The Bipolar Ablation Probes are disposable, bipolar electrosurgical devices intended to be used for ablation and hemostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EAS™ generator.

Device Description

The ORATEC Bipolar Ablation Probes are disposable, bipolar electrosurgical devices designed to cut or ablate soft tissues. They provide minimally invasive access to the targeted tissues. The Bipolar Ablation Probes are used in conjunction with the ORATEC Vulcan™ EAS™ RF generator to deliver bipolar radiofrequency (RF) energy for ablation of soft tissues. The probes consist of an insulated shaft, an insulated power electrode, a return electrode, and a handle. Probes may incorporate suction capability for the removal of ablated tissue from the surgical site.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called ORATEC Bipolar Ablation Probes. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a novel therapy would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or not explicitly detailed in this type of regulatory submission.

However, I can extract the information that is present and indicate where information is not provided.

Here's the analysis based on the provided text:

Acceptance Criteria and Study for ORATEC Bipolar Ablation Probes

The provided 510(k) summary describes ORATEC Bipolar Ablation Probes and aims to demonstrate their substantial equivalence to a predicate device, the ArthroCare Ablation Probes. As such, the "acceptance criteria" are primarily related to showing that the ORATEC probes are as safe and effective as the predicate device, and the "study" mentioned refers to comparative testing against that predicate.

1. Table of Acceptance Criteria and Reported Device Performance

No explicit quantitative acceptance criteria or detailed performance metrics are given in the 510(k) summary. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device. The performance is assessed comparatively.

Acceptance Criteria Category (Implied by Substantial Equivalence)	Reported Device Performance (Comparative)
Safety: No new questions of safety raised by design differences.	The submission states: "These design differences [between ORATEC and ArthroCare probes] do not raise any new questions of safety or effectiveness." This implies the safety profile is equivalent to the predicate. Specific safety metrics (e.g., adverse event rates, tissue damage thresholds) are not detailed.
Effectiveness: Equivalent performance for ablation and hemostasis of soft tissues in arthroscopic procedures.	"The ORATEC Bipolar Ablation Probes performed equivalently to the predicate devices in bench and in clinical testing." This indicates the device successfully performs ablation and hemostasis of soft tissues, consistent with the predicate. No specific performance metrics (e.g., ablation rate, hemostasis time, tissue removal efficiency) are provided.
Functionality: Ability to cut/ablate soft tissues, provide minimally invasive access, deliver bipolar RF energy, and potentially incorporate suction.	The device description outlines these functions, stating the probes "are disposable, bipolar electrosurgical devices designed to cut or ablate soft tissues. They provide minimally invasive access to the targeted tissues." They are used "to deliver bipolar radiofrequency (RF) energy for ablation of soft tissues," and "Probes may incorporate suction capability." The comparison notes that both the ORATEC and predicate devices "deliver bipolar radiofrequency energy for ablation of soft tissues" and "both are capable of suction."
Sterility & Single Use: Provided sterile, designed for single-use only.	The comparison explicitly states both the ORATEC and predicate devices "both are provided sterile and are designed for single-use only." This is a fundamental design and use principle for the device, confirmed to be present.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided 510(k) summary. The summary mentions "bench and in clinical testing" but does not detail the number of participants, cases, or tests.
Data Provenance: Not specified. It's likely from the US, given the FDA submission, but no country of origin is explicitly stated. The summary does not indicate if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable / Not Specified. This type of information is typically related to diagnostic image interpretation or complex clinical outcome assessments, which are not the primary focus of this 510(k) for an electrosurgical device assessing substantial equivalence. The "clinical testing" would likely have involved surgeons or other medical professionals, but their role in "ground truth establishment" in the context of diagnostic accuracy is not relevant here.

4. Adjudication method for the test set:

Not Applicable / Not Specified. Adjudication methods (e.g., 2+1, 3+1 consensus) are typically used for establishing ground truth in diagnostic accuracy studies. For an electrosurgical device demonstrating functional equivalence, such a method would not typically be used. Performance assessment would involve direct observation of function, tissue effects, and patient outcomes (if a clinical study was performed).

