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The Daum NeuroCut NeuroBiopsyNeedle is designed for biopsy of the soft tissue in the brain. The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle.

Daum NeuroCut NeuroBiopsy Needle

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Daum NeuroCut NeuroBiopsy Needle). This type of document does not contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert involvement in a study.

The letter primarily confirms that the device is substantially equivalent to a previously marketed device and can therefore be legally marketed. It details regulatory classifications, general controls, and responsibilities of the manufacturer.

Therefore, according to the provided input, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets those criteria.

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The DAUM Bone Biopsy Set is intended for the biopsy of bone tissue. The DAUM Bone Biopsy Set is also a low-artifact-instrument designed to be used in the MRI for the above purpose.

The DAUM Bone Biopsy Set consists of a working tube, stylet, power drill drive, manual drill and an ejector drift. The drill is supplied as a disposable unit. All of the other components of the set are supplied as reusable products.

The provided text describes a 510(k) summary for the DAUM Bone Biopsy Set. It focuses on establishing substantial equivalence to a predicate device and notes performance data related to MR Safety. However, it does not contain the detailed clinical study information typically found when a device's diagnostic or therapeutic efficacy is being evaluated against specific acceptance criteria.

Therefore, many of the requested fields cannot be filled 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

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

• Not available in the provided text. The document only mentions "Performance Data: The DAUM Bone Biopsy Set has been tested for MR Safety in a 0.2T static magnetic field." It does not specify the sample size of any test set (e.g., number of patients, number of devices tested), nor its provenance (e.g., country of origin, retrospective/prospective nature).

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 available in the provided text. The testing described relates to MR safety, not a diagnostic or efficacy study requiring expert assessment of ground truth in the usual sense (e.g., disease presence). No experts are mentioned in relation to establishing ground truth for the MR Safety test.

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

• Not applicable/Not available in the provided text. This type of adjudication is typically for diagnostic studies. The MR safety test described would not involve such a method.

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 device is a biopsy set, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical medical device (bone biopsy set), not an algorithm.

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

• For the MR Safety testing, the ground truth would have been established by engineering standards and measurement criteria for magnetic field interactions, heating, and artifact generation, not clinical outcomes or expert consensus on diagnosis. The method for determining "acceptable for patient use" in an MR environment would be based on established safety limits and methods for testing metallic implants/devices in MRI.

8. The sample size for the training set

• Not applicable/Not available in the provided text. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. As above, no training set for an AI/ML device.

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The Daum NeuroBiopsy Needle is designed for biopsy of the soft tissues in the brain. The Daum NeuroBiopsy Needle is also a low-artifact-instrument designed to be used in the MRI for the above purpose.

Not Found

This looks like a 510(k) clearance letter for the Daum NeuroBiopsy Needle and an Indications for Use statement. This type of document generally contains regulatory approval information for a medical device but does not include details on acceptance criteria or studies proving device performance. The letter confirms the device is substantially equivalent to legally marketed predicate devices and can proceed to market, but it doesn't present data from clinical trials or performance studies.

Therefore, I cannot provide the requested information based on the provided text.

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The Daum AspirationBiopsy Needle is intended for use in precutaneous or open surgical biopsies, including, but not limited to biopsy of breast, kidney, liver, lymph nodes, and prostate. The Daum AspirationBiopsy Needle is also a low-artifact-instrument designed to be used in the MRI for the above purposes.

Daum AspirationBiopsy Needle

This letter is a 510(k) clearance for the Daum AspirationBiopsy Needle. The provided document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the device is substantially equivalent to legally marketed predicate devices, which means it has been found to have the same intended use and technological characteristics as a device already on the market, or to have different technological characteristics but be as safe and effective as a legally marketed device.

Therefore, I cannot provide the requested information based on the provided text.

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The Daum BiopsyGun is deigned to automatically perform a biopsy of soft tissues. The Daum BiopsyGun is also a low-artifact-instrument designed to be used in the MRI for the above purpose.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria, study details, or performance data for the "Daum BiopsyGun." The document is an FDA 510(k) clearance letter, which confirms the device's substantial equivalence to a legally marketed predicate device but does not include the specifics of performance studies. Therefore, I cannot generate the requested table and answer the study-related questions based on this input.

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The Daum NeuroPuncture Needle is designed for use in open and percutaneous sur cal pr of the brain i.e., punctures, biopsies and instillation of substrates. The Doum NeuroPunchia Needle is also a low-artifact-instrument designed to be used in the MRI for the above purposes.

Daum NeuroPuncture Needle

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance,
or details about any studies conducted (sample size, experts, adjudication, MRMC, standalone performance, training set details).
The document is a US FDA 510(k) clearance letter for the Daum NeuroPuncture Needle, indicating that the device has been
found substantially equivalent to a predicate device. It defines the device's indications for use but does not contain
the kind of detailed study results you are asking for.

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