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510(k) Data Aggregation

    K Number
    K242748
    Device Name
    Oncospace
    Manufacturer
    Oncospace, Inc.
    Date Cleared
    2025-04-11

    (211 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oncospace, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oncospace is used to configure and review radiotherapy treatment plans for a patient with malignant or benign disease in the head and neck, thoracic, abdominal, and pelvic regions. It allows for set up of radiotherapy treatment protocols, association of a potential treatment plan with the protocol(s), submission of a dose prescription and achievable dosimetric goals to a treatment planning system, and review of the treatment plan. It is intended for use by qualified, trained radiation therapy professionals (such as medical physicists, oncologists, and dosimetrists). This device is for prescription use by order of a physician.
    Device Description
    The Oncospace software supports radiation oncologists and medical dosimetrists during radiotherapy treatment planning. The software includes locked machine learning algorithms. During treatment planning, the Oncospace software works in conjunction with, and does not replace, a treatment planning system (TPS). The Oncospace software is intended to augment the treatment planning process by: - allowing the radiation oncologist to select and customize a treatment planning protocol that includes dose prescription (number of fractions, dose per fraction, dose normalization), a delivery method (beam type and geometry), and protocol-based dosimetric goals/objectives for treatment targets, and organs at risk (OAR); - predicting dosimetric goals/objectives for OARs based on patient-specific anatomical geometry; - automating the initiation of plan optimization on a TPS by supplying the dose prescription, delivery method, protocol-based target objectives, and predicted OAR objectives; - providing a user interface for plan evaluation against protocol-based and predicted goals. Diagnosis and treatment decisions occur prior to treatment planning and do not involve Oncospace. Decisions involving Oncospace are restricted to setting of dosimetric goals for use during plan optimization and plan evaluation. Human judgement continues to be applied in accepting these goals and updating them as necessary during the iterative beam optimization process. Human judgement is also still applied as in standard practice during plan quality assessment; the protocol-based OAR goals are used as the primary means of plan assessment, with the role of the predicted goals being to provide additional information as to whether dose to an OAR may be able to be further lowered. When Oncospace is used in conjunction with a TPS, the user retains full control of the TPS, including finalization of the treatment plan created for the patient. Oncospace also does not interface with the treatment machines. The risk to patient safety is lower than a TPS since it only informs the treatment plan, does not allow region of interest editing, does not make treatment decisions, and does not interface directly with the treatment machine or any record and verify system. Oncospace's OAR dose prediction approach, and the use of predictions in end-to-end treatment planning workflow, has been tested for use with a variety of cancer treatment plans. These included a wide range of target and OAR geometries, prescriptions and boost strategies (sequential and simultaneous delivery). Validity has thus been demonstrated for the range of prediction model input features encountered in the test cases. This range is representative of the diversity of the same feature types (describing target-OAR proximity, target and OAR shapes, sizes, etc.) encountered across all cancer sites. Given that the same feature types will be used in OAR dose prediction models trained for all sites, the modeling approach validated here is not cancer site specific, but rather is designed to predict OAR DVHs based on impactful features common to all sites. The software is designed to be used in the context of all forms of intensity-modulated photon beam radiotherapy. The planning objectives themselves are intended to be TPS-independent: these are instead dependent on the degree of organ sparing possible given the beam modality and range of delivery techniques for plans in the database. To facilitate streamlined transmission of DICOM files and plan parameters Oncospace includes scripts using the treatment planning system's scripting language (for example, Pinnacle). The Oncospace software includes an algorithm for transforming non-standardized OAR names used by treatment planners to standardized names defined by AAPM Task Group 263. This matching process primarily uses a table of synonyms that is updated as matches are made during use of the product, as well as a Natural Language Processing (NLP) model that attempts to match plan names not already in the synonym table. The NLP model selects the most likely match, which may be a correct match to a standard OAR name, an incorrect match, or no match (when the model considers this to be most likely, such as for names resembling a target). The user can also manually match names using a drop-down menu of all TG-263 OAR names. The user is instructed to check each automated match and make corrections using the drop-down menu as needed.
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    K Number
    K222803
    Device Name
    Oncospace
    Manufacturer
    Oncospace, Inc.
    Date Cleared
    2023-02-02

