The Best Radiopaque Strand (Marker Strand) is made of radiopaque xxx markers (i.e, seeds) and absorbable spacers, inside an absorbable strand, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures.

The Best Radiopaque Marker (Marker) is made of a radiopaque xxx solid seed, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures.

Device Description

The Best Radiopaque Strand (marker strand) is composed of two radiopaque markers, separated by absorbable spacers, and enclosed in an absorbable strand. It is supplied sterile.

The Best Radiopaque Marker (marker) is composed of a radiopaque nonradioactive seed (gold, platinum, stainless steel, titanium, or tungsten) which is supplied non-sterile.

The placement of the markers and marker strand in soft tissue, prior to therapeutic procedures, allows better dosimety coverage of the targeted site due to clearer identification of the anatomic regions.

AI/ML Overview

The provided text is a 510(k) summary for the Best Radiopaque Strand and Best Radiopaque Marker. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to legally marketed predicate devices.

However, this document does not contain explicit acceptance criteria or a study demonstrating that the device meets specific performance criteria. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance studies with acceptance criteria in the same way a clinical trial for a new drug or a more complex medical device might.

Therefore, many of the requested details about acceptance criteria and study design are not present in this document.

Here's a breakdown of what can be extracted and what is missing:

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

Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices, which implies that the performance is at least similar to the predicate, but specific quantitative acceptance criteria are not given.
Reported Device Performance: The document describes the characteristics and intended use of the device, primarily that it is a radiopaque marker or strand for brachytherapy and soft tissue/organ localization. It does not provide quantitative performance metrics (e.g., visibility in specific imaging modalities, migration rates, etc.) that would typically be associated with a "reported device performance" in the context of acceptance criteria.

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

Not provided. The document does not describe any specific test set or clinical study with patient data.

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/Not provided. Since no specific test set or ground truth establishment process is described, this information is not available.

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

Not applicable/Not provided. No test set or adjudication process is mentioned.

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 a physical radiopaque marker, not an AI or software device. Therefore, an MRMC study comparing human readers with AI assistance is not relevant or described.

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

Not applicable. This device is a physical radiopaque marker, not an algorithm or software.

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

Not applicable/Not provided. No specific ground truth for performance evaluation is mentioned, as the submission focuses on substantial equivalence to predicate devices rather than a detailed performance study with a defined ground truth.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/machine learning device, so there is no training set in that context. If "training set" refers to any pre-clinical testing or validation work on the materials or design, that information is not detailed in this summary.

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

Not applicable/Not provided.

In summary:

This 510(k) summary focuses on the administrative process of demonstrating substantial equivalence of the Best Radiopaque Strand and Best Radiopaque Marker to existing predicate devices. It provides device descriptions, intended use, and classification information. It does not include detailed studies with specific acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods typically found in a performance study report for a novel or more complex device, especially those involving AI or diagnostic interpretation. The FDA's letter confirms that substantial equivalence was found based on the provided information, allowing the device to be marketed.

Summary

{0}------------------------------------------------

BEST MEDICAL INTERNATIONAL, INC.

DEC - 9 2004

Proprietary

K043117

510(k) Summary of Safety and Effectiveness VII.

1. Manufacturer and Contact Information:

Manufacturer:	Best Medical International, Inc.7643 Fullerton RoadSpringfield, VA 22153
Contact Information:	Sankara RamaswamyDirector, Regulatory AffairsBest Medical International, Inc.(703) 451-2378, Ext. 107

1. Device Classification Name:
  Pursuant to 21 CFR 892.5730, both the Best Radiopaque Strand and the Best Radiopaque Marker are class II devices.

Proprietary Name:	Best Radiopaque StrandBest Radiopaque Marker
Common/Usual Name:	Best Marker StrandBest Marker
ClassificationName:	Best Implantable Marker StrandBest Implantable Strand

1. Intended Use:
  Please see Appendix 2 below titled, "Indications for Use Form".
1. Device Description and Characteristics:
  The Best Radiopaque Strand (marker strand) is composed of two radiopaque markers, separated by absorbable spacers, and enclosed in an absorbable strand. It is supplied sterile.

The Best Radiopaque Marker (marker) is composed of a radiopaque nonradioactive seed (gold, platinum, stainless steel, titanium, or tungsten) which is supplied non-sterile.

{1}------------------------------------------------

BEST MEDICAL INTERNATIONAL, INC. Proprietary

1. Summary of Safety and Effectiveness:
  This 510(k) Summary of Safety and Effectiveness is in accordance with the requirements of the Safe Medical Devices Act (SMDA) 1990, and is provided in Appendix 1 below.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized symbol. The symbol consists of three curved lines that resemble a human figure or a stylized representation of a person. The logo is printed in black ink on a white background.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 2004

Dr. Joseph C. Whang Official Correspondent Best Medical International, Inc. 7643 Fullerton Road SPRINGFIELD VA 22153

Re: K043117

Trade/Device Name: Best Radiopaque Strand Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source

Regulatory Class: II Product Code: 90 KXK Dated: November 11, 2004 Received: November 10, 2004

Dear Dr. Whang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced work 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 reasy 20, 1110, 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 do not require approvisions of the Act. The Act. The general controls provisions of the Act include reguirements 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.

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.

{3}------------------------------------------------

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.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrl/dsma/dsmamain.html

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

{4}------------------------------------------------

BEST MEDICAL INTERNATIONAL, INC. Proprietary

Appendix 2

Indications for Use Form

K043117

510 (k) Number: Reference xxx

(1) Device Name: Best Radiopaque Strand

Indications For Use:

(2) Devise Name: Best Radiopaque Marker

Indications For Use;

gold, platinum, stainless steel, titanium, or tungsten a

(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

David A. Norman

(Division Sian-Q 510kl Num

1 |

Regulation Number and Section

§ 892.5730 Radionuclide brachytherapy source.

(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.