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The Calypso System is intended for use as an adjunct in treatment planning and radiation the our poor ijo align and/or the patient's position relative to the isocenter of a radiation therapy system. The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders.

The optional Dynamic Edge™ Gating component may signal a radiation therapy system to impose a beam-hold when the treatment target position has moved outside the defined tracking limits and to signal the radiation therapy system to remove the beam-hold upon the target's return to a position inside the defined tracking limits. The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces.

Implanted Beacon® transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.

Permanent Beacon transponders are indicated for implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed) to align and monitor the treatment isocenter in real time during radiation therapy.

Surface Beacon® transponders are indicated for temporary external placement on the skin, to monitor respiratory motion and other patient motion in real time during radiation therapy.

The Calypso System utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy.

Use of the Calypso System for target localization is based on the system's detection of non-ionizing electromagnetic signals from passive markers, called Beacon® transponders which are implanted in or near the treatment target or placed externally on the surface of a patient.

Implanted Beacon transponders when used with the Calypso System enable objective measurement of the location of the target in 3 dimensions. The system operator uses this information to align the patient's treatment target to the isocenter of the therapy system prior to treatment. This information can also be used to monitor (track) the position of the treatment target during radiation therapy treatment.

When using Surface Beacon transponders this information can be used to monitor respiratory motion and other patient motion in real time during radiotherapy. When correlated to the patient's treatment target motion the system provides objective measurement of the location of the target in 3 dimensions.

The Dynamic Edge™ Gating feature enables the Calypso System to interface with radiation therapy systems configured with gating capabilities via an interface to external systems. With this optional feature added to the Calypso System, a beam hold is signaled to the radiation therapy system when the treatment target position has moved outside the defined tracking limits. The radiation therapy system is signaled to remove the beam-hold upon the target's return to a position inside the defined tracking limits.

The provided text is a 510(K) summary for the Calypso® System Surface Beacon® transponders. It describes the device, its indications for use, and a summary of performance testing. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test/training sets, or details about expert ground truth establishment for the performance testing.

The summary states: "Results of verification and validation testing demonstrate that the Surface Beacon transponder satisfies the intended use as described above." This is a general statement that implies the device met its performance goals, but the specific metrics, criteria, and detailed study information are not included in this document.

Therefore, I cannot populate the requested table or provide the detailed information about the study design using only the provided text.

Here's a breakdown of what could be extracted if the information were present, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information for 2-9:

• Sample size used for the test set and the data provenance: The document mentions "verification and validation testing" but does not specify the sample size (number of cases/patients) or the data source (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: The document describes a "patient localization system" and "monitoring respiratory motion," which suggests it's a device for real-time tracking, not an AI for image interpretation that would typically involve human readers needing improvement with AI assistance. Therefore, an MRMC study in this context is unlikely, and no such study is described or referenced.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "Summary of Performance Testing" notes that "Results of verification and validation testing demonstrate that the Surface Beacon transponder satisfies the intended use." While this implies standalone performance was evaluated, the details of that evaluation are missing.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified. For a tracking system, ground truth would likely involve highly precise physical measurements or a gold-standard tracking system, but this is not detailed.
• The sample size for the training set: The document doesn't mention any training sets, which is typical for a hardware-based tracking system rather than an AI/machine learning model.
• How the ground truth for the training set was established: Not applicable, as no training set is mentioned for this type of device.

In summary, the provided 510(k) summary only states that performance testing was conducted and the device met its intended use. It does not provide the specific details of the acceptance criteria or the study methodology requested.

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The Calypso® System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a radiation therapy system. The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon® transponders.

The optional Dynamic Edge™ Gating component may signal a radiation therapy system to impose a beam-hold when the treatment target position has moved outside the defined tracking limits and to signal the radiation therapy system to remove the beam-hold upon the target's return to a position inside the defined tracking limits. The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces.

Beacon transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.

Permanent Beacon transponders are indicated for permanent implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed).

The Calypso System utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy. Use of the Calypso System for target localization is based on the system's detection of non-ionizing electromagnetic signals from passive markers, called Beacon® transponders. The Beacon Transponders are implanted in either the prostatic tissue (i.e., prostatic bed). When used with the Calypso System, the Beacon transponder signals enable objective measurement of the location of the treatment target in 3 dimensions.