    (139 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oncospace, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oncospace is used to configure and review radiotherapy treatment with malignant or benign disease in the prostate, head, and neck regions. It allows for set up of radiotherapy treatment protocols, association of a potential treatment plan with the protocol(s), submission of a dose prescription and achievable dosimetric goals to a treatment planning system, and review of the treatment plan. It is intended for use by qualified, trained radiation therapy professionals (such as medical physicists, oncologists, and dosimetrists). This device is for prescription use by order of a physician.
    Device Description
    The Oncospace software supports radiation oncologists and medical dosimetrists during radiotherapy treatment planning. The software includes locked machine learning algorithms. During treatment planning, the Oncospace software works in conjunction with, and does not replace, a treatment planning system (TPS). The Oncospace software is intended to augment the treatment planning process by: allowing the radiation oncologist to select and customize a treatment planning protocol that includes dose prescription (number of fractions, dose normalization), a delivery method (beam type and geometry), and protocol-based dosimetric goals/objectives for treatment targets, and organs at risk (OAR); predicting dosimetric goals/objectives for OARs based on patient-specific anatomical geometry; automating the initiation of plan optimization on a TPS by supplying the dose prescription, delivery method, protocol-based target objectives, and predicted OAR objectives; providing a user interface for plan evaluation against protocol-based and predicted goals. Diagnosis and treatment decisions occur prior to treatment planning and do not involve Oncospace. Decisions involving Oncospace are restricted to setting of dosimetric goals for use during plan optimization and plan evaluation. Human judgement continues to be applied in accepting these goals and updating them as necessary during the iterative beam optimization process. Human judgement is also still applied as in standard practice during plan quality assessment; the protocol-based OAR goals as the primary means of plan assessment, with the role of the predicted goals being to provide additional information as to whether dose to an OAR may be able to be further lowered. When Oncospace is used in conjunction with a TPS, the user retains full control of the TPS, including finalization of the treatment plan created for the patient. Oncospace also does not interface with the treatment machines. The risk to patient safety is lower than a TPS since it only informs the treatment plan, does not allow region of interest editing, does not make treatment decisions, and does not interface directly with the treatment machine or any record and verify system. Oncospace's OAR dose prediction approach, and the use of predictions in end-to-end treatment planning workflow, has been tested for use with a variety of cancer treatment plans. These included a wide range of target and OAR geometries, prescriptions and boost strategies (sequential and simultaneous delivery). Validity has thus been demonstrated for the range of prediction model input features encountered in the test cases. This range is representative of the diversity of the same feature types (describing target-OAR proximity, target and OAR shapes, sizes, etc.) encountered across all cancer sites. Given that the same feature types will be used in OAR dose prediction models trained for all sites, the modeling approach validated here is not cancer site specific, but rather is designed to predict OAR DVHs based on impactful features common to all sites. The software is designed to be used in the context of all forms of intensity-modulated photon beam radiotherapy. The planning objectives themselves are intended to be TPS-independent: these are instead dependent on the degree of organ sparing possible given the beam modality and range of delivery techniques for plans in the database. To facilitate streamlined transmission of DICOM files and plan parameters Oncospace includes scripts using the treatment planning system's scripting language (for example, Pinnacle).
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    K Number
    K202284
    Device Name
    Oncospace
    Manufacturer
    Oncospace, Inc.
    Date Cleared
    2021-03-12

    (212 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oncospace, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oncospace is used to configure and review radiotherapy treatment with malignant or benign disease in the prostate, thoracic, pancreas, or head & neck regions. It allows for set up of radiotherapy treatment protocols, association of a potential treatment plan with the protocol(s), submission of a dose prescription and achievable dosimetric goals to a treatment planning system, and review of the treatment plan. It is intended for use by qualified, trained radiation therapy professionals (such as medical physicists, oncologists, and dosimetrists). This device is for prescription use by order of a physician.
    Device Description
    The Oncospace software supports radiation oncologists and medical dosimetrists during radiotherapy treatment planning for prostate, thoracic, pancreas, and head & neck cases. The software includes machine learning algorithms that are locked during use. During treatment planning, the Oncospace software works in conjunction with, and does not replace, a treatment planning system (TPS). The Oncospace software is intended to augment the treatment planning process by: allowing the radiation oncologist to select and customize a treatment planning protocol that includes dose prescription (number of fractions, dose normalization), a delivery method (beam type and geometry), and protocol-based dosimetric goals/objectives for treatment targets, and organs at risk (OAR); predicting dosimetric goals/objectives for OARs based on patient-specific anatomical geometry; automating the initiation of plan optimization on a TPS by supplying the dose prescription, delivery method, protocol-based target objectives, and predicted OAR objectives; providing a user interface for plan evaluation against protocol-based and predicted goals.
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