(41 days)
The Codman Integrated Irrigation Tubing and Bipolar Cord Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.
They are intended for use with the Codman/Malis CMC®-II and the Codman/Malis CMC® III I.E.C. Irrigation Modules and the Codman/Malis Bipolar Coagulators.
The Codman Integrated Irrigation Tubing and Bipolar Cord Set is designed to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation. A co-extrusion process integrates a disposable bipolar cord and irrigation tubing. This integrated set allows for one unit instead of two units and helps to keep the bipolar electrosurgery organized.
The provided text describes a 510(k) summary for the "Codman Integrated Irrigation Tubing and Bipolar Cord Set." This device is a Class II electrosurgical accessory. The submission focuses on establishing substantial equivalence to a predicate device rather than presenting a de novo device with novel performance data.
Therefore, the study supporting the device's acceptance is a comparison to a predicate device and performance testing based on established industry standards, rather than a clinical study with a detailed examination of diagnostic performance metrics like sensitivity, specificity, or accuracy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific quantitative acceptance criteria or detailed numerical performance metrics for the device itself. Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence (General) | "Substantially equivalent to the Codman/Malis Integrated Irrigation Tubing and Bipolar Cord Set based on the device's similarity to the predicate device in intended use, materials, design, and principles of operation." |
| Performance Testing (General) | "Device qualification criteria meet performance criteria for the predicate device." |
| Industry Standards Compliance | "Tests meet or exceed the minimum levels as set forth by the Association for the Advancement of Medical Instrumentation in the ANSI/AAMI HF18: 2001: Electrosurgical devices § 4.2.5.1-3, 5." |
Note: The acceptance criteria here are focused on ensuring the new device performs at least as well as the predicate device and adheres to relevant industry safety and performance standards for electrosurgical devices. There are no specific metrics like accuracy or AUC typically associated with AI/diagnostic devices.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for the Test Set: Not applicable in the context of this device and submission. The testing described is performance testing against engineering standards rather than clinical validation with a "test set" of patient data.
- Data Provenance: Not applicable. The testing is laboratory-based performance testing of hardware, not analysis of patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. Ground truth for this type of device is established by engineering specifications, regulatory standards, and comparison to a legally marketed predicate device, not by expert consensus on clinical data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No "test set" in the clinical sense is described, and therefore no adjudication of clinical outcomes is relevant for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an electrosurgical accessory, not an AI software for diagnostic image interpretation that would typically require such a study to evaluate human reader performance with and without AI assistance.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance
- Standalone Performance Study: No, a standalone algorithm performance study was not done. This device is a physical electrosurgical accessory, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device is based on engineering specifications, performance criteria of the predicate device, and compliance with recognized industry standards (ANSI/AAMI HF18: 2001 for Electrosurgical devices).
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI algorithm; therefore, there is no "training set" of data in the AI sense.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm.
§ 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.