(62 days)
Both the GammaMedplus iX and GammaMedplus 3/24 iX are indicated, in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote controlled high dose rate brachytherapy for conditions anywhere in the body when brachytherapy treatment is indicated.
The GammaMedplus iX Series High Dose Rate Afterloader system is a computer controlled remote electro/mechanical system used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 24 channels.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GammaMedplus iX Series HDR Brachytherapy Afterloader:
Based on the provided S10(k) summary, the device is an HDR Brachytherapy Afterloader, which is a medical device used to deliver radiation therapy. The submission is for a medical device that delivers treatment, not one that diagnoses or predicts. Therefore, the typical "acceptance criteria" related to diagnostic performance metrics like sensitivity, specificity, or AUC based on a test set and ground truth are not applicable in this context.
Instead, for a device like an afterloader, acceptance criteria would typically revolve around functional performance, safety, and equivalence to predicate devices. The provided document focuses on demonstrating substantial equivalence to previously cleared devices (GammaMedplus K983436 and GammaMedplus 3/24 K031524).
The document does not contain information about a study that involves human readers, AI assistance, or diagnostic performance metrics. It's a regulatory submission for a therapeutic device, not a diagnostic AI system.
Here's a breakdown based on your requested categories, highlighting what is (and isn't) present in the text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a therapeutic device (an afterloader) and not a diagnostic AI/image processing system, the acceptance criteria are focused on functional equivalence and safety rather than diagnostic accuracy. The document implicitly relies on demonstrating substantial equivalence to predicate devices. Explicit acceptance criteria in terms of quantitative performance metrics for a diagnostic task are not detailed in this submission.
| Acceptance Criterion (Implied) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence to Predicate Devices | The device is described as "a computer controlled remote electro/mechanical system used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy." This functional description aligns with the predicate devices. |
| Similar Intended Use | "The GammaMedplus iX Series is computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specified clinical purpose in a patient." This mirrors the intended use of prior approved afterloaders. |
| Similar Technological Characteristics | "The Substantial Equivalence Comparison Charts provide a comparison of the technological characteristics to those of the predicate devices. These charts are located in Tab 9 of the submission." (The charts themselves are not provided in the extract, but their existence is stated as the basis for claiming equivalence). |
| Safety and Control Mechanisms | "The console control application runs on validated PCs under a Microsoft® windows operating system. The firmware controlling the High Dose Rate Afterloader runs on an embedded Intel 8085 processor. In addition, embedded processors, both based on the Intel 8051, control the afterloaders control desk and its junction interface box." This describes the control systems in place for safe operation. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided in the document. The device is not a diagnostic tool evaluated on a "test set" of patient data in the typical sense. Its performance is related to its mechanical and software operation in delivering radiation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. "Ground truth" in the context of diagnostic accuracy is not relevant for this type of medical device submission.
4. Adjudication Method for the Test Set
This information is not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done, as this is not a diagnostic or AI-assisted interpretation device. The concept of human readers improving with AI assistance does not apply here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is an electro-mechanical system controlled by software and hardware, not a standalone AI algorithm for medical image interpretation or diagnosis. Its "performance" would be evaluated through engineering testing and validation (e.g., accuracy of source positioning, dose delivery, safety interlocks) rather than standalone algorithmic diagnostic performance.
7. The Type of Ground Truth Used
This information is not applicable and not provided. The "ground truth" for an afterloader would relate to its engineering specifications and successful delivery of radiation according to a treatment plan, confirmed through physical measurements and calibration, not pathology or outcomes data in the sense of a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This is not an AI/machine learning device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided.
In summary: The provided document is an S10(k) premarket notification for a therapeutic device (an HDR brachytherapy afterloader), not a diagnostic device or an AI/machine learning system. Therefore, the questions related to diagnostic performance, ground truth, test sets, training sets, and human reader studies are not applicable to the content presented in this filing abstract. The "study" referenced would be the demonstration of substantial equivalence through comparison of technological characteristics to predicate devices, and likely internal validation and verification testing of the device's functional and safety aspects, which are not detailed in this summary.
§ 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.