(139 days)
Not Found
Yes
The device description explicitly states that the software includes "locked machine learning algorithms" and mentions the development and addition of a "machine-learning algorithm" for head and neck models.
No.
The device is a software tool used for configuring and reviewing radiotherapy treatment plans, not directly delivering therapy.
No
The device is described as software that assists in radiotherapy treatment planning by configuring and reviewing treatment protocols, submitting dose prescriptions, and reviewing treatment plans. The "Intended Use / Indications for Use" explicitly states that it is for "prescription use by order of a physician," and the "Device Description" clarifies that "Diagnosis and treatment decisions occur prior to treatment planning and do not involve Oncospace." It is intended to augment the treatment planning process, not to diagnose a condition.
Yes
The device description explicitly states "The Oncospace software supports radiation oncologists and medical dosimetrists during radiotherapy treatment planning." and describes its function solely as software interacting with a Treatment Planning System (TPS). There is no mention of accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Oncospace is used for configuring and reviewing radiotherapy treatment. It focuses on treatment planning, setting dosimetric goals, and evaluating treatment plans. It explicitly states that "Diagnosis and treatment decisions occur prior to treatment planning and do not involve Oncospace."
- Device Description: The description reinforces that Oncospace supports radiation oncologists and medical dosimetrists during radiotherapy treatment planning. It augments the planning process by assisting with setting goals and evaluating plans, but it does not perform diagnostic tests or analyze biological samples.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of Oncospace does not mention any interaction with biological samples or diagnostic testing.
In summary, Oncospace is a software tool designed to assist in the planning and optimization of radiation therapy treatment, not for diagnosing a disease or condition using in vitro methods.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
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 intensitymodulated photon beam radiotherapy. The planning objectives themselves are intended to be TPSindependent: 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Yes, the software includes locked machine learning algorithms.
Input Imaging Modality
Not Found. The device processes DICOM-RT files that contain patient-specific anatomical geometry without specifying an imaging modality.
Anatomical Site
prostate, head, and neck regions
Indicated Patient Age Range
Not Found. "There are no demographic, regional, or cultural limitations for patients. It is up to the user to determine if the system can be used for a patient."
Intended User / Care Setting
Qualified, trained radiation therapy professionals (such as medical physicists, oncologists, and dosimetrists). This device is for prescription use by order of a physician.
The system can be used in a hospital environment or in a doctor's office.
Description of the training set, sample size, data source, and annotation protocol
Description of the training set: Retrospective clinical data of traditionally planned radiation treatment plans.
Sample size:
Prostate: 1336 treatment plans
Head and Neck: 796 treatment plans
Data source: Not explicitly stated, but it is implied that these are existing clinical treatment plans.
Annotation protocol: Not explicitly stated.
Description of the test set, sample size, data source, and annotation protocol
Description of the test set: Retrospective clinical data of traditionally planned radiation treatment plans.
Sample size:
Prostate: 13 plans
Head and Neck: 19 plans
Data source: Not explicitly stated, but it is implied that these are existing clinical treatment plans.
Annotation protocol: Not explicitly stated.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: Validation testing using retrospective clinical data. A validation trial designed to demonstrate non-inferiority of mean organ-at-risk (OAR) dose sparing.
Sample size: Prostate (n=13), head & neck (n=19).
AUC: Not found.
MRMC: Not found.
Standalone performance: Not a standalone diagnostic device. The device aims to reduce the number of iterations necessary to achieve a clinically viable and deliverable radiation treatment plan.
Key results:
- For prostate, the Oncospace plan mean dose was statistically significantly lower for 2 OARs, and no statistically significant differences for the remaining 5 OARs. The trial demonstrated non-inferiority of mean OAR dose to 5 Gy.
- For head & neck, the Oncospace plan mean dose was statistically significantly lower for 1 OAR, and no statistically significant differences for the remaining 26 OARs. The trial demonstrated non-inferiority of mean OAR dose to 8 Gy.
- No statistically significant difference in target coverage between clinical plans and plans created with use of the Oncospace system.
