative data.
8. Sample Size for the Training Set
- Not applicable / Not disclosed. This is a medical device approval that primarily relies on engineering specifications, safety standards, and preclinical (animal) performance, not machine learning or AI models that require a "training set" in the conventional sense. The device itself is designed and tested, not "trained" on data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no "training set" in the AI/machine learning sense, no ground truth was established for it.
§ 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.