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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

"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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