(60 days)
The nContact Coagulation System is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy.
The nContact Coagulation System consists of a sterile, single-use, disposable coagulation electrode device (2cm & 5cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile).
The provided text is a 510(k) summary for the nContact Coagulation System. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics that would typically be found in a clinical or non-clinical validation report.
Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC study, ground truth details, training set size) cannot be answered from the provided document.
However, I can extract the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria with corresponding performance results. Instead, it states:
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | The device should be capable of coagulating cardiac tissue using radiofrequency (RF) energy. | The nContact Coagulation System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy. (This is a statement of intent, not a measured performance against a criterion). |
| Technological Characteristics & Principle of Operation | Must be comparable to listed predicate devices. The features of the subject device should be covered by those in at least one predicate device to demonstrate substantial equivalence. | "The nContact Coagulation System has been compared to the listed predicate devices with respect to intended use, technological characteristics, and principle of operation. All of the features specified for the subject device are covered by those listed in at least one predicate device." |
| Safety and Efficacy | Must not raise new questions of safety and efficacy compared to predicate devices. | "The nContact Coagulation System may be considered substantially equivalent to the predicate devices based on performance and comparative data, and does not raise new questions of safety and efficacy." |
| Performance Testing | Performance testing should validate its intended use. (Specific metrics or thresholds for "validation" are not provided.) | "Performance testing was completed to validate its intended use." (No specific results are given.) |
2. Sample size used for the test set and the data provenance
- The document states that "Performance testing was completed," but it does not specify the sample size for any test set or provide details about the data provenance (e.g., country of origin, retrospective or prospective nature). This document is a 510(k) summary, which often summarizes testing without full detail.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices through technical comparison and non-clinical performance, rather than an expert-adjudicated test set typically used for AI algorithms.
4. Adjudication method for the test set
- This information is not provided in the document, as no specific test set requiring expert adjudication is described.
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
- An MRMC comparative effectiveness study is not mentioned in the document. This submission pertains to a medical device for coagulation, not an AI-assisted diagnostic or interpretative tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The nContact Coagulation System is a physical medical device (electrode device and electrosurgical generator), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" as typically applied to AI does not apply in this context. The non-clinical performance testing implicitly refers to the device's functional integrity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document implies that "performance testing" was conducted to validate its intended use (coagulation of cardiac tissue). However, the specific type of "ground truth" (e.g., histological assessment of coagulation, functional cardiac outcomes) used to evaluate this performance is not described. For a device that performs coagulation, "ground truth" would likely involve objective measures of tissue effect.
8. The sample size for the training set
- The concept of a "training set" is not applicable to this device. The nContact Coagulation System is a traditional medical device (electrosurgical) and does not involve AI or machine learning that would require a training set.
9. How the ground truth for the training set was established
- As the device is not an AI/ML system, there is no training set, and therefore no ground truth established for it in that context.
§ 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.