- The average number of iterations was reduced by 77% using Oncospace, and no plan required more optimizations using Oncospace versus traditional radiation treatment planning workflow.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not directly applicable or provided in these terms. The key metrics focused on mean OAR dose sparing, target coverage, and number of plan optimizations.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Oncospace, K202284
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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February 2, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Oncospace, Inc. % Sigrid Schoepel Regulatory Affairs 1812 Ashland Ave., Suite 100k BALTIMORE MD 21205
Re: K222803
Trade/Device Name: Oncospace Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: January 4, 2023 Received: January 5, 2023
Dear Sigrid Schoepel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Lora D. Weidner. The signature was signed on February 2nd, 2023 at 10:53:29 -05'00'.
Lora Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222803
Device Name Oncospace
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/2 description: The image shows the logo for OncoSpace. The logo consists of a stylized letter "C" made up of two curved segments, one teal and one yellow. To the right of the "C" is the word "ONCOSPACE" in a light gray, sans-serif font. The overall design is clean and modern.
510(k) Summary
SUBMITTER I.
Oncospace, Inc. 1812 Ashland Ave., Suite 100K Baltimore, MD 21205 USA
Phone: 608-335-3176 Email: Sigrid.Schoepel@oncospace.com
Contact Person: Sigrid Schoepel Date Prepared: 2023 February 1
II. DEVICE
Name of Device: Oncospace Common or Usual Name: System, Planning, Radiation Therapy Treatment Classification Name: Medical charged-particle radiation therapy system (21 CFR 892.5050) Regulatory Class: II Product Code: MUJ
III. PREDICATE DEVICE
Oncospace, K202284
This predicate device has not been the subject of a recall.
IV. 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);
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Image /page/4/Picture/2 description: The image contains a logo for OncoSpace. The logo features a stylized letter "C" made up of two different colored arcs, teal and yellow. To the right of the "C" is the word "ONCOSPACE" in a light gray color. The logo is set against a light gray background.
- 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 intensitymodulated photon beam radiotherapy. The planning objectives themselves are intended to be TPSindependent: 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).
INDICATIONS FOR USE V.
Oncospace is used to configure and review radiotherapy treatment plans for a patient 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.
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Image /page/5/Picture/2 description: The image shows the logo for OncoSpace. The logo consists of a stylized letter "C" made up of two different colors, teal and yellow. To the right of the "C" is the word "ONCOSPACE" in a sans-serif font.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Oncospace subject device is a software-only medical device that performs the same functions in the Oncospace predicate device. The following differences exist between the subject and predicate devices:
- . The machine-learning algorithm has been generalized to allow training, modeling, and testing of dosimetric predictions for treatment target/organ-at-risk geometries and a head and neck model has been developed and added to the subject device.
- The plan-matching method (a non-ML based method for dosimetric predictions) that was in place in the predicate device for head & neck, thoracic, and pancreas geometries has been removed.
Note: The predicate device and subject device algorithms, and any future algorithm updates, are locked prior to clinical use.
| Element | Subject | Predicate | Conclusion |
|---|---|---|---|
| Device Name | Oncospace | Oncospace | Identical |
| 510(k) Owner | Oncospace, Inc. | Oncospace, Inc. | Identical |
| 510(k) Number | K222803 | K202284 | |
| Product Code | MUJ | MUJ | Identical |
| Product Name | System, Planning, Radiation | ||
| Therapy Treatment | System, Planning, Radiation | ||
| Therapy Treatment | Identical | ||
| Intended Use | Oncospace is used to | ||
| configure and review | |||
| radiotherapy treatment plans | |||
| for a patient 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). | Oncospace is used to | ||
| configure and review | |||
| radiotherapy treatment plans | |||
| for a patient 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). | Removed | ||
| thoracic and | |||
| pancreas since | |||
| plan-matching | |||
| methodology | |||
| was removed. | |||
| Prostate, head, | |||
| and neck use the | |||
| ML models. | |||
| Element | Subject | Predicate | Conclusion |
| This device is for prescription use by order of a physician. | This device is for prescription use by order of a physician. | ||
