(33 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 Probe Connection Module .
- Stellartech Coagulation Probe .
- Optional Accessory Stellartech Sizing Probe .
- . Optional Stellartech Footswitch.
The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Probe Connection Module. The proximal end of the Stellartech Probe Connection Module cable connects to the Stellartech Coagulation Generator.
This 510(k) submission (K032721) for the Stellartech Coagulation System does not contain a study that proves the device meets specific acceptance criteria in the manner you've outlined for AI/diagnostic devices.
Here's why and what information can be extracted from the provided text:
This is a substantial equivalence (510(k)) submission for an electrosurgical device. The core of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove efficacy against pre-defined performance metrics through clinical trials, especially for common device types like electrosurgical units.
Therefore, many of your requested fields related to diagnostic study design (like sample sizes for test and training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable and are not present in this document.
What can be described from the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The primary "acceptance criteria" for a 510(k) is substantial equivalence to predicate devices. This means the device must demonstrate comparable safety and effectiveness. The document doesn't list quantifiable performance metrics with targets in the way one would for a diagnostic AI. Instead, it relies on the predicate devices having already established safety and effectiveness.
- Reported Device Performance: The document states: "The technological characteristics of the Stellartech Coagulation System are substantially equivalent to those of the above listed predicate devices." It does not provide specific performance data (e.g., coagulation time, power output, precision of ablation) for the new device or the predicates. Instead, it relies on the known performance of the predicate device family.
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance (from K032721) |
|---|---|
| Substantial Equivalence to Predicate | "The technological characteristics of the Stellartech Coagulation System are substantially equivalent to those of the above listed predicate devices." |
| Safety | Implied by substantial equivalence to legally marketed predicates. |
| Effectiveness | Implied by substantial equivalence to legally marketed predicates, for the stated indications. |
2. Sample sized used for the test set and the data provenance:
- Not applicable / Not provided. This device is an electrosurgical unit, not an AI diagnostic system. There is no "test set" of images or patient data in the context of diagnostic performance.
- The "study" is a comparison to predicate devices, which typically involves engineering testing, bench testing, and potentially some animal or cadaveric testing (though not detailed here) to ensure the new device functions similarly to the predicate. This is qualitative rather than a quantitative diagnostic performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth is not established in this manner for an electrosurgical system's 510(k). The "ground truth" for predicate devices is their long-standing use and FDA clearance for safety and effectiveness.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / None. No adjudication method for a test set is described, as there isn't a diagnostic test set.
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:
- No. This is an electrosurgical device, not an AI clinical decision support or diagnostic tool that assists human readers. Therefore, an MRMC study is not relevant or included.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. There is no "algorithm only" performance for this type of device. The device is used by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" for its safety and effectiveness is primarily established by:
- The regulatory history and performance of the predicate devices. These predicates have been legally marketed and are presumed safe and effective for their indicated uses.
- Engineering and functional testing to ensure the new device meets specifications consistent with the predicate.
- Biocompatibility and electrical safety testing (implied for any medical device but not detailed in this summary).
8. The sample size for the training set:
- Not applicable / Not provided. There is no "training set" of data for this type of device.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set, there's no ground truth establishment for it.
In summary: The provided document is a 510(k) summary for an electrosurgical device, which is cleared based on substantial equivalence to existing predicate devices. It does not involve the kind of diagnostic performance studies with acceptance criteria, test sets, or training sets that are typical for AI/CADe devices. The "study" here is a regulatory review comparing technical characteristics and indications to existing cleared devices.
§ 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.