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Disposable Biopsy Needle is intended for use in soft tissue biopsies such as liver, kidney, breast, thyroid, prostate, spleen, pancreas, lymph nodes, lung and various soft tissue tumors. It is not intended for use in bone.

Disposable Biopsy Needle is intended for use in obtaining an aspirate for cytology. Disposable Biopsy Needle has five models: BN-MAR-1, BN-MAR-2, BN-MAR-3, BN-MAR-4, BN-MAR-8. The Disposable Biopsy Needle consists of operating handle of Inner stylet, operating handle of cutting cannula, cutting cannula, inner stylet, depth stopper and protective sheath. The models differ as follows:

• Cutting cannula tip type: The cannula tip type of BN-MAR-1, BN-MAR-2, BN-MAR-3 is chiba. The cannula tip type of BN-MAR-4, BN-MAR-8 is greene.
• Operating handle designs:
  • BN-MAR-1, BN-MAR-3, BN-MAR-4 Models:
    a. BN-MAR-1, BN-MAR-3, and BN-MAR-4 have the same operating handle, including the operating handle of inner stylet and operating handle of cutting cannula.
    b. The Operating handle of Inner stylet connector connects to the Operating handle of cutting cannula connector via a straight snap-fit design, allowing for easy disconnection with one hand to remove the Inner stylet.
  • BN-MAR-2, BN-MAR-8 Models:
    a. The Operating handle of Inner stylet of BN-MAR-2 connects to the Operating handle of cutting cannula via a straight snap-fit design connector, allowing easy disconnection with one hand to remove the Inner stylet.
    b. The Operating handle of inner stylet of BN-MAR-8 connects to the Operating handle of cutting cannula via a female Luer taper and male Luer thread taper, which can meet the sealing performances in clinical applications.
• Bevel Angle of the Cutting cannula tip: There are three kinds of bevel angle of the Cutting cannula tip, which are α, β, δ. The bevel angle of the cutting cannula tip of BN-MAR-1 and BN-MAR-2 is α. The bevel angle of the needle tip of BN-MAR-3 is β. The bevel angle of the Cutting cannula tip of BN-MAR-4 and BN-MAR-8 is δ.

Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The cutting cannula has numerically ordered centimeter markings on it to provide reference for depth placement. In the distal area of the cutting cannula, an ultrasound enhancement is available to promote accurate placement under ultrasound or X-ray guidance.

An adjustable depth stopper allows the user to restrict forward movement, localizing the needle tip to the biopsy site.

The Operating handle of Inner stylet is color-coded, which indicates gauge size of the needle. It is available in several needle gauge sizes and lengths.

The Disposable Biopsy Needle is a single-use device, supplied in a sterile state sterilized by EO gas. Re-sterilization by users is forbidden. The shelf life is defined for 3 years, which is verified.

The provided document is a 510(k) clearance letter for a Disposable Biopsy Needle. It is a physical device, not an AI/software device. Therefore, the questions regarding acceptance criteria and studies related to AI performance, such as human-in-the-loop, standalone performance, ground truth establishment for training sets, multi-reader multi-case studies, and effect size of AI assistance, are not applicable.

The document discusses non-clinical tests to demonstrate the safety and effectiveness of the device as a physical product.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with reported performance values in a side-by-side comparison. Instead, it describes various performance tests conducted. The acceptance criteria are implied by successful completion of these tests as per relevant standards.

• Appearance
• Basic dimensions
• Sample collection space and accessibility
• Luer connection
• Connection firmness
• Stiffness
• Toughness
• Corrosion resistance
• Leakage
• Ultrasound detectability
• X-ray detectability
• Protective sheath
• Puncture force
• Chemical Characteristics
• EO and ECH Residual
• Sterility test
• Bacterial endotoxin |
  | Comparative Performance (Sampling) | No significant difference in sampling weight or cell integrity compared to predicate devices across various tissues (liver, kidney, breast, thyroid, prostate, spleen, pancreas, lymph nodes, lungs). |

2. Sample size used for the test set and the data provenance
The document details testing conducted on the device itself and does not refer to a "test set" in the context of diagnostic data. The tests performed are for physical and functional properties of the biopsy needle.

