Rocket Electrode is to be used as a gynecologic electrocautery device for tissue excision. It is designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. This is to excise cervical lesions, perform biopsies, or treat chronic cervititis under direct visual observation

Device Description

This group of electrodes consists basically of a metal shaft partly insulated with two extensions connected by means of a metal wire (square and loop types). Or in case of the other types, it may be connected by blade, ball or needle. All the electrodes are supplied with different sizes

AI/ML Overview

The provided 510(k) submission for the "Rocket Electrode" does not contain a study that proves the device meets specific acceptance criteria related to its performance on diagnostic tasks.

Instead, this submission is for a medical device (electrocautery electrodes) that establishes substantial equivalence to existing predicate devices. The safety and effectiveness are determined by comparing its technological characteristics to those of already approved devices, rather than through a standalone performance study with predefined acceptance criteria.

Here's why the requested information cannot be fully provided based on the input:

Type of Device: The "Rocket Electrode" is a gynecologic electrocautery device for tissue excision. It's a surgical instrument, not a diagnostic imaging or AI-powered device that performs a diagnostic task. Therefore, metrics like sensitivity, specificity, or AUC, which are common for AI/diagnostic devices, are not applicable here.
Regulatory Pathway: This is a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not require extensive clinical trials or performance studies against specific acceptance criteria in the same way a device seeking PMA approval or a novel diagnostic AI algorithm might.

However, I can extract information related to the comparison with predicate devices and the intent of the submission:

1. Table of acceptance criteria and the reported device performance

No specific acceptance criteria (e.g., sensitivity, specificity, AUC) are listed because this is not a diagnostic device and the submission method is 510(k) substantial equivalence.
Instead of "performance," the submission focuses on technological characteristics comparison to demonstrate comparable safety and effectiveness.
The reported "performance" is that the device's technological characteristics are "Equivalent" or "Similar" to the predicate device.

Feature / Characteristic	Acceptance Criteria (Implicit for Substantial Equivalence)	Rocket Electrode Performance (Relative to Predicate K942986 from Aaron Medical Industries)
Indications for use	Similar/Equivalent to predicate	Equivalent (m)
Target population	Similar/Equivalent to predicate	Equivalent (m)
Design	Similar/Equivalent to predicate	Equivalent (m)
Materials	Similar/Equivalent to predicate	Equivalent (m)
Performance (general)	Similar/Equivalent to predicate	Equivalent (m)
Sterility	Similar/Equivalent to predicate	Equivalent (m)
Biocompatibility	Similar/Equivalent to predicate	Equivalent (m)
Mechanical Safety	Similar/Equivalent to predicate	Equivalent (m)
Chemical Safety	N/A (Not Applicable for predicate, thus implicitly for new device in this context)	N/A (as per predicate)
Anatomical sites	Similar/Equivalent to predicate	Equivalent (m)
Human Factors	Similar/Equivalent to predicate	Equivalent (m)
Energy used and/or delivered	Similar/Equivalent to predicate	Equivalent (m)
Compatibility w/ environment & other devices	Similar/Equivalent to predicate	Equivalent (m)
Where used	Similar/Equivalent to predicate	Equivalent (m)
Standards met	Similar/Equivalent to predicate	Equivalent (m)
Electrical Safety	Similar/Equivalent to predicate	Equivalent (m)
Thermal Safety	Similar/Equivalent to predicate	Equivalent (m)
Radiation Safety	N/A (Not Applicable for predicate, thus implicitly for new device in this context)	N/A (as per predicate)

Abbreviations: m = Equivalent, N/A = Not Applicable

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. There is no "test set" in the context of a diagnostic performance study, as this is a device for surgical intervention, not diagnostic analysis. The submission is a comparison of product specifications.

3. 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)

Not applicable. There is no "ground truth" establishment by experts in a diagnostic context for this type of device submission. The substantial equivalence determination is based on a regulatory review of engineering and design specifications compared to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or expert adjudication related to diagnostic outcomes is mentioned or required for this type of device.

