Search Results

The GC Medtech Esophageal Applicator (E-App) is an applicator used to facilitate delivery of a prescription of radiation to the esophagus when used in conjunction with a high dose rate after-loader.

Not Found

I apologize, but the provided text is a 510(k) premarket notification letter from the FDA to GC Medtech, LLC, for their E-App device. This document primarily focuses on the FDA's decision regarding substantial equivalence and regulatory compliance.

The document does not contain any information about:

• Acceptance criteria for device performance.
• Any study details, including sample sizes, data provenance, expert qualifications, or adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used or how it was established for training or testing sets.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text.

Ask a specific question about this device

The GentleCare AR Applicator is Intended for use during brachytherapy procedures. The nultiple lumens of the GC MedTech device are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

The GentleCare AR Applicator is a specialized applicator that is temporarily inserted into the vagina or rectum to facilitate the application of radiation to the target site in the treatment of carcinoma. The GentleCare AR Applicator is provided sterile for single use and is disposable.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the GentleCare AR Applicator:

Disclaimer: The provided text is a 510(k) summary for a medical device. These summaries are intended to demonstrate substantial equivalence to an existing predicate device, not necessarily to prove the device's efficacy through a rigorous clinical trial in the same way a new drug would. Therefore, the "study" described is primarily focused on engineering and biocompatibility testing, rather than clinical performance (e.g., diagnostic accuracy or treatment outcomes).

Acceptance Criteria and Device Performance for GentleCare AR Applicator

The provided documentation describes the acceptance criteria and performance for the GentleCare AR Applicator, primarily focusing on its equivalence to a predicate device (CAPRI Applicator) through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" and "reported device performance" in a direct comparative table for clinical outcomes, as this is a 510(k) for a device demonstrating substantial equivalence, not a novel device requiring extensive clinical efficacy studies. Instead, the acceptance criteria are implicitly tied to meeting engineering and biocompatibility standards, and the performance is demonstrated by similarity to the predicate and successful completion of specified tests.

Implied Acceptance Criteria and Performance based on Non-Clinical Testing:

Note: The "acceptance criteria" are inferred from the types of non-clinical tests performed. The document simply states that "Product testing was completed and met all of the acceptance criteria," without detailing the specific numeric or qualitative thresholds for each test.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact sample size for each non-clinical test (dimensional measurements, visual inspection, balloon inflation, etc.). It generally states "Product testing was completed." This implies that a sufficient number of units were tested to provide statistical confidence in the results, as per standard engineering testing protocols, but the specific numbers are not provided in this summary.
• Data Provenance: The data is generated from non-clinical testing of the manufactured device. This is internal testing performed by the applicant (GC MedTech, LLC) or a contracted lab. The data is prospective in the sense that the tests were specifically conducted for this submission. The "country of origin" for the data is not specified beyond being generated by the applicant, who is based in the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission. The ground truth for engineering and biocompatibility tests is established by industry standards (e.g., ISO10993) and the device's design specifications, not by expert consensus on clinical data. No "experts" were used in the sense of clinical reviewers establishing ground truth for a test set of patient data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers interpreting clinical data, which is not the nature of the tests performed for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This type of study assesses how AI impacts human reader performance (e.g., diagnostic accuracy, efficiency). The GentleCare AR Applicator is a physical medical device (brachytherapy applicator), not an AI algorithm. Therefore, an MRMC study is not relevant to its clearance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical brachytherapy applicator, not an algorithm. Its performance is inherent in its physical properties and function, always used with a human operator and remote afterloading equipment.

7. Type of Ground Truth Used

The "ground truth" for this device's testing is based on:

• Engineering Specifications: The design parameters and functional requirements of the device (e.g., dimensions, bond strength, balloon integrity).
• Biocompatibility Standards: Adherence to established international standards like ISO10993, which define acceptable levels for cytotoxicity, sensitization, and irritation.
• Predicate Device Characteristics: The characteristics of the legally marketed predicate device (Capri Applicator, K092822) serve as a benchmark for substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This device is hardware, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI algorithm, there is no ground truth related to one for this device.

Summary of the "Study" (Non-Clinical Testing):

The "study" or testing performed for the GentleCare AR Applicator was non-clinical in nature, designed to demonstrate its safety and performance equivalence to a legally marketed predicate device. This involved:

• Biocompatibility Testing: According to ISO10993 standards (cytotoxicity, sensitization, irritation).
• Engineering and Performance Testing: Including dimensional measurements, visual inspection, balloon inflation/deflation/burst tests, bond strength, and overall mechanical performance.

The success of these tests, along with a detailed comparison of its characteristics to the predicate device, formed the basis for the FDA's determination of substantial equivalence (K133922). The FDA letter confirms the device was found substantially equivalent for its stated indications for use.

Ask a specific question about this device