• Sample size: Not explicitly stated for each test, but standard testing practices involve a sufficient number of samples to ensure representativeness and statistical validity.
• Data provenance: Not applicable in the context of patient data; the data is generated directly from testing manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device. Ground truth refers to diagnostic accuracy in AI/imaging studies.

4. Adjudication method for the test set
Not applicable. Adjudication methods are used to establish ground truth in diagnostic studies, typically involving disagreements between expert readers.

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 physical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Comparative study" mentioned in section 4 (Non-Clinical Tests), the ground truth for evaluating sampling performance would inherently be pathology-based assessment of the collected tissue samples (e.g., measuring sampling weight and assessing cell integrity). While not explicitly stated as "ground truth," this is the objective measure used to compare the device's performance against predicates.

8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.

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The Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate. It is not intended for use in bone.

The disposable biopsy needle is a sterile, spring loaded, disposable percutaneous soft tissue biopsy instrument. The disposable biopsy needle consists of a cannula, an inner stylet, a mechanical power device and a protective cover. It is used to obtain tissue samples for tissue biopsy, suitable for tissue biopsy of various organs such as the kidney, liver, prostate etc. The needle need to be inserted by a qualified physician under ultrasound guidance. The button of the mechanical power unit comply with the color coding requirements of ISO 6009, i.e. 18 gauge = Pink. The disposable biopsy needle includes three models: CMBNA/1810, CMBNA/1815, CMBNA/1820.

The provided text is a 510(k) clearance letter for a "Disposable Biopsy Needle." It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information about acceptance criteria, device performance from a clinical study, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

Therefore, many of the requested elements cannot be extracted from this document. However, I can provide what is available, noting where information is absent.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

The document does not explicitly present a table of "acceptance criteria" against which a clinical device performance study was measured. Instead, it details that non-clinical testing was performed to demonstrate substantial equivalence to the predicate device. The performance data provided is primarily related to the physical and material characteristics of the device, rather than diagnostic accuracy or clinical outcomes.

Summary of Reported Performance (Non-Clinical):

Additional Requested Information:

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

   • Sample Size: Not specified for any "test set" in the context of clinical performance. For non-clinical functional testing, "24 repeated sampling steps" were conducted for functional reliability.
   • Data Provenance: Not specified for any clinical data. Non-clinical bench testing was conducted.

2. 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 applicable/Not provided. No clinical test set requiring expert ground truth was described.

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

   • Not applicable/Not provided. No clinical test set requiring adjudication was described.

4. 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:

   • No MRMC study was mentioned. This device is a biopsy needle, not an AI-powered diagnostic tool.

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

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

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

   • Not applicable for clinical ground truth. For non-clinical sampling verification, the "mass and quality" of collected tissue samples were compared.

7. The sample size for the training set:

   • Not applicable/Not provided. This device is a physical instrument, not an AI model requiring a training set.

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

   • Not applicable/Not provided. This device is a physical instrument, not an AI model requiring a training set.

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The Forsvall biopsy needle is intended to collect histological biopsy samples from soft tissue intended for clinical examination. The Forsvall biopsy needle is part of the Forsvall biopsy needle system for prostate biopsy and shall be used together with the Forsvall biopsy gun.

The Forsvall biopsy gun is intended to be used by medical professionals, together with the Forsvall biopsy needle, on male patients to obtain soft tissue samples. The Forsvall biopsy gun is part of the Forsvall biopsy needle system for prostate biopsy.

The Forsvall biopsy needle system for prostate biopsy is indicated whenever there is a need to obtain prostate biopsy samples.

The Forsvall biopsy needle system for prostate biopsy consists of two items: the Forsvall biopsy needle and the Forsvall biopsy gun. The Forsvall biopsy needle is intended for use with the Forsvall biopsy gun. The Forsvall biopsy gun is reusable and the biopsy needle is single use. The Forsvall biopsy system uses a spring loaded gun that mediates a biopsy needle with a side notch used to obtain tissue samples. The biopsy gun is made of metal and hard plastic and the 16/18 gauge 10/15/20/25 cm biopsy needle is made of stainless medical grade steel.

