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The Calypso System is intended for use as an adjunct in treatment planning and radiation therapy, to align and/or 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.

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. The Beacon transponders 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 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.

The Calypso® System with Dynamic Edge™ Gating is a patient localization system. The application describes its key features and how it differs from already cleared devices.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria for the Calypso System's performance (e.g., specific accuracy thresholds in millimeters or latency requirements in milliseconds). Instead, it makes a general statement about performance testing.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any test set or provide details about the data provenance (e.g., country of origin, retrospective or prospective) for performance testing. It generally refers to "software, hardware and system verification and validations testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

The document does not mention the use of experts or a ground truth established by experts for performance testing related to target localization or gating. The performance testing appears to be internal engineering and validation tests rather than clinical studies requiring expert interpretation of ground truth.

4. Adjudication Method for the Test Set

As there is no mention of an expert panel or subjective assessment for performance testing, no adjudication method is described or implied.

5. 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 does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is a localization and gating system, not an AI-based diagnostic imaging tool, so such a study would not typically apply.

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

The entire system, including the Dynamic Edge Gating feature, operates as an automated system to monitor and signal beam-holds based on target position. While a human operator defines the tracking limits, the gating process itself is standalone in its execution (i.e., the algorithm automatically signals the beam-hold/release without constant human intervention during the process). The performance testing would therefore inherently be "standalone" in this context, evaluating the system's ability to accurately track and gate. However, the document does not explicitly use the term "standalone study" in this manner.

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

The document does not explicitly state the type of ground truth used for its performance testing. Given the nature of the device (a localization and gating system), the "ground truth" for its accuracy and precision would likely be established through:

• Physical phantoms and precise measurement systems: For validating the 3D localization accuracy of the Beacon transponders.
• Simulated motion profiles: For validating the tracking and gating capabilities under controlled conditions.
• Technical specifications and engineering measurements: For assessing compliance with electrical and EMC safety standards.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. The Calypso System is described as utilizing non-ionizing electromagnetic and optical technology for localization and monitoring, which implies a deterministic algorithm based on physics principles rather than a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned or implied, this information is not applicable and not provided.

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The Implanet Calypso System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Implanet Calypso System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.

The Calypso System is a posterior instrumentation system consisting of monoaxial and polyaxial pedicle screws, union rods, transverse connectors, and hooks. The implants in the system are composed of Ti6Al4V titanium alloy described by ISO 5832-3.

The Implanet S.A.'s Calypso System is a spinal fixation device. The provided text details the performance data for the device, focusing on its mechanical strength and biological compatibility to demonstrate substantial equivalence to predicate devices. It does not describe an AI medical device. Therefore, several of the requested categories (e.g., number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable as they pertain to AI/ML device studies.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the "sample size" in terms of number of devices tested for each mechanical test. It mentions "bench testing," implying a set of physical samples were tested.

• Data Provenance: The tests are bench tests performed by Implanet S.A. No country of origin for data or retrospective/prospective status is relevant for these types of mechanical and biological tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth for mechanical and biological testing is established by adherence to recognized international standards (e.g., ASTM, ISO) and laboratory measurements, not by expert consensus interpreting complex data like medical images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., imaging studies) to resolve disagreements. Here, objective measurements against pre-defined standards are used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a spinal fixation device, not an AI medical device, so an MRMC study is not relevant to its regulatory submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is defined by established industry standards and specifications (e.g., ASTM F1798, ASTM F1717, ISO 10993, ISO 11137, ISO 17665). The measurements taken during bench testing are compared directly against these quantitative and qualitative criteria.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for such a set.

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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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