(130 days)
The Stellartech 100 Coagulation System is intended for coagulating soft tissue during open (non-laparoscopic or non-endoscopic) general surgical procedures. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
The Stellartech 100 Coagulation System consists of the following components.
- Stellartech 100 Coagulation Generator Models #1050B-115 & 1050B-230 .
- . Stellartech 101 Probe
- Optional Stellartech Footswitch. .
The proximal end of the Stellartech 101 Probe connects to the Stellartech 100 Coagulation Generator Models #1050B-115 & 1050B-230.
This document is a 510(k) premarket notification for the Stellartech 100 Coagulation System. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance data.
Therefore, many of the requested categories related to performance studies, sample sizes, ground truth establishment, and expert involvement cannot be extracted from the provided text because these types of studies were not included or required for this type of submission.
Here's what can be extracted based on the information provided:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Implicit Acceptance Criteria for 510(k) Equivalence:
The device's design, principles of operation, materials, and intended use are substantially equivalent to legally marketed predicate devices.
Specific Performance Criteria (Not explicitly stated):
The document does not detail specific quantitative performance acceptance criteria (e.g., coagulation efficacy, power output ranges, safety limits) against which the device was tested. The focus is on substantial equivalence to predicate devices. | The Stellartech 100 Coagulation System is substantially equivalent to the listed predicate devices by virtue of its design, principles of operation, materials, and intended use. |
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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):
- Information Not Provided: The submission is a 510(k) for substantial equivalence and does not describe a clinical study with a "test set" in the context of performance metrics. It references comparison to 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):
- Information Not Provided: The submission does not detail any expert-driven ground truth establishment for a performance test set. The "ground truth" for a 510(k) substantial equivalence determination generally relies on the established safety and efficacy of the predicate devices and the manufacturer's engineering assessment of their device's equivalence.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information Not Provided: As no performance study with a "test set" requiring adjudication is described, this information is not applicable.
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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:
- Not Applicable / Information Not Provided: This device is an electrosurgical unit, not an AI-assisted diagnostic or imaging device used by "readers." Therefore, an MRMC study is not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Information Not Provided: This device is a physical electrosurgical system, not an algorithm. Standalone algorithm performance is not relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implicit Ground Truth for Substantial Equivalence: The ground truth for this 510(k) submission is the legally marketed predicate devices and their established safety and effectiveness. The manufacturer asserts that the Stellartech 100 Coagulation System's characteristics are "substantially equivalent" to these known devices. There is no mention of specific clinical outcomes data or pathology reviews presented in this summary to establish "ground truth" for a novel performance claim beyond equivalence.
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The sample size for the training set:
- Not Applicable / Information Not Provided: This device is an electrosurgical unit, not a machine learning model, so there is no "training set" in the context of AI.
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How the ground truth for the training set was established:
- Not Applicable / Information Not Provided: As there is no training set, this question is not applicable.
§ 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.