(17 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 document is a 510(k) Safety Summary for a medical device called the "Stellartech Coagulation System." This type of document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
It's important to understand that a 510(k) submission primarily focuses on demonstrating "substantial equivalence" of a new device to existing predicate devices, rather than establishing acceptance criteria through new clinical studies measuring performance against specific metrics.
Therefore, the document does not contain information about:
- A table of acceptance criteria and reported device performance directly derived from a new study specific to this submission.
- Sample sizes used for a test set, data provenance, or the number/qualifications of experts for ground truth establishment.
- Adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance studies.
- Training set sample sizes or how their ground truth was established.
Instead, the document asserts substantial equivalence based on prior predicate devices and their established safety and effectiveness.
Here's what the document does provide and why the requested information is not present:
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A table of acceptance criteria and the reported device performance:
- N/A. The document does not present specific acceptance criteria in the form of performance metrics (like sensitivity, specificity, accuracy, etc.) and then report the device's measured performance against those criteria. The acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device. The "performance" demonstrated is that its technical characteristics, principles of operation, materials, and intended use are comparable to legally marketed predicate devices.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No new clinical or test set data is presented in this 510(k) summary for performance evaluation against specific metrics. The substantial equivalence argument relies on the inherent safety and effectiveness of the predicate devices.
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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):
- N/A. As no new test set is described, there's no mention of experts for establishing ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set described.
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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:
- N/A. This device (Electrosurgical Unit) is not an AI/imaging diagnostic device, and no MRMC study or AI assistance is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithmic device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. As no new performance study is detailed, no ground truth types are described. The "ground truth" in a 510(k) for substantial equivalence is the safety and effectiveness of the legally marketed predicate devices.
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The sample size for the training set:
- N/A. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- N/A. Not applicable, as it's not an AI/machine learning device.
In summary: The provided document is a 510(k) submission, which aims to demonstrate "substantial equivalence" to existing devices, not to present novel clinical study data with specific acceptance criteria and performance metrics. The information requested (acceptance criteria, study details, sample sizes, ground truth methods, MRMC studies, etc.) is typically found in PMA (Premarket Approval) applications or clinical studies for novel devices, not generally in 510(k) summaries like this one.
§ 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.