The system operator uses this information to align the patient's treatment target to the isocenter of the therapy system prior to treatment. This information can also be used to monitor (track) the position of the treatment target during radiation therapy treatment.

The Dynamic Edge Gating feature enables the Calypso System to connect with radiation therapy systems configured with gating capabilities via an interface to external systems. With this feature added to the Calypso System, a beam hold is signaled to the radiation therapy system when the treatment target position has moved outside the defined tracking limits. The radiation therapy system is signaled to remove the beam-hold upon the target's return to a position inside the defined tracking limits.

This 510(k) summary does not contain the acceptance criteria or a study proving the device meets specific acceptance criteria for the new "Dynamic Edge Gating" feature beyond compatibility. The document explicitly states: "There has been no change to the device performance, software or hardware. Testing performed in support of K102373 demonstrated substantial equivalency and safety and effectiveness." This indicates that the current submission (K112768) is a modification to an already cleared device, and thus, relies on previous clearances for performance validation.

However, based on the information provided, we can infer some details related to the device's functionality and the predicate device's performance, as well as the context of substantial equivalence.

Here's an analysis based on the provided text, highlighting the absence of specific details for the requested categories related to this specific submission:

Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document primarily focuses on the capabilities and compatibility of the new feature and states "No change" in performance for core functionalities. It refers to previous submissions (K102373, K060906, K080726) for substantial equivalency and safety/effectiveness testing. Therefore, specific quantitative acceptance criteria (e.g., "accuracy must be within X mm") for the new feature are not detailed in this particular summary. The "compatibility" statement for Varian and Siemens systems serves as a key performance criterion for the "Dynamic Edge Gating" component.

Study Details (for the new "Dynamic Edge Gating" feature)

Based on the provided 510(k) summary, specific details about a new study for the "Dynamic Edge Gating" feature are largely absent, as the submission relies on previous clearances.

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

   • Not explicitly stated for the "Dynamic Edge Gating" feature. The document states, "The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces." This implies testing was done, but specific sample sizes (e.g., number of tests, duration, patient data if any) are not provided. The provenance of data for this compatibility testing is also not specified.

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

   • Not applicable / Not stated for this submission. The determination of "compatibility" for the gating feature would likely involve technical verification against specifications of the interfaced systems, rather than expert interpretation of medical images or outcomes.

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

   • Not applicable / Not stated for this submission. This refers to methods for resolving discrepancies in expert opinion, which is not relevant for the type of technical compatibility testing implied here.

4. 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. This device is a patient localization and motion monitoring system, not an AI diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to its function.

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

   • The core device operation, including localization and gating, functions largely automatically once parameters are set. The "Dynamic Edge Gating" component autonomously signals beam holds based on defined tracking limits. The "compatibility" testing would have assessed this automated function. However, the device is explicitly "an adjunct in treatment planning and radiation therapy" and involves operator alignment, so it's not entirely without human involvement in its overall use. The performance of the gating system itself (signaling beam holds) is an automated function.

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

   • For the "Dynamic Edge Gating" feature's "compatibility" claim: The ground truth would likely be the actual operational state of the interfaced Varian and Siemens radiation therapy systems (i.e., did the beam-hold signal correctly trigger a beam hold, and did the release signal correctly release it, according to the predefined motion thresholds). This is a technical validation against the expected behavior of the interconnected systems. For the underlying localization, the ground truth would be precise physical measurements of transponder positions.

7. The sample size for the training set:

   • Not applicable. This device is hardware and software for real-time localization and gating based on electromagnetic signals. It does not explicitly mention machine learning or AI models that require a "training set" in the conventional sense (e.g., for image classification or diagnosis). Its functionality is based on known physics and engineering principles.

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

   • Not applicable. (See #7).

Summary of the K112768 Submission's Approach:

This 510(k) submission (K112768) is for an updated version of an existing device (Calypso System) with an added feature, "Dynamic Edge Gating." The document explicitly states that there are "no changes to the device performance, software or hardware" for the core system. The primary focus of this new submission, regarding performance and a "study," is the compatibility of the "Dynamic Edge Gating" feature with specific Varian and Siemens radiation therapy systems. The claim of "substantial equivalency" largely rests on the predicate device's existing performance data and the successful technical integration of the new gating function. Specific, detailed reports of new clinical studies with quantitative acceptance criteria for this particular submission are not provided within the 510(k) summary.

