RAPID Strand ™ is indicated for permanent interstitial implantation of selected localized tumors which are low to moderate radiosensitivity. They may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor.

RAPID Strand™ may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

Device Description

RAPID Strand™ consists of 11 absorbable seeding spacers and 10 Model 6711 OncoSeed™ seeds (welded titanium capsule containing I-125 adsorbed onto a silver rod) spaced at a fixed distance within absorbable braided carrier. The absorbable braided carrier containing OncoSeeds and absorbable seeding spacer is stiffened and then sterilized by Ethylene Oxide. The seeds are housed in a plastic spacing jig within a stainless steel shielding tube which attenuates >99% of the I-125 photons. RAPID Strand™ is STERILE when shipped.

The Customized RAPID Strand allows the variable seed spacing to reflect individual patient prescriptions as specified by the treating physician. This Customized RAPID Strand will have less than ten (10) OncoSeed™ seeds and a variable number of Absorbable Seeding Spacers. The treating physician will determine the required dose and total number of active seeds for each Customized RAPID Strand.

AI/ML Overview

The provided document is a 510(k) summary for the RAPID Strand™ device. It describes a medical device, its intended use, and claims substantial equivalence to predicate devices. However, this type of document, particularly from 2003, typically focuses on demonstrating equivalence based on technological characteristics and intended use, rather than rigorous performance studies with specific acceptance criteria, test sets, or ground truths as might be expected for modern AI/ML medical devices.

Therefore, much of the requested information (acceptance criteria, specific study details proving it meets criteria, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types for test/training sets, and training set sizes) is not present in the provided text.

Based on the available text, here's what can be extracted and what cannot:

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

This information is not provided in the document. The document describes technological characteristics and claims substantial equivalence to predicate devices, but does not present specific performance metrics with acceptance criteria for the new device.

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

This information is not provided. The document describes nonclinical test data focusing on infrared spectroscopy of the materials, but does not mention a "test set" in the context of clinical performance or a dataset for evaluating an algorithm's performance.

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)

This information is not provided. As there's no mention of a "test set" requiring ground truth establishment, this detail is absent.

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

This information is not 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

This information is not provided. The device described (RAPID Strand™) is a radionuclide brachytherapy source, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is not applicable to this device and is not mentioned.

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

This information is not provided. This device is a physical medical implant, not an algorithm.

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

This information is not provided.

8. The sample size for the training set

This information is not provided. This device is a physical medical implant, not an AI algorithm that requires a training set.

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

This information is not provided.

Summary of available and missing information:

The provided document is a 510(k) summary for a physical medical device (brachytherapy source). It focuses on demonstrating substantial equivalence by comparing the device's technical specifications and intended use to previously cleared predicate devices. It includes:

Device Description: RAPID Strand™ consists of absorbable seeding spacers and Model 6711 OncoSeed™ seeds embedded within a Polyglactin 910 Synthetic Absorbable Braided Carrier. The Customized RAPID Strand allows variable seed spacing.
Intended Use/Indications for Use: Permanent interstitial implantation for selected localized tumors with low to moderate radiosensitivity, either as primary treatment (e.g., prostate cancer, unresectable tumors) or for residual disease after excision. It may be used concurrently with other treatment modalities like external beam radiation therapy or chemotherapy.
Technological Characteristics Comparison (Subject vs. Predicate Device):
- Absorbable Seeding Spacers: Subject device has 11 spacers, made of 90% Glycolide + 10% L-lactide with D&C Violet No.2 color, cleared under K013964. Predicate had none.
- Coated VICRYL (Polyglactin 910) Braided Carrier Material: Both use Polyglactin 910 (90% Glycolide + 10% L-lactide coated with Polyglactin 370 and calcium stearate). The subject device's carrier is undyed (natural), cleared under K022269. The predicate's carrier was Coated Vicryl Violet (D&C Violet #2), cleared under K940632.
- Sterilization: Both are sterile via Ethylene Oxide (EtO).
Nonclinical Test Data: Infrared Spectroscopy FTIR Spectra of both the subject and predicate RAPID Strand were analyzed by Northview Laboratories, Inc. (reports provided in Section-G, but details of the reports are not given in this extract).
Conclusion: The device is concluded to be substantially equivalent to the predicate RAPID Strand (K940632) based on intended use, indications for use, method of use, and other technological characteristics.

The specific details about acceptance criteria, performance studies involving test sets, ground truth establishment, expert involvement, and AI-related metrics (MRMC, standalone performance, training sets) are not applicable to this type of device or not present in this 510(k) summary from 2003.

Summary

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APR 1 0 2003

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Kp3p594

The following 510(k) Summary of Safety and Effectiveness is prepared and provided in accordance with the requirements of 21 CFR 807.92 as amended under the Safe Medical Devices Act of 1990 (SMDA).