| Operating System | Windows/Web-browser | Windows/Web-browser | Identical |
| Platform | Client-Server (Clinic-provided client machines, cloud Windows servers controlled by Oncospace) | Client-Server (Clinic-provided client machines, cloud Windows servers controlled by Oncospace) | Identical |
| DICOM-RT Compliant | Yes | Yes | Identical |
| Full Treatment Planning System | No | No | Identical |
| Connected to or Controlling of Radiation Delivery Devices | No | No | Identical |
| Typical Users | Medical professionals, including but not limited to, radiation oncologists, medical physicists or physicians. | Medical professionals, including but not limited to, radiation oncologists, medical physicists or physicians. | Identical |
| Patient Population | There are no demographic, regional, or cultural limitations for patients. It is up to the user to determine if the system can be used for a patient. | There are no demographic, regional, or cultural limitations for patients. It is up to the user to determine if the system can be used for a patient. | Identical |
| Environment | The system can be used in a hospital environment or in a doctor's office. | The system can be used in a hospital environment or in a doctor's office. | Identical |
| JPEG image support | Yes | Yes | Identical |
| Import Treatment Plans | Yes. Import existing plans from third-party systems to compare dose objectives against templates. | Yes. Import existing plans from third-party systems to compare dose objectives against templates. | Identical |
| Element | Subject | Predicate | Conclusion |
| "Template" | |||
| Treatment | |||
| Plans | Yes. Factory-default plans | ||
| with dose goals exist and users | |||
| can configure a dose template. | Yes. Factory-default plans | ||
| with dose goals exist and users | |||
| can configure a dose template. | Identical | ||
| Automatic | |||
| Initial Tumor | |||
| Selection | Yes. Regions of interest are | ||
| matched as the study is opened | |||
| in the device. Users can adjust | |||
| or match to more available | |||
| regions of interest. | Yes. Regions of interest are | ||
| matched as the study is opened | |||
| in the device. Users can adjust | |||
| or match to more available | |||
| regions of interest. | Identical | ||
| Dose Objective | |||
| Comparison | Yes. Comparison can be done | ||
| between more than one | |||
| selected treatment plan. Dose | |||
| is based on calculated dose | |||
| and curated, gold-standard | |||
| treatment plans. | Yes. Comparison can be done | ||
| between more than one | |||
| selected treatment plan. Dose | |||
| is based on calculated dose | |||
| and curated, gold-standard | |||
| treatment plans. | Identical | ||
| Image Viewer | |||
| Capabilities | Yes. Display, pan, zoom, | ||
| scroll, windowing, viewport | |||
| layout. | Yes. Display, pan, zoom, | ||
| scroll, windowing, viewport | |||
| layout. | Identical | ||
| Calculate and | |||
| Display Isodose | |||
| Lines | Yes | Yes | Identical |
| Calculate and | |||
| Display Dose | |||
| Volume | |||
| Histograms | Yes | Yes | Identical |
| Compare Dose | |||
| from Multiple | |||
| Plans | Yes | Yes | Identical |
| Dose | |||
| Summation/ | |||
| Treatment- | |||
| Over-Time | |||
| Data | Yes | Yes | Identical |
| Plan Review | Yes. Contains features for | ||
| review of isodose lines, review | |||
| of DVHs, dose comparison | |||
| and dose summation. | Yes. Contains features for | ||
| review of isodose lines, review | |||
| of DVHs, dose comparison | |||
| and dose summation. | Identical | ||
| Element | Subject | Predicate | Conclusion |
| Export Plan | |||
| Information | Yes. Can export the selected | ||
| plan for review and setup by a | |||
| dosimetrist. | Yes. Can export the selected | ||
| plan for review and setup by a | |||
| dosimetrist. | Identical | ||
| Oncospace does not export a | |||
| final plan, it will not export to | |||
| a record-and-verify system. | Oncospace does not export a | ||
| final plan, it will not export to | |||
| a record-and-verify system. |
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Image /page/6/Picture/2 description: The image shows the logo for OncoSpace. The logo consists of a circular graphic with a segment in teal and another in yellow, followed by the word "ONCOSPACE" in white, set against a gray background. The overall design is clean and modern.
oncospace.com
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Image /page/7/Picture/2 description: The image contains the logo for ONCOSPACE. The logo features a stylized letter "C" made up of two different colors, teal and yellow. The text "ONCOSPACE" is written in a sans-serif font to the right of the "C" symbol.
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Image /page/8/Picture/2 description: The image shows the logo for OncoSpace. The logo consists of a stylized letter "C" made up of two different colored arcs, teal and yellow. To the right of the "C" is the word "ONCOSPACE" in white, sans-serif font.
