The Secca™ System is intended for general use in the electrosurgical coagulation of tissue and intended for use specifically in the treatment of fecal incontinence in those patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy.

Device Description

Radiofrequency electrosurgical generator and electrosurgical accessories

AI/ML Overview

Here's an analysis of the provided text regarding the Secca™ System's acceptance criteria and study, structured to answer your questions.

It's important to note that the provided text is a 510(k) Summary for a medical device submitted to the FDA in 2002. This document is focused on demonstrating "substantial equivalence" to previously cleared predicate devices, rather than presenting a detailed clinical study report with specific acceptance criteria and performance metrics for a novel AI device. Therefore, many of your requested points, especially those related to AI-specific metrics (like ML model performance, test/training set details, ground truth establishment for ML, MRMC studies, etc.), are not applicable or available within this type of regulatory submission. I will explicitly state where the information cannot be found.

Acceptance Criteria and Device Performance

The 510(k) summary for the Secca™ System does not explicitly list quantitative "acceptance criteria" in the way one might see for an AI algorithm's performance (e.g., a specific AUC or sensitivity/specificity threshold). Instead, the primary "acceptance" for a 510(k) submission is demonstrated by substantial equivalence to existing legally marketed predicate devices. This means that the new device (Secca™ System) must be shown to be as safe and effective as the predicates, and not raise new questions of safety or effectiveness.

The "device performance" reported is the demonstration that its intended use, indications for use, technological characteristics, and principles of operation are substantially equivalent to its predicates.

Acceptance Criteria (Implied by 510(k) Process)	Reported Device Performance (from K014216)
Intended Use: Substantially equivalent to predicate devices.	Met: "The Secca™ System is intended for general use in the electrosurgical coagulation of tissue and intended for use specifically in the treatment of fecal incontinence... The general intended use of the Secca System... is the same as the general intended use of Curon Medical's previously cleared Stretta System... The Secca System's specific indication for use for treatment of fecal incontinence is also substantially the same as for a number of predicate biofeedback devices."
Indications for Use: Substantially equivalent to predicate devices.	Met: "Any minor differences in indications between the Secca System and the predicates do not alter its therapeutic effect, considering the impact on safety and effectiveness. Furthermore, although minor modifications have been made to the technological features of the Secca System... these changes are minimal and do not affect the safety or effectiveness of the Secca System."
Technological Characteristics & Principles of Operation: Substantially similar to predicate devices, with no new significant questions of safety or effectiveness.	Met: "Comparing the principles of operation and the technological characteristics of the Secca System to its predicates, the device and generator design also is substantially similar to the Company's previously cleared Stretta System... Likewise, its design is substantially similar to Curon's cleared Tubular Electrodes... These devices have been designed, tested, and produced by the same manufacturer in much the same manner." "The Secca System presents no new significant technological features compared to the previously cleared predicates."
Safety and Effectiveness: Demonstrated through comparison to predicates and preclinical/clinical testing (if any was submitted as part of the 510(k) to address minor differences).	Met: The FDA cleared the device, implying they found sufficient evidence for substantial equivalence in terms of safety and effectiveness. The document states, "Any minor differences in indications... do not alter its therapeutic effect, considering the impact on safety and effectiveness as not [sic] and met by preclinical and clinical testing." This suggests some testing was performed to support this claim, but details are not provided in this summary.

Study Details (as inferable from a 510(k) Summary)

Sample size used for the test set and the data provenance:
- Not applicable/Not provided in this summary. This 510(k) summary describes a regulatory submission for a medical device (radiofrequency electrosurgical system), not an AI algorithm. Therefore, there isn't a "test set" in the context of an AI model. The submission relies on comparison to predicate devices and potentially "preclinical and clinical testing" (mentioned in passing) to support its claim of substantial equivalence. The details of any such testing (sample size, data provenance) are not included in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. As this is not an AI algorithm evaluation, there is no "ground truth" to be established by experts for a test set in the sense you are asking. The safety and effectiveness would be evaluated by clinicians/engineers in any underlying studies, but not in the format of "expert consensus ground truth" for an AI model.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This concept is not relevant to a 510(k) submission for a non-AI medical device.
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 a hardware/electrosurgical device, not an AI system. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device, not an algorithm. Therefore, a standalone algorithm performance evaluation was not performed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided in this summary. For a device like this, the "ground truth" for its safety and effectiveness would implicitly come from established clinical practice, physiological effects of electrosurgery, and observations in any preclinical/clinical studies (if performed) leading to clinical outcomes. However, the details of how this was established or measured are not in this 510(k) summary. The summary focuses on equivalence to known devices rather than establishing novel ground truth for a new paradigm.
The sample size for the training set:
- Not applicable/Not provided. This is not an AI device, so there is no training set in the context of machine learning.
How the ground truth for the training set was established:
- Not applicable/Not provided. As there is no AI training set, this question is not relevant.

