(66 days)
The intended use of the modified Gammacell with version 1.0 control system remains unchanged. Both the improved and the predicate device effectively irradiate blood components to inactivate leukocytes and lymphocytes.
The modified Gammacell E- series Blood Irradiator models, the 1000 Elite and the 3000 Elan use the new software version 1.0 control system. With the exception of the modified control system, the 1000 Elite and 3000 Elan are identical to previously cleared models.
The basic operation of an irradiator involves placing of the blood product into the beaker, loading the beaker into the Gammacell, closing the safety door and pressing the "start" button. Upon start of the cycle, the unit moves the beaker to irradiate position and rotates the blood product continuously at a uniform speed to provide a consistent dose of irradiation. Concurrently, the timer begins to count down (irradiation time is pre-programmed by the site supervisor) from the set time and when the time reaches zero, the sample returns to unload position and the audible alarm sounds. If the cycle is completed as pre-programmed the message "cycle completed OK." is displayed. Any problems in the irradiation cycle will be displayed specifically and clearly.
This document describes a 510(k) summary for a modified Gammacell E-series Blood Irradiator, specifically the 1000 Elite and 3000 Elan models with a new software version 1.0 control system. The primary goal of the submission is to demonstrate substantial equivalence to previously cleared versions (Version 2.09).
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific quantitative thresholds. Instead, it describes general functional requirements and claims of equivalence to the predicate device.
| Acceptance Criteria (Stated Concept) | Reported Device Performance |
|---|---|
| Functional Requirements | |
| Security Functions | Met functional requirements |
| Safety Functions | Met functional requirements |
| Operational Features | Met functional requirements |
| Timing Functions | Met functional requirements |
| Counting Functions | Met functional requirements |
| Ancillary Equipment: Independent Backup Timer | Met functional requirements |
| Ancillary Equipment: Beaker Rotation Sensing System | Met functional requirements |
| Operator Interface | Met functional requirements; simplified and user-friendly with clear messages |
| Technological Equivalence | |
| Basic Function (blood irradiation) | Unchanged from predicate Gammacell 1000E and 3000E |
| Electrical Safety | Complies with Canadian Standards Association (CSA) standards; CSA certified |
| Electromagnetic Compatibility (EMC) | Tested and demonstrated compliance; withstands electromagnetic interference |
| Safety (overall) | Equivalent or better than the predicate device; irradiation source and radioactivity unchanged |
| Efficacy (overall) | As safe and effective as the predicate device |
| Intended Use | Unchanged |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for the test set. It mentions "Validation testing results" but does not detail the number of units or test cases involved.
- Data Provenance: The testing appears to be internal validation by the manufacturer, Nordion International Inc., based in Canada. The document states, "The performance of the device was tested against a set of functional specifications in an environment which simulated, as much as possible, the actual operating environment." This suggests controlled, internal testing rather than external clinical data. It is retrospective in the sense that it's based on internal validation performed by the developer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The validation testing seems to be based on engineering and functional testing against predetermined specifications, rather than a clinical assessment requiring expert consensus on ground truth. The "predetermined specifications" may have been established by internal experts, but their number and qualifications are not disclosed.
4. Adjudication Method for the Test Set
This information is not provided and is likely not applicable given the nature of the validation described. The validation appears to be against functional requirements and engineering specifications rather than a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through functional and safety testing, not a comparative clinical study involving human readers or clinicians.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
The device described is a blood irradiator, not a diagnostic algorithm. Therefore, the concept of an "algorithm only, standalone performance" study as typically applied to AI/ML diagnostic devices is not applicable. The "algorithm" here is the software control system of a physical medical device. The validation described is of this control system's functional performance.
7. The Type of Ground Truth Used
The "ground truth" for this device's validation is the functional specifications and engineering requirements for the blood irradiator's control system. This includes aspects like security functions, safety functions, operational features, timing, counting, and interface behavior, as well as compliance with electrical safety and EMC standards. It is not based on clinical outcomes, pathology, or expert consensus on diagnostic interpretations.
8. The Sample Size for the Training Set
The concept of a "training set" as understood in machine learning is not explicitly applicable here. The software control system was likely developed and verified using standard software engineering practices. No "training set" of data for an AI/ML model is mentioned or implied.
9. How the Ground Truth for the Training Set Was Established
As the concept of a training set for an AI/ML model is not applicable here, the method for establishing its ground truth is not relevant or described. The "ground truth" for engineering and functional validation is the set of design specifications and regulatory standards.
N/A