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 tool, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.

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

Not Applicable. This is an electrosurgical device, not a standalone AI algorithm. Its function inherently involves a human operator (surgeon).

7. The type of ground truth used:

Direct functional assessment and clinical observation. For this device, "ground truth" would likely refer to the direct observation of the device successfully ablating and achieving hemostasis in soft tissues during "bench and in clinical testing," as well as surgical outcomes in a clinical setting. It's not a diagnostic "ground truth" established by expert consensus or pathology in the sense of an image interpretation task. The primary "ground truth" in this 510(k) is the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

Not Applicable / Not Specified. As this is not an AI/machine learning device, there is no "training set" in that context. If "training set" refers to pre-clinical or in-vitro testing for design optimization, details are not provided.

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

Not Applicable. See point 8.

Summary

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Additional Information, K991218 ORATEC Bipolar Probes

SEP 1 3 1999

510(k) Summary

ORATEC Interventions, Inc. Bipolar Ablation Probes

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

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

A. Submitter:

Oratec Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025

phone: (650) 369-9904 (650) 369-9902 fax:

Sheila Ramerman Contact: Date Prepared: June 25, 1999

B. Device Names:

Proprietary Name:	Bipolar Ablation Probes
Common/usual Name:	Electrosurgical Accessory
Classification Name:	Electrosurgical Device

ArthroCare Ablation Probes, ArthroCare Corporation C. Predicate Device:

D. Device Description:

Interventions, Inc. 3700 Haven Court

Menlo Park, CA

94025

ነ' በሰክፉ

ORATEC

The probes consist of an insulated shaft, an insulated power electrode, a return electrode, and a handle. Probes may incorporate suction capability for the removal of ablated tissue from the surgical site.

(650) 369-9904 Fax: (650) 369-9905

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E. Intended Use:

Comparison with the Predicate Device: F.

The ORATEC Interventions Bipolar Ablation Probes and the ArthroCare Ablation Probes are the same in that:

both provide minimally invasive access to targeted tissues; .
both deliver bipolar radiofrequency energy for ablation of soft tissues; .
. both are capable of suction;
both are provided sterile and are designed for single-use only. .

The ORATEC Bipolar Ablation Probes and the ArthroCare Ablation Probes differ in that:

The ORATEC probes may be of different physical dimensions than the ArthroCare . probes;
the ORATEC probes may use different electrode, shaft, or insulating materials than . the ArthroCare probe;
the ORATEC probe shafts may have a malleable distal end to allow orientation of the . tip during use, whereas the ArthroCare probe does not;
the ORATEC probes typically consist of one electrode to deliver RF energy whereas . the ArthroCare probes typically consist of multiple electrodes.

These design differences do not raise any new questions of safety or effectiveness. The ORATEC Bipolar Ablation Probes performed equivalently to the predicate devices in bench and in clinical testing.

Based on the information presented here, the ORATEC Bipolar Ablation Probes are substantially equivalent to the ArthroCare Ablation Probes manufactured and distributed by ArthroCare Corporation.

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Image /page/2/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with a wing-like shape above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 1999

Ms. Sheila Ramerman Director, Regulatory and Clinical Affairs ORATEC Interventions, Inc. 3700 Haven Court Menlo Park, California 94025

Re: K991218 Trade Name: ORATEC® Bipolar Ablation Probes Regulatory Class: II Product Code: GEI Dated: July 28, 1999 Received: July 29, 1999

Dear Ms. Ramerman :

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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (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 (QS) 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Sheila Ramerman

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) 594-4595. 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" (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,

picollaza

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

Enclosure

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Additional Information, K991218 ORATEC Bipolar Probes

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ORATEC Interventions Bipolar Ablation Probes

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	code
Division of General Restorative Devices	K991218
510(k) Number

Prescription Use _(Per 21 CFR 801.109)	OR	Over-The-Counter Use _
--------------------------------------------	----	------------------------

(Optional Format 1-2-96)

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.