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The Disposable Semi Automatic Biopsy Instrument is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone.

The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures

The disposable semi automatic biopsy instrument (hereinafter referred to as biopsy instrument) is divided into A and B in accordance with different configuration. A contains semi automatic biopsy needle. B contains semi automatic biopsy needle and coaxial biopsy needle.

The disposable semi automatic biopsy instrument consists of cannula, stylet, protecting sheath and mechanical powering parts. The coaxial biopsy needle consists of canular housing, canula, marker, stylet with sharping, stylet without sharping (option), stylet housing and protecting sheath.

It is available in several gauge sizes and lengths. Both the A and B of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, and green= 14G). The needles have a protecting sheath.

The disposable semi automatic biopsy instrument is loaded a semi automatic biopsy needle that is visible in ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. Centimeter markings on the cannula surface permits an easy identification of the insertion depth with the maximum safety for the patient.During use, the position of the device is monitored using technique. The inner stylet which has a triple face ultra-sharp tip to penetrate easily also into fibrous tissues is equipped with a slot/ groove (a 19mm specimen notch) to collect a biopsy specimen.

During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen.

The materials used for construction of disposable semi automatic biopsy instrument are typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10.

As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

This document describes acceptance criteria and testing for the Disposable Semi Automatic Biopsy Instrument (K212820) by Suzhou Leapmed Healthcare Corporation.

Acceptance Criteria and Device Performance Study

The acceptance criteria for the Disposable Semi Automatic Biopsy Instrument are based on non-clinical testing, particularly bench testing, to assess performance and functionality against requirement specifications and recognized consensus standards. The study demonstrates that the device performs equivalently to its predicate device (SemiCut Semi-automatic Biopsy Needle, K160316) and meets safety and effectiveness requirements.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each bench test. However, it indicates that "bench testing was performed" and "results from testing performed confirms that the design requirement specification and user needs have been met." The tests involved evaluating the subject device against technical specifications and sometimes comparing it directly with the predicate device.

The data provenance is non-clinical bench testing conducted by the manufacturer, Suzhou Leapmed Healthcare Corporation. No information regarding country of origin for the test data itself is given beyond the company's location in China. The testing is reported as retrospective in the sense that it evaluates the manufactured device against pre-defined specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of submission. The ground truth for the bench testing is established by compliance with international standards (ISO 9626, ISO 10993, ISO 11607, ISO 7864) and manufacturer's design specifications. No human expert "ground truth" in the diagnostic sense is required for these mechanical and material tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against defined criteria in established international standards. There is no human interpretation or adjudication in the typical sense (e.g., 2+1, 3+1 consensus) as would be the case for clinical image interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission." This device gained clearance based on non-clinical (bench) testing and substantial equivalence to a predicate device.

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

Not applicable. This device is a physical medical instrument (biopsy instrument), not an AI algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on:

• Engineering specifications: The device's design requirements, such as depth projection and bonding strength.
• International Consensus Standards: ISO 9626 (Stiffness, Resistance to Breakage), ISO 10993 (Biocompatibility), ISO 11607-1 (Sterilization and Shelf Life), ISO 7864 (Bonding Strength).
• Functional requirements: The ability to successfully retrieve biopsy specimens and ultrasound visibility.

8. The Sample Size for the Training Set

Not applicable. This submission concerns a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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Disposable Biopsy Refill Needle is intended for soft tissue core biopsy from liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. The device is not intended for use in bone.

The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The disposable biopsy refill needle (hereinafter referred to as refill needle) is divided into A and B in accordance with different configuration. A contains biopsy refill needle. B contains biopsy refill needle and coaxial biopsy needle.

The disposable biopsy refill needle consists of stylet housing, stylet, canular housing, fixation parts, canula and protecting sheath.

It is available in several gauge sizes and lengths. Both the A and B of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, green= 14G, pale blue= 12G). The needles have a protecting sheath.