Summary regarding the nature of the document:

This 510(k) summary is a regulatory document from the year 2002 for an electrosurgical medical device. It predates the widespread regulatory frameworks and expectations for Artificial Intelligence (AI) and Machine Learning (ML) in medical devices. Consequently, it does not contain the specific information you are looking for regarding AI model evaluation, ground truth, test/training sets, or MRMC studies. The "study" referenced in the acceptance criteria is implicitly the demonstration of substantial equivalence through comparison to predicate devices and any internal testing (preclinical and clinical) mentioned briefly.

Summary

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Attachment 14

MAR 2 1 2002

510(k) SUMMARY

Curon Medical, Inc.'s Secca™ System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Submitter:

Curon Medical, Inc. 735 Palomar Avenue Sunnyvale, CA 94085 408-733-9910 main 408-522-8699 fax

Contact Person:

Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson, LLP 555 13th Street, N.W. Washington, DC 20004 Phone: (202) 637-5794 Fax: (202) 637-5910

Date Prepared: December 20, 2001

Name of Device

Secca™ System

Common or Usual Name

Radiofrequency electrosurgical generator and electrosurgical accessories

Classification Name

Electrosurgical cutting and coagulation device and accessories

Predicate Devices

1. Stretta System (K010210
1. Stretta System (K000245)
Stretta Inflatable Basket Electrode (K991291) ತೆ.
ಈ
Secca Tubular Electrode (K000170) ধ:

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2/3 K014216

1. A4000 Tubular Electrode (K992542)
1. BioCare International's BCI-100 Fecal Incontinence System (K904646)
1. Biosearch, Inc.'s Anorectal Biofeedback System 5 (K913736)
1. Ethicon's PowerStar Bipolar Scissors (K981361)
1. Ellman's Surgitron Radiolase System and Accessories (K992382)

Portlyn Corporation's Dynabite Hot Gastroenterology Biopsy Forceps (K970083)

Intended Use

Substantial Equivalence

The Secca System is substantially equivalent to other marketed devices that have received premarket clearance. The general intended use of the Secca System to coagulate tissue electrosurgically is the same as the general intended use of Curon Medical's previously cleared Stretta System (K010210 and K000245) ("Stretta"), Secca Tubular Electrode (K000170), A4000 Tubular Electrode (K992542), and Stretta Inflatable Basket Electrode (K991291). The Secca System's specific indication for use for treatment of fecal incontinence is also substantially the same as for a number of predicate biofeedback devices. Specifically, BioCare International's BCI-100 Fecal Incontinence System (K904646) ("BCI-100 System") and Biosearch, Inc.'s Anorectal Biofeedback System 5 (K913736) ("Anorectal System 5") are cleared for biofeedback training of the anal sphincter in the treatment of fecal incontinence and/or constipation. Finally, FDA also has cleared a number of other devices for use in anorectal procedures to perform tissue ablation or coagulation, including Ethicon's PowerStar Bipolar Scissors (K981361) device, Ellman's Surgitron Radiolase System and Accessories (K992382), and Portlyn Corporation's Dynabite Hot Gastroenterology Biopsy Forceps (K970083) device. Although these devices are not specifically indicated for use in the treatment of fecal incontinence, like the Secca System they are all generally used to apply electrical energy within the lower GI tract for treatment of gastroenterological pathologies.

Comparing the principles of operation and the technological characteristics of the Secca System to its predicates, the device and generator design also is substantially similar to the Company's previously cleared Stretta System (K010210 and K000245), except for a few minor modifications. Likewise, its design is substantially similar to Curon's cleared Tubular Electrodes (K000170 and K992542) and Stretta Inflatable Basket Electrode (K991291). All of these devices have been designed, tested, and produced by the same manufacturer in much the same manner.

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Any minor differences in indications between the Secca System and the predicates do not alter its therapeutic effect, considering the impact on safety and prodicates as not and med by preclinical and clinical testing. Furthermore, although minor modifications have been made to the technological features of the Secca System since the Company's clearance of the predicate Stretta System, these changes are minimal and do not affect the safety or effectiveness of the Secca System. Thus, the Secca System presents no new significant technological features compared to the previously cleared predicates. Therefore, because the intended use and indications for use of the device are substantially the same as the cleared predicates and there are no significant new technological features, the device may be found substantially equivalent to those other devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2002

Curon Medical, Inc. c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109

Re: K014216

Trade Name: Secca System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 20, 2001 Received: December 21, 2001

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Jonathan Kahan

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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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K014216

SECCA™ SYSTEM INDICATIONS FOR USE:

Muriann C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K014216

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.