(136 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 footswitch, a hand-piece, single use RF electrodes and FDA cleared Disposable neutral electrode pad (K102372).
The provided text describes a 510(k) summary for the AGNES RF electrosurgical device. It primarily focuses on demonstrating substantial equivalence to a predicate device, particularly for newly added electrode models. However, it does not explicitly detail acceptance criteria or a comprehensive study proving the device meets specific performance thresholds in a clinical or AI-assisted context.
The document is a K223805 510(k) submission for an electrosurgical cutting and coagulation device. The key information is about the device's technical specifications and the comparison of the subject device (AGNES with additional electrode models) to its predicate device (AGNES with a previously cleared electrode model).
Based on the provided text, a robust study proving the device meets acceptance criteria, especially in the context of an AI/human-in-the-loop diagnostic accuracy study, is NOT present. The document describes a bench testing and an animal testing study to demonstrate the safety and effectiveness of the device as an electrosurgical tool, but not a study designed to evaluate diagnostic performance or human reader improvement with AI assistance.
Therefore, many of the requested sections regarding acceptance criteria and performance in a diagnostic or AI-assisted context cannot be directly answered from the provided text.
Here's an analysis of what CAN be extracted or inferred from the document regarding its performance in the context of a 510(k) submission, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical "acceptance criteria" table for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" can be inferred from the comparison table demonstrating substantial equivalence to the predicate device and the results of the bench and animal testing.
| Acceptance Criterion (Inferred from Substantial Equivalence and Testing) | Reported Device Performance (Subject Device: AGNES with new electrode models) |
|---|---|
| Intended Use Equivalence: | AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. (Same as predicate) |
| Principle of Operation Equivalence: | Uses RF energy delivered through micro needle electrode to apply heat to target tissue for coagulating. (Same as predicate) |
| Output Frequency: | 1MHz (Same as predicate) |
| Output Operating Time: | Min 50ms / Max 2,000ms (Same as predicate) |
| Output Power Levels: | 25 levels (2 to 46 W) (Same as predicate) |
| Max. Output Power: | 46 W at 200 ohm (Same as predicate) |
| Max. Output Voltage: | 104V (Same as predicate) |
| Electrode Functionality: | Transfers RF energy through single-use RF electrodes (Needle type and Rounded type). Expanded to include new rounded electrode models (AG-CN21G, AG-CN20G, AG-CN19G, AG-CN18G) with varying diameters. |
| Biocompatibility: | All materials for the additional models RF electrodes were tested according to ISO 10993-1, ISO 10993-5, and ISO 10993-10, ensuring no risks from biological hazards. (Presumed to meet standard requirements) |
| Sterilization: | EO gas sterilization method of the additional models RF electrode validated according to ISO 11135:2014 + A1:2018. SAL (10^-6) and EO gas residuals verified according to ISO 10993-7:2008+A1:2019. (Presumed to meet standard requirements) |
| RF Output Power (Bench Test): | Performed in accordance with IEC 60601-2-2:2017. (Presumed to meet standard requirements) |
| Thermal Tissue Damage/Spread (Animal Test): | Evaluated in mini pig tissues (skin, liver, kidney, femoral muscle). Thermal imaging area analysis, max temperature, time to reach basal temperature, and histopathological analysis were evaluated. (Study performed, implied to show acceptable performance for electrosurgical use) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (for performance validation of the electrosurgical function):
- Bench Testing: Not explicitly stated as a "sample size" of devices, but implies testing of the subject device and its new accessories against electrical safety and performance standards (IEC 60601-2-2:2017).
- Animal Testing: Tissues from 3 mini pigs were used for thermal tissue spread experiment (skin, liver, kidney, femoral muscle). Skin from 1 mini pig was used for histopathological analysis. This is not a "test set" in the context of an AI/diagnostic study, but for evaluating the physical tissue effects of the electrosurgical device.
- Data Provenance: The studies were conducted by AGNES Medical Co., Ltd, based in Korea. The provenance of the specific test data for the animal study is "mini pig tissues." It would be considered prospective for the device's validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable to the provided document. The document describes a medical device (electrosurgical unit), not a diagnostic AI system requiring expert consensus for ground truth establishment. The "ground truth" in this context relates to the physical and biological effects of the electrosurgical energy, evaluated through standard engineering tests and pre-clinical animal studies. Histopathological analysis for the animal study would typically involve a veterinary pathologist, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set:
- Not applicable in the context of diagnostic AI. For the animal study, the evaluation methods were "Thermal imaging area analysis, the maximum temperature, the time to reach basal temperature, and histopathological analysis." Adjudication among human readers is not relevant here.
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 study was NOT done. This type of study is relevant for diagnostic AI devices where human readers interpret medical images. The AGNES device is an electrosurgical cutting and coagulation device, not an image interpretation or diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The AGNES device is not an algorithm or AI system. It's a hardware medical device used by a human operator. Its performance is inherent in its electrosurgical capabilities, not in an independent software algorithm.
7. The Type of Ground Truth Used:
- Bench Testing: Engineering measurements against established performance standards (e.g., output power, frequency, safety parameters).
- Animal Testing: Direct measurement of physical effects on biological tissues (thermal imaging, temperature readings, histopathological analysis). This is a form of direct biophysical ground truth.
8. The Sample Size for the Training Set:
- Not applicable. The AGNES device is not an AI/ML device, so there is no "training set" in the context of machine learning. Its design and efficacy are based on established electrosurgical principles and engineering/biological validation, not on learned patterns from a dataset.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set.
In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of an electrosurgical device, particularly regarding the addition of new electrode models, to its predicate. The "studies" mentioned (bench and animal testing) are for validating the physical and biological safety and performance of the electrosurgical function, not for evaluating diagnostic accuracy or AI-assisted human performance, which are the typical contexts for the detailed questions about acceptance criteria and ground truth in your prompt.
§ 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.