Search Results

Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.

Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.

Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.

Automatic Disposable Biopsy Needle, Semi-automatic Disposable Biopsy Needle and Coaxial Biopsy Needle are hand-operated, non-electronic, surgical instruments.

Automatic Disposable Biopsy Needle is designed for the automatic extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/ testing. Automatic Disposable Biopsy Needle is first loaded and then inserted into the edge of the target tissue. Then, the inner needle rod is threaded into the target lesion (automatic firing), then, the outer needle tube is fired to push forward, and the tissue sample is cut through the relative movement of the outer needle tube and the inner needle rod of the biopsy needle, later, the tissue sample is cut off and stored in the sampling groove. Finally, specimen was removed after withdrawing the biopsy needle.

Semi-automatic Disposable Biopsy Needle is designed for the extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/testing. The semi-automated biopsy needle requires manual advancement of the inner needle to expose the specimen notch. With pressure on its plunger, a spring action rapidly advances the outer needle (cutting cannula) over the specimen notch of the inner needle.

Coaxial Biopsy Needle is used with biopsy needles to quide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is supplied with trocar tip stylet with or without blunt tip needle.

All of these devices are sterile with a Sterility Assurance Level (SAL) of 10-6, nonpyrogenic and single-use devices.

This submission is a 510(k) Pre-Market Notification for a traditional medical device (a biopsy needle), not an AI/ML-enabled device. As such, the information provided does not include the details typically found in submissions for AI/ML devices regarding acceptance criteria, training/test sets, expert adjudication, or MRMC studies.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, non-clinical bench testing (biocompatibility, packaging, shelf life), and the assertion that "Bench testing is sufficient to demonstrate performance of the device. No preclinical testing of the subject device is necessary" and "Performance Test is sufficient to demonstrate safety and effectiveness of the subject devices with the predicate devices."

Therefore, I cannot extract the requested information about acceptance criteria for an AI/ML device, training/test set details, expert ground truth establishment, or clinical study methodologies (like MRMC) from this document.

The document discusses the following types of tests and their conformity:

1. Acceptance Criteria and Device Performance (Summary of Non-Clinical Testing):

The acceptance criteria are not explicitly numerical thresholds like sensitivity/specificity for an AI model. Instead, they are met by demonstrating compliance with recognized consensus standards and by comparing performance to predicate devices. The "reported device performance" is essentially that the device passed these tests and met the design requirements.

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

• This information is not applicable and not provided in the context of this traditional medical device submission. The "test set" here refers to physical devices undergoing bench testing, not a dataset for an AI model.
• The data provenance would be that the tests were conducted by the manufacturer according to specified standards.

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

• Not applicable as this is not an AI/ML device requiring expert-labeled ground truth for a test set. Ground truth for the device's performance is established through objective physical and chemical testing against established standards and comparisons to predicate devices.

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

• Not applicable. This concept is relevant for AI/ML model training/testing, not for physical device bench testing.

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 not an AI/ML device used for reading or interpretation.

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

• Not applicable. This is a physical biopsy needle, not an algorithm.

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

• Ground truth for this device's performance is based on pre-defined engineering specifications, material properties, sterility assurance levels, biocompatibility standards, and functional requirements (e.g., puncture force, resistance to breakage, sample integrity). It is not derived from clinical outcomes or expert consensus on image interpretation.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. No machine learning training set is involved.

Ask a specific question about this device