(651 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 needle type RF electrodes and FDA cleared Disposable neutral electrode pad (K102372).
This document, K203013, is a 510(k) summary for a medical device called AGNES, an RF electrosurgical device. It's a submission to the FDA to demonstrate substantial equivalence to a previously cleared device (K192728).
The document details changes made to the device and the testing performed to ensure safety and effectiveness. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of human clinical performance or AI algorithm performance. This is because K203013 is for an electrosurgical device, not an AI or imaging device that would typically have performance metrics like sensitivity, specificity, or reader improvement.
The tests performed are primarily bench tests, animal studies, and biocompatibility tests related to the physical changes made to the device (e.g., power input, connector color, and a new type of RF electrode). Therefore, I cannot fulfill your request for information on acceptance criteria and a study proving performance in the way you've outlined for an AI/imaging device.
To directly address your specific points, based on the provided document:
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A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) because it's not evaluating an AI or diagnostic imaging device in that manner. The "performance" discussed relates to electrical safety, electromagnetic compatibility, and thermal effects, for which the acceptance is successful compliance with recognized standards.
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Sample size used for the test set and the data provenance:
- Bench Testing (Electrical Safety, EMC): These tests are typically performed on a sample of the manufactured device and new accessories. Sample size is not specified but would follow standard engineering testing practices for medical devices, often a small number of units.
- Biocompatibility Testing: Tested on materials of manufacture and the final device. Sample size not specified.
- Animal Testing: Conducted on tissues from 3 mini pigs for thermal tissue damage/spread, and skin from 1 mini pig for histopathological analysis.
- Data Provenance: Not explicitly stated for specific test data, but the submitter is Agnes Medical CO., LTD in South Korea.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's performance is established by compliance with engineering and biological safety standards (e.g., IEC standards, ISO standards for biocompatibility), not through expert consensus on diagnostic interpretations. For the animal study, histopathological analysis would be performed by a qualified pathologist, but the number and qualifications are not specified.
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Adjudication method for the test set: Not applicable. There's no human interpretation or diagnostic decision-making being assessed by multiple readers that would require adjudication.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI or diagnostic imaging device; therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
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The type of ground truth used:
- Bench Testing: Engineering specifications and compliance with international standards (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2).
- Biocompatibility: Compliance with ISO 10993 series standards.
- Animal Testing: Histopathological analysis of tissue and thermal imaging measurements.
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The sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document pertains to the regulatory clearance of an electrosurgical device based on engineering and biological safety standards, not an AI or diagnostic imaging device involving clinical performance metrics and reader studies.
§ 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.