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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.

Ask a specific question about this device

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.

Ask a specific question about this device

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, 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 of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland), and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).

Leksell Gamma Knife Perfexion is a radiosurgery system for use in the stereotactic irradiation of intra-cranial 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 Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.

Each unit contains 192 sealed sources of Cobalt 60.

Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room.

• The medical side consists basically of the radiation unit with a patient positioning system. The system control and power units are placed inside the cover of the radiation unit.
• The office side consists of the operator console with control panel and office computer.

This document is a 510(k) premarket notification for the Leksell Gamma Knife Perfexion device. The primary purpose of this submission is not to establish new performance criteria for the device itself, but rather to expand the "Indications for Use" for an already cleared device (K133565). Therefore, the provided text explicitly states that clinical and non-clinical testing were NOT required to support substantial equivalence, and no new performance testing has been made. This means there is no study described in this document that proves the device meets specific acceptance criteria based on new performance data.

Instead, the submission argues that the expanded indications for use for the Leksell Gamma Knife Perfexion are substantially equivalent to its predicate devices because the new indications apply to conditions within the previously cleared treatment area (head and neck) and do not affect the safety or effectiveness of the device.

Given this, I cannot provide the requested information in its entirety because the document explicitly states that no new studies or performance tests were conducted for this 510(k) submission.

However, I can extract the relevant statements from the document regarding the lack of new testing and the rationale for claiming substantial equivalence without new performance data:

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

• No new acceptance criteria or reported device performance for new testing are provided in this document. The purpose of this submission (K151159) is to expand "Indications for Use" for an already cleared device, not to present new performance data. The document explicitly states: "The technical characteristics of the device has not changed compared to the previously cleared Leksell Gamma Knife® Perfexion K133565 and no new performance testing has been made."

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

• Not applicable. No new clinical or non-clinical studies were conducted or presented in this submission. The claim of substantial equivalence is based on the device's prior clearance and the nature of the expanded indications.

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. No new clinical or non-clinical studies were conducted or presented.

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

• Not applicable. No new clinical or non-clinical studies were conducted or presented.

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 device is a radiation therapy system, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.

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

• Not applicable. This device is a medical device for radiation therapy, not a standalone algorithm. The device's performance is tied to its physical components and established treatment parameters, which are stated as unchanged from K133565.

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

• Not applicable. No new performance studies requiring a ground truth were conducted for this particular submission. The substantial equivalence argument relies on prior clearance and a risk analysis review.

8. The sample size for the training set

• Not applicable. No algorithms requiring a training set are discussed in this submission.

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

• Not applicable. No algorithms requiring a training set are discussed in this submission.

Ask a specific question about this device

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, arteriovenous malformations, trigeminal neuralgia, medically refractory essential tremor, meningiomas, post-surgical pituitary adenomas and recurrent glioblastomas.

Leksell Gamma Knife Perfexion is a radiosurgery system for use in the stereotactic irradiation of intra-cranial 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 Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.

Each unit contains 192 sealed sources of Cobalt 60.

Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room.

• The medical side consists basically of the radiation unit with a patient positioning . system. The system control and power units are placed inside the cover of the radiation unit.
• The office side consists of the operator console with control panel and office computer. .

This device, the Leksell Gamma Knife® Perfexion™, is a medical device for stereotactic radiosurgery. The provided documentation is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with explicit acceptance criteria for a novel device.

Therefore, the typical acceptance criteria and study design for proving performance in the context of a new device are not directly applicable here. Instead, the "study" that proves the device meets the acceptance criteria is the demonstration of substantial equivalence to its predicate device (K120811). The acceptance criteria for this type of submission are implicitly that the new device is as safe and effective as the predicate and shares fundamental technical characteristics.

Here's an attempt to structure the information based on your request, highlighting where the traditional study components are not directly present or are addressed through literature review and comparison:

Acceptance Criteria and Device Performance

Further Details on the "Study" and Ground Truth Establishment

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

   • No explicit "test set" in the traditional sense of a new clinical trial was used.
   • The "test set" information for demonstrating safety and effectiveness relied on a clinical literature review. The provenance of this data would be from various scientific publications, likely international, covering retrospective and prospective studies performed with Gamma Knife technology (including previous models and the predicate device).

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

   • The document mentions that "scientific advisors found extensive scientific publications" and "reports have been approved by physicians regarding clinical relevance, based on experience of previous models of the system."
   • The number of experts is not specified.
   • Their qualifications are generally described as "physicians" and "scientific advisors" with experience in the field of stereotactic radiosurgery and Gamma Knife systems. Specific years of experience (e.g., "radiologist with 10 years of experience") are not provided.

3. Adjudication method for the test set:

   • Not applicable in the context of a literature review. The "adjudication" was effectively through peer review of published scientific literature and the internal review and acceptance by the notifying company's scientific advisors and physicians.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, a MRMC comparative effectiveness study was not explicitly done for this 510(k) submission. The submission relies on demonstrating equivalence to the predicate device and literature review for new indications, not a direct comparison of human readers with vs. without AI assistance (as this is a treatment device, not an diagnostic AI).

