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The proposed device is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate.

The proposed device is designed to simultaneously fire a stylet followed by a cannula to capture a biopsy sample of soft organs, tumor or masses for histological analysis. The design includes a handle with a thumb tab activated drive mechanism, a side fire button, a rear fire button, and a cannula with a needle tip. The cannula may have marker bands spaced at 1 cm (10 mm) intervals starting from the stylet tip and extending various lengths depending upon the needle. When the device is fully loaded, the yellow indicator is visible when looking at the top of the handle.

The provided text is a 510(k) Premarket Notification for the EasyCore Biopsy System II. This document focuses on establishing substantial equivalence to a predicate device, not on demonstrating performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and study details is not present in this document.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in this document. 510(k) submissions for Class II devices often rely on demonstrating substantial equivalence to a legally marketed predicate device rather than setting new, quantitative performance acceptance criteria that require extensive clinical trials for de novo devices.
• Reported Device Performance: The document states, "The intended use, design, operating principles and materials are similar to devices previously cleared via the 510(k) process." This implies that the device is expected to perform comparably to its predicate device (Easy Core Biopsy System, K040893). No specific performance metrics (e.g., successful biopsy rate, tissue quality, adverse event rates) are reported.

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

• Sample Size: Not applicable/not provided. This document does not describe a test set or a clinical study with human subjects for performance evaluation.
• Data Provenance: Not applicable/not provided.

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

• Not applicable/not provided, as no test set or ground truth establishment process is described.

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

• Not applicable/not provided.

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 a biopsy system, not an AI-powered diagnostic imaging device.

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

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

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

• Not applicable/not provided. The document focuses on the physical characteristics and intended use of the device, not its diagnostic accuracy requiring ground truth. The purpose of the biopsy system is to retrieve tissue for histological analysis, where pathology would establish the ground truth of the sample.

8. The sample size for the training set:

• Not applicable/not provided, as no machine learning algorithm development is described.

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

• Not applicable/not provided.

In summary, the provided 510(k) document for the EasyCore Biopsy System II primarily asserts substantial equivalence to a predicate device (Easy Core Biopsy System K040893) based on similar intended use, design, operating principles, and materials. It does not contain details of a clinical study with acceptance criteria, ground truth establishment, or performance metrics specific to the new device.

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The Easy Core Biopsy System is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs/tumors or masses for histological analysis. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate.

The Easy Core Biopsy System is a sterile, single-use biopsy needle.

The provided document describes a 510(k) premarket notification for the "Easy Core™ Biopsy System." It highlights the device's intended use and substantial equivalence to predicate devices but does not contain information regarding specific acceptance criteria, performance metrics, or a study that would demonstrate the device meets those criteria.

Therefore, most of the requested information cannot be extracted from the given text. The document is primarily a regulatory approval letter and a summary of the device's classification, intended use, and substantial equivalence, not a detailed study report.

Here's what can be inferred or explicitly stated from the provided text:

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

This information is not available in the provided document. The document states "All data gathered demonstrate this device as substantially equivalent" to predicate devices, but it does not specify what performance metrics were measured or what success criteria were set.

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

This information is not available in the provided document. The document refers to "data gathered" but does not detail the specifics of any test set, sample size, 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):

This information is not available in the provided document. As no specific test set or ground truth establishment process is described, this detail cannot be provided.

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

This information is not available in the provided document.

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:

This information is not available in the provided document. The device is a biopsy system, not an AI-assisted diagnostic tool, so an MRMC study in this context is unlikely and not mentioned.

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

This information is not available in the provided document. The device is a physical biopsy system, not an algorithm, so "standalone performance" in that context is not relevant or described.

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

This information is not available in the provided document. While the device is used for "histological analysis," the method for establishing ground truth for any potential comparative study is not discussed.

8. The sample size for the training set:

This information is not available in the provided document. The document does not describe a training set for an algorithmic device.

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

This information is not available in the provided document.

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