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510(k) Data Aggregation
(58 days)
Brachytherapy applicators are commonly used to facilitate the positioning of a radioactive source inside or near the patient in order to administer radiation therapy to cancerous tissue.
Cervix Ring Applicator: The Cervix Ring Applicator is for gynecological Brachytherapy of cervix, endometrium and vagina, to be used only by trained physicians. The Maximum implementation per treatment application is 28 days.
Trocar Needle Sets: The intended use is interstitial HDR/PDR brachytherapy treatment, to be used only by trained physicians. The maximum implantation period of the needles is 28 days.
Martinez Prostate Template Set: The Martinez Prostate Template Set is for assisting interstitial HDR/PDR brachytherapy of the prostate gland, to be used only by trained physicians. The Maximum application duration per treatment application is 28 days.
Bonvoisin Gerard Esophageal Applicator Set: The Bonvoisin Gerard Esopheagel Applicator is intended for brachytherapy treatment of the esophagus, to be used only by trained physicians. The maximum implementation duration per treatment application is 24 hours.
The following described medical instruments are brachytherapy applicators for use with the Flexitron Brachytherapy Afterloader. Brachytherapy applicators are commonly used to facilitate the placement and positioning of a radioactive source inside or near the patient in order to administer radiation therapy to cancerous tissue. Prior to treatment radiation X-ray markers are positioned into the applicator channel(s) in order to determine source dwell positions with the help of radiographic images as part of the brachytherapy treatment planning process.
Cervix Ring Applicator: The Cervix Ring Applicator is a tandem and ring brachytherapy instrument. The applicator consists of 2 separately placed ridged brachytherapy channels, i.e. 1 tandem (intrauterine tube) and a ring tube. The Cervix Ring Applicator is used as a gynaecological intracavitary instrument to assist the positioning of a radioactive source under remote control (involving HDR or PDR Flexitron Remote Afterloader system), in order to administer radiation therapy to cervix and uterus carcinoma.
Trocar Needle Sets: The trocar Needles are straight ridged needles made out of stainless steel and have closed end sharp tip for skin and tissue perforation. The Trocar Needles are used as interstitial brachytherapy instruments to assist the positioning of a radioactive source under remote control (involving HDR or PDR Flexitron Remote Afterloader system), in order to administer radiation therapy to tissue and organ carcinoma.
Martinez Prostate Template Set: The Martinez Prostate template is to be used for HDR/PDR brachytherapy of the prostate gland. In order to administer brachytherapy to the prostate, needles are inserted interstitially into the prostate with the guidance of a prostate template. The prostate template can be mounted on an Ultra Sound probe stepper device in such a manner that the US grid coordinates projected over the images of the prostate are corresponding to the grid indication of the prostate template and its holder.
Bonvoisin Gerard Esophageal Applicator Set: The Bonvoisin Gerard Esophageal Applicator consists of a flexible tube with a tapered distal tip. This applicator tube is advanced through the mouth into the esophagus, the tapered distal tip gently dilitates the esophagus, in order to facilitate the placement of the applicator tube. When the applicator tube is in position the tube is to be immobilised in relation to the patient's mouth with the accompanied fixation mask. For connection and treatment with the brachytherapy remote afterloader a separate flexible treatment catheter is provided in the set. The distal end of the treatment catheter is to be inserted into the applicator tube and the proximal end is to be connected to the afterloader device. In order to fit different esophagus anatomy sizes and/or treatment requirements the applicator tube is provided in different diameter sizes, ranging in diameter from 5 mm to 20 mm. Both the fixation mask and the treatment catheter can be applicator tube sizes.
This product is a medical device, and the provided text is a 510(k) summary for its clearance. Therefore, the "acceptance criteria" for a medical device in this context refer to the criteria for demonstrating Substantial Equivalence to legally marketed predicate devices, rather than a performance study with specific quantitative metrics. The study proving this typically involves comparing the new device's technological characteristics and intended use to those of the predicate devices.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on FDA 510(k) requirements for Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Intended Use: The proposed device must have the same intended use as legally marketed predicate devices. | The intended uses of the Cervix Ring Applicator Set, Trocar Needle sets, Martinez Prostate Template Set, and Bonvoisin Gerard Esophageal Applicator Set are the same as their mentioned corresponding predicate devices (Section 5.7). |
| Technological Characteristics: The proposed device must have similar technological characteristics to legally marketed predicate devices. Any differences should not raise new questions of safety or effectiveness. | The described brachytherapy applicators have similar technological characteristics compared to the legally marketed predicate devices listed (Section 5.6). Differences do not concern the basic principle of operation and usage nor do they adversely affect the safety or effectiveness of the device (Section 5.7). |
| Basic Principle of Operation and Usage: The proposed device must operate on the same basic principles as legally marketed predicate devices. | The differences between the devices and predicates do not concern the basic principle of operation and usage (Section 5.7). All devices are considered brachytherapy applicator instruments and accessories to a remote afterloading system, similar to predicates (Section 5.6). |
| Safety and Effectiveness: The proposed device must be as safe and effective as legally marketed predicate devices. | The differences between the devices and predicates do not adversely affect the safety or effectiveness of the device (Section 5.7). The FDA's 510(k) clearance letter indicates that the device has been determined to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a "test set" in the context of a performance study with a defined sample size. This 510(k) submission relies on a comparison to predicate devices, not a clinical trial or performance evaluation of the device in isolation against specific metrics. Therefore, there is no sample size for a test set or data provenance from a performance study to report. The "data" here refers to the design specifications and intended use of the new devices in comparison to existing ones.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since there was no "test set" for a performance study evaluating the device's accuracy or efficacy in the way a diagnostic algorithm might be assessed, there is no mention of experts used to establish ground truth. The "ground truth" for a 510(k) submission of this type is essentially derived from the established safety and effectiveness of the legally marketed predicate devices.
4. Adjudication Method for the Test Set
As there was no "test set" or performance study described in the document, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) summary. This type of study is typically used for diagnostic devices to compare human reader performance with and without AI assistance. The submitted devices are brachytherapy applicators, which are instruments used in radiation therapy, not diagnostic devices or AI-powered tools.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study (algorithm only) was not done. The devices are physical medical instruments, not algorithms.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices. The new devices are deemed "substantially equivalent" if they share the same intended use and similar technological characteristics, and do not raise new questions of safety or effectiveness compared to these predicates.
8. The Sample Size for the Training Set
There is no mention of a training set or its sample size. The devices are physical instruments, not AI algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, there is no information on how ground truth for a training set was established.
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