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

   • Not explicitly applicable. The Leksell Gamma Knife Perfexion is a complete radiosurgery system, not a standalone algorithm. Its performance is inherent to the system delivering radiation based on a treatment plan, which involves human input (e.g., physicians defining targets). The "performance" assessment focuses on the system's ability to safely and effectively deliver radiation as prescribed, consistent with its predicate.

6. The type of ground truth used:

   • For the demonstration of safety and effectiveness, the "ground truth" was derived from:
     • Clinical outcomes data reported in the scientific literature for treatments performed with Leksell Gamma Knife systems (including previous models and the predicate).
     • Expert consensus among physicians and scientific advisors regarding the clinical relevance and safety/efficacy based on existing knowledge and literature.
     • Risk analysis review for safety, which serves as a form of internal validation against established safety standards.

7. The sample size for the training set:

   • Not applicable in the context of a 510(k) submission for a physical device, as there isn't a "training set" for an algorithm in the traditional sense here. Any "training" for the device's development would be part of engineering and design validation, not typically reported with a sample size like for an AI model.

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

   • Not applicable for the same reasons as above. The device's underlying physics and engineering principles are established, and its performance is validated against these principles and against the performance of the predicate device, not through an algorithm's training set as in AI.

Ask a specific question about this device

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, arteriovenous malformations, trigeminal neuralgia, meningiomas and vestibular schwannomas.

Leksell Gamma Knife Perfexion is a radiosurgery system for use in the stereotactic irradiation of intra-cranial 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 Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.

Each unit contains 192 sealed sources of Cobalt 60.

Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room.

• . The medical side consists basically of the radiation unit with a patient positioning system. The system control and power units are placed inside the cover of the radiation unit.
• The office side consists of the operator console with control panel and office computer. .

The provided text is a 510(k) summary for the Leksell Gamma Knife Perfexion. This document primarily focuses on establishing substantial equivalence to a predicate device and regulatory information. It does not contain a study that demonstrates the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML device would.

The "acceptance criteria" here would be the regulatory requirements for showing substantial equivalence for a medical device that performs radiation therapy, not a set of performance metrics for an AI algorithm.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth, and expert adjudication are not applicable to the information provided in this 510(k) submission.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as performance metrics in the context of a clinical study demonstrating AI/ML performance. The "acceptance criteria" for this 510(k) are implicitly the requirements for showing substantial equivalence (same intended use, similar technical characteristics, safety, and effectiveness) to the predicate device.
• Reported Device Performance: Not presented as a results table from a performance study. The document states that the device's functionality is "equivalent" to its predicate in safety and effectiveness.

2. Sample sized used for the test set and the data provenance

• Not Applicable: This document does not describe a clinical performance study with a test set. There is no information on sample size or data provenance in this context.

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

• Not Applicable: No test set or ground truth in the context of an AI/ML performance study is mentioned.

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

• Not Applicable: No test set or adjudication method is mentioned.

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 a study for an AI-assisted device, nor does it describe a comparative effectiveness study.

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

• Not Applicable: This is a physical radiation therapy device, not an algorithm, so the concept of standalone performance does not apply in the manner typically asked for AI/ML devices.

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

• Not Applicable: No ground truth in the context of an AI/ML performance study is mentioned.

8. The sample size for the training set

• Not Applicable: No training set is mentioned as this is not an AI/ML device.

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

• Not Applicable: No training set or ground truth establishment is mentioned.

Summary of Relevant Information from the Provided Text:

• Device Name: Leksell Gamma Knife® Perfexion™
• Intended Use: Stereotactic irradiation of head structures (e.g., metastatic tumors, arteriovenous malformations, trigeminal neuralgia, meningiomas, vestibular schwannomas).
• Device Type: Teletherapy device (radiation therapy system)
• Predicate Device: Leksell Gamma Knife® Perfexion™ (K063512)
• Basis for Substantial Equivalence: "The functionality for the Leksell Gamma Knife Perfexion is equivalent to its predicate device K063512 in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 (k) submission." (These comparison charts are not provided in the snippet.)

In conclusion, this 510(k) submission is for a physical radiation therapy device establishing substantial equivalence to a prior version, not an AI/ML device that would typically undergo a performance study with specific acceptance criteria, test sets, and ground truth as described in your prompt.

Ask a specific question about this device

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.

Leksell Gamma Knife® PERFEXION ™ is a radiosurgery system for use in the stereotactic irradiation of intra-cranial 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 system consists basically of the radiation unit with patient positioning system and the operator console (with control panel and system computer).

This document is a 510(k) summary for the Leksell Gamma Knife® PERFEXION™. It is a Traditional 510(k) submission.

Analysis of Acceptance Criteria and Study Details:

Based on the provided text, the submission is a Traditional 510(k) for a medical device (Radionuclide radiation therapy system), specifically the Leksell Gamma Knife® PERFEXION ™. The purpose of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to establish novel performance criteria or conduct studies proving the device meets new acceptance criteria in the same way an AI/ML device might.

Therefore, many of the requested details regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment, which are typical for an AI/ML device study, are not applicable or not explicitly detailed in the provided 510(k) summary.

