The BioLucent Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

Device Description

The BioLucent Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The BioLucent Applicator is provided sterile and is a single use device.

AI/ML Overview

The provided text is a 510(k) summary for the BioLucent Applicator, a medical device for brachytherapy. It details the device's intended use, classification, and substantial equivalence to predicate devices, but does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through quantitative metrics.

The relevant sections state:

"Performance Data Summary: Performance testing was conducted on the BioLucent Applicator to demonstrate the integrity, suitability and substantial equivalence of the device."
"Conclusion: Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the BioLucent Applicator is determined to be substantially equivalent to existing legally marketed devices."

This indicates that performance testing was done, but the specific acceptance criteria, reported performance statistics, and details of the study (like sample size, ground truth, expert qualifications, etc.) are not included in this summary. The 510(k) process relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against novel acceptance criteria in a comprehensive clinical study as might be required for a PMA application or a de novo submission for a truly novel device.

Therefore, I cannot provide the requested table and study details from the given text.

However, based on the information provided, here's what can be inferred or explicitly stated regarding your questions:

1. A table of acceptance criteria and the reported device performance

Information Not Provided: The specific acceptance criteria and detailed quantitative performance metrics are not included in this 510(k) summary. The summary only states that "Performance testing was conducted... to demonstrate the integrity, suitability and substantial equivalence of the device."

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

Information Not Provided: Details on the sample size for any test set or the provenance of data are absent. The submission relies on "substantial equivalence" to predicate devices rather than a new clinical study.

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)

Information Not Provided: This information is not relevant or included in a 510(k) submission focused on substantial equivalence. There is no mention of a "test set" in the context of expert ground truth for performance evaluation of a diagnostic or AI device.

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

Information Not Provided: Not applicable to the content provided.

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

Information Not Provided: This device is a physical applicator, not an AI or diagnostic device that would involve human readers or MRMC studies.

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

Information Not Provided: This is a physical medical device, not an algorithm.

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

Information Not Provided: Not applicable, as the submission focuses on substantial equivalence of a physical device.

8. The sample size for the training set

Information Not Provided: Not applicable, as this is not an AI or algorithm-based device that requires a training set.

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

Information Not Provided: Not applicable.

Summary

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1. 510(k) Summary of Safety and Effectiveness
	K061241
Device Name:	BioLucent Applicator	JUL 2 8 2006
Device Model Numbers:	RTA-06RTA-08RTA-10
Classification Name:	Remote Controlled Radionuclide Applicator System(JAQ),21 CFR, 892.5700
Device Classification:	Class II
Predicate devices:	NoviSad Rectal Applicator (Nucletron, B.V.)Wright Vaginal Cuff Applicator (K980601)Comfort Catheters (K032372)H.A.M. Applicator (K961601)
Manufacturer:	BioLucent, Inc.6 Journey, Suite 325Aliso Viejo, CA 92656
Establishment Registration Number:	2032338
Official Contact:	Sheryl HigginsBioLucent, Inc.6 Journey, Suite 325Aliso Viejo, CA 92656Phone: (949) 349-1380 (x101)

Intended Use:

Device Description:

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Technological Characteristics Summary

The BioLucent Applicator is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics.

Performance Data Summary

Performance testing was conducted on the BioLucent Applicator to demonstrate the integrity, suitability and substantial equivalence of the device.

Conclusion:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the BioLucent Applicator is determined to be substantially equivalent to existing legally marketed devices

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 2 8 2006

Mr. J. David Campbell Director of Operations BioLucent, Inc. 6 Journey, Suite 325 ALISO VIEJO CA 92656

Re: K061241

Trade/Device Name: BioLucent Applicators Model RTA-06, RTA-08 and RTA-10 Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: June 27, 2006 Received: June 28, 2006

Dear Mr. Campbell:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo in a bold, sans-serif font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The logo appears to be a commemorative emblem for the centennial of the FDA.

oting Public

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Page 2 -

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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrlvindustry/support/index.html.

Sincerely yours,

Nancy C.Bogdon
Nancy C. Bogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3. Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K ob 124 /

Device Name:

BioLucent Applicator

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

Regulation Number and Section

§ 892.5700 Remote controlled radionuclide applicator system.

(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.