VII. PERFORMANCE DATA
The following verification and validation testing results (performance data) are provided in support of the substantial equivalence determination. Since this is a software-only medical device that does not control other devices the performance data do not include biocompatibility, electrical safety, electromagnetic compatibility, mechanical, acoustic, or animal testing.
The verifications tests met all system requirements and acceptance criteria which address clinical, standard user interface, and cybersecurity requirements for the Oncospace device.
The validation testing was performed using retrospective clinical data. The Oncospace device's purpose is to reduce the number of iterations necessary to achieve a clinically viable and deliverable radiation treatment plan. A validation trial was designed to demonstrate non-inferiority of mean organ-at-risk (OAR) dose sparing, an indicator of plan quality. This comparison of OAR sparing is only valid if target coverage is maintained, so this comparison was also made. Alongside these dosimetric comparisons, comparison of number of plan optimizations required to arrive at a clinically acceptable plan was carried out as a measure of any gain in planning efficiency. Sample sizes were determined by estimating variance in mean OAR dose so that the trial would have 80% power at a significance level of 0.05 and a non-inferiority margin of 10 Gy.
A heterogenous retrospective set of traditionally planned radiation treatment plans for prostate (n=13, 10 different prescriptions) and head & neck (n=19, 12 different prescriptions) cancers was used for validation. Mean doses were compared for 7 OARs for prostate and 27 OARs for head & neck.
- Prostate OARs for clinical performance testing: bladder, left and right femur, rectum, sigmoid colon, penile bulb, and bowel bag. For the prostate performance 1336 treatment plans were used for model development and internal validation (split 80/20), 13 plans were used for clinical performance testing.
- Head and Neck OARs for clinical performance testing: brain, brainstem, spinal cord, left and right cranial nerve VIII (acoustic nerve) , left and right parotid glands , left and right eyes, left and right lens , left and right optic nerve, optic chiasm, oral cavity, soft palate, glottis, cricopharyngeus, esophagus, sublingual gland, mandible bone, left and right submandibular glands, left and right cochlea, thyroid gland, and pharyngeal constrictor muscle(s). For the head
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Image /page/9/Figure/2 description: The image shows the logo for OncoSpace. The logo consists of a circular graphic on the left, made up of two curved segments in teal and yellow. To the right of the graphic is the word "ONCOSPACE" in a sans-serif font. The letters are white with a slight drop shadow, giving them a three-dimensional appearance.
and neck performance 796 treatment plans were used for model development and internal validation (split 80/20). 19 plans were used for clinical performance testing.
The Oncospace plan mean dose was statistically significantly lower for 2 OARs for prostate and 1 OAR for head & neck, and there were no statistically significant differences in mean dose for any of the remaining 5 OARs for prostate and 26 OARs for head & neck. The trial demonstrated non-inferiority of mean OAR dose to 5 Gy for prostate and 8 Gy for head & neck. There was no statistically significant difference in target coverage between clinical plans and plans created with use of the Oncospace system. Out of all the plans tested, no plan required more optimizations using Oncospace versus using traditional radiation treatment planning clinical workflow, and the average number of iterations was reduced by 77% using Oncospace.
Conclusion
Verification and validation (including performance testing) was conducted in accordance with FDA guidance recommendations to confirm the device design met all specifications, user needs, and was acceptable to qualified clinical users. Oncospace has passed all the tests and the provided testing results demonstrate safety and effectiveness as compared to the predicate device. It is therefore concluded that Oncospace is substantially equivalent to the predicate device.
VIII. CONCLUSIONS
The subject Oncospace device is similar in intended use and functionality to the predicate Oncospace device. Oncospace has the same technological characteristics and features as the previously cleared device and does not raise new questions of safety or efficacy compared to the predicate device as demonstrated through the system design and testing.
Non-clinical and clinical verification, validation, and performance testing was conducted to confirm the device design met user needs and specifications and was acceptable to qualified clinical and non-clinical users. Oncospace has passed the verification and validation tests and provided clinical performance testing results with a library clinical dataset in order to demonstrate safety or effectiveness as compared to the predicate device. It is therefore concluded that the subject Oncospace device is substantially equivalent to the predicate Oncospace device.