The primary "acceptance criterion" for a Traditional 510(k) is substantial equivalence to a predicate device in terms of safety and effectiveness. The "study" that proves this is the comparison to the predicate device itself.

Here's a breakdown based on your requested information, highlighting what is present and what is not applicable/detailed:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a medical device like a radiation therapy system, specific performance metrics (e.g., radiation dose accuracy, positional accuracy, treatment time) would be detailed in the underlying engineering and validation studies, but these are summarized by the claim of substantial equivalence in the 510(k) document.

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

• Not Applicable/Not detailed. This 510(k) submission does not describe a clinical performance study with a "test set" in the context of an AI/ML device performing diagnostic or prognostic tasks. The "test" for a Traditional 510(k) is the demonstration of substantial equivalence through comparison of design, materials, and intended use, often supported by engineering verification and validation (V&V) tests rather than clinical studies with "test sets" of patient data for algorithm performance.

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

• Not Applicable. No "ground truth" for a test set is discussed, as this is not an AI/ML diagnostic device submission.

4. Adjudication method for the test set

• Not Applicable. No clinical test set requiring adjudication 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

• Not Applicable. This is a hardware/software system for radiation therapy delivery, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

• Not Applicable. This is not an algorithm-only device. It's a complete radiation therapy system. While it contains algorithms for dose calculation and positioning, the 510(k) focuses on the system as a whole and its equivalence to a predicate, not isolated algorithm performance.

7. The type of ground truth used

• Not Applicable. The concept of "ground truth" as typically applied to image analysis or diagnostic AI is not present in this 510(k) summary. The "truth" for a radiation therapy system relates to its ability to accurately deliver radiation as intended, which is verified through engineering tests, phantom studies, and quality assurance protocols (not detailed in this summary, but inherent to the device type).

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device where a "training set" is used to develop a model.

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

• Not Applicable.

Summary Regarding the Study(ies) for K063512:

The "study" that proves the device meets (the implied) acceptance criteria for this Traditional 510(k) is the comparison to its predicate device, Leksell Gamma Knife® PERFEXION ™ (K061941). The manufacturer asserts that:

• "The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its predicate device... in safety and effectiveness."
• "The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 k submission."

The 510(k) process for this type of device does not typically require new clinical studies with patient test sets, expert ground truth, or training sets as would be seen for a novel diagnostic AI/ML algorithm. Instead, it relies on demonstrating that the new device is as safe and effective as a device already on the market through engineering specifications, design comparisons, and adherence to recognized standards. The provided text doesn't offer details on specific engineering verification/validation studies, such as phantom measurements or simulation results, which would underpin the claim of equivalent technical characteristics.

Ask a specific question about this device

Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for use in the stereotactic irradiation of intra-cranial structures.

Leksell Gamma Knife® PERFEXION ™ is a radiosurgery system for use in the stereotactic Lessen Gamilia Nime Fire - Fire Erivery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

The system consists basically of the radiation unit with patient positioning system and the operator console (with control panel and system computer).

This document is a 510(k) summary for the Leksell Gamma Knife® PERFEXION™ and does not contain detailed information about acceptance criteria or specific study results to prove meeting those criteria.

The document primarily focuses on:

• Identifying the device and its manufacturer.
• Classifying the device and its regulation number.
• Identifying predicate devices for substantial equivalence.
• Stating the intended use of the device.
• Confirming its regulatory clearance by the FDA.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies from this document.

However, based on the provided text, here is what can be inferred and what is missing:

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

• Missing. The document explicitly states: "The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its predicate device... The fundamental technical characteristics are similar to those of its predicate device(s) and are listed on the comparison charts provided in this 510(k) submission." This implies that acceptance criteria and performance are likely demonstrated through a comparison to the predicate device's established performance, rather than a separate, detailed performance study with explicit acceptance criteria laid out in this summary. The actual comparison charts are not included in this extract.

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

• Missing. No information on a specific "test set" or data provenance (country of origin, retrospective/prospective) is provided. The submission relies on demonstrating substantial equivalence to a predicate device.

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

• Missing. No information on "ground truth" establishment or expert involvement for a test set is provided.

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

• Missing. No information on an adjudication method is provided.

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:

• Missing. This device is a "Radionuclide radiation therapy system" (a hardware system for radiosurgery), not an AI-based diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

• Missing. This is a physical radiosurgery device, not an algorithm, so a standalone algorithm performance study is not applicable.

7. The type of ground truth used:

• Missing. As no specific performance study is detailed, no ground truth type is mentioned.

8. The sample size for the training set:

• Missing. As this is a hardware device submission, not a machine learning algorithm submission, there is no concept of a "training set" in the context of device performance as described here.

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

• Missing. Not applicable.

In summary, this 510(k) document is a regulatory submission for a physical medical device (Leksell Gamma Knife® PERFEXION™) seeking substantial equivalence to a predicate device. It confirms the device's classification, intended use, and substantial equivalence, but it does not include the detailed performance study data, acceptance criteria, or ground truth methodologies that would typically be found in a submission for, for example, a novel diagnostic AI algorithm.

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