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The Bio-Cut Soft Tissue Biopsy Needle is intended for harvesting soft tissue biopsy specimens.

The biopsy instrument is a sterile disposable device which features a stainless steel cannula with an echogenic tip, and a stainless steel stylet which is spring loaded and fitted into a plastic handle permitting single handed specimen collection. Sizes are available in 14 - 20 gauge needles. The length of the needles ranges between 9 and 20 cm. The needle is used by advancing the entire device to the site of soft tissue sampling. The needle is advanced with gentle but firm pressure. Once the needle is in position, the sample is taken and the device is removed from the sampling site. The sample can then be expelled from the stylet notch.

The provided text describes a Special 510(k) Premarket Notification for the Manan Bio-Cut Soft Tissue Biopsy Needle. However, it does not contain the detailed information necessary to answer all the questions about specific acceptance criteria and a study proving the device meets them. The document focuses on establishing substantial equivalence to predicate devices and outlines the device's description and intended use.

Here's an attempt to answer the questions based on the available information and, where information is missing, to explicitly state that it is not provided in the text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not specify quantifiable acceptance criteria or reported device performance metrics from a study. It focuses on the device's description, intended use, and substantial equivalence to legally marketed predicate devices.

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

The document does not describe a specific test set, its sample size, or its data provenance. This type of information would typically be found in a detailed study report.

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

The document does not mention any experts used to establish ground truth or their qualifications. This is because no specific performance study with a test set is detailed.

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

As no specific test set or ground truth establishment method is described, there is no information on an adjudication 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

The device described is a physical medical instrument (a biopsy needle), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and not mentioned in the document.

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

This question is not applicable as the device is a physical biopsy needle, not an algorithm or AI system.

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

Since no specific performance study is detailed, the document does not describe the type of ground truth used. For a biopsy needle, performance might be evaluated by factors like sample adequacy (confirmed by pathology), ease of use, or mechanical properties, but these are not specified here.

8. The sample size for the training set

The document does not mention a training set. This is irrelevant for a physical medical device that is not an AI/machine learning product.

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

This question is not applicable as no training set is mentioned for this physical device.

Summary of Study Information in the Document:

The provided 510(k) summary for the Manan Bio-Cut Soft Tissue Biopsy Needle, K052802, is a regulatory submission focused on demonstrating substantial equivalence to predicate devices (Manan Super-Core Biopsy Needle K950732 and Medical Device Technologies Super-Core Biopsy Needle K974814). It describes the device, its intended use, and technological characteristics. The document does not include details about specific performance studies, clinical trials, acceptance criteria, or expert evaluations related to device performance in the way often associated with AI/software devices or more complex diagnostic tools. The FDA's letter confirms that the device is substantially equivalent, allowing it to be marketed under general controls.

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For the spinal administration of anesthetic agents to elicit regional anesthesia.

Spinal Needle

The provided document is a 510(k) clearance letter from the FDA for a spinal needle. It does not contain any information about acceptance criteria, device performance studies, or the use of AI/algorithms.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and study designs. The document is strictly a regulatory clearance letter acknowledging substantial equivalence to a predicate device.

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For the epidural placement, directly or through a catheter, of anesthetic agents to elicit regional anesthesia.

Epidural Needle (Touhy, Hustead, Crawford, Weiss)

This document is a 510(k) clearance letter from the FDA for an "Epidural Needle." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to the request.

Therefore, I cannot provide the requested table and study details based on the provided text. The document is solely a regulatory clearance letter.

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For simplifying insertion of a guide-wire and/or catheter through various ports(such as a Touhy-Borst) used in intravascular administration sets.

Blunt Needle

This document is a 510(k) clearance letter from the FDA for a "Manan Blunt Needle." It's a regulatory document indicating substantial equivalence to a predicate device, and it does not contain information about acceptance criteria or a study proving device performance as requested.

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

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These needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating.

The breast localization needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.

The biopsy needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating.

The breast localization need in MRI, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.

The provided text pertains to a 510(k) submission for various medical needles (biopsy and breast localization needles) and focuses on the "Substantial Equivalence" claim, rather than a study demonstrating performance against specific acceptance criteria for a novel device. The document identifies substantially equivalent predicate devices but does not detail a study conducted to prove the performance of the new device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because the document does not contain this type of performance study data. The 510(k) summary explicitly states "SUBSTANTIAL EQUIVALENCE" and lists predicate devices, indicating the regulatory pathway chosen.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Stand-alone algorithm performance data.
7. The type of ground truth used in a performance study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

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Needle can be used for obtaining core and/or aspiration biopsies of various tissues (Prostate, lung, kidney, liver, spleen, thyroid, adrenals, abdominal soft tissue masses, breast). For Breast Biopsy this product is for diagnosis only-not for therapeutic use.

Automatic Cutting Needle

This document is a 510(k) clearance letter from the FDA for a medical device called the "Manan Automatic Cutting Needle." It indicates that the device has been found substantially equivalent to a predicate device already on the market.

However, the letter does not contain any information regarding specific acceptance criteria, study details, or performance data for the device. It primarily focuses on the regulatory clearance process and the device's classification.

Therefore, I cannot provide the requested information in the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document is a regulatory approval letter, not a technical report or study summary.

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Needles can be used in MRI, Flouroscopic, CT and Mammographic procedures for obtaining biopsies of various tissues.

MRI Chiba Needle, MRI Spinal Needle, MRI Automatic Cutting Needle, MRI General Purpose Introducer Needle, MRI Techna-Cut Biopsy Needle, MRI Super-Core Biopsy Needle, MRI Breast Localization Needle, and MRI Simon Breast Localization Needle

The provided text is a 510(k) clearance letter from the FDA for a set of MRI-compatible needles. It states that the devices are substantially equivalent to devices marketed prior to May 28, 1976. This type of clearance does not require the submission of clinical study data demonstrating specific performance criteria or a study proving the device meets those criteria.

Therefore, based solely on the provided text, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not provided. The 510(k) clearance simply asserts substantial equivalence, not specific performance metrics.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not 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: Not applicable. This is for medical devices, specifically needles, and not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for medical devices, specifically needles, and not an AI or imaging diagnostic device.
7. The type of ground truth used: Not applicable, as there's no study described for performance evaluation.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary based on the provided document:

The document is an FDA 510(k) clearance letter confirming that the listed MRI needles are substantially equivalent to predicate devices already on the market. It does not contain information about specific acceptance criteria, performance studies, or clinical trial data that would be relevant to evaluating new performance claims for an AI or diagnostic device. The clearance is based on the devices being comparable to existing ones, rather than demonstrating novel performance against defined criteria through a study.

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