The InLine™ Bi-Polar RF Linear Coagulation Device is a single use, sterile, bipolar, hand-held Radiofrequency (RF) Device that is used to coagulate/ablate tissue. The device is designed for use in intraoperative surgical procedures or used through a non-conductive hand-port during laparoscopic surgical procedures.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the InLine™ Bi-Polar RF Linear Coagulation Device:

It's important to note that this document is a 510(k) summary for a medical device submitted to the FDA. As such, the level of detail regarding specific "acceptance criteria" and "device performance" in clinical study format (as you might see for a diagnostic AI device) is often different for electrosurgical devices. For these types of devices, the demonstration of substantial equivalence and safety/efficacy often relies heavily on bench testing and comparison to a predicate device, rather than extensive clinical efficacy trials with patient outcomes.

Acceptance Criteria and Study Details for InLine™ Bi-Polar RF Linear Coagulation Device

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific performance metrics against a predefined acceptance criterion in a clinical study. The "acceptance criteria" for this submission are implicitly tied to proving that the device performs as well as or similarly to the predicate device and does not raise new questions of safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Implicit Acceptance Criterion: The device must demonstrate substantial equivalence to the predicate device in terms of intended use, materials, and principle of operation, and not raise new questions of safety and efficacy.	Bench testing/functional testing was performed on the InLine™ Bi-Polar RF Linear Coagulation Device to ensure that the product is substantially equivalent to the predicate device and to ensure that the new device does not raise new questions of safety and efficacy.
Implicit Acceptance Criterion: The device must be safe and effective for its intended use (coagulating tissue during laparoscopic and intraoperative surgical procedures).	The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed under general controls. This implies the FDA found sufficient evidence of safety and effectiveness based on the provided data.

Explanation: The document does not explicitly state numerical performance metrics (e.g., accuracy, sensitivity, specificity) with corresponding acceptance thresholds. Instead, the "acceptance criteria" are met by demonstrating that the device is substantially equivalent to a previously cleared predicate device (Radionics Cool-tip RF Electrode, K984552) through bench and functional testing.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Bench testing/functional testing was performed on the InLine™ Bi-Polar RF Linear Coagulation Device".

Sample Size: Not specified. It typically refers to the number of devices or components tested in a laboratory setting.
Data Provenance: The testing was "performed on the InLine™ Bi-Polar RF Linear Coagulation Device," implying prospective testing conducted by the manufacturer for the purpose of this 510(k) submission. The country of origin of the data is not specified beyond the applicant's address in Fremont, CA, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. For a device like an electrosurgical tool, "ground truth" is typically established through engineering specifications, validated test methods, and direct physical measurement of device performance (e.g., temperature output, power delivery, coagulation effect on tissue models) rather than expert consensus on interpretation. There would not be "experts" establishing a ground truth in the sense of reviewing medical images or patient data for this type of submission.

4. Adjudication Method for the Test Set

Not applicable. As described above, the testing involved bench and functional assessments, not human interpretation or a test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC comparative effectiveness study is typically relevant for diagnostic devices, especially those involving image interpretation by human readers, often comparing human performance with and without AI assistance. This device is an electrosurgical tool, not a diagnostic AI device, so such a study would not be applicable or expected.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical electrosurgical tool, not an algorithm, and inherently requires human operation. The concept of "standalone performance" without human-in-the-loop is not relevant here.

7. The Type of Ground Truth Used

The "ground truth" for this device would be based on engineering specifications and validated test methods to assess parameters such as:

RF energy output
Temperature profiles
Coagulation depth/width on tissue surrogates (e.g., ex vivo animal tissue)
Integrity of materials
Electrical safety standards

It is not based on expert consensus, pathology, or outcomes data in the context of this 510(k) summary, as it's primarily a performance and equivalence submission.

8. The Sample Size for the Training Set

Not applicable. This device is an electrosurgical tool, not a machine learning or AI algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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KO40763 APPENDIX A. 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Name, Address, Phone and Fax Number of Applicant A.

Resect Medical, Inc. 40874 Calido Place Fremont, CA 94539, USA Telephone: (650) 776-4804 Fax: (510) 573-3343

Contact Person B.

Nancy Lincé

Regulatory Affairs Consultant

Telephone: (650) 759-6186 Fax: (510) 885-9935

C. Date Prepared

February 20, 2004

D. Device Name

Trade Name: InLine™ Bi-Polar RF Linear Coagulation Device

Classification Name: Electrosurgical cutting and coagulation device and accessories

E. Device Description

ட். Intended Use Statement:

The Intine™ Bi-Polar RF Linear Coagulation Device is intended to coaqulate tissue during laparoscopic and intraoperative surgical procedures.

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Substantial Equivalence G.

The InLine Bi-Polar RF Linear Coagulation Device is substantially equivalent to the Radionics Cool-tip RF Electrode (K984552). It has the same intended use, similar materials of construction, and principles of operation as the predicate device. Both devices are designed to coagulate tissue by delivering RF energy with the use of electrodes.

Summary of Data: H.

Bench testing/functional testing was performed on the InLine™ Bi-Polar RF Linear Coagulation Device to ensure that the product is substantially equivalent to the predicate device and to ensure that the new device does not raise new questions of safety and efficacy.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2004

Resect Medical, Inc. c/o Mr. J.A. van Vugt KEMA Quality B.V. P.O. Box 5185 6802 Ed Arnhem Arnhem Netherlands

Re: K040763

Trade/Device Name: InLine™ Bi-Polar RF Linear Coagulation Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 24, 2004 Received: March 25, 2004

Dear Mr. van Vugt:

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 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. J.A. van Vugt

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,

Mark N. Millerson

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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Indications for Use

K040763

510(k) Number (if known):

Device Name: InLine™ Bi-Polar RF Linear Coagulation Device

Indications For Use:

The InLine™ Bi-Polar RF Linear Coagulation Device is intended to coagulate tissue during laparoscopic and intraoperative surgical procedures.

Prescription Use -(Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Wilkerson

Division of General, Restorative, and Neurological Devices

510(k) Number K040763

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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.