(20 days)
The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and nonbleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
The Stellartech Coagulation System consists of the following components.
- Stellartech Coagulation Catheter .
- Stellartech Coagulation Catheter Connection Module t
- . Stellartech Coagulation Generator
- Stellartech Sheath .
- Optional Stellartech Footswitch. .
- Optional Stellartech Sizing Catheter .
- Optional Stellartech Sizing Sheath .
The proximal end of the Stellartech Coagulation Catheter connects to the Stellartech Coagulation Catheter Connection Module. The Stellartech Coagulation Catheter Connection Module cable connects to the Stellartech Coagulation Generator.
The provided text is a 510(k) premarket notification for the Stellartech Coagulation System. It focuses on establishing substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving performance against specific acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided document. This type of information is typically found in design validation studies, clinical trials, or performance testing reports, which are not included in this summary.
Here's a breakdown of what can and cannot be extracted from the provided text, following your requested format:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document does not specify quantitative acceptance criteria (e.g., specific thresholds for coagulation effectiveness, safety metrics, or device longevity) nor does it report specific performance data from a study that would demonstrate meeting such criteria. The submission is based on substantial equivalence, implying that its performance is assumed to be similar to legally marketed predicate devices without explicitly stating and measuring against specific acceptance targets.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available: No test set or data provenance is mentioned. This submission is a regulatory filing for substantial equivalence, not a clinical study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Available: The concept of a "ground truth" and expert adjudication is not present in this type of regulatory submission focusing on substantial equivalence for a medical device like a coagulation system. Ground truth is usually relevant for AI/ML device assessments that rely on image or data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available: Not applicable, as no test set or ground truth adjudication process is described in this document.
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
- Not Available: This device is a medical instrument (electrosurgical unit), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Available: This device is a physical electrosurgical system, not an algorithm. Standalone performance as typically described for AI/ML devices is not applicable or discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available: Ground truth is not a concept discussed in this 510(k) summary. The device's safety and effectiveness are established by demonstrating substantial equivalence to predicate devices, implying that their previously established safety and effectiveness apply to this new device due to similar design and intended use.
8. The sample size for the training set
- Not Available: There is no mention of a training set. This is a medical device, not an AI/ML product developed using training data.
9. How the ground truth for the training set was established
- Not Available: Not applicable, as there is no training set described.
Summary of Device and Regulatory Context (based on provided text):
The Stellartech Coagulation System is an electrosurgical unit and accessories intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including specific indications such as Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
The 510(k) premarket notification (K041383) establishes substantial equivalence to several predicate Stellartech Coagulation Systems (K013139, K023765, K032062, K032452, K032721, K040240). The basis for FDA clearance is that the technological characteristics, design, principles of operation, materials, and intended use are substantially equivalent to these already marketed predicate devices. This means that extensive de novo studies with explicit acceptance criteria and performance reporting, as requested in your prompt regarding AI/ML devices, are typically not required for a 510(k) submission based on substantial equivalence to well-established technology.
§ 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.