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Leksell Gamma Knife® is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g.

• · Metastatic tumors
• Recurrent glioblastomas
• · Trigeminal neuralgia
• · Medically refractory essential tremor
• · Orbital tumors
• · Ocular tumors
• · Optic nerve tumors
  · Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, chordomas, chordomas, glomus tumors, hemangiomas)
• · Skull base tumors
  · Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx,
• nasopharynx, sinonasal, salivary gland)
  · Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, skull base tumors)

Leksell Gamma Knife® (available models Icon™, Perfexion™ and Elekta Esprit) is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

The provided text does not contain detailed information about specific acceptance criteria and a study that proves the device meets those criteria as it relates to a specific performance metric (like diagnostic accuracy). Instead, it focuses on the substantial equivalence of a new device model (Leksell Gamma Knife® - Elekta Esprit) to a predicate device (Leksell Gamma Knife® K173789) through non-clinical performance testing.

Here's an analysis based on the provided text, highlighting what is and isn't available:

Overall Conclusion from the Text: The document claims the new device is substantially equivalent to the predicate device because its fundamental technical characteristics are unchanged despite hardware and software updates to the user interface. Therefore, the performance is assumed to be equivalent, and no new clinical studies were conducted for this 510(k) submission.

Missing Information (per the request, but not available in the provided text):

• A table of acceptance criteria and reported device performance for a specific performance characteristic (e.g., diagnostic accuracy, sensitivity, specificity).
• Sample size used for a "test set" in the context of diagnostic performance.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts, their qualifications, and adjudication methods for establishing ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Specific type of ground truth used (pathology, outcomes data, etc.) for performance evaluation.
• Sample size for a "training set" for an algorithm.
• How ground truth for a "training set" was established.

Information Available from the Text (interpreted in the context of "acceptance criteria" as general device functionality and safety):

The "acceptance criteria" here are implicitly related to ensuring the device performs as intended and is as safe and effective as its predicate, primarily through non-clinical testing of hardware and software updates.

1. A table of acceptance criteria and the reported device performance:

The document describes non-clinical performance testing to ensure the new model functions as intended and meets requirements.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in terms of patient cases or images, as the testing was non-clinical and focused on system functionality. It refers to "module, integration and system level verification testing."
• Data Provenance: Not applicable in the context of patient data. The testing was conducted internally by Elekta Solutions AB (Sweden).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable to this 510(k) submission, as no clinical performance study involving diagnostic accuracy with expert-established ground truth was performed for substantial equivalence. "Design and usability validation... performed by competent and professionally qualified personnel" (Page 5) speaks to the expertise in verifying engineering and human factors aspects, not medical image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) 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:

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate device." (Page 5). This device is a radiation therapy system, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable in the context of an algorithm's diagnostic performance. The device itself is a treatment system, and its standalone performance refers to its ability to deliver radiation as specified, validated through non-clinical tests.

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

• For the non-clinical testing, the "ground truth" was the device's technical specifications and intended functionality. Verification and validation ensured the device met these engineering and design requirements. There was no medical "ground truth" (e.g., pathology, clinical outcomes) established for diagnostic or treatment efficacy in a clinical setting in this submission.

8. The sample size for the training set:

• Not applicable, as this device is not an AI/ML algorithm trained on a dataset in the sense of image recognition or diagnostic prediction.

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

• Not applicable.

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Leksell Gamma Knife® Icon™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g.
• Metastatic tumors
• Recurrent glioblastomas
• Trigeminal neuralgia
• Medically refractory essential tremor
• Orbital tumors
• Ocular tumors
• Optic nerve tumors
• Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas)
• Skull base tumors
• Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland)
• Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).

Leksell Gamma Knife® Perfexion™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g.
• Metastatic tumors
• Recurrent glioblastomas
• Trigeminal neuralgia
• Medically refractory essential tremor
• Orbital tumors
• Ocular tumors
• Optic nerve tumors
• Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas)
• Skull base tumors
• Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland)
• Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).

Leksell Gamma Knife® Icon™ and Leksell Gamma Knife® Perfexion™ are radiosurgery systems for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

Based on preoperative radiological examinations, the Leksell Gamma Knife unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.

This submission describes the Leksell Gamma Knife® Icon™ and Leksell Gamma Knife® Perfexion™ devices, which are teletherapy systems for stereotactic irradiation of head structures. The submission focuses on a new control system software version for these devices.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria in a numerical form typically associated with AI/ML device performance (e.g., sensitivity, specificity, AUC, Dice score). Instead, the acceptance criteria are implicitly linked to the successful completion of various engineering and design validation tests. The reported device performance is described qualitatively.

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

The document does not specify a "test set" in the context of clinical data for performance evaluation. The testing described is primarily non-clinical, focusing on system verification, integration, and design validation. There's no mention of a clinical test set size or data provenance specifically for evaluating the performance of the software upgrade or the device's clinical efficacy.

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)

No information is provided regarding the number or qualifications of experts used to establish a ground truth for a test set, as no clinical test set is described in the provided sections. The "competent and professionally qualified personnel" mentioned for design and usability validation are not further defined.

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

No information on an adjudication method is provided, as no clinical test set evaluation 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 MRMC comparative effectiveness study is mentioned. The device is a radiation therapy system, not an AI-assisted diagnostic or interpretation tool for human readers.

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

This document describes a medical device, the Leksell Gamma Knife, which is a teletherapy device for stereotactic irradiation. The "new control system software version" is an integral part of this device. It is not an "algorithm only" device in a standalone AI sense, but rather a software component controlling a physical device. Its performance is evaluated through system-level verification and validation.

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

Since clinical testing for device performance is stated as "not required to support substantial equivalence," the concept of a clinical ground truth (like pathology or outcomes data) for evaluation is not relevant to this submission. The "ground truth" for the engineering and design validation tests would be the established technical requirements and user needs.

8. The sample size for the training set

This document does not describe an AI/ML component in the sense of a machine learning model that requires a "training set." The software upgrade is a new control system software version, not a learning algorithm trained on data. Therefore, no training set size is applicable or mentioned.

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

As there is no mention of a training set for an AI/ML model, the establishment of ground truth for such a set is not applicable.

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