The Disposable Biopsy Refill Needle is visible in ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen.

The materials used for construction of Disposable Biopsy Refill Needle is typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10.

As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

The provided text describes the regulatory clearance (510(k)) of a medical device, the "Disposable Biopsy Refill Needle," and focuses on demonstrating its substantial equivalence to a predicate device. This type of submission relies heavily on non-clinical (bench) testing and comparison to an already cleared device, rather than extensive clinical studies for standalone or comparative effectiveness of an AI/human-in-the-loop system.

Therefore, many of the requested elements for an AI-based device (like MRMC studies, ground truth establishment for large datasets, sample sizes for training/test sets for machine learning models, and expert qualifications for data labeling) are not applicable to this specific traditional medical device clearance.

Here's an analysis based solely on the provided text:

Device: Disposable Biopsy Refill Needle
Regulatory Submission Type: 510(k) Premarket Notification (for substantial equivalence to a predicate device, not an AI/ML device)

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

Based on the provided text, the acceptance criteria are generally established by meeting recognized consensus standards and demonstrating performance equivalent to the predicate device. The performance is reported as "Conformity has been demonstrated" for various tests.

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

The document primarily discusses bench testing of a physical device. It does not refer to a "test set" in the context of a machine learning model, nor does it detail specific sample sizes for each bench test performed (e.g., how many needles were tested for penetration force). The data provenance is from non-clinical bench testing conducted by Suzhou Leapmed Healthcare Corporation. No country of origin for data is specified, as it's not a data-driven AI study. All tests are inherently retrospective as they are performed before submission.

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

This question is not applicable to this type of device clearance. There is no "ground truth" in the sense of expert annotation of medical images or data for an AI algorithm. Ground truth for a physical device is established through engineering and quality control measurements against pre-defined specifications and international standards (e.g., ISO, ASTM).

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling disagreements among human readers/experts in AI model ground truth establishment or MRMC studies. For bench testing, results are quantitative or qualitative assessments against defined criteria, not subject to individual interpretation requiring adjudication.

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

There was no MRMC comparative effectiveness study done. The device is a physical biopsy needle, not an AI-assisted diagnostic or interventional system. The submission explicitly states: "No clinical study is included in this submission."

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

This is not applicable. This is a physical medical device, not an algorithm or AI system.

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

For the physical device, the "ground truth" (or basis for acceptance) is derived from:

• Engineering specifications and design requirements: For physical properties like dimensions, material strength, and performance characteristics (e.g., penetration force, stiffness).
• International consensus standards: Such as ISO 9626 (needles), ISO 10993 (biocompatibility), ISO 11607-1 (packaging/sterilization), and ISO 7864 (bonding strength).
• Comparative testing against a legally marketed predicate device: Demonstrating that the new device performs equivalently to a device already deemed safe and effective.

8. The sample size for the training set

This is not applicable. There is no training set as this is not an AI/machine learning device.

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

This is not applicable. There is no training set.

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Disposable Coaxial Biopsy Needle is intended for use with biopsy devices cannula during soft tissue core biopsy procedures. The device is not intended for use in bone.

The disposable coaxial biopsy needle consists of canular housing, canula, marker, stylet with sharping, stylet without sharping, stylet housing and protecting sheath. It is available in several gauge sizes and lengths. The disposable coaxial biopsy needle (hereinafter referred to as coaxial biopsy needle) is divided into 11G、13G、15G、17G、19G in accordance with the outer diameter of canula and 70mm、78mm、100mm、130mm、138mm、170mm、170mm and 178mm in accordance with the length of canula. The materials used for construction of disposable coaxial biopsy needle are typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10. The disposable coaxial biopsy needle can be used with the matching biopsy needle under the guidance of medical imaging, as a channel for other biopsy needles to enter the body and obtain biopsy samples through negative pressure or cutting for clinical diagnosis or treatment. In clinical practice, doctors sometimes repeatedly puncture the target site for biopsy. At this time, the coaxial needle is configured, which provides a channel that the device can take multiple samples at the target site. That avoids repeated puncture and injury on the patient's skin surface. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

The provided text describes a 510(k) premarket notification for a Disposable Coaxial Biopsy Needle. It includes a summary of non-clinical testing, but does not contain any information about acceptance criteria or a study proving the device meets those criteria (e.g., clinical studies, human-in-the-loop studies, or detailed performance metrics from a test set).

