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The ECHO-COAT™ Ultrasound Needle is indicated for use where improved visibility on ultrasound images is required compared to an uncoated needle. The coated needle also assumes the specific indications for use of the currently marketed uncoated needle, for example biopsy, amniocentesis, vascular access, aspiration, and drainage needles.

STS Biopolymers, Inc. will purchase in bulk currently marketed needles designated by application (biopsy, aspiration, amniocentesis, etc.), needle type (spinal, Chiba, Franseen, other), needle gauge (11 to 30), and length (3 to 20 cm), and then apply a polymer coating. The coating, called ECHO-COAT™, is visible in ultrasound images, assisting with positioning. The coated needles will be repackaged as single-use devices, sterilized with EtO, and distributed commercially under the STS Biopolymers, Inc. name.

The provided text, K983647, describes the ECHO-COAT™ Ultrasound Needles and their substantial equivalence to a predicate device. However, it does not contain the detailed study information regarding acceptance criteria and performance data that you've requested.

The document states:

• "STS is providing performance data to demonstrate equivalence where necessary."
• "STS Biopolymers, Inc. carried out performance testing on the ECHO-COAT™ Ultrasound Needles. This testing addressed the following issues: Sterilization, Package Integrity, Biocompatibility, Imaging Performance Testing. All of the results demonstrate substantial equivalence."

Crucially, the K983647 document summarizes that testing was done and performance was demonstrated, but it does not provide the specific acceptance criteria, the reported device performance against those criteria, sample sizes, ground truth establishment methods, or any details about multi-reader studies.

Therefore, I cannot fill out the requested table and answer many of your questions based solely on the provided input.

Based on the available information in K983647, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be provided. The document states that "performance testing" and "imaging performance testing" were done, and that "all of the results demonstrate substantial equivalence," but it does not specify the quantitative acceptance criteria or the measured performance values for the ECHO-COAT™ Ultrasound Needles.

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

Cannot be provided. The document mentions "performance testing" but does not detail the sample sizes used for any of the tests (Sterilization, Package Integrity, Biocompatibility, Imaging Performance Testing). It also does not specify the data provenance (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Cannot be provided. The document does not describe the establishment of a "ground truth" for a test set, nor does it mention the use of experts for this purpose, especially in the context of imaging performance. The "imaging performance testing" is mentioned as a general category.

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

Cannot be provided. No information on adjudication methods is present.

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

Cannot be provided. This K983647 submission is for an ultrasound needle with a coating for improved visibility, not an AI-powered diagnostic device. Therefore, an MRMC study with AI assistance would not be applicable or expected for this type of device.

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

N/A. This device is a physical medical instrument (an ultrasound needle), not an algorithm or software. Standalone performance testing would refer to direct measurement of the needle's physical and imaging properties. The document implies such testing was done under "Imaging Performance Testing" but provides no details.

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

Cannot be provided. The document does not specify how ground truth was established for "Imaging Performance Testing." Given the nature of the device, it would likely involve objective measures of visibility (e.g., contrast-to-noise ratio, depth of visibility in tissue phantoms) rather than clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

N/A. This is not an AI/machine learning device, so there is no concept of a "training set."

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

N/A. As above, no training set, so no ground truth establishment for it.

Summary of what is known from K983647:

• Device Name: ECHO-COAT™ Ultrasound Needles
• Purpose: The polymer coating (ECHO-COAT™) improves visibility of the needles in ultrasound images, assisting with positioning.
• Predicate Device: Disposable Chiba Biopsy Needle for Use with Ultrasound manufactured by Cook (K851957), as modified with the "EchoTip" for ultrasound imaging visibility.
• Technological Characteristics: The coating is visible in ultrasound images, unlike the predicate which uses etching. This is identified as the key technological difference.
• Testing Performed: Sterilization, Package Integrity, Biocompatibility, and Imaging Performance Testing.
• Conclusion: All tests "demonstrate substantial equivalence."

To obtain the detailed information you requested, one would need to access the full submission documents, specifically the sections detailing the performance testing for the ECHO-COAT™ Ultrasound Needles. This 510(k) summary only provides a high-level overview.

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