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The Gallini BIOSYSTEM Needle is used for bone biopsy and aspiration procedures.

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The provided text is a 510(k) premarket notification approval letter for the Gallini BIOSYSTEM® Bone Marrow Aspiration/Biopsy Needle. This document determines substantial equivalence to a predicate device based on its indications for use, but it does not contain any information regarding acceptance criteria or the results of a study demonstrating device performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than a detailed technical performance study.

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CThe Gallini Atra-Cut Needle is used for fine bone biopsy and aspiration procedures.

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The provided text is a 510(k) clearance letter from the FDA for the Gallini Atra-Cut® Needle. It does NOT contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.

The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices, which allows it to proceed to market. It refers to a "510(k) notification of intent to market" which would have contained the technical details and performance data, but this specific document (the clearance letter) itself does not include that information.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies based only on the text you provided.

To answer your request, you would need the actual 510(k) submission document or a summary thereof, which typically includes the performance data and comparisons to predicate devices.

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The Gallini Bycut Needle is used for bone biopsy.

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The provided text is a 510(k) clearance letter from the FDA for a bone biopsy needle. It does not contain any information about acceptance criteria or a study that proves a device meets those criteria.

The letter only states that the device, the Gallini Bycut® Bone Biopsy Needle, is substantially equivalent to legally marketed predicate devices for bone biopsy and can therefore be marketed.

Therefore, I cannot provide the requested information.

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The Speed-Cut is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney.

The Speed-Cut is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney.

This document is a 510(k) clearance letter for the Speed-Cut Automatic Biopsy System and only confirms the device's substantial equivalence to a predicate device. It does not contain the acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information.

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This device is to be used for spinal biopsies.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called the "Spigal Needle." It confirms the device's substantial equivalence to previously marketed devices.

This document does not contain information about:

• Acceptance criteria and reported device performance in a table.
• Details of any study, including sample sizes, data provenance, expert qualifications, or adjudication methods for ground truth.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used or details about training sets.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA clearance letter.

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This device is to be used for soft tissue biopsy.

Quick-Cut® Automatic Biopsy System

This document is a 510(k) clearance letter from the FDA for a medical device called the "Quick-Cut® Automatic Biopsy System." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Unfortunately, this document does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in the 510(k) submission itself, which is a much more extensive document presented to the FDA for review, rather than in the final clearance letter. The clearance letter is a summary of the FDA's decision based on its review of that submission.

Therefore, I cannot provide the requested table and study details based solely on the provided text.

Here's what I can extract and what is missing:

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

• Not present. The document does not define any specific performance metrics or acceptance criteria for the device, nor does it report any performance data.

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

• Not present. The document makes no mention of test sets, sample sizes, or data provenance.

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 present. The document does not discuss ground truth establishment or the involvement of experts in that process.

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

• Not present. The document does not describe any adjudication methods.

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 present. The document is for a biopsy system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to AI assistance would not be applicable or mentioned.

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

• Not present. This device is a biopsy system, a physical tool, not an algorithm. Standalone performance for an algorithm is not applicable.

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

• Not present. The document does not describe how ground truth was established for any studies. For a biopsy system, the de facto "ground truth" for its performance would typically be the quality of tissue samples obtained and their subsequent pathological analysis, but this is not discussed in the provided text.

8. The sample size for the training set

• Not present. This device is a biopsy system, not a machine learning algorithm that requires a training set.

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

• Not present. Not applicable for this type of device.

What the document does state:

• Device Name: Quick-Cut® Automatic Biopsy System
• Indications for Use: This device is to be used for soft tissue biopsy.
• Regulatory Class: II
• Product Code: KNW
• Regulatory Decision: Substantially equivalent to devices marketed prior to May 28, 1976. This means the FDA found that the device is as safe and effective as a legally marketed predicate device, and thus does not require a full Premarket Approval (PMA) submission. Substantial equivalence is determined by comparing the new device to a predicate device regarding intended use, technological characteristics, and performance data if needed to demonstrate equivalence. The details of that comparison are what's missing here.

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This device is to be used for bone marrow aspiration biopsy from the sternum or iliac crest.

ACRI-R Needle

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "ACRI® Needle." This letter indicates that the device has been determined to be substantially equivalent to a predicate device already on the market.

