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510(k) Data Aggregation
(356 days)
The Kelowna GYN Templates are interstitial brachytherapy treatments for gynecological and rectal/anal cancer using HDR or PDR brachytherapy. The Crook Prostate Templates are intended for interstitial brachytherapy treatments for prostate cancer using HDR or PDR brachytherapy.
The Kelowna GYN and Crook Prostate Templates are applicator accessories for Brachytherapy. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicators act to guide the radioactive source to the correct location or locations for treatment.
The devices do not contain or consist of software/firmware. The devices do not contain any biologics or drug components. The devices have patient-contacting materials. The devices are designed for repeated use. No parts of the system are provided sterile. The devices can be steam sterilized with common parameters using pre-vacuum sterilization. These devices are used on both female and male patients.
The Kelowna GYN and Crook Prostate Templates are compatible with the following Varian Afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™.
The Kelowna GYN and Crook Prostate Templates are CT compatible.
The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.
The provided document details a 510(k) premarket notification for the "Kelowna GYN and Crook Prostate Templates," which are applicator accessories for brachytherapy. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance and Results |
|---|---|---|
| Biocompatibility | Meet standards for medical devices in contact with breached surfaces and prolonged contact duration (ISO 10993-1). | Cytotoxicity, Sensitization, Irritation, System Toxicity, Subacute Toxicity, and Implantation tests were conducted. The components are categorized as a medical device, surface device in contact with breached or compromised surfaces and prolonged contact duration (>24h to 30d) according to ISO 10993-1. (Implied: All tests passed). |
| Sterilization | Effectiveness of cleaning, disinfection, and sterilization procedures; device performance and safety/effectiveness after repeated sterilization cycles. | Validation/Efficacy Testing of Cleaning, Disinfection, and Sterilization Cycles; Verification of the Suitability of Applicator Design and Material for the Stated Use Life and Reprocessing Cycles were performed. (Implied: All tests passed and demonstrated effectiveness and suitability). |
| Mechanical/Acoustic | Compatibility with CT imaging; adherence to applicator design specifications. | CT Compatibility Tests and Analysis; Verification and Validation Testing for Applicator Design Specifications were conducted. (Implied: Demonstrated CT compatibility and adherence to specifications). |
| General Comparison to Predicate | Must perform comparably to the predicate device (GammaMed Plus High Dose Rate Remote Afterloading System, K983436) for its intended use and indications. | The non-clinical tests support the safety and effectiveness, and validation/verification testing demonstrates that the subject devices perform comparably to the predicate device, meeting the intended use. The device shares the same intended use (brachytherapy for cancer) and compatible afterloader series as the predicate. Different designs and materials (PEEK, Titanium vs. PPSU, Stainless Steel) are used but are considered biocompatible and suitable. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the individual non-clinical tests (biocompatibility, sterilization, mechanical) beyond stating that "testing was conducted" or "components were subjected." It is common for these types of tests to use a statistically adequate number of samples as per the relevant standards, but the specific numbers are not disclosed.
The data provenance is retrospective non-clinical bench testing and analysis, as indicated by the "Non-Clinical Tests" section. There is no mention of human subject data or data from a specific country of origin, as the testing relates to the device's physical and material properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or provided in the document. The "ground truth" for non-clinical performance data like biocompatibility, sterilization efficacy, and mechanical properties is typically established by adherence to international standards (e.g., ISO 10993, AAMI TIRs) and validated by laboratory testing following established protocols. The expertise lies in the execution and interpretation of these standardized tests by qualified laboratory personnel, rather than expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or provided. Adjudication methods are typically used in clinical studies or image-based evaluations where multiple human readers assess data and discrepancies need to be resolved. For non-clinical bench testing, the results are objectively measured against defined criteria within the test protocols.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes physical medical devices (applicators for brachytherapy) and their non-clinical performance. It does not involve AI, software, or human interpretation of images or data that would necessitate an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for these non-clinical tests is based on:
- Established International Standards: For biocompatibility (ISO 10993 series), sterilization (AAMI and ISO standards), and mechanical properties (internal design specifications validated through testing).
- Objective Measurements: Laboratory test results measured against predefined acceptance limits set by these standards and engineering specifications.
There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense, as this is a pre-market notification for a physical device demonstrating substantial equivalence through bench testing.
8. The sample size for the training set
This information is not applicable or provided. There is no "training set" as this device does not involve machine learning or artificial intelligence.
9. How the ground truth for the training set was established
This information is not applicable or provided. As there is no training set, there is no ground truth established for one.
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(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.
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