Submitter's Information

Company Name:	Medi-Physics, Inc DBA Amersham Health
Address:	101 Carnegie CenterPrinceton, NJ 08540-6231
Contact Name:	Subhash PatelAssociate Director, Regulatory Affairs
Telephone Number:	(609) 514-6846
Summary Prepared Date:	February 19, 2003
Subject Device Information
Trade Name:	RAPID Strand™
Model:	7000

Common Name:	Radionuclide Brachytherapy Source
Class:	II
Classification:	21 CFR 892.5730	Product Code: 90-IWI

Legally marketed devices to which equivalence is claimed. Predicate Devices

1.	Trade Name:	RAPID Strand™	Model: 7000
	Common Name:	Radionuclide Brachytherapy Source
	Class:	II
	Classification:	21 CFR 892.5730	Product Code: 90-IWI
	Cleared 510(k) No.:	K940632
	Submitted by:	Medi-Physics, Inc., Arlington Heights, IL
2.	Trade Name:	OncoSeed™	Model: 6711
	Common Name:	Radionuclide Brachytherapy Source
	Class:	II
	Classification:	21 CFR 892.5730	Product Code: 90-KXK
	Cleared 510(k) No.:	K914281
	Submitted by:	Medi-Physics, Inc., Arlington Heights, IL
3.	Trade Name:	Coated VICRYL (Polyglactin 910) Synthetic Absorbable Sutur
	Common Name:	Absorbable Poly (glycolide/L-lactide) surgical suture
	Class:	II
	Classification:	21 CFR 892.4493	Product Code: GAM
	Cleared 510(k) No.:	K022269 (September 13, 2002)
	Submitted by:	Ethicon. Inc.. Somerville. NJ

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Ky3$\phi$594

CP Medical, Portland, OR

Trade Name: Common Name:

Class: Classification: Cleared 510(k) No .: Submitted by:

Absorbable Seeding Spacers Accessory to applicator and accessory to radionuclide Brachytherapy Sources II 21 CFR 892.5730 Product Code: 90 KXK K013964 (January 24, 2002)

Description of Device

Intended Use

RAPID Strand™ consists of absorbable seeding spacers and Model 6711 OncoSeed™ seeds, embedded within Polyglactin 910 Synthetic Absorbable Braided Carrier and is intended for medical purposes to be placed into a body cavity or tissue as a source of nuclear radiation for therapy.

Indications for Use

RAPID Strand ™ is indicated for permanent interstitial implantation of selected localized turnors which are low to moderate radiosensitivity. They may be used either as primary treatment (such as prostate cancer or unresectable turnors) or for treatment of residual disease after excision of the primary tumor.

RAPID Strand™ may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

When compared with the Intended Use and Indications for Use of the predicate model 7000 RAPID Strand™, the Intended Use and Indications for Use of the subject model 7000 RAPID Strand™ have not changed.

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y30594

Technological Characteristics

The following modifications have been incorporated in the subject device - Model 7000 RAPID StrandTM when compared to predicate device:

ModifiedCharacteristics	7000 RAPID Strand(Subject Device)	7000 RAPID Strand(Predicate Device)Cleared in 510(k)# K940632
Absorbable Seeding Spacers
Regulatory Status	Cleared in 510(k)# K013964	Not applicable
Number of Spacers	11 (Eleven)	None
Base Material	90% Glycolide + 10% L-lactide	None
Color	D&C Violet No.2(21 CFR 74.3602)	None
Coated VICRYL (Polyglactin 910) Braided Carrier Material
Regulatory Status	Cleared in 510(k) # K022269	Cleared in 510(k) # K940632
Base Material	Ethicon JB947 - Coated VICRYL(Polyglactin 910) SyntheticAbsorbable Suture	Ethicon J617 - Coated VICRYL(Polyglactin 910) SyntheticAbsorbable Suture
Formulation	Polyglactin 910[90% Glycolide + 10% L-lactidecoated with Polyglactin 370 andcalcium stearate]	Polyglactin 910[90% Glycolide + 10% L-lactidecoated with Polyglactin 370 andcalcium stearate]
Appearance	Undyed (Natural)	Coated Vicryl Violet (D&C Violet#2)
Sterilization	Sterile (EtO sterilizationperformed on finished device)	Sterile (EtO sterilizationperformed on finished device)

All other technological characteristics of the subject 7000 RAPID Strand™ remain unchanged compared to the predicate RAPID Strand™ that was cleared in the 510(k) # K940632.

Nonclinical Test Data

The copies of the following Nonclinical Test Data reports have been provided in the Section-G of this submission.

Report of Analysis: Infrared Spectroscopy FTIR Spectra of the predicate RAPID Strand 1. (finished device) by Northview Laboratories, Inc., Northbrook, IL
Report of Analysis: Infrared Spectroscopy FTIR Spectra of the subject RAPID Strand 1.5 2. (finished device) by Northview Laboratories, Inc., Northbrook, IL

Conclusion:

Upon reviewing the safety and effectiveness information provided in this submission and comparing the intended use, indications for use, method of use and other technological characteristics, it can be concluded that the subject RAPID Strand™ is substantially equivalent to the predicate RAPID Strand™, which was cleared under 510(k)# K940632.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a wave or fabric.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2003

Mr. Subhash Patel Associate Director Regulatory Affairs Amersham Health 101 Carnegie Center PRINCETON NJ 08540

Re: K030594

Trade/Device Name: I-125 RAPID Strand Model 7000 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: March 25, 2003 Received: March 27, 2003

Dear Mr. Patel:

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 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.

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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 the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

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

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EXHIBIT-2

Indications for Use Form

Page 1 of 1

Labels	Values
510(k) Number (if known):	K$\phi$5$\rho$59i4

Device Name:

Model: 7000 RAPID Strand™

Indications For Use:

RAPID Strand™ may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

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

Concurrence of CDRH2 Office of Device Evaluation (ODE)

David H. Legum

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030594

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _

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.