Search Results

The Mini Stick ENVI Non-Vascular Introducer Kit is utilized to facilitate the introduction and placement of a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) diameter guidewire for non-vascular procedures.

The Mini Stick ENVI Non-Vascular Introducer Kit contains one or more of the following components. Reference unit label for specific devices: Triaxial Sheath/Dilator assembly with stiffening cannula; 18G (1.4 mm) or 21G (0.9 mm) needle with stylet; 0.018 in (0.46 mm) floppy tip guidewire; 0.035 in (0.89 mm) or 0.038 in (0.97 mm) heavy duty guidewire. For user convenience, all kit components are also available in multiple kit configurations as sterile, standalone devices.

The provided document is a 510(k) Premarket Notification for a medical device called the "Mini Stick ENVI Non-Vascular Introducer Kit." This document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical performance data.

Therefore, the concepts of acceptance criteria for diagnostic performance, a test set, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to this type of submission. This device is an introducer kit, and the evaluation is primarily focused on its physical and functional characteristics, not on diagnostic accuracy of an AI or image-based system.

Here's an analysis based on the information provided, explaining why certain sections of your request are not relevant:

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

The document does not explicitly state "acceptance criteria" in the context of diagnostic performance metrics like sensitivity, specificity, accuracy, etc., because it's a physical medical device, not a diagnostic algorithm. However, it lists performance tests conducted to demonstrate the device's functional integrity and safety. We can infer the "acceptance criteria" were successful completion of these tests in accordance with the cited ISO standards.

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

Not applicable. This device is not a diagnostic tool or algorithm that uses a "test set" of patient data. The "tests" mentioned are non-clinical engineering and material tests, which would involve specific numbers of device components or assemblies, not patient samples or data provenance.

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

Not applicable. Ground truth, in the context of diagnostic performance, is not relevant here. The "truth" in this context is whether the device physically meets its intended specifications and safety standards, determined by engineering and scientific testing, not expert interpretation of diagnostic images or clinical data.

4. Adjudication method for the test set

Not applicable for the same reasons as above. Adjudication methods are used to establish a consensus ground truth from multiple expert interpretations, which is not relevant for the functional testing of a physical introducer kit.

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

Not applicable. MRMC studies are for evaluating the performance of diagnostic systems (often AI-assisted) with human readers. This device is an introducer kit, not a diagnostic system.

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

Not applicable. There is no algorithm associated with this device.

7. The type of ground truth used

Not applicable in the diagnostic sense. The "ground truth" for this device's performance is established by its manufacturing specifications and compliance with international standards for medical devices (e.g., ISO 11070, ISO 594-2, ISO 10993-1) as demonstrated through physical and chemical testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth to be established for it.

Ask a specific question about this device

The PneumRx Family of Biopsy Needles and Kits is intended for use in obtaining bone, vertebral body, and bone marrow biopsy specimens, and single and multiple tissue biopsy specimens of tissues or lesions, partial or complete removal of imaged abnormalities, in soft tissues, for applying radionuciide sources into the body, and for aspirating, or injecting various fluids or contents (e.g., sclerosing agents, vasoconstrictors, anesthetics, ethanol, saline, heparin, and other historically used, and/or generally accepted medical fluids in accordance with the judgment and training of the medical practitioner).

The PneumRx Family of Biopsy Needles and Kits is indicated for use in obtaining bone, vertebral body, and/or bone marrow biopsy using coring, cutting or aspiration, as well as providing and maintaining surgical site access with coaxial biopsy needle kits.

They are also indicated for use in percutaneous, open surgical, fine needle, tissue core, coaxial, and aspiration biopsy/ tissue sampling of soft tissues for:

• . Microscopic, histologic, diagnostic, evaluation
• Fluoroscopic, ultrasound (US), computed tomography (CT)/x-ray, mammographic imaging, . MRI (magnetic resonance imaging), and/or direct visualization
• . Guiding biopsy needles to the target lesion
• Avoiding punctures in non-penetrable anatomic obstacles (e.g., bone, spine) or vital structures (e.g., blood vessels, nerves)
• Obtaining multiple biopsy, core biopsy, and aspiration biopsy tissue samples with partial or . complete removal of the imaged abnormality
• Aspirating, draining, or injecting various fluids or contents in soft tissues, including . introduction of sclerosing agents or vasoconstrictors to control actual or potential bleeding
• Pericardiocentesis, transhepatic cholorangiography, and other applications requiring injection . or aspiration of fluids
• Lumbar puncture, spinal fluid sampling, local anesthetic injection to provide regional nerve . block/anesthesia, and amniocentesis
• Manual application of a radionuclide source into or on the body for radiation therapy .
• Including, but not limited to, the following anatomical locations and lesions; .
  • Pleural cavity
  • Lung
  • Lymph nodes
  • Thyroid
  • Adrenals
  • Soft tissue organs of the abdomen and thorax
  • Abdominal cavity/ abdominal soft tissue masses
  • Kidney
  • Liver
  • Spleen
  • Pancreas
  • Prostate
  • Tumors
  • Cysts
  • Fluid spaces
  • Soft tissue lesions or tissue spaces
  • Breast:
    • The PneumRx Family of Biopsy Needles and Kits is indicated to provide breast . tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality;
    • The extent of a histologic abnormality cannot be reliably determined from its . mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The PneumRx Family of Biopsy Needles and Kits are comprised of the following main components:

• Standard and steerable biopsy needles in a range of sizes;
• Standard straight and steering stylets compatible with a range of steerable and . standard biopsy needles;
• . Remote Control Steering Handle accessory:
• Procedure accessories including drapes, gauze sponges, syringes, scalpels, depth . markers, and prep tray.

