(172 days)
The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The ShenB Co Ltd PlaDuo is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis.
The PlaDuo system consists of a system console, footswitch, handpiece, and tip with 3 interchangeable guides.
The provided text is a 510(k) summary for the PlaDuo System, an electrosurgical device. It outlines non-clinical tests conducted to support its substantial equivalence to predicate devices, but no clinical studies or acceptance criteria based on clinical performance are mentioned. Therefore, I cannot provide details on acceptance criteria or studies that prove the device meets them in the context of clinical performance.
However, based on the non-clinical tests performed, I can infer acceptance criteria for those tests and describe the study that proves the device met them.
Here's a summary of the non-clinical acceptance criteria and the studies performed:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-05:2009) | Device components (electrode tips) must show no cytotoxic effects in vitro. | Pass |
| Sensitization (ISO 10993-10:2010, Guinea Pig Maximization Test) | Device components (electrode tips) must not induce sensitization (allergic reaction). | Pass | |
| Irritation or Intracutaneous Reactivity (ISO 10993-10:2010, Animal Intracutaneous Test) | Device components (electrode tips) must not cause irritation or intracutaneous reactivity. | Pass | |
| Electrical Safety & EMC | IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2-12 (General requirements for basic safety and essential performance) | Device must meet general requirements for basic safety and essential performance for medical electrical equipment. | Not explicitly stated as "Pass" but implied by submission to standards. |
| IEC 60101-2-2:2017 (Particular requirements for the basic safety and essential performance of high-frequency surgical equipment) | Device must meet particular requirements for basic safety and essential performance of high-frequency surgical equipment. | Not explicitly stated as "Pass" but implied by submission to standards. | |
| IEC 60601-1-2:2014 (General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and Tests) | Device must meet electromagnetic compatibility (EMC) requirements and relevant tests for medical electrical equipment. | Not explicitly stated as "Pass" but implied by submission to standards. | |
| Software Verification & Validation | FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005 (moderate level of concern) | Software must be verified and validated according to FDA guidance for a moderate level of concern, ensuring proper functionality and safety. | Documentation provided. Not explicitly stated as "Pass" but implied by submission and acceptance of documentation. |
| Bench Testing | Output Energy | Output energy must be within predefined design specifications. | Operates safely and within predefined design specifications. |
| Durability of the tip | Tip must demonstrate adequate durability according to predefined design specifications. | Operates safely and within predefined design specifications. | |
| Thermal testing (in accordance with FDA's "Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery”) | Thermal effects must be within acceptable limits as outlined by FDA guidance to ensure patient safety and device efficacy. | Operates safely and within predefined design specifications. |
Important Note: The document explicitly states "No Clinical study was conducted as part of this submission." Therefore, the following points address the questions in the context of the available non-clinical information.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Biocompatibility: The sample sizes for these tests are specific to the biological assay standards (e.g., number of cells for cytotoxicity, number of guinea pigs for sensitization, number of animals for intracutaneous reactivity). These specific numbers are not detailed in the provided summary, but the tests were performed in accordance with international ISO standards.
- Electrical Safety & EMC: These are typically laboratory tests performed on a single or a few units of the device. The specific number of units tested is not stated.
- Software Verification & Validation: This involves reviewing and testing the software, often through simulated scenarios or on development units. Sample size for actual "test cases" within software testing is not specified.
- Bench Testing: This involved testing of the device and its components (e.g., tips). The specific number of devices or tips tested is not provided.
The provenance of this non-clinical data is from the manufacturer, ShenB Co. Ltd., which is based in South Korea (Seongdong-Gu, Seoul). These were prospective tests conducted to demonstrate compliance with the relevant standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This question is not directly applicable as the studies were non-clinical, involving engineering, materials science, and software experts.
- Biocompatibility: The "ground truth" (i.e., whether a material is biocompatible) is established by the results of standardized laboratory tests interpreted by trained toxicologists/biocompatibility specialists.
- Electrical Safety & EMC: The "ground truth" (i.e., whether the device meets electrical safety and EMC standards) is established by measurements against predefined limits by qualified electrical engineers and testing laboratories.
- Software Verification & Validation: The "ground truth" (i.e., whether the software functions as intended and is safe) is established by software engineers and quality assurance specialists comparing software behavior against its requirements and design specifications.
- Bench Testing: The "ground truth" (i.e., performance against specifications) is established by engineers performing measurements and observations against design requirements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This concept is primarily relevant for clinical studies involving human interpretation or subjective endpoints. For these non-clinical tests, adjudication methods like 2+1 or 3+1 are not typically used. The results of these tests are objectively measured against established standards and specifications. If there were any ambiguous results, internal quality processes or re-testing would be employed.
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 study was performed as no clinical studies were conducted, and the device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the PlaDuo System is an electrosurgical device, not an algorithm. The "standalone" performance relates to the device's functional integrity as an electrosurgical unit, which was assessed through bench testing and compliance with electrical safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests:
- Biocompatibility: The ground truth is established by standardized laboratory test results (e.g., cell viability, immune response observed in animal models) compared against established safety thresholds defined by ISO standards.
- Electrical Safety & EMC: The ground truth is established by objective measurements of electrical characteristics (e.g., leakage current, electromagnetic emissions) against the limits defined in IEC standards.
- Software Verification & Validation: The ground truth is established by the software requirements specification and design documents, against which the functionality and performance of the software are tested.
- Bench Testing: The ground truth is established by the device's predefined design specifications and engineering requirements for parameters like output energy, tip durability, and thermal effects.
8. The sample size for the training set
This question is not applicable as there is no mention of an algorithm or AI model in the submission that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/algorithm was mentioned.
§ 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.