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510(k) Data Aggregation
(177 days)
General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Cushions, Cushions, and Accessories. The following are other positioning devices:
Head. Neck. and Shoulders Device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions.
Support Garments: The device is indicated to aid in supporting adolescents undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
Breast Positioning Devices: The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
The CIVCO Positioning and Immobilization devices have been used for many years and were previously cleared under other 510(k) is to have these identical Class II products cleared for use in Proton Therapy environment.
The Head, Neck, and Shoulder Devices are used to treat cancer of the head, neck, brain and spine. Organs that are located in these anatomical regions are applicable.
The General Positioning Devices are used to treat cancer of the spine, thorax, breast, abdomen, pelvis and prostate. Organs that are located in these anatomical regions are applicable.
The Support Garments are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.
The Breast Positioning Devices are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.
The devices are intended for therapeutic treatment (including proton, photon, and electron beam therapy) and diagnostics (including CT and MR as indicated). The devices will be used in a variety of types of external beam radiation therapy including Intensity Modulated Proton Therapy (IMPT), Intensity Modulated Radiation Therapy (IMRT), Pencil Beam Proton Therapy (PBPT), Image Guided Radiation Therapy (IGRT), Volumetric Modulated Arc Therapy (VMAT), Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Stereotactic Body Radiation Therapy (SBRT), and Craniospinal Treatment.
The intended users of the devices are radiation oncology therapists, medical physicists, and oncologists. The provider selects the appropriate equipment based on a patient's individual clinical goals and unique constraints.
Thermoplastic mask, AccuForm Cushion, and Support Garment devices are single patient use. All devices are non-powered and static.
The subject devices are reusable or disposable as provided in product labeling, provided non-sterile, and are used in a healthcare facility/hospital. The devices are labeled for MR safety, as applicable.
This document is a 510(k) Pre-market Notification for medical devices, specifically Proton Positioning and Immobilization Devices. It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, primarily for the modified intended use/indications for use to include proton treatment and pediatric/adolescent use.
The document does not describe a study involving an algorithm or artificial intelligence (AI) with acceptance criteria in the traditional sense of a computer-aided diagnosis (CAD) or AI-driven diagnostic device. Instead, it describes non-clinical performance testing for physical medical devices. Therefore, many of the requested details about acceptance criteria, ground truth establishment, expert consensus, and multi-reader multi-case (MRMC) studies are not applicable to this type of device submission.
Here's an interpretation of the relevant information provided, framed as closely as possible to your request for acceptance criteria and study proof for a medical device:
Device Type: Physical Medical Devices (Positioning and Immobilization for Radiation Therapy)
Purpose of Submission: To expand the Indications for Use of existing, previously cleared devices to include proton treatment and pediatric/adolescent use.
1. Table of "Acceptance Criteria" (Performance Goals) and Reported Device Performance
Given that this is a 510(k) for physical positioning devices, the "acceptance criteria" are not quantitative performance metrics like sensitivity/specificity for an AI algorithm. Instead, they are functional performance goals related to the physical interaction with the proton beam and patient. The "reported device performance" is the confirmation that these functional goals are met.
| Acceptance Criteria (Performance Goal) | Reported Device Performance (Conclusion from Testing) |
|---|---|
| Primary Goal: Device will not perturb or impact the proton beam in a way that cannot be accounted for in the facility's proton treatment planning process. | Devices evaluated, including edge effects, were considered safe and effective for use with proton. The performance tests confirmed that these devices would not perturb or impact the proton beam in a way that cannot be accounted for in the proton treatment planning process. (No recognized threshold for proton attenuation; criteria based on non-perturbation given facility's planning capabilities). |
| Maintain safety and effectiveness with expanded use (proton treatment, pediatric/adolescent use). | The risk analysis confirmed the safety and effectiveness of similar devices used for pediatrics/adolescents and Proton Therapy, ensuring no new issues are raised. CIVCO devices were found to be safe and effective for use with adults, pediatrics, and/or adolescents in the Proton Therapy environment. |
| No additional biocompatibility issues with expanded use. | All devices are previously cleared and manufactured with the same or substantially equivalent material that was previously cleared, thus no additional biocompatibility testing is required. |
| Devices used in MRI environment maintain their MR safety. | Devices labeled for use in an MRI environment were previously cleared by predicate 510(k)s included in this submission. Therefore, no additional MR testing is required. |
| Mechanical function without software/electronics. | Confirmed: The devices are mechanical without the use of software or electronics. |
| Limited contact duration (<24 hours) for surface devices (skin). | Confirmed: The devices are intended for limited contact duration (<24 hours) for surface devices (skin). |
| Devices are non-sterile. | Confirmed: Devices are non-sterile. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a quantitative "sample size" in terms of number of devices tested or number of patient images/cases. The testing appears to be conducted on representative devices from the product families concerned. It mentions "devices were selected for performance testing" and "devices were evaluated." For physical devices like these, performance testing often involves a small number of physical units to verify properties.
- Data Provenance: Not applicable in the sense of patient data. The "study" is a non-clinical, in-house performance evaluation and literature review. This is not retrospective or prospective patient data, but rather engineering-level testing of the device's interaction with a proton beam.
- Country of Origin: The non-clinical testing was performed by CIVCO (MEDTEC, Inc.), which is located in the USA (Orange City, Iowa).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not directly applicable. The "ground truth" for these physical devices is established by physical measurements and engineering principles related to proton beam physics and material interactions, rather than expert interpretation of medical images.
The document states: "Because there is no recognized threshold for Proton attenuation, the criteria used for determining acceptable performance was to verify the part will not perturb or impact the proton beam in a way that cannot be accounted for in the facility's proton treatment planning process." This implies reliance on established physics and a facility's ability to plan around the device, rather than a clinical "truth" adjudicated by experts.
The intended users of the devices are mentioned as "radiation oncology therapists, medical physicists, and oncologists," implying their expertise is relevant for the clinical application but not for establishing the fundamental physical properties of the device materials.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert disagreement or clinical findings. Performance is assessed against physical properties and effects on proton beams.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The devices in this submission are physical positioning and immobilization tools, not diagnostic AI software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a conceptual sense, the "standalone" performance of the physical devices was assessed. The non-clinical testing evaluated the physical interaction of the devices with the proton beam independent of a "human-in-the-loop" clinical application, to ensure they meet the criteria of "not perturbing or impacting the proton beam in a way that cannot be accounted for in the facility's proton treatment planning process."
7. The Type of Ground Truth Used
The ground truth used is primarily physics-based experimental data related to proton beam attenuation and material properties, and engineering validation that the devices maintain their mechanical function and safety characteristics when exposed to a proton environment or used by various patient populations (pediatric/adolescent). The lack of a "recognized threshold for Proton attenuation" indicates that the "ground truth" for acceptable performance is framed by a facility's ability to integrate the device's known characteristics into their treatment planning.
8. The Sample Size for the Training Set
Not applicable. These are physical medical devices, not an AI algorithm, so there is no concept of a "training set" for model development.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI algorithm.
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