The provided text is a 510(k) summary for the PneumRx Family of Biopsy Needles and Kits. This type of submission focuses on demonstrating substantial equivalence to predicate devices, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert involvement, or AI-specific performance metrics.

However, based on the context of a 510(k) summary for a biopsy needle, we can infer the nature of the acceptance criteria and the type of study that would have been performed, even if the specifics are not explicitly stated in this document.

Here's an analysis of the provided text in relation to your questions:

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

• Acceptance Criteria (Inferred): For a biopsy needle, acceptance criteria would typically revolve around:
  • Biopsy Yield/Quality: Ability to obtain adequate tissue samples for histological examination.
  • Mechanical Integrity/Functionality: Needle sharpness, rigidity, ease of penetration, absence of breakage, smooth operation of steering mechanisms (if applicable).
  • Biocompatibility: Absence of adverse reactions to materials.
  • Sterility: Maintenance of sterility.
  • Safety: Absence of sharp edges, proper disposal, minimal tissue trauma during deployment and retraction.
• Reported Device Performance: The document states:

  "In addition, comparative performance test data demonstrated adequate device performance."
  and
  "The review of the indications for use and technical characteristics provided demonstrates that the PneumRx Family of Biopsy Needles and Kits is substantially equivalent to the predicate devices."

  • Explanation: This is a high-level statement indicating that the device met the necessary performance characteristics to be deemed substantially equivalent to existing, legally marketed predicate devices. It does not provide specific metrics or raw data. For a biopsy device, "adequate performance" likely refers to successful tissue acquisition and mechanical function on in-vitro or in-vivo (animal) models, confirming it performs comparably to the predicates.

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

• The document does not provide details on the sample size for a test set, nor the data provenance (e.g., country of origin, retrospective/prospective).
• For a 510(k) of this nature (biopsy needle), performance testing often involves bench testing (mechanical strength, sharpness, fluid flow), and potentially animal studies for tissue yield, rather than large human clinical trials, unless a novel feature or indication warrants it.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not mentioned. The 510(k) summary focuses on demonstrating substantial equivalence through technical characteristics and "comparative performance test data," which would primarily involve engineering and possibly animal model assessments. There is no indication of human expert review for establishing ground truth in a "test set" in the context of AI or diagnostic accuracy.

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

• Not applicable/Not mentioned. This concept is typically relevant for studies involving human interpretation or AI performance assessment, which is not the focus of this 510(k) summary.

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. This is a conventional medical device (biopsy needle), not an AI diagnostic tool. Therefore, an MRMC study or AI-related effectiveness study was not performed or mentioned.

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

• No. As explained above, this is a physical medical device, not an algorithm, so standalone algorithm performance is not applicable.

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

• For a biopsy needle, the "ground truth" during performance testing would likely be:
  • Pathology: Confirmation of tissue type and quality from samples retrieved in animal models or bench test substitutes (e.g., gelatin, synthetic tissue).
  • Mechanical Measurement: Engineering specifications for strength, sharpness, bend resistance, etc.
• The document does not explicitly state the ground truth methodology but implies technical verification and potentially histological analysis of acquired tissue in performance testing.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. As above, this is a physical medical device.

In summary:

The provided 510(k) summary for the PneumRx Family of Biopsy Needles and Kits serves to demonstrate substantial equivalence to predicate devices. It relies on the inherent safety and effectiveness of similar devices already on the market and "comparative performance test data" to show that the new device performs adequately. It does not contain the detailed clinical study data, acceptance criteria, or AI-specific performance metrics that would be found in a submission for a novel diagnostic device or an AI-powered system.

Ask a specific question about this device

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.

Ask a specific question about this device

The PunctureNeedle device is intended for use in puncturing precise anatomical locations (including but not limited to cysts, lesions, fluid spaces, etc.) and aspirating or injecting various fluids or contents. The device may be utilized under MRI guidance.

The PunctureNeedle is a standard needle to puncture precise anatomical locations and inject or aspirate various fluids or contents. The proposed device is different than many needles in that the PunctureNeedle device has components manufactured of titanium alloy, which yields less artifact than stainless steel when utilized under magnetic resonance conditions.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a study, or any of the other specific details requested in your prompt regarding a study that proves a device meets acceptance criteria.

The documents are a 510(k) summary for the "PunctureNeedle" device and the FDA's clearance letter for it. They describe the device, its intended use, technological characteristics, and its substantial equivalence to predicate devices, particularly highlighting its titanium alloy components for reduced MRI artifact. However, there is no mention of a clinical or technical study proving specific performance metrics against defined acceptance criteria.

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

Ask a specific question about this device