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The Calypso 4D Localization System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders.

Beacon transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.

Permanent Beacon transponders are indicated for permanent implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed).

The Calypso System with the Dynamic Edge™ Gating modification enables the Calypso System to interface with radiation therapy systems configured with gating capabilities via an interface to external systems. This modification includes updated computer software and hardware.

All other features of the Calypso System remain as cleared by K060906 and K080726.

The provided text doesn't contain detailed acceptance criteria or a study that proves the device meets those criteria in the typical format of a clinical study with performance metrics. The information focuses on the regulatory submission (510(k)) for the Calypso System with Dynamic Edge™ Gating.

Here's an analysis of what information is available and what is not available based on your request:

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

• Available: The document states, "The Calypso System with the gating interface option utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target."
• Not available: Specific quantitative acceptance criteria (e.g., target localization accuracy in mm, latency requirements) and reported performance values against these criteria are not provided in this summary.

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

• Not available: This information is not present in the provided text. The document broadly mentions "performance testing, including design verification and validation, software verification and validation, electromagnetic compatibility as well as other assessments." It does not describe a clinical study with a test set of patient data.

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

• Not available: As no specific clinical study with a test set involving expert review is described, this information is absent.

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

• Not available: No test set or 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

• Not available: The Calypso System is a patient localization system, not an AI-assisted diagnostic imaging device that involves "human readers." Therefore, an MRMC study or AI assistance effect size is not applicable in this context and is not mentioned.

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

• Available (implicitly): The device itself is designed for "accurate, precise and continuous localization of a treatment isocenter," suggesting it performs this function independently. The "performance testing" mentioned, including software verification and validation, would evaluate its standalone function.
• Not available (explicit results): While implied, specific standalone performance metrics are not detailed.

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

• Not available (for clinical ground truth): For a localization system, the "ground truth" would likely involve highly precise physical measurements or gold-standard imaging techniques to verify the system's ability to accurately locate the transponders. The document does not specify the methods used to establish this "ground truth" during testing.

8. The sample size for the training set

• Not available: The document does not mention a training set, as it describes a localization system, not a machine learning or AI-driven diagnostic device that typically requires a large training set of data.

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

• Not available: Not applicable, as no training set is described.

Summary of what can be inferred from the text:

The document describes a medical device (Calypso System with Dynamic Edge™ Gating) that helps in radiation therapy by accurately locating a patient's position. It is an update to a previously cleared device. The "Summary of Performance Testing" section broadly states that the system underwent various tests (design, software, EMC) to ensure it meets its intended use, is safe and effective, and performs comparably to its predicate device. However, it does not provide specific performance metrics, study designs, or patient data details that would address your specific questions about acceptance criteria and proof of meeting them. This type of detailed performance data is typically found in the full 510(k) submission and associated test reports, which are summarized at a high level in this document.

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The Calypso® 4D Localization System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The Calypso® System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders.

Beacon® transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.

Permanent Beacon® transponders are indicated for permanent implantation in the prostate and the peri-prostatic tissue.

The Calypso 4D Localization System (Calypso System) utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy. Use of the Calypso System for target localization is based on the system's detection of non-ionizing electromagnetic signals from passive implanted markers, called Beacon transponders. The Beacon transponders are implanted in or near the treatment target. When used with the Calypso System, the Beacon transponder signals enable objective measurement of the location of the treatment target in 3 dimensions. The system operator uses this information to align the patient's treatment target to the isocenter of the linear accelerator prior to treatment. This information can also be used to monitor (track) the position of the treatment target during radiation therapy treatment.

The provided 510(k) summary for the Calypso® 4D Localization System (K080726) does not contain detailed information about specific acceptance criteria and a study proving that the device meets these criteria. The document states "Performance testing demonstrated substantial equivalence," but it lacks the specific data, methodology, and results required to answer many of your questions.

Here's an breakdown of what can and cannot be answered based on the provided text:

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

Explanation: The document does not list any specific performance metrics or thresholds that the device was required to meet. It broadly states "Performance testing demonstrated substantial equivalence," but no details on what was tested or the results are provided.

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

Information not provided. The document does not mention any test set sample sizes, data provenance (country of origin), or whether the study was retrospective or prospective.

