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510(k) Data Aggregation
(117 days)
The Esophagus Bougie Set was designed to treat cancer of the esophagus. The Esophagus Bougie Set is an applicator used to facilitate delivery of a radiation source to the esophagus when used with a Varian high dose rate afterloader.
The Varian Medical Esophagus Bougie is an HDR applicator designed to facilitate delivery of radiation to the Esophagus and has been modified to work with Varian Medical afterloaders. The product can be steam sterilized up to 20 times and has a maximum implantation time of 24 hours. The device does not contain any electronics or software. A high activity radioactive source is placed within the applicator which has previously been placed for a specified clinical purpose in a patient. The radioactive source (enclosed within the wire/cable) is driven via coupling catheters (Transfer Guide Tubes) from the Afterloader into the applicator within the patient. The length of time and position that the High Dose Rate source spends within the applicator is controlled in accordance with an Irradiation Treatment Prescription.
The provided document describes the Esophagus Bougie Set, a device used in brachytherapy to deliver radiation to the esophagus. The document focuses on the regulatory submission (510(k)) to the FDA, asserting substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific quantitative targets for "device performance" in the way one might expect for a diagnostic or AI-powered device. Instead, it describes bench testing to validate changes made to the device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Cleaning & Disinfection | Bench testing performed to evaluate the efficacy of the automatic manual cleaning and disinfection process. Test results: "Testing showed the test articles met the pre-defined acceptance criteria, thereby demonstrating the effectiveness of the cleaning and disinfection process plus the cleaning and disinfection agents according to DIN EN ISO 17664 (July 2004)." |
| Biocompatibility | Biocompatibility testing performed in accordance with ISO 10993-5 and 10993-10. Test results: "show the device is safe for bodily contact." |
| Material Reformulation | Evaluation of a reformulated PVC material (DEHP replaced with a safer alternative) through design verification and testing. Test results: "Non-clinical test articles met the predefined acceptance criteria, thereby demonstrating the reformulated material did not impact device performance or biocompatibility." (Specific acceptance criteria for "impact on device performance" are not detailed.) |
| Overall Conclusion | "All the tests that were performed met the applied pass criteria. Varian considers to be safe and effective and to perform as well or better than the predicate." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or AI model evaluation. The tests described are bench tests of the device's physical properties, cleaning efficacy, and biocompatibility. Therefore, descriptions of sample size and data provenance (country of origin, retrospective/prospective) are not applicable in the way they would be for a clinical study or AI model validation. The text mentions "test articles" for the bench testing, but not the number of these articles.
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 as the document describes bench tests for a medical device's physical properties and safety, not a study involving expert assessment of clinical data or AI output.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3.
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
This information is not applicable. The device described is an "Esophagus Bougie Set," which is a physical applicator for radiation delivery. It is not an AI-powered diagnostic or decision-support system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed was based on:
- Established standards: DIN EN ISO 17664 (July 2004) for cleaning and disinfection efficacy.
- International standards: ISO 10993-5 and 10993-10 for biocompatibility.
- Pre-defined acceptance criteria: For the material reformulation, implying internal Varian specifications.
These are technical standards and internal specifications, not clinical "ground truth."
8. The sample size for the training set
This information is not applicable as the document describes a physical medical device, not an AI system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
In summary:
The provided text details a 510(k) submission for a physical medical device. The "acceptance criteria" and "study" refer to engineering and materials testing, not clinical trials or AI validation studies. Therefore, many of the requested data points (related to clinical data, expert reviews, AI performance, training sets) are not present in this document. The document confirms that bench testing was performed and met predefined technical and safety standards.
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