(63 days)
The SIR-Spheres® Microspheres Activity Calculator (SMAC) is intended as a tool to assist with developing personalized dose activity calculations , based on relevant data, for patients undergoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres . Using the BSA formula, the SMAC automatically performs calculations that are typically done manually by a physicist and/ or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature.
The SIR-Spheres Microspheres Activity Calculator (SMAC) is a software modelling program that is designed to assist physicians and licensed healthcare practitioners when prescribing Selective Internal Radiation Therapy (SIRT) with SIR-Spheres Y-90 resin microspheres. It allows physicians and licensed healthcare practitioners to determine an individualized dose activity calculation based upon specific patient characteristics. The program computes the prescribed activity calculation using the Body Surface Area (BSA) formula that has been published in peer reviewed journals of medicine and models treatment parameters. This is a tool only and does not replace the need for the physician or licensed healthcare practitioner to make an independent determination of the therapy best suited for the patient. The SIR-Spheres Microspheres Activity Calculator (SMAC) tool employs a simple algorithm to calculate Y90 dose activity based on the Body Surface Area (BSA) model and patient specific user inputs. The SMAC tool does not incorporate imaging capabilities.
The provided document describes the SIR-Spheres Microspheres Activity Calculator (SMAC) and its performance evaluation.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the SMAC uses the same Body Surface Area (BSA) formula for calculating Y90 dose activity as the predicate device, HERMES Hybrid3D v3.0 SIRT (K181468). The primary performance claim is the accurate calculation of this dose.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of Y90 Dose Activity Calculation (BSA Formula) | "The SMAC tool employs a simple algorithm to calculate Y90 dose activity based on the Body Surface Area (BSA) model and patient specific user inputs." |
"Algorithm performs Y90 dose calculations based upon the Body Surface Area (BSA) model using patient specific characteristics."
"Identical: The proposed and predicate devices utilize the BSA Method to perform dose calculations."
"The proposed SMAC software is equivalent when compared to the marketed predicate in comparison to software design, function, and operation as the identified predicate." |
| Functional Equivalence to Predicate Device | "Both software programs calculate dose based on the exact same SIRTEX BSA formula as seen in the instructions for use."
"The proposed SMAC software is equivalent when compared to the marketed predicate in comparison to software design, function, and operation as the identified predicate." |
| Software Design, Function, and Operation | "The proposed SMAC software is equivalent when compared to the marketed predicate in comparison to software design, function, and operation as the identified predicate." |
| Safety and Effectiveness | "Results of this testing demonstrate safety and effectiveness of the proposed device and substantial equivalence." (Though specific metrics beyond the calculation accuracy are not detailed in the provided text.) |
| Conformity to FDA Guidance and Standards | "The performance evaluation of the proposed SMAC Calculator included testing conducted in accordance to the following FDA Guidance Documents, domestic and international standards." (Specific guidance documents and standards are not listed in the provided text, but the general conformity is stated.) |
| Browser Compatibility | "The SMAC system is designed to be supported by the last two versions of the web browsers: Chrome, Firefox, Safari, Opera, Mobile Safari, and Internet Explorer (IE) mobile as well as Internet Explorer 9+ and android browser 2.3." (This is a compatibility criterion rather than a performance criterion for calculation accuracy.) |
2. Sample Size for the Test Set and Data Provenance
The provided document does not specify a sample size for any test set or the provenance of the data used for performance evaluation. It only states that "testing" was conducted.
3. Number of Experts and Qualifications for Ground Truth
The provided document does not mention the number of experts used or their qualifications for establishing ground truth for any test set.
4. Adjudication Method for the Test Set
The provided document does not mention any adjudication method (e.g., 2+1, 3+1) for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss any effect size regarding human reader improvement with AI assistance. The SMAC is presented as a tool to automate calculations typically done manually, implying a replacement or augmentation of manual calculation, rather than assisting in image interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, the information suggests that a standalone performance was done for the algorithm's accuracy. The SMAC is described as a "software modelling program" that "automatically performs calculations" using a "simple algorithm." The comparison with the predicate device focuses on the identical algorithms for Y90 dose calculations. The device "does not incorporate imaging capabilities." This implies that the core function of the SMAC is purely algorithmic computation without human intervention in the calculation process itself.
7. Type of Ground Truth Used
The ground truth for the device's performance appears to be primarily based on the established and documented BSA formula used in scientific literature and the equivalence to the predicate device's calculations. The document states:
- "The algorithms used have been established and documented in scientific literature."
- "Both software programs calculate dose based on the exact same SIRTEX BSA formula as seen in the instructions for use."
- "The proposed and predicate devices utilize the BSA Method to perform dose calculations."
This suggests that the "ground truth" for the calculations is the accepted mathematical formula itself, and the device is evaluated on its ability to accurately implement that formula.
8. Sample Size for the Training Set
The provided document does not specify a sample size for a training set. As the device performs calculations based on a known formula rather than a machine learning model trained on data to predict outcomes, a traditional "training set" in the machine learning sense is not applicable.
9. How the Ground Truth for the Training Set Was Established
Since a traditional training set with associated ground truth (e.g., expert labels, pathology) is not applicable for this type of calculation software, this question is not directly addressed. The "ground truth" for the algorithm itself is the inherent mathematical correctness of the BSA formula, which is "established and documented in scientific literature." The validation would then be to confirm the software implements this formula correctly.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.