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

Not applicable. This device is an electrocautery electrode used by a surgeon, not an AI diagnostic tool. Therefore, an MRMC study or AI-assistance evaluation is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a manual surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The concept of "ground truth" in a diagnostic sense does not apply to this device. The "truth" in this submission relates to whether the device's physical and functional characteristics are substantially equivalent to marketed devices for its intended use.

8. The sample size for the training set

Not applicable. This device is a physical instrument, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set or ground truth in the AI/diagnostic sense is involved.

Summary

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1173 K974138

510(k) Summary As Required by 21 section 807.92 ( c )

A & A Medical, Inc. 1-Submitter Name: 4100 Nine McFarland Drive, suite B 2-Address: Alpharetta, GA 30004 3-Phone: (770) 343- 8400 (770) 343- 8985 4-Fax: 5-Contact Person: Jihad Mansour 6-Date summary prepared: October 31tt, 1997 7-Device Trade or Proprietary Name: Rocket Electrode 8-Device Common or usual name: Electrode (Blade, Ball, Needle, Square and Loop) Gynecologic electrocautery and accessories 9-Device Classification Name:

10-Substantial Equivalency is claimed against the following devices:

*Electrodes (Blade, Ball, Needle, Square and Loop) from AARON MEDICAL INDUSTRIES

11-Description of the Device:

12-Intended use of the device: (ALSO PRINTED SEPARATELY ON FDA FORM)

Each Rocket Electrode is to be used as a gynecologic electrocautery device for tissue excision.

It is designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. This is to excise cervical lesions, perform biopsies, or treat chronic cervitiis under direct visual observation

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11974138

13-Safety and Effectiveness of the device:

PLU)

Rocket Electrode is as safe and effective as the other predicate devices cited above. This is better expressed in the tabulated comparison ( Paragraph 14 below )

14-Summary comparing technological characteristics with other predicate devices:

Please find below a tabulated comparison supporting that Rocket Electrode is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached

P.S. Abbreviations used below: E=Equivalent, S=Similar, D=Different, N/A= Not Applicable, DES=Description available, N/I=No Information available, 510(k)Sum=510(k)Summary available, 510(k)=510(k) available, web=fda web printout enclosed

	TECHNOLOGICAL CHARACTERISTICS
	FDA file reference number	Attachments inside Notification	Indications for use	Target population	Design	Materials	Performance	Sterility	Biocompatibility	Mechanical Safety	Chemical Safety	Anatomical sites	Human Factors	Energy used and/or delivered	Compatibility w/ environment & other devices	Where used	Standards met	Electrical Safety	Thermal Safety	Radiation Safety
Electrodes (Blade, Ball, Needle, Square& Loop) from Aaron Medical Industries	K942986	web 510k	m	m	m	m	m	m	m	m	N/A	m	m	m	m	m	m	m	m	N/A

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Image /page/2/Figure/2 description: This image is a flowchart titled "510(k) "Substantial Equivalence" Decision-Making Process (Overview)". The flowchart outlines the steps involved in determining whether a new device is substantially equivalent to a marketed device. The process begins with comparing the new device to a marketed device and proceeds through a series of questions about intended use, technological characteristics, and performance information. The flowchart indicates that if the new device is not substantially equivalent, additional information may be required.

A more Detailed version is also available in ndf version or found directly below.

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 1998

Jihad Mansour A & A Medical, Inc. 4100 Nine McFarland Drive Suite B Alpharetta, GA 30004

Re: K974138 Rocket Electrode (Gynecological Electrocautery and accessories) Dated: October 31, 1997 Received: November 3, 1997 Regulatory Class: II 21 CFR 884.4120/Procode: 85 HGI

Dear Mr. Mansour:

We have reviewed your Section 510(k) 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drog-and Eosmetic Act (Act): You may, therefore, 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, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h.T.Liau Yi

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page	__________ of __________
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K914158 510(k) Number (if known):

Rocket Electrode Device Name:

Indications For Use:

Rocket Electrode is to be used as a gynecologic electrocautery device for tissue excision.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Peter R Satling (Division Sign-Off)
--	-------------------------------------------------------------------------------	--

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number	K974138
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Prescription Use	✓	OR	Over-The-Counter Use ______
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

Regulation Number and Section

§ 884.4120 Gynecologic electrocautery and accessories.

(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).