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.

Device Description

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.

AI/ML Overview

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.

Summary

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OCT-6 2003 K032721 (pg 1 of 1)

510(k) Safety Summary

Name of Device A.

Stellartech Coagulation System Trade Name: ●
Electrosurgical Unit and Accessories Common Name: .
Classification Name: Device, Electrosurgical Cutting and Coagulation and Accessories . (21 CFR 878.4400)

B. Predicate Devices

Device	Premarket Notification
Stellartech Coagulation System	K013139, 12/18/01
Stellartech Coagulation System	K023765, 11/29/02
Stellartech Coagulation System	K032062, 7/29/03
Stellartech Coagulation System	K032452, 8/21/03

Device Description: C.

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.

D. Indicated Use

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.

E. Technical characteristics

The technological characteristics of the Stellartech Coagulation System are substantially equivalent to those of the above listed predicate devices.

F. Summary

By virtue of design, principles of operation, materials and intended use, the Stellartech Coagulation System is substantially equivalent to devices currently marketed in the United States.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 6 2003

Mr. Gary A. Seeger Vice President, Quality Assurance and Regulatory Affairs Stellartech Research Corporation 1346 Bordeaux Drive Sunnyvale, California 94089

Re: K032721

Trade/Device Name: StellarTech Coagulation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 2, 2003 Received: September 9, 2003

Dear Mr. Seeger:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Gary A. Seeger

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K032721

510(k) NUMBER (IF KNOWN):

DEVICE NAME: INDICATIONS FOR USE:

Stellartech Coagulation System

Miriam C. Provost

Division of General, Restorative and Neurological Devices

03270 510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter-Use

Regulation Number and Section

§ 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.