(56 days)
The Epicor Medical UltraCinch is intended for the ablation of cardiac tissue during cardiac surgery.
The items in the UltraCinch Accessory Pack are intended for use in the ablation of cardiac tissue during cardiac surgery.
Epicor Medical UltraCinch Tissue Ablation Device and Accessories
This document is a 510(k) premarket notification for the Epicor Medical UltraCinch Tissue Ablation Device and Accessories. It focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel safety and effectiveness criteria through specific performance goals and studies.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types cannot be fully provided from the given text. This type of submission relies on showing that the new device is as safe and effective as existing legally marketed predicate devices, often by demonstrating similar technological characteristics and performance in standard tests, rather than setting and meeting new, specific quantitative acceptance criteria for a novel clinical outcome.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific percentages, measurements, or clinical outcomes) that the device must meet. Instead, it states that "Results of in vitro testing, in vivo testing, and human clinical studies demonstrate that the Epicor Medical UltraCinch tissue ablation device and accessories are safe and effective for their intended use."
The device performance is generally reported as:
- "safe and effective for their intended use."
- "meet the requirements of ISO 10993-1." (for biocompatibility)
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided text. The document mentions "clinical studies" but does not give details about their size or structure.
- Data Provenance: Not explicitly stated. The document refers to "in vitro testing, in vivo testing, and human clinical studies." These could be retrospective or prospective, and the country of origin is not mentioned.
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 text. As this is a 510(k) submission focused on substantial equivalence, the "ground truth" (in the sense of a diagnostic or predictive AI model) is not the primary focus. The "ground truth" for the device's function would be the physical effect of ablation, which is assessed through the "in vivo testing" and "human clinical studies" mentioned in a general sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the text.
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 to this device. The Epicor Medical UltraCinch is a tissue ablation device, not an AI software or diagnostic imaging system that would involve human readers interpreting cases with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable to this device. As explained above, this is a physical medical device for cardiac tissue ablation, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this type of device, the "ground truth" would likely relate to:
- Successful ablation: Confirmation of tissue destruction/modification.
- Clinical outcomes: Reduction of arrhythmias or other target conditions.
- Safety metrics: Absence of adverse events.
However, the specific methods for establishing this ground truth (e.g., pathology reports from ablated tissue, electrophysiological mapping results, long-term patient follow-up, etc.) are not detailed in the provided text.
8. The sample size for the training set:
This is not applicable as this is a physical medical device, not an AI/ML model that requires a training set. The "studies" mentioned would be for device validation, not model training.
9. How the ground truth for the training set was established:
This is not applicable as this is a physical medical device, not an AI/ML model that requires a training set.
§ 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.