It is crucial to understand that a 510(k) clearance process does not inherently require a study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel high-risk medical device might. Instead, substantial equivalence is often demonstrated through:

• Comparison to a predicate device: Showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
• Performance testing: This typically involves bench testing, biocompatibility testing, sterilization validation, and potentially some limited clinical performance data, but not necessarily a full-fledged comparative effectiveness study or a study with pre-defined acceptance criteria for diagnostic accuracy (as would be common for AI/ML devices).

Therefore, based on the provided text, many of the requested details about acceptance criteria and a study proving their achievement cannot be extracted because they are not typically part of a 510(k) clearance document for this type of device (a biopsy needle).

However, I can extract the following information that is relevant to the device and its intended use:

Device Information:

• Trade Name: ACRI® Needle
• Regulatory Class: II
• Product Code: KNW
• Indications For Use: This device is to be used for bone marrow aspiration biopsy from the sternum or iliac crest.
• Type of Device: Bone marrow aspiration biopsy needle.

Regarding your specific questions, this document does not contain the information you are looking for related to performance studies with acceptance criteria as typically understood for AI/ML or diagnostic devices.

Let's address each point based on the absence of this information in the provided document:

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

   • Information not available in the provided text. The 510(k) letter does not detail specific acceptance criteria for a performance study nor report device performance against such criteria. The "performance" being assessed here is its substantial equivalence to a predicate device, which implies it performs as safely and effectively for its intended use.

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

   • Information not available in the provided text. This type of detail would be found in a study report, not a 510(k) clearance letter for a mechanical device like a needle.

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):

   • Information not available in the provided text. This is not relevant for a mechanical device like a needle and its 510(k) clearance.

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

   • Information not available in the provided text.

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:

   • Information not available in the provided text. This device is a biopsy needle, not an AI/ML diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

   • Information not available in the provided text. This is not an algorithm-based device.

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

   • Information not available in the provided text. For a biopsy needle, the "ground truth" of its performance might relate to its ability to successfully obtain a biopsy or its safety (e.g., prevention of breakage). However, these specific metrics are not detailed in the FDA letter.

8. The sample size for the training set:

   • Information not available in the provided text. This concept is completely inapplicable to a mechanical, non-AI device.

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

   • Information not available in the provided text. Also inapplicable.

In summary: The provided document is an FDA 510(k) clearance letter for a medical device (a biopsy needle), demonstrating substantial equivalence rather than reporting on a study with specific performance acceptance criteria often associated with diagnostic or AI-based devices. Therefore, most of the detailed information you requested regarding study design, sample sizes, ground truth, and expert involvement is not present nor relevant for this type of FDA submission.

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This device is to be used for taking histological and cytological biopsies of soft tissue.

IBI® Needle

The provided document is a 510(k) clearance letter from the FDA for a device named "IBI® Needle". This letter confirms substantial equivalence to a predicate device and outlines regulatory information. However, the document does not contain information about specific acceptance criteria for device performance, a study proving the device meets these criteria, or any details related to AI performance, sample sizes for testing or training, ground truth establishment, or expert involvement.

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

The document only states the "Indications for Use: This device is to be used for taking histological and cytological biopsies of soft tissue." It does not delve into the performance metrics of the device itself.

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The instrument is designed to be used for high-speed histological biopsy.

ABS® Device

This document is a 510(k) premarket notification letter from the FDA to Gallini U.S., L.L.C. for their "Gallini ABS Device" (K973152). It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The letter is a notification of substantial equivalence, which primarily means the FDA believes the device is as safe and effective as a legally marketed device and can be cleared for market. It does not typically include detailed performance study results or acceptance criteria within the letter itself. Such information would usually be found in the 510(k) submission document, which is not provided here.

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

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The instrument is designed to be used to provide access to lesions to be biopsied.

Coaxial Introducer

This document is an FDA 510(k) clearance letter for the "Coaxial Introducer" and does not contain the acceptance criteria or study details requested in the prompt.

The letter explicitly states:

• Trade Name: Coaxial Introducer
• Regulatory Class: II
• Product Code: KNW
• Indications for Use: The instrument is designed to be used to provide access to lesions to be biopsied.
• Date of Clearance: July 29, 1997

The letter confirms that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This is a regulatory determination, not a clinical performance study. The letter does not describe any specific performance criteria, testing, or studies, as it is solely focused on the regulatory clearance process.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria from the provided text.

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