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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Oncospace device, based on the provided document:

Acceptance Criteria and Device Performance

The document describes the validation testing as demonstrating "non-inferiority of mean organ-at-risk (OAR) dose sparing" and maintaining "target coverage." While specific numerical acceptance criteria are not explicitly presented in a table format in the provided text, the reported performance is detailed against the implicit goal of non-inferiority.

Table of Acceptance Criteria (Implicit) and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Non-inferiority of mean OAR dose sparing (vs. traditional planning workflow) for prostate cancers. Non-inferiority margin: 10 Gy (originally estimated).	The trial demonstrated non-inferiority of mean OAR dose to 5 Gy for prostate. Oncospace plan mean dose was statistically significantly lower for 2 OARs for prostate (indicating superior sparing). No statistically significant differences in mean dose for the remaining 5 OARs for prostate.
Non-inferiority of mean OAR dose sparing (vs. traditional planning workflow) for head & neck cancers. Non-inferiority margin: 10 Gy (originally estimated).	The trial demonstrated non-inferiority of mean OAR dose to 8 Gy for head & neck. Oncospace plan mean dose was statistically significantly lower for 1 OAR for head & neck (indicating superior sparing). No statistically significant differences in mean dose for the remaining 26 OARs for head & neck.
Maintenance of target coverage (vs. traditional planning workflow).	No statistically significant difference in target coverage between clinical plans and plans created with use of the Oncospace system.
Reduction or maintenance of the number of plan optimizations required to arrive at a clinically acceptable plan.	Out of all the plans tested, no plan required more optimizations using Oncospace versus using traditional radiation treatment planning clinical workflow. The average number of iterations was reduced by 77% using Oncospace.
All system requirements and acceptance criteria for clinical, standard user interface, and cybersecurity.	The verification tests met all system requirements and acceptance criteria. (Specific details of these criteria are not provided for inclusion in the table, but the document states they were met).

Study Details

Sample sizes used for the test set and the data provenance:
- Prostate cancer: 13 retrospective, heterogenous, traditionally planned radiation treatment plans.
- Head & neck cancer: 19 retrospective, heterogenous, traditionally planned radiation treatment plans.
- Data Provenance: Retrospective clinical data from an unspecified country (likely USA, given the FDA submission, but not explicitly stated).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that "traditional radiation treatment plans" served as the reference for comparison, effectively the "ground truth" for OAR sparing and target coverage.
- The "qualified, trained radiation therapy professionals (such as medical physicists, oncologists, and dosimetrists)" are mentioned as the intended users and presumably responsible for creating and validating these traditional plans, thus establishing their clinical acceptability. However, the exact number of experts involved in establishing the ground truth for this specific test set, or their specific qualifications, is not explicitly stated.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe an explicit adjudication method for the test set. The ground truth ("traditional radiation treatment plans") is assumed to be clinically established by the "qualified, trained radiation therapy professionals" who created them. The comparison is between the performance of Oncospace-assisted plans and these established traditional plans, rather than a re-adjudication of the traditional plans themselves.
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:
- This was not a MRMC comparative effectiveness study in the typical sense of evaluating human reader performance with and without AI assistance on diagnostic tasks.
- The study compared the dosimetric outcomes and planning efficiency of plans generated with Oncospace assistance versus traditionally planned cases.
- The "improvement" is in the efficiency of the planning process (77% reduction in iterations) and the non-inferiority (and sometimes superiority) of OAR sparing with Oncospace, when compared to traditional planning methods. It's a system-level comparison rather than a human-reader performance comparison directly.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this was not a standalone algorithm-only study. Oncospace "does not replace, a treatment planning system (TPS)" and is explicitly designed to "augment the treatment planning process." The study compared "plans created with use of the Oncospace system" against "traditional plans," implying human-in-the-loop for both scenarios (one assisted by Oncospace, the other by traditional workflow).
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for the dosimetric comparisons (OAR doses and target coverage) were the retrospective, traditionally planned radiation treatment plans which were clinically established as acceptable. This implicitly represents expert consensus through the standard clinical planning process.
- The ground truth for planning efficiency was the number of optimizations required for the traditional plans, compared to those with Oncospace.
The sample size for the training set:
- Prostate cancer: 1336 treatment plans were used for model development and internal validation (split 80/20).
- Head & neck cancer: 796 treatment plans were used for model development and internal validation (split 80/20).
How the ground truth for the training set was established:
- The document states that the training data consisted of "treatment plans." These would typically be clinically approved and delivered (or deliverable) radiation treatment plans, implying that their dosimetric characteristics (including OAR doses and target coverage) were established as acceptable by qualified medical professionals (radiation oncologists, medical physicists, dosimetrists) during their routine clinical use. The "gold-standard treatment plans" are mentioned in a different context (dose objective comparison), but this concept likely extends to the training data as well.

