(90 days)
The RadiaPak™ Brachytherapy Applicator Balloon Device is a single use, non-sterile, disposable, inflatable, non-powered positioning device, manufactured without the use of latex, intended to be used on a daily treatment basis to position and stabilize the brachytherapy radiation delivery applicator within the vagina or rectum during brachytherapy radiation therapy procedures, x-ray, or computed tomography (CT) exam. The placement of the balloon device requires a physician directed healthcare professional.
The RadiaPak™ Device is designed to position and stabilize the brachytherapy applicator and to space the applicator surface from the targeted vaginal or rectal mucosa during computed tomography and brachytherapy procedures. The proposed device is a latex free balloon and can be inflated with either air or saline, is provided non-sterile, and is intended for single use.
The provided text describes a 510(k) submission for the RadiaPak™ Brachytherapy Applicator Balloon Device. This document does not include detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the way typically seen for AI/software-as-a-medical-device (SaMD) clearances.
Instead, this is a traditional medical device submission based on substantial equivalence to predicate devices. For such devices, the "acceptance criteria" are primarily related to general safety and effectiveness characteristics, and the "study" is a comparison to legally marketed predicate devices, along with performance testing and biocompatibility testing.
Here's an attempt to answer your questions based on the provided text, recognizing that it's not a SaMD-style submission with AI performance metrics:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a physical medical device cleared via substantial equivalence), the "acceptance criteria" are implied by the characteristics of the predicate devices and general regulatory requirements for safety and effectiveness. The "reported device performance" demonstrates that the new device meets these implied criteria.
| Acceptance Criteria (Implied by Predicate Devices & Regulatory Standards) | Reported Device Performance (RadiaPak™) |
|---|---|
| Intended Use: Position and stabilize brachytherapy radiation delivery applicator within vagina or rectum during brachytherapy, x-ray, or CT. | Meets this exact intended use. |
| Material Biocompatibility: Non-toxic, non-irritating, non-sensitizing for mucosal membrane contact. | Biocompatibility testing performed in accordance with ISO 10993-1. |
| Mechanical Performance: |
- Inflatable and Deflatable
- Balloon Fill Volume and Pressure
- Flexible
- Expands | - Inflatable: Yes
- Deflatable: Yes
- Performance testing to determine balloon fill volume and fill pressure completed.
- Flexible: Yes
- Expands: Yes |
| Treatment Area: Vaginal or rectal mucosa compatibility. | Vaginal or rectal mucosa compatibility. |
| Body Contact Area: Mucosal Membrane. | Mucosal Membrane. |
| Procedure Time: Approx. ≤ 90 minutes. | Approx. ≤ 90 minutes. |
| Single Use: Designed for single use. | Yes, single use. |
| Inflation Medium: Compatibility with air, saline, or water. | Pressurized with air, saline, water. |
| Connection Type: Functioning connection mechanism. | Stopcock valve. |
| Sterility: Whether supplied sterile or non-sterile is a characteristic, not an acceptance value. | Supplied non-sterile. |
| Latex-free: If aiming for latex-free status. | Manufactured without the use of latex. |
| No new questions of safety or effectiveness. | Differences to predicates do not raise new questions of safety/effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This submission relies on non-clinical testing (biocompatibility and performance) and comparison to predicate devices, not clinical data from a test set of patients in the way an AI/SaMD product would.
- Data Provenance: Not applicable for a clinical test set. The data provenance for biocompatibility and performance testing would be from in vitro or in vivo (animal) lab studies, but the document does not specify the country or whether it was retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There was no clinical test set requiring expert ground truth in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a physical medical device, not an AI/SaMD. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for a clinical ground truth. For the non-clinical performance and biocompatibility testing, the "ground truth" would be established by validated test methods and passing criteria defined by relevant industry standards (e.g., ISO 10993 for biocompatibility) and engineering specifications.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI model.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.