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The Acueity ViaDuct Miniscope and Accessories are intended for use by a physician for viewing an interior cavity of the human body through either a natural opening or an incision. The accessory device is capable of grasping soft tissue for biopsy. The instruments are to be used for diagnostic or graspilly son thisue not intended for therapeutic use.

Like the predicate devices, the Acueity ViaDuct Miniscope and Accessories consist of a semi-rigid fiberscope with an irrigating outer sheath or introducer capable of passing a biopsy needle to a soft tissue site for view or, to view and assess/biopsy soft tissue. The Acueity ViaDuct Miniscope and Accessories is also designed with an inner grasping sheath or tube that can be placed within the outer introducer, which together act as forceps capable of grasping soft tissue for biopsy. The combination of these devices allows access to very finite spaces.

The provided 510(k) summary (K040949) for the ViaDuct Miniscope and Accessories does not contain any information regarding specific acceptance criteria, device performance studies, or clinical trial data. It is a premarket notification for a medical device seeking substantial equivalence to predicate devices, rather than a submission detailing performance against predefined metrics.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be extracted from the given text.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

• Cannot be provided. The document does not specify any quantitative acceptance criteria or provide a table of reported device performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or biopsy. The submission focuses on demonstrating substantial equivalence in terms of intended use, principles of operation, anatomical site, safety characteristics, and physical characteristics.

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 states, "All necessary testing was or will be performed on the ViaDuct Miniscope and Accessories to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness." However, it does not detail any specific test sets, sample sizes, or data provenance from studies designed to prove clinical performance. This typically refers to bench testing, biocompatibility, sterilization, and sometimes animal studies, but not necessarily human clinical trials for diagnostic performance in the way AI/ML devices often do.

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)

• Cannot be provided. No clinical test set involving expert ground truth determination is described in this document.

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

• Cannot be provided. As no clinical test set is detailed, no adjudication method is mentioned.

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 document predates the common practice of extensive AI/ML efficacy studies and does not describe any MRMC studies comparing human readers with and without AI assistance. The device is purely an imaging and biopsy tool, not an AI-powered diagnostic algorithm.

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

• Cannot be provided. This device is a manual, physical instrument (fiberscope, biopsy forceps) and does not involve an algorithm with standalone performance.

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

• Cannot be provided. No specific ground truth type is mentioned for a performance study. For a device like this, "ground truth" might refer to the successful retrieval of tissue biopsies or direct visual confirmation of anatomical structures, but this is not detailed in the context of a performance study proving diagnostic accuracy.

8. The sample size for the training set

• Cannot be provided. This refers to a physical device, not an AI algorithm, so there is no "training set."

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

• Cannot be provided. As there is no training set for an algorithm, this question is not applicable.

Summary of Device and Regulatory Context from the Document:

• Device Name: ViaDuct Miniscope and Accessories
• Device Description: Semi-rigid fiberscope with an irrigating outer sheath/introducer, capable of passing a biopsy needle, and an inner grasping sheath/tube functioning as forceps for soft tissue biopsy.
• Intended Use: For use by a physician for viewing an interior cavity of the human body (via natural opening or incision) and for grasping soft tissue for biopsy. It is for diagnostic purposes only and not therapeutic use.
• Regulatory Pathway: 510(k) Pre-market Notification, seeking substantial equivalence.
• Predicate Devices: Acueity (formerly DOFI Communications, Inc.) Miniaturized Biopsy Scope (K011189) and Acueity ViaDuct Microendoscope and Accessories (K983527).
• Substantial Equivalence Claim: Based on similar intended use, principles of operation, anatomical site for viewing and sampling, safety characteristics, and physical characteristics compared to predicate devices.
• Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed under general controls.

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The Acueity Excisor Bioptome is a multiple action biopsy system intended for obtaining a soft tissue breast biopsy. The instruments are to be used for diagnostic purposes only and are not intended for therapeutic use.

The Excisor Bioptome is a percutaneous, mechanical coring device utilizing imaging quidance such as ultrasound and X-ray for breast biopsy. The basic structure of the device includes a Motorized Cutter and detachable stainless steel Introducer with aluminum handle or finger piece and aspiration port and a stainless steel trocar.

The provided text describes a 510(k) submission for the Acueity Excisor Bioptome, a breast biopsy device. However, it does not contain details about acceptance criteria, device performance metrics, or study design for clinical or standalone performance evaluation.

The submission states:

• "All necessary testing will be performed on the Exisor Bioptome to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness." (Section H)
• The FDA's response confirms substantial equivalence based on the provided information but does not detail the specific tests or results.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based solely on the provided text.

The document focuses on the regulatory submission process, intended use, and substantial equivalence to predicate devices (US Biopsy Single Action Bioipsy Device (K954231) and Ethicon Mammotome Hand Held System (K991980)), rather than on detailed performance study results.

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The Acueity Medical Light Source is indicated for use in illuminating the operative site and providing video images that can be displayed on a monitor. The device is designed for attachment to endoscopes and laparoscopes that are used in medical procedures.

The Medical Light Source was specifically designed for medical applications. Therefore, the highest safety requirements for the patient as well as for the physician are applied. The Light Source combines highest illumination requirements with high-resolution video capabilities through an integrated highresolution ¼", ½" or 1/3" CCD camera board.

This document does not contain information about specific acceptance criteria or an analytical study with performance metrics for the Acueity Medical Light Source beyond general claims of safety and effectiveness.

Based on the provided text, the device's approval relied on demonstrating substantial equivalence to a predicate device (Welch Allyn Illumination Platform K951647) rather than meeting predefined numerical performance targets in a study specific to this submission.

Here's a breakdown of why the requested information cannot be extracted and what the document does state:

Missing Information:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence, not detailed performance metrics against specific criteria.
• 2. Sample size used for the test set and the data provenance: Not provided. No specific test set data is mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set with ground truth.
• 4. Adjudication method for the test set: Not applicable.
• 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. This device is a light source and video system, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding acceptance criteria and study:

The document states:

• Substantial Equivalence: "The Acuiety Light Source and Video Camera System is substantially equivalent to the Welch Allyn Illumination Platform (K951647). The Medical Light Source is substantially equivalent to the predicate device in intended use, technological characteristics, materials, manufacturing processes, and components."
• General Testing: "All necessary testing was performed on the Medical Light Source to ensure that the product is substantially equivalent to the predicate devices and to ensure that the device does not raise new questions of safety and effectiveness."

Conclusion:

The provided 510(k) summary is for a medical light source and video camera system, not an AI-powered diagnostic device. Its approval hinges on demonstrating substantial equivalence to a previously cleared predicate device, rather than through a study with specific, numerically defined acceptance criteria for performance as would be expected for a novel AI or diagnostic tool. The document confirms that "all necessary testing was performed" to support this claim of substantial equivalence and to ensure safety and effectiveness, but it does not specify what those "necessary testing" protocols entailed or provide quantitative results for them.

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