Search Results

The Modified CRE™ Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label.

Not Found

The provided text describes a 510(k) premarket notification for a medical device, the Modified CRE™ Balloon Dilatation Catheter. However, it does not include detailed information regarding specific acceptance criteria, a dedicated study proving performance against those criteria, or the specific elements requested in your prompt (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance).

The document focuses on establishing substantial equivalence to previously marketed devices based on descriptive, technological, and general performance characteristics.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Study for Modified CRE™ Balloon Dilatation Catheter (K974788)

The submitted 510(k) summary and associated letter discuss the substantial equivalence of the Modified CRE™ Balloon Dilatation Catheter. The documentation focuses on demonstrating that the new device is as safe and effective as predicate devices through laboratory testing and biocompatibility assessments, rather than presenting a study with specific acceptance criteria and performance metrics in the format requested.

1. A table of acceptance criteria and the reported device performance

Explanation: The documentation does not provide quantitative or specific performance metrics or acceptance criteria typically seen in clinical studies for AI/software devices. Instead, it relies on a qualitative statement that "laboratory testing... verified its safety and performance" and "biocompatibility assessment... with satisfactory results." The primary "acceptance" is the FDA's determination of substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not specified. The document refers to "laboratory testing" and "biocompatibility assessment" but does not give details about the number of devices tested, the duration, or the context of these tests (e.g., in vitro, ex vivo, or animal studies).
• Data Provenance: Not specified. The nature of the "laboratory testing" and "biocompatibility assessment" implies internal testing conducted by Boston Scientific Corporation, likely in a controlled laboratory environment. No country of origin or retrospective/prospective nature of data for a "test set" is mentioned, as this is not a clinical study on patient data.

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 and not provided in the document. The device is a physical medical device (balloon dilatation catheter), not an AI/software device that requires expert-established ground truth from images or other data for performance evaluation. The "ground truth" for this device would be its mechanical and material properties meeting design specifications and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical trials or studies involving expert review of data for AI/software evaluations, which is not the context here.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or decision support systems. The Modified CRE™ Balloon Dilatation Catheter is a physical therapeutic device.

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 concept is specific to AI/software algorithms. The performance of this physical device is evaluated via laboratory testing of its physical properties and biocompatibility.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The concept of "ground truth" as typically applied to AI/software evaluation (e.g., expert consensus, pathology) is not applicable here. The "ground truth" for this device would be its adherence to established engineering standards, material specifications, and biological safety requirements, verified through standard laboratory tests and assessments.

8. The sample size for the training set

• Not applicable / Not provided. This device is a physical product, not an AI/software system that uses a "training set."

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

• Not applicable / Not provided. This information pertains to AI/software development, which is not the subject of this 510(k) submission.

Summary of Device Performance and Basis for Substantial Equivalence:

The core of the 510(k) submission for the Modified CRE™ Balloon Dilatation Catheter is the demonstration of substantial equivalence to existing, legally marketed predicate devices (current CRE™ Balloon Dilatation Catheter and Vector TTS™ Balloon Dilatation Catheter).

The justification for substantial equivalence is based on:

• Descriptive and Technological Characteristics: The device is considered substantially equivalent in its design and technology to the predicate devices.
• Performance Characteristics (Laboratory Testing): In-house laboratory testing was conducted to "verify its safety and performance." While no specific quantifiable results are given, the conclusion is that these tests were satisfactory.
• Biocompatibility Assessment: An assessment of patient- and fluid-contact materials was performed, yielding "satisfactory results."
• Packaging, Sterilization, and Pyrogenicity: These aspects were addressed, with the device being sterilized using ethylene oxide gas per AAMI protocol and pyrogenicity testing deemed unnecessary due to typical non-blood contact.

The FDA's letter confirms that they "reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This determination is the "acceptance" that allows the device to be marketed.

Ask a specific question about this device