The provided text is a 510(k) summary for the RadioMed™ Marker, a medical device. This type of document is a premarket notification to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. It primarily focuses on device description, intended use, and comparison to predicates, along with a summary of performance testing and adherence to standards.

However, the provided text does not contain the detailed information required to fill out all aspects of your request regarding acceptance criteria and the study that proves the device meets them.

Specifically, the document mentions "Visibility Testing (see section V)" and refers to various standards (FDA QSR, ISO 10993-1, AAMI Standard 11134-1994) but does not detail the specific performance acceptance criteria for visibility, a quantitative measure of performance, or the results of the visibility study. It also lacks information on the sample sizes, data provenance, ground truth establishment, or specific details of a comparative effectiveness study.

Therefore, I can only populate the table and answer the questions based on the limited information available in the provided text. Many fields will be marked as "Not provided in the text."

Here's the breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Visibility	Visible under fluoroscopy, ultrasound, CT, and x-ray. (No quantitative criteria or specific performance metrics provided in this document excerpt)
Biocompatibility	Passes biocompatibility testing per ISO 10993-1
Material (Chemical Composition)	Rhodium (Stated to be identical to a predicate device's material)
Manufacturing Standards	Complies with FDA QSR 21 CFR Part 820 Good Manufacturing Practices, AAMI Standard 11134-1994 Recommended Practice for Steam Autoclave

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

Sample size for test set: Not provided in the text. The document refers to "Visibility Testing" and "animal and bench studies" but no sample sizes are mentioned.
Data Provenance: Not provided in the text.
Retrospective/Prospective: Not provided in the text.

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 provided in the text.

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

Not provided in the text.

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 MRMC comparative effectiveness study is described for this device, nor is it an AI-based device. The device is a physical marker.

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

Not applicable. This is a physical marker, not an algorithm.

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

For "Visibility Testing," the ground truth likely involved direct visual confirmation on imaging modalities, possibly by a human observer or sensor, but the specific method (e.g., expert consensus on image quality, quantitative measurement) is not detailed.
For "Biocompatibility," the ground truth would be established by the results of standardized biological tests as per ISO 10993-1.

8. The sample size for the training set

Not applicable. This is a physical marker, not a machine learning model requiring a training set.

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

Not applicable. This is a physical marker, not a machine learning model.

Summary

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K022326

Appendix S 510(k) Summary

JAN 3 1 2003

1. Sponsor Name

RadioMed Corporation One Industrial Way, Tyngsboro, Massachusetts 01879 Telephone: (978) 649 0300 (978) 649 0333 Fax: Contact Person: Gordon Roberts

1. Device Name
  Proprietary Name: Common/Usual Name: Classification Name:

RadioMed™ Marker RadioMed™ Marker Implantable Marker

1. Identification of Predicate of Legally Marketed Device The predicate devices for the RadioMed™ Marker are: United States Surgical Auto Suture Site Marker Staple, K983400 Senorx Gel Mark 1M Biopsy Site Marker, K000060 Genetra™ Source, K013660

4. Device Description

The RadioMed™ Marker is a non-sterile, disposable device in the form of a rhodium coil that is 0.35mm in diameter.

5. Intended Use

RadioMed Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

6. Comparison of Technological Characteristics

The design of each of the predicates and the RadioMed™ Marker is a metallic wire or coil that is visible as a marker under fluoroscopy or ultrasound. The material used in the RadioMed 110 Marker is rhodium, which is identical to the Genetra "M Source and passes biocompatibility testing per ISO 10993-1, and as shown in the animal and bench studies, is visible under fluoroscopy, ultrasound, CT and x-ray.

1. Performance Testing
  Summary of Standards Achieved:

FDA OSR 21 CFR Part 820 Good Manufacturing Practices ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices AAMI Standard 11134-1994 Recommended Practice for Steam Autoclave Visibility Testing (see section V)

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a bird, possibly an eagle, with three overlapping profiles, creating a sense of depth and movement.

JAN 3 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gordon Roberts Director, Quality Assurance & Regulatory Affairs RadioMed Corporation One Industrial Way TYNGSBORO MA 01879

Re: K022326 Trade/Device Name: RadioMed™ Marker Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 JAK and IYE Dated: October 24, 2002 Received: November 4, 2002
Dear Mr. Roberts:

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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RadioMed Corporation July 16, 2002

RadioMed™ Marker Premarket Notification

510(k) Number (if known): K022326

Device Name: RadioMed Marker

Indications For Use: RadioMed™ Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

(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 ·

Nancy C. Houghton

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number _

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Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.