The document explicitly states: "No clinical study is included in this submission." and focuses on bench testing, biocompatibility, and sterilization validations to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study that proves the device meets them, as this information is not present in the provided text.

Specifically, the following points from your request cannot be addressed based on the provided document:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria with numerical performance targets are provided, beyond general statements that "Conformity has been demonstrated" for bench tests.
2. Sample sized used for the test set and the data provenance: No sample sizes for performance tests are given, nor data provenance (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical or human-in-the-loop studies are mentioned.
4. Adjudication method for the test set: Not applicable.
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, as this is a physical medical device (biopsy needle), not an AI/software device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the type of device and studies described.
8. The sample size for the training set: Not applicable (no AI/machine learning involved).
9. How the ground truth for the training set was established: Not applicable (no AI/machine learning involved).

The document details the following about the device and its testing:

• Type of Study: Primarily non-clinical bench testing, sterilization validation, and biocompatibility testing.
• Bench Tests Performed (Summary, no detailed results or acceptance criteria given):
  • Depth projection (to confirm no over-throw)
  • Penetration force (comparative to predicate device)
  • Mechanical durability
  • Ultrasound Visibility (of the invasive part)
  • Qualification of metal tubing/needle component (conforms to ISO 9626)
• Biocompatibility Testing: Successfully tested for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and material-mediated pyrogenicity according to ISO 10993 standards.
• Sterilization and Shelf Life: EO sterilized, 3 years shelf life, validated per ISO 11607-1.

The overall conclusion is based on the "substantial equivalence" to a predicate device (MDL INTRO Coaxial Introducer Needles, K160316), primarily through comparing technological characteristics and non-clinical performance, rather than clinical or user-performance studies.

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The Disposable Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not Intended for use in bone.

The disposable automatic core biopsy instrument is divided into QZDA and QZDB in accordance with different configuration. QZDA contains automatic core biopsy instrument. QZDB contains automatic core biopsy instrument and coaxial biopsv needle. The automatic core biopsy instrument consists of canula, stylet, protecting sheath and mechnical powering parts. The coaxial biopsy needle consists of canular housing, canula, marker, stylet, stylet housing and protecting sheath. The subject device is a single use full core biopsy device. It is available in several gauge sizes and lengths. Both the QZDA and QZDB of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, and green= 14G). The needles have a protecting sheath. The disposable automatic core biopsy instrument is a spring-loaded automatic biopsy needle that is visible in CT (computed tomography) and ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen. The materials used for construction of disposable automatic core biopsy instrument are typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

The provided document is a 510(k) Premarket Notification for a Disposable Automatic Core Biopsy Instrument. It details the device's characteristics, intended use, and a comparison to a predicate device.

Crucially, this document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance study.

The submission focuses entirely on a physical medical device (a biopsy instrument) and its substantial equivalence to a legally marketed predicate device through engineering bench testing, biocompatibility testing, and sterilization validation.

Therefore, I cannot provide answers to questions 1-9 as they pertain to AI/Machine Learning device studies, which are not present in this document.

The document explicitly states:
"No clinical study is included in this submission." and "Summary of Non-Clinical Testing".

The "acceptance criteria" and "device performance" mentioned in the document relate to the physical and functional aspects of the biopsy instrument (e.g., depth projection, penetration force, mechanical durability, tip configuration, ultrasound visibility, etc.), demonstrated through bench testing. These are not related to AI model performance (e.g., sensitivity, specificity, AUC) or human reader performance with AI assistance.

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