(125 days)
To shape the beam from a low energy radiation therapy source up to 50kVp.
The Axxent FlexiShield Mini is intended to shape the beam from a low energy radiation therapy source up to 50kVp. It is a flexible pad placed over the surface requiring shielding that can be cut by the customer to shape the radiation therapy beam. It can be used on external patient surfaces, as well as internally during Intraoperative Radiation Therapy (IORT). The Axxent FlexiShield Mini is fabricated from a composite made from tungsten and silicone rubber. The pad is available in a circular shape with a diameter of 12.7 cm and a thickness of 1 cm. The Axxent FlexiShield Mini is provided non-sterile. The device is steam sterilizable.
The provided document, a 510(k) summary for the Axxent® FlexiShield Mini, is primarily an administrative submission to the FDA demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way one would typically find for a new diagnostic imaging AI algorithm.
The Axxent® FlexiShield Mini is a radiation therapy beam-shaping block, which is a physical medical device, not an AI algorithm or a diagnostic tool. Therefore, the questions regarding AI study design (sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable to this type of device and are not addressed in the document.
The "study" in this context is a demonstration of substantial equivalence to a legally marketed predicate device.
Here's the relevant information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance:
The document does not specify "acceptance criteria" in a quantitative, performance-based manner typically associated with clinical trials or AI algorithm validation. Instead, the primary "acceptance criterion" for 510(k) clearance is substantial equivalence to a predicate device.
| Acceptance Criterion (Implied for 510(k)) | Reported Device Performance (Summary of Technological Characteristics) |
|---|---|
| Substantial Equivalence to Predicate Device | The technological characteristics of the Axxent® FlexiShield Mini are the same as the Arplay Medical Lead Blocks approved in K010172. The device is substantially equivalent in terms of design, materials, principles of operation, and product specification to the predicate device. |
2. Sample size(s) used for the test set and the data provenance:
Not applicable. This is a physical medical device, so there is no "test set" of data or "data provenance" in the context of an AI algorithm or diagnostic study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There is no "ground truth established by experts" for this type of device's 510(k) submission.
4. Adjudication method for the test set:
Not applicable.
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 is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable.
7. The type of ground truth used:
Not applicable.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
In summary: The provided document is a 510(k) summary for a physical medical device used in radiation therapy. It establishes equivalence to a predicate device based on design, materials, principles of operation, and product specifications. The questions posed in your request are primarily relevant to the evaluation of AI algorithms or diagnostic tools, which is not the nature of the Axxent® FlexiShield Mini.
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のアルバリー
Xoft, Inc Xoft, Inc.
JUN 2 3 2009
a ab 510(k) Summary
Submitter
| Xoft, Inc. | |
|---|---|
| 345 Potrero Ave | |
| Sunnyvale, CA 94085 | |
| Contact Name: | Steve Lin |
| Phone Number: | (408) 419-2341 |
| Fax Number: | (408) 419-2301 |
| Email: | steve.lin@xoftinc.com |
| Summary was prepared on February 17, 2009 |
Name of Device
| Trade name: | Axxent® FlexiShield Mini |
|---|---|
| Common name: | Beam Blocks for Radiation Therapy |
| Classification Name: | Radiation Therapy Beam Shaping Block90 IXI (per 21 CFR 892.5710) |
Predicate Device
| Device Name | Premarket Notification |
|---|---|
| Arplay Medical Lead Blocks | K010172 |
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Device Description
The Axxent FlexiShield Mini is intended to shape the beam from a low energy radiation therapy source up to 50kVp. It is a flexible pad placed over the surface requiring shielding that can be cut by the customer to shape the radiation therapy beam. It can be used on external patient surfaces, as well as internally during Intraoperative Radiation Therapy (IORT).
The Axxent FlexiShield Mini is fabricated from a composite made from tungsten and silicone rubber. The pad is available in a circular shape with a diameter of 12.7 cm and a thickness of 1 cm.
The Axxent FlexiShield Mini is provided non-sterile. The device is steam sterilizable.
Intended Use
To shape the beam from a low energy radiation therapy source up to 50kVp.
Summary of the Technological Characteristics
The technological characteristics of the Axxent FlexiShield Mini are the same as the Arplay Medical Lead Blocks approved in K010172. The device is substantially equivalent in terms of design, materials, principles of operation, and product specification to the predicate device. A comparison table is available in Tab 8.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2009
Mr. Steve Lin Director of Regulatory Affairs and Quality Assurance Xoft, Inc. 345 Potrero Ave. SUNNYVALE CA 94085
Re: K090417
Trade/Device Name: Axxent® FlexiShield Mini Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: IXI Dated: June 5. 2009 Received: June 9, 2009
Dear Mr. Lin:
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); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/cdrh/industry/support/index.html.
Sincerely yours:
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: Ko90417
Device Name: Axxent® FlexiShield Mini
Indications for Use:
To shape the beam from a low energy radiation therapy source up to 50kVp.
AND/OR Prescription Use Over-The Counter Use . X (Per 21 CFR 801 subpart D) (Per 21 CFR 801 subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 09041 510(k) Number
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.