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)

Information not provided. The document does not describe any human expert involvement in establishing ground truth for a test set.

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

Information not provided. Since no expert review or test set is described, no 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 device is a patient localization system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The primary function is to track the physical position of a treatment target. The document does not describe any MRMC study.

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

The device's core function is "algorithm only" in the sense that it automatically detects and tracks transponders. However, the document does not explicitly provide data from a "standalone" performance study in the way this question is typically asked for AI diagnostic tools (i.e., comparing algorithm output to ground truth without human intervention). The "performance testing" mentioned is likely related to the system's ability to accurately and precisely localize the transponders.

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

Information not provided. The document does not specify how "ground truth" was established for any performance testing. For a localization system, ground truth would likely involve highly accurate physical measurement systems.

8. The sample size for the training set

Information not provided. This device is not described as a machine learning/AI predictive model that would typically have a "training set" in the conventional sense. Its function relies on detecting electromagnetic signals from transponders, not on learning patterns from a large dataset.

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

Information not provided. As mentioned above, a training set in the AI context is not applicable here given the device's description.

In summary, the provided 510(k) summary is very high-level and focuses on the regulatory aspects of substantial equivalence, rather than providing detailed technical performance study results and methodologies. For a device of this nature (a localization system), the performance testing would typically involve evaluating accuracy, precision, and response time under various conditions (e.g., different transponder configurations, distances, and potential interference). However, these details are not present in this document.

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The Calypso® 4D Localization System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The Calypso System provides accurate, precise, and continuous localization of a treatment isocenter by using two or more Beacon® transponders.

Beacon transponders are indicated for permanent implantation in the prostate only.

The Calypso 4D Localization System (Calypso System) is designed to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy. Use of the Calypso System for target localization is based on the system's detection of electromagnetic signals from passive implanted markers, called Beacon transponders. The Beacon transponders are implanted in or near the treatment target. When used with the Calypso System, the Beacon transponder signals enable objective measurement of the location of the treatment target in 3 dimensions. The system operator uses this information to align the patient's treatment target to the isocenter of the linear accelerator prior to radiation therapy and to monitor the position of the treatment target during treatment.

The provided text does not contain explicit acceptance criteria or a detailed study description with specific metrics and results that would allow for the completion of the requested table.

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices and outlining the device's indications for use. It mentions "performance testing" and "clinical and nonclinical testing" but does not provide the specific details needed to answer most of your questions.

Here's an analysis of what is and isn't available:

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

• Acceptance Criteria: Not explicitly stated in the provided text. There are no numerical targets or thresholds mentioned for accuracy, precision, or other performance metrics.
• Reported Device Performance: The text generally states that the system is "accurate and reliable" and "can accurately and reliably provide localization and tracking information." However, it does not provide quantitative results like mean error, standard deviation, sensitivity, specificity, or AUC.

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

• Test Set Sample Size: Not mentioned. The text refers to "a subset of the patients" for tracking prostate motion but provides no number.
• Data Provenance: Not mentioned. It's unclear if the data was retrospective or prospective, or from what country.

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):

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

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

• Not mentioned. There is no information on how ground truth was established by experts.

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:

• MRMC Study: Not mentioned. The device is for patient localization and tracking, not for analysis by human readers in the traditional sense of an imaging diagnostic AI. The "human-in-the-loop" would be the operator using the system for alignment and monitoring, but no comparative effectiveness study on their improvement is described.
• Effect Size: Not applicable based on the available information.

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

• The device inherently involves a human operator to physically align the patient based on the system's output. Therefore, a purely "standalone" (algorithm only, no human action) performance test as typically understood for an AI diagnosing images, is not directly applicable. The performance described relates to the system's ability to provide localization data, which then enables human action.

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

• Not explicitly stated. Given the nature of the device (localization of an implanted transponder), the ground truth for localization would likely be derived from a highly accurate, independent measurement system or fiducial reference, but this is not detailed.

8. The sample size for the training set:

• Not mentioned.

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

• Not mentioned.

In summary, the provided document focuses on regulatory compliance (510(k) summary) and broad statements of safety and effectiveness, rather than a detailed scientific study report with specific performance metrics and methodologies. To obtain the requested information, a full clinical study report or a more detailed technical document would be required.

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