(65 days)
General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of RF (radio frequency) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
The System 2450 is an electrosurgical generator with the basic modes of operation being conventional electrosurgical cutting and coagulation. When cutting, the edge of the electrode is drawn across the tissue while electrosurgical energy is being applied. When coagulating, the accessory electrode may be held in contact with the tissue for desiccation or separated from the tissue by distance for fulguration to achieve the desired result. The device consists of an electrosurgical generator unit to supply high frequency (HF) electrosurgical current to accessory handpieces to produce the therapeutic effect. The device utilizes previously cleared/marketed and required accessories.
Here's an analysis of the provided text regarding the CONMED System 2450 ESU, focusing on the acceptance criteria and the study that proves the device meets those criteria:
The provided document is a 510(k) Premarket Notification for the CONMED System 2450 ESU. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards. It does not contain information about a clinical study or performance data against specific acceptance criteria in the manner one would typically find for an AI/CADe device.
The "acceptance criteria" presented are primarily compliance with recognized electrical and medical device safety standards, and the "study" is the conformity to these standards and validation of software.
Here's the breakdown based on your request, with an emphasis on what information is not present:
Acceptance Criteria and Device Performance (Based on the provided document)
| Acceptance Criteria Category | Reported Device Performance (Summary from text) |
|---|---|
| Electrical Safety Standards | Designed to comply with: |
- ANSI/AAMI HF-18
- IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-1-8, 60601-2-2
- UL60601-1 |
| Risk Management | Designed to comply with: - ISO 14971 |
| Biocompatibility | Designed to comply with: - ISO 10993 |
| Software Validation | Validated and verified according to internal ConMed procedures and FDA guidance "General Principles of Software Validation." - Level of concern: "Moderate"
- System Level Hazard Analysis, peer review of software design, software module testing performed. |
| Output Characteristics | Output characteristics are "equivalent to the values for other previously cleared electrosurgical generators." |
| Operational Control | Operator controls device use and sets mode/output. |
| Safety Features | Device provides alarms for risky conditions. |
Detailed Breakdown of Missing Information for an AI/CADe Device:
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Sample size used for the test set and the data provenance:
- Not applicable/Not provided. This is an electrosurgical unit, not an AI/CADe device that uses a "test set" of patient data for performance evaluation. The "tests" relate to electrical and software validation.
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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/Not provided. No such ground truth establishment is described for this type of device. Electrical and software validation involves engineering and quality control experts, but not in the context of diagnostic "ground truth."
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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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:
- Not applicable/Not provided. This device is an electrosurgical generator, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. The "software valuation" described is for the operational software of the electrosurgical unit, not a diagnostic algorithm. The device itself is "standalone" in that it performs its intended function (cutting/coagulation) without AI assistance, but this is a fundamental difference in the type of device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided in the traditional sense. For this device, "ground truth" would relate to the correct functioning of the electrosurgical current delivery, safety mechanisms, and adherence to electrical engineering specifications, validated through laboratory testing and engineering analysis rather than medical consensus or pathology.
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The sample size for the training set:
- Not applicable/Not provided. This device does not use machine learning or AI models developed with "training sets" of data.
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How the ground truth for the training set was established:
- Not applicable/Not provided.
In summary:
The provided 510(k) submission for the CONMED System 2450 ESU demonstrates its safety and effectiveness primarily through showing substantial equivalence to previously cleared predicate devices and by stating compliance with relevant national and international electrical safety, risk management, and biocompatibility standards. It also details the software validation procedures undertaken to ensure its proper functioning.
The document does not describe clinical performance studies, AI algorithm validation, or the use of patient data sets for training or testing, as it is an electrosurgical generator and not a diagnostic AI/CADe device. The "acceptance criteria" are compliance with engineering standards and safe operational characteristics.
§ 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.