Search Results

The kallisio Stentra™ oral stent is intended to be used for repeat positioning and immobilization of a patient's tongue and jaw while undergoing a course of external beam radiation therapy for treatment of cancer and other diseases. The kallisio Stentra oral stent is intended to be used by or under the direction of a licensed physician.

The Kallisio Stentra Oral Stent is a single patient, reusable custom tongue and jaw positioner used for repeat positioning and immobilization of a patient's tongue and jaw while receiving a course of external beam radiation therapy for treatment of cancer and other diseases. Q-bite bite block accessories are supplied separately. The Stentra Stent is a prescription device.

The Kallisio Stentra™ oral stent is a medical device intended for repeat positioning and immobilization of a patient's tongue and jaw during external beam radiation therapy. The provided text, however, is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical performance acceptance criteria and study results for the subject device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document, nor can I describe a study proving the device meets those criteria, as such specific clinical performance validation is not the primary purpose of this type of submission.

The document primarily discusses non-clinical testing to demonstrate performance characteristics and material safety compared to a predicate device.

Here's an analysis of the provided information based on the requested categories, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as it would be for a clinical trial establishing efficacy for a new device. The document summarizes non-clinical performance data to demonstrate substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable in the context of clinical performance for this 510(k) submission. The non-clinical testing involved "test units" for biocompatibility, corrosion-resistance, mechanical strength, and attenuation, but specific sample sizes for these tests are not detailed beyond "test units."
• Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer or contracted labs. Country of origin is not specified, and they are inherently not retrospective or prospective clinical studies.

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 there is no mention of a human-read test set or ground truth establishment by experts in the context of clinical performance within this document. The non-clinical tests rely on established scientific methods and instrumental measurements.

4. Adjudication method for the test set:

This information is not applicable as there is no human-read test set or ground truth establishment by experts for adjudication.

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 is an oral stent for physical positioning and immobilization during radiation therapy, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study with human readers and AI assistance is irrelevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The Kallisio Stentra is a physical medical device, not a software algorithm.

7. The type of ground truth used:

This information is not applicable in the context of clinical "ground truth" for diagnostic accuracy. For the non-clinical tests mentioned:

• Biocompatibility: Ground truth is established by "acceptable biocompatibility... for its intended contact category and duration" based on ISO 10993-1 guidelines.
• Corrosion-resistance: Ground truth is the "absence of corrosion or surface changes" after specific immersion tests.
• Mechanical strength: Ground truth is "no cracks or fractures" after applying a compressive load.
• Attenuation: Ground truth is "similar shielding performance" compared to the predicate device.

8. The sample size for the training set:

This information is not applicable as this is a physical medical device, not an AI or software system that requires a "training set."

9. How the ground truth for the training set was established:

This information is not applicable as this is a physical medical device.

Summary of Non-Clinical Performance Data Provided (from Section VII):

The document provides a summary of non-clinical testing performed to support substantial equivalence.

Study Details (Non-Clinical):

• Type of Study: Non-clinical laboratory testing.
• Objective: To demonstrate the safety and performance characteristics of the Kallisio Stentra oral stent.
• Methodology:
  • Biocompatibility: Tested in accordance with FDA Guidance Use of International Standard ISO 10993-1, including cytotoxicity, irritation, and sensitization.
  • Corrosion-resistance: Test units immersed in a simulated saliva solution at body temperature, followed by immersion in boiling water. Visual and microscopic (20x) examination performed.
  • Mechanical Strength: A compressive load 2x the maximum force applicable by a human jaw was applied to test units. Visual and microscopic (20x) examination performed.
  • Attenuation: Performed with a 6 MV photon beam to assess shielding.
• Sample Size: "Test units" were used; specific numbers are not detailed.
• Ground Truth: Industry standards (ISO 10993-1) for biocompatibility, and observational/measurement-based outcomes (absence of damage/corrosion, similar attenuation) for the other tests.
• Experts/Adjudication: Not applicable in the context of clinical ground truth or human interpretation; testing relies on laboratory procedures and measurements.

In conclusion, the provided document focuses on demonstrating that the Kallisio Stentra is substantially equivalent to a previously cleared device (GrayDuck Stent K183374) through non-clinical performance data and comparison of technological characteristics. It does not contain information about clinical acceptance criteria or studies with human subjects that would typically involve many of the requested categories.

Ask a specific question about this device