By pulling a handle on the Forsvall biopsy gun, the front wagon therein is tensioned and connected to the Forsvall biopsy needle. When tensioning the load pin also moves along a guide curve. When the front wagon is in its loaded position, the load pin has moved the front needle bracket a small distance backwards in the Forsvall biopsy gun.

The handle is pulled a second time to tension the rear wagon that is connected to the needle in the Forsvall biopsy needle. A tension is created between the outer tube and the needle in order to force closing of the Forsvall biopsy needle. The purpose is to prevent an interstice from arising in order to prevent accumulation of bacteria.

The Forsvall biopsy gun is fired by pushing the trigger, which causes the rear wagon to move forward of the front wagon. This results in the inner part of the needle being forced forward, followed by forward movement of the outer tube. When the Forsvall biopsy gun is fired, the load pin moves the outer tube the final millimeter in order to achieve a soft closing mechanism. On the Forsvall biopsy needle, the outer tube thus stops against the needle head and it is forced closed.

The Forsvall biopsy operates by the outer tube stopping against the needle head in the closing motion. Additionally, the final millimeter in the closing motion is a soft close action in order to protect the needle head from too strong forces. To enable the soft closing action, the Forsvall biopsy gun has a design similar to the predicate device.

This looks like a 510(k) summary for a medical device called the "Forsvall biopsy needle system for prostate biopsy." Unfortunately, the provided text does not contain the information necessary to answer your questions about acceptance criteria and the study proving the device meets them.

The document focuses on demonstrating substantial equivalence to a predicate device (Möller Medical Biopsy Needles and Systems) based on similar indications for use, technological characteristics, and general safety and performance.

Here's why I cannot provide the requested information from the given text:

• Acceptance Criteria and Device Performance Table: The document lists "Non-Clinical and/or Clinical Tests Summary & Conclusions," but it does not provide specific acceptance criteria (e.g., minimum sample length, specific force measurements) or a table comparing these criteria to the device's reported performance. It only states that "All non-clinical tests related to performance as described above passed."
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document briefly mentions "User Testing" in a "simulated clinical setting" but provides no details about:
  • The sample size of this user testing.
  • The provenance of any data (e.g., country, retrospective/prospective).
  • The number or qualifications of experts.
  • Adjudication methods.
  • Whether it was an MRMC comparative effectiveness study or a standalone study.
  • The type of ground truth used.
  • Any training set information.

In summary, the provided FDA 510(k) summary (K242128) does not contain the detailed study information you are asking for regarding acceptance criteria and performance data. It's a regulatory document focused on establishing substantial equivalence, not a detailed scientific study report. Such detailed study information would typically be found in the full 510(k) submission, which is not publicly available in its entirety.

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

Semi-Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors. It is not intended for use in bone.

Disposable Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid and various soft tissue tumors. It is designed for use with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. It is not intended for use in bone.

Automatic Core Biopsy Instrument has seven models. Some models are automatic firing, and others have both automatic firing and delay firing options. The structure is consisted of Inner Stylet, Cutting Cannula, Operating Handle, Actuation button, Depth stopper, Slide block, Protective sheath, Adjustable Knob (on some models), Charging handle (on some models), and Security Lock (on some models). Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The cutting cannula has centimeter scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas.

Semi-Automatic Core Biopsy Instrument has two models. It consists of Inner stylet, Cutting cannula, Fixed handle, Windows, Safety switch, Plunger and Protective sheath. Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The plunger is color-coded. The Cutting cannula has centimeter scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas.

Disposable Coaxial Biopsy Needle has two models. It consists of Inner Stylet, Cutting cannula, Operating handle of Cutting cannula, Operating handle of Inner stylet, Depth stopper, Protective Sheath, Adaptor (optional) and Blunt needle (optional). An adjustable depth stopper is included and is color-coded. It is