(272 days)
The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure.
Disposable General Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is categorized by three families: Blade, Needle and Ball. Each electrode family offers three series S, M and L in length and different insulation designs. The conductive post of electrode is inserted into the nozzle of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in electrosurgical procedure. This device is used in conjunction with a compatible monopolar electrosurgical generator and patient grounding pad and complies with IEC60601-1 and IEC60601-2-2.
The provided document, a 510(k) summary for the "Disposable General Electrode" (K152059), primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study outlining acceptance criteria and device performance in the manner typically associated with clinical trials of AI/diagnostic devices.
Therefore, many of the requested fields cannot be directly answered from the given document as it describes a conventional medical device (electrosurgical electrode) and its safety and performance through comparison to a predicate device, rather than an AI-powered diagnostic tool. The document does not feature a typical AI/diagnostic device study with acceptance criteria, ground truth, expert review, sample sizes for training/test sets, or comparative effectiveness with human readers.
However, I will extract the information that is present and indicate where the information is not applicable or not provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as such, but inferred from testing) | Reported Device Performance |
|---|---|
| Functional Performance (Electrosurgical Operation) | Comparative testing performed on porcine kidney, liver, and muscle for both Cut mode (at 50W, 100W, 200W, and 300W output power) and Coagulation mode (at 50W and 100W). |
| Specific acceptance criteria for cutting/coagulation effectiveness are not quantified in the document. | Demonstrates that the performance result of device operation is no significant difference between the proposed device and the predicate device. |
| Eschar Buildup | Comparative testing performed on porcine kidney, liver, and muscle for both Cut mode (at 50W, 100W, 200W, and 300W output power) and Coagulation mode (at 50W and 100W). |
| Specific acceptance criteria for eschar buildup are not quantified in the document. | Demonstrates that the amount of eschar buildup on the tip of the electrode is no significant difference between the proposed device and the predicate device. |
| Electrical Safety (IEC 60601-1 and IEC 60601-2-2) | Safety Testing was performed to comply with: |
- IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007)
- IEC60601-2-2: 2009 (Fifth Ed) |
| Compliance with these standards is the implicit acceptance criterion. | The device's safety testing was performed to comply with these standards. (Assumed compliance, as it's a 510(k) submission). |
| Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) Residue | EO and ECH residue test performed in accordance with ISO10993-7. |
| EO residue ≤ 4 mg per device
ECH residue ≤ 10 mg per device | The residue level on the patient contact portion of the device shall be met below standard (interpreted as compliance was achieved). |
| Biocompatibility (ISO 10993-1) | Biological evaluation performed in accordance with ISO10993-1. |
| Specific acceptance criteria for biocompatibility tests are not stated, but compliance with the standard and passing the tests below are implied acceptance criteria. | Verified that the material use of the proposed electrode is biocompatible with intended use, through: - Intracutaneous Reactivity Test
- In vitro Cytotoxicity Test
- Skin sensitization tests |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions "comparative testing was performed on porcine kidney, liver, and muscle." The number of porcine samples or tests performed is not specified.
- Data Provenance: The data is from laboratory testing performed using animal tissues (porcine kidney, liver, and muscle). The country of origin of the data is not explicitly stated, but the manufacturer is based in Hong Kong, China. The testing described is prospective, as it was conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is Not Applicable as the device is an electrosurgical electrode, not a diagnostic device requiring expert interpretation for ground truth. The performance is assessed through objective measurements (cutting/coagulation effectiveness, eschar buildup, residue levels, biological reactions) and compliance with engineering standards.
4. Adjudication method for the test set
This is Not Applicable. Performance was assessed through direct measurements and comparison to a predicate device, not through subjective expert adjudication.
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
This is Not Applicable. This is a conventional medical device, not an AI-powered diagnostic tool, and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is Not Applicable. The device is an electrosurgical electrode and does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established through:
- Objective performance comparison: "No significant difference" in operation result and eschar buildup compared to the predicate device on animal tissue (porcine kidney, liver, and muscle).
- Compliance with international standards: Adherence to IEC 60601-1, IEC 60601-2-2, ISO 10993-7, and ISO 10993-1.
- Chemical and biological tests: Measured EO/ECH residue levels and positive outcomes from intracutaneous reactivity, in vitro cytotoxicity, and skin sensitization tests.
8. The sample size for the training set
This is Not Applicable. This is not an AI/machine learning device, so there is no training set.
9. How the ground truth for the training set was established
This is Not Applicable, as there is no training set for an AI/machine learning 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.