(203 days)
The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.
The OLINDA/EXM® v2.0 is a modification of OLINDA/EXM® v1.1 (K033960) and includes new human models and nuclides. OLINDA/EXM® 2.0 employs a new set of decay data recommended by the International Commission on Radiological Protection (ICRP). OLINDA/EXM® 2.0 introduces a new series of anthropomorphic human body models (phantoms), so new values of Specific Absorbed Fractions (SAF), di (T←S) were generated. These phantoms were based on updated values of the mass of the target region (mr) recommended by the ICRP. The base product design of OLINDA/EXM® V2.0 is the same as for the OLINDA/EXM® V1.1 (K033960).
The provided document is a 510(k) summary for a medical device called OLINDA/EXM v2.0. This document primarily focuses on demonstrating substantial equivalence to a predicate device (OLINDA/EXM v1.1) rather than presenting a detailed clinical study with acceptance criteria and device performance in the way one might expect for a diagnostic or therapeutic AI device.
However, based on the information provided, here's a breakdown of what can be extracted and what is not explicitly stated in the document regarding acceptance criteria and a study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or effect sizes, as would be common for diagnostic algorithms. Instead, the "acceptance criteria" appear to be related to the verification and validation of the software itself and its consistency with the previous version. The performance is described in terms of "good compliance" with the predicate device.
| Acceptance Criteria (Inferred from "Testing" description) | Reported Device Performance |
|---|---|
| All software specifications met | The testing results supports that all the software specifications have met the acceptance criteria. |
| Risk analysis completed and risk control implemented to mitigate identified hazards | (Implicitly met as per submission) |
| "Good compliance" in comparison to OLINDA/EXM v1.1 (K033960) | Comparisons were made between OLINDA/EXM® v2.0 and OLINDA/EXM® v1.1 (K033960). The results showed a good compliance. |
| Same technological characteristics as OLINDA EXM® v1.1 | The proposed device OLINDA/EXM® v2.0 has the same technological characteristics as the original device OLINDA EXM® v1.1. |
| Same indication for use as OLINDA EXM® v1.1 | The proposed device OLINDA/EXM® v2.0 and the predicate devices OLINDA/EXM® v1.1 (K033960) have the same indication for use. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly provided in the document. The "tests for verification and validation" are mentioned, but the specific details of a "test set" (e.g., number of cases, type of data) are not described. Given that the device calculates radiation dose based on input data regarding biodistribution and relies on established models (ICRP decay data, anthropomorphic phantoms), the testing likely involved comparing output values for a range of inputs rather than a clinical dataset of patient images.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided. Since the device calculates deterministic radiation doses based on models, the "ground truth" would likely be derived from established physical and biological models, rather than expert interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not explicitly provided. Adjudication methods like 2+1 or 3+1 are typically used when human experts are disagreeing on interpretations for a ground truth. This is not applicable to a dose calculation software validating against established models and data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This information is not explicitly provided, and it is unlikely such a study was performed or needed given the nature of the device. MRMC studies are typically for diagnostic AI systems where human readers interpret medical images. This device is a software tool for calculating radiation dose.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document implies that the "testing" described for verification and validation was a standalone evaluation of the algorithm's performance against its specifications and the predicate device. The comparison showing "good compliance" between OLINDA/EXM v2.0 and OLINDA/EXM v1.1 suggests an algorithm-only evaluation. However, the exact methodology is not detailed.
7. The Type of Ground Truth Used
The "ground truth" for this device likely refers to:
- Established physical and biological models: The document mentions "new human models and nuclides," "new set of decay data recommended by the International Commission on Radiological Protection (ICRP)," and "updated values of the mass of the target region (mr) recommended by the ICRP." These are the underlying scientific references against which the calculations would be validated.
- Outputs of the predicate device (OLINDA/EXM v1.1): The comparison showing "good compliance" with the predicate device implies that the predicate's outputs served as a reference for validating the new version.
8. The Sample Size for the Training Set
This information is not applicable/provided. OLINDA/EXM v2.0 is a deterministic calculation software based on established physical and biological models, not a machine learning or AI model that requires a "training set" in the conventional sense. It's a software tool that implements mathematical models and data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the same reasons as #8. The "ground truth" here is derived from scientific consensus and established data (e.g., ICRP recommendations) that are used as inputs or validation references for the software's calculations, not a "training set" for a learning algorithm.
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).