(26 days)
The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding 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 Generator ●
- Stellartech Coagulation Probe Connection Module ●
- Stellartech Coagulation Probe .
- Optional Stellartech Footswitch. .
The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe Connection Module cable connects to the Stellartech Coagulation Generator.
The provided text is related to a 510(k) clearance for the Stellartech Coagulation System. It focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a study demonstrating specific performance metrics against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary focuses on demonstrating "substantial equivalence" of the Stellartech Coagulation System to existing predicate devices (Hobbs Medical Dilation Balloon Catheter, Stellartech Coagulation System K013139, Stellartech Coagulation System K023765) based on design, principles of operation, materials, and intended use. It does not provide specific acceptance criteria or performance metrics for the device itself.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission is a regulatory premarket notification based on equivalence, not a clinical study with a test set.
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)
This information is not provided in the document. No test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No test set or adjudication method 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
This information is not provided in the document. The device is an electrosurgical unit, not an AI-assisted diagnostic tool, so an MRMC study related to human reader improvement with AI would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided in the document. The device is a physical electrosurgical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. No ground truth is mentioned as it's not a study requiring such data.
8. The sample size for the training set
This information is not provided in the document. No training set is mentioned.
9. How the ground truth for the training set was established
This information is not provided in the document. No training set or ground truth establishment is described.
§ 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.