Summary

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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

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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)

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 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, RadiationTherapy Treatment	System, Planning, RadiationTherapy Treatment	Identical
Intended Use	Oncospace is used toconfigure and reviewradiotherapy treatment plansfor a patient with malignant orbenign disease in the prostate,head, and neck regions. Itallows for set up ofradiotherapy treatmentprotocols, association of apotential treatment plan withthe protocol(s), submission ofa dose prescription andachievable dosimetric goals toa treatment planning system,and review of the treatmentplan. It is intended for use byqualified, trained radiationtherapy professionals (such asmedical physicists,oncologists, and dosimetrists).	Oncospace is used toconfigure and reviewradiotherapy treatment plansfor a patient with malignant orbenign disease in the prostate,thoracic, pancreas, or head &neck regions. It allows for setup of radiotherapy treatmentprotocols, association of apotential treatment plan withthe protocol(s), submission ofa dose prescription andachievable dosimetric goals toa treatment planning system,and review of the treatmentplan. It is intended for use byqualified, trained radiationtherapy professionals (such asmedical physicists,oncologists, and dosimetrists).	Removedthoracic andpancreas sinceplan-matchingmethodologywas removed.Prostate, head,and neck use theML 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"TreatmentPlans	Yes. Factory-default planswith dose goals exist and userscan configure a dose template.	Yes. Factory-default planswith dose goals exist and userscan configure a dose template.	Identical
AutomaticInitial TumorSelection	Yes. Regions of interest arematched as the study is openedin the device. Users can adjustor match to more availableregions of interest.	Yes. Regions of interest arematched as the study is openedin the device. Users can adjustor match to more availableregions of interest.	Identical
Dose ObjectiveComparison	Yes. Comparison can be donebetween more than oneselected treatment plan. Doseis based on calculated doseand curated, gold-standardtreatment plans.	Yes. Comparison can be donebetween more than oneselected treatment plan. Doseis based on calculated doseand curated, gold-standardtreatment plans.	Identical
Image ViewerCapabilities	Yes. Display, pan, zoom,scroll, windowing, viewportlayout.	Yes. Display, pan, zoom,scroll, windowing, viewportlayout.	Identical
Calculate andDisplay IsodoseLines	Yes	Yes	Identical
Calculate andDisplay DoseVolumeHistograms	Yes	Yes	Identical
Compare Dosefrom MultiplePlans	Yes	Yes	Identical
DoseSummation/Treatment-Over-TimeData	Yes	Yes	Identical
Plan Review	Yes. Contains features forreview of isodose lines, reviewof DVHs, dose comparisonand dose summation.	Yes. Contains features forreview of isodose lines, reviewof DVHs, dose comparisonand dose summation.	Identical
Element	Subject	Predicate	Conclusion
Export PlanInformation	Yes. Can export the selectedplan for review and setup by adosimetrist.	Yes. Can export the selectedplan for review and setup by adosimetrist.	Identical
	Oncospace does not export afinal plan, it will not export toa record-and-verify system.	Oncospace does not export afinal plan, it will not export toa 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.

Regulation Number and Section

§ 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.