(202 days)
The Leksell GammaPlan (LGP) is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument, AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professionals (Neurosurgeons, Radiation Therapists, Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.
The Leksell GammaPlan® is a computer based dose planning system specifically designed for use with the Leksell Gamma Knife. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. Digital images from CT or MR scanners, or angiograms are imported and processed for treatment planning. Patient treatment protocols are based on single or multiple targets and alternative treatment plans can be generated by the GammaPlan.
The provided documentation (K973441) is a 510(k) summary for the Leksell GammaPlan device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies with detailed acceptance criteria and statistical analyses common in more recent submissions.
Based on the provided text, the acceptance criteria and study information are quite limited. The device is a computer-based dose planning system, and the "performance data" section focuses on software testing, not clinical performance.
Here's a breakdown of the available information according to your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: The device must perform the same fundamental algorithm principle of calculation and achieve safe and accurate simulation/plan of stereotactic Leksell Gamma Knife radiosurgery/radiation therapy as the predicate device (Leksell GammaPlan, K914808). | The submission states: "The Leksell GammaPlan® is substantially equivalent to the previous version of the Leksell GammaPlan currently in commercial distribution by Elekta Instrument, AB, in terms of achieving a safe and accurate simulation or plan of stereotactic Leksell Gamma Knife radiosurgery/radiation therapy." "The fundamental algorithm principle of calculation and other technical characteristics are the same as that of the predicate device." "Calculation of the radiation dose for the treatment plan and overlay of the isodose curve is the same in the new version, as in the predicate device." |
| Software Functionality and Reliability: All software modules, their integration, and the overall system must function as intended. | The submission states: "The Leksell GammaPlan® has been demonstrated to perform as intended. Testing of the software includes Module, Integration and System testing. All test results have been included in Section 14 of this notification." (However, Section 14 is not provided in this excerpt.) |
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: Not explicitly stated. The "performance data" refers to software testing, not a clinical test set.
- Data Provenance: Not applicable, as no patient or clinical data is described for testing the "device performance." The software testing would likely involve simulated data or predefined test cases.
- Country of Origin: Not specified for the software testing. The company is based in Stockholm, Sweden.
- Retrospective or Prospective: Not applicable.
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. The performance data described is related to software testing, not the establishment of ground truth by clinical experts. The indications for use mention "health care professionals (Neurosurgeons, Radiation Therapists, Radiation Physicists)" as users, implying their expertise in the application of the device, but not in validating its "ground truth" performance in a study mentioned here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set and therefore no adjudication method is described.
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, an MRMC comparative effectiveness study was not done. The device is a dose planning system, not an AI-assisted diagnostic tool for human readers. This submission is from 1998, predating widespread use of "AI" in medical devices as we understand it today.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in a sense, the "performance data" described refers to the algorithm's performance as a software system. The testing mentioned ("Module, Integration and System testing") would inherently evaluate the software's ability to calculate and process data according to its design specifications, which is a standalone evaluation of the algorithm. However, this is distinct from a clinical standalone study evaluating diagnostic accuracy against a ground truth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the software performance described, the "ground truth" would be the expected outputs based on predefined mathematical models and engineering specifications for dose calculation and image processing. It's an engineering/mathematical ground truth, not a clinical ground truth like pathology or outcomes.
8. The sample size for the training set
- Not applicable. This is a 510(k) submission for an updated version of a dose planning software. There is no mention of a "training set" in the context of machine learning algorithms. The device's "training" refers to its software development and validation against established physics principles and algorithms.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the device's design and functionality would be based on established physics, dosimetry principles, and the calculations implemented in the original predicate device (K914808).
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SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 19:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
APR - 1 1998
SUBMITTER INFORMATION 19.1
rau v
| a. Company Name: | Elekta Instrument, AB |
|---|---|
| b. Company Address: | Birger Jarlsgatan 53Stockholm, Sweden |
| c. Company Phone:Company Facsimile: | (011) 46 8 587 254 00(011) 46 8 587 255 00 |
| d. Contact Person: | Sverker GlansVice PresidentQuality/Regulatory AffairsElekta Instrument, AB |
September 2, 1997 e. Date Summary Prepared:
DEVICE IDENTIFICATION 19.2.
| a. Trade/Proprietary Name: | Leksell GammaPlan® | |
|---|---|---|
| -- | ---------------------------- | -------------------- |
b. Classification Name:
Radionuclide radiation therapy system. CFR 892.5750
IDENTIFICATION OF PREDICATE DEVICE 19.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Elekta Instrument, AB | Leksell GammaPlan® | K914808 | January 23, 1992 |
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19.4 DEVICE DESCRIPTION
The Leksell GammaPlan® is a computer based dose planning system specifically designed for use with the Leksell Gamma Knife. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. Digital images from CT or MR scanners, or angiograms are imported and processed for treatment planning. Patient treatment protocols are based on single or multiple targets and alternative treatment plans can be generated by the GammaPlan.
19.5 SUBSTANTIAL EQUIVALENCE
The Leksell GammaPlan® is substantially equivalent to the previous version of the Leksell GammaPlan currently in commercial distribution by Elekta Instrument, AB, in terms of achieving a safe and accurate simulation or plan of stereotactic Leksell Gamma Knife radiosurgery/radiation therapy.
The fundamental algorithm principle of calculation and other technical characteristics are the same as that of the predicate device.
19.6 INTENDED USE
The Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife®. The Leksell GammaPlan® is intended to beused for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs from the health care professionals such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.
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TECHNOLOGICAL CHARACTERISTICS 19.7
A comparison of the technological characteristics of the predicate and legally marketed devices has been completed. Both the original and upgraded versions of the Leksell GammaPlan® use the same algorithm principle. Calculation of the radiation dose for the treatment plan and overlay of the isodose curve is the same in the new version, as in the predicate device. The computer workstation has remained the same in the upgraded version. Image input from CT, MR and AI, modalities have remained the same.
19.8 PERFORMANCE DATA
The Leksell GammaPlan® has been demonstrated to perform as intended. Testing of the software includes Module, Integration and System testing. All test results have been included in Section 14 of this notification.
510(K) CHECKLIST 19.9
This notification contains all information required by 21 CFR 807 87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
10008 APR - I
Sverker Glans Elekta Instrument. AB c/o Carol Patterson Consultant for Elekta Instrument, AB 18140 Smokesignal Drive San Diego, CA 92127
Re:
K973441 Leksell GammPlan (Radionuclide Radiation Therapy Planning System) Dated: January 8, 1998 Received: January 12, 1998 Regulatory class: II 21 CFR 892.5750/Procode: 90 IWB
Dear Ms. Glans:
We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act increde 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrhdsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number:
To Be Assigned By FDA K 9734 4 |
Device Name:
Leksell GammaPlan®
Indications For Use: The Leksell GammaPlan (LGP) is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument, AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professionals (Neurosurgeons, Radiation Therapists, Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
Kand H. Kymm
(Division Sign-Off)
(Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number.
§ 892.5750 Radionuclide radiation therapy system.
(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.