(19 days)
The PROPLATE of Bio Protech is a disposable, single use, neutral electrode, which provides a return path for high frequency electrical current to the ESU device.
The PROPLATE Electrosurgical Grounding Plate (and as also to be offered for sale under various private label trade names) is a flexible, conductive adhesive electrosurgical grounding plate with integrated 3 meter PVC coated cable and standard MSB-female connector. It is an Electrosurgical Grounding Plate at which no electrosurgical effect is intended. It is also known as the patient plate or inactive, indifferent, neutral, return or dispersive electrode. It is frequently, and sometimes inaccurately, referred to as the ground plate. The Electrosurgical Grounding Plate is for use with monopolar instruments only. The role of the Electrosurgical Grounding Plate is preventing highly current density from doing damage to the patient's tissue. And Electrosurgical Grounding Plate transfer input current from the active electrode to ESU device in operation. The Electrosurgical Grounding Plate is large in area, compared to the active electrode, promoting low current density and thereby reducing the possibility or risk of electrosurgical effect or burns. The PROPLATE is made from conductive hydro gel and aluminum foil. The adhesive on the backing material prevent them from falling off the patient's skin during operation. The plates are supplied either uncorded or corded. The electrodes are packaged with 100 pieces (Uncorded plates) or 25 pieces (Corded plates) per an inner box. The plates are provided non-sterile with an expiration date of 24 months.
The provided document describes a 510(k) submission for the PROPLATE Electrosurgical Grounding Plate, demonstrating its substantial equivalence to a predicate device. This submission focuses on technical specifications and performance testing against established safety standards rather than clinical performance or AI algorithm performance. Therefore, many of the requested categories regarding AI-specific criteria, such as training sets, ground truth establishment for AI, and MRMC studies, are not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The device, PROPLATE, meets the acceptance criteria by demonstrating performance equivalent to its predicate device, the Leonhard Lang GmbH electrosurgical grounding plate. The acceptance criteria are based on established technical standards and physiological requirements for such devices.
Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Performance) | Reported Device Performance (PROPLATE) |
|---|---|---|
| Biocompatibility | ISO 10993-1 compliant | Pass (ISO 10993-1 compliant) |
| Maximum Safe Temperature Rise | Pass | Pass |
| Contact Impedance | Pass | Pass |
| Adherence | Pass (Pull test) | Pass (Pull test) |
| Conformability | Pass | Pass |
| Fluid Tolerance | Pass | Pass |
| Electrical Safety | HF-18 requirements met | HF-18 requirements met |
Study Details
The study described is a bench testing and substantial equivalence comparison rather than a clinical trial or AI performance study.
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Sample Size used for the test set and the data provenance:
- The document does not explicitly state the specific sample sizes for each test (e.g., number of plates tested for adherence, temperature rise, etc.). Instead, it indicates that the PROPLATE was subjected to "Pass" or "met" for each technical requirement.
- Data Provenance: The tests are likely laboratory-based bench tests performed by the manufacturer (Bio Protech, Inc.) and/or certified testing facilities (e.g., those ensuring ISO 10993-1 compliance or HF-18 requirements). The country of origin for these tests is not explicitly stated, but the manufacturer is based in South Korea. The study is prospective in the sense that the tests were conducted specifically to demonstrate compliance for this 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "ground truth" for electrosurgical grounding plates is based on established engineering and safety standards (e.g., ISO 10993, HF-18) rather than expert clinical consensus or interpretation of complex data. Compliance with these standards serves as the benchmark.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. The performance evaluations are based on objective measurements against predefined technical specifications and standards, not on human interpretation or adjudication of ambiguous cases.
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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, an MRMC comparative effectiveness study was not done. This device is a passive medical device (electrosurgical grounding plate), not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was not done. This device does not incorporate any AI algorithms.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is compliance with established technical and safety standards for electrosurgical grounding plates (e.g., maximum safe temperature rise, contact impedance, adherence, biocompatibility as per ISO 10993-1, and electrical safety as per HF-18).
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The sample size for the training set:
- This is not applicable. The device does not involve a "training set" as it is not an AI/machine learning product.
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How the ground truth for the training set was established:
- This is not applicable. There is no training set for this type of medical 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.