(245 days)
ERGO SRS is stcreotactic radiosurgery module for DMLCIV-ERGO (K001163). It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.
ERGO SRS is a stereotactic radiosurgery treatment planning software module for 3D Line USA's ERGO radiotherapy treatment planning system (K001163).
This 510(k) summary (K031281) for ERGO SRS, a stereotactic radiosurgery treatment planning module, does not contain the detailed acceptance criteria or study results typically found in performance studies for AI/ML-driven medical devices.
The document primarily focuses on establishing substantial equivalence to a predicate device (PLATO SRS V2) based on the fact that ERGO SRS is "identical to PLATO SRS V2. It is the same software integrated with 3D Line USA's ERGO system rather than Nucletron's PLATO system."
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.
Here's what can be extracted:
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The document states that the device is "identical" to the predicate, implying that its performance is presumed to be equivalent to the predicate, but no specific performance metrics or acceptance criteria are listed for the ERGO SRS device itself.
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Sample size used for the test set and the data provenance: Not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
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Adjudication method for the test set: Not provided.
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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 provided. This type of study is more common for diagnostic AI tools, whereas ERGO SRS is a treatment planning module.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated, however, as a treatment planning software, it is inherently a "standalone" algorithm in its function of generating plans, which are then reviewed by human clinicians. No performance metrics for this standalone function are provided in this summary.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided. For a treatment planning system, ground truth would typically relate to the accuracy of dose calculations, geometric accuracy of planned beams, or clinical outcomes (though outcomes data would be for post-market surveillance rather than 510(k) clearance).
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The sample size for the training set: Not applicable/provided. This device is described as being "identical" to a previously cleared predicate and is software for treatment planning, not a machine learning model that undergoes "training" in the modern sense.
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How the ground truth for the training set was established: Not applicable/provided.
In summary: The provided 510(k) summary primarily relies on substantial equivalence to a predicate device by stating the software is "identical" and merely integrated into a different system. It does not contain the detailed performance study results that would typically include acceptance criteria, specific performance metrics, sample sizes, or ground truth establishment methods for an independent evaluation of the ERGO SRS device's performance.
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APPENDIX 6: 510 (K) SUMMARY
K03/281
510(k) Summary As required by 807.92 For ERGO SRS Prepared on January 17, 2003
Submitted by: 3D Line USA, Inc. 11419 Cronridge Dr. Suite 15 Owings Mills, MD 21117
Tel. 410-581-6701
Fax: 410-581-9007
Contact Person: Nader Salehi Vice President
Device Trade Name: ERGO SRS
Common Name: Stereotactic radiosurgery treatment planning module
Classification: Medical charged-particle radiation therapy system, Class II Sec. 21 CFR 892.5050
Predicate Device: PLATO SRS V2, K010784
Manufactured by: Nucletron Corporation, 7080 Columbia Gateway Drive, Columbia, MD 21046-2133
Description of the Device: ERGO SRS is a stereotactic radiosurgery treatment planning software module for 3D Line USA's ERGO radiotherapy treatment planning system (K001163).
Intended Use for the Device: It is intended for use in the planning of 3 dimensional radiation therapy.
Substantial Equivalence to Predicate Device: ERGO SRS is identical to PLATO SRS V2. It is the same software integrated with 3D Line USA's ERGO system rather than Nucletron's PLATO system.
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2003
Mr. Nader Salehi Vice President 3D Line USA, Inc. Reston Executive Center 12100 Sunset Hills Road, Suite 150 RESTON VA 20190
Re: K031281 Trade/Device Name: ERGO SRS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: December 4, 2003 Received: December 8, 2003
Dear Mr. Salehi:
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 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.
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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. Brygdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Image /page/3/Picture/0 description: The image shows a logo with the text "3D LINE USA". The "3D" is stacked on top of "LINE", and "USA" is below "LINE". The "3D" is large and bold, and the "LINE" and "USA" are smaller. The logo is black and white.
Applicant: 3D Line USA, Inc._
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: __ ERGO SRS______________________________________________________________________________________________________________________________________________________
Indications For Use:
ERGO SRS is stcreotactic radiosurgery module for DMLCIV-ERGO (K001163). It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Daniel R. Ingram
(Division Sign-Off)
Division of Reproductive, Abdor and Padiological Devices 510(k) Number _
Prescription Use
3D Line USA, Inc. 11419 Cronridge Drive / Suite 15 / Owings Mills, Maryland 21117 / Office: 410-581-6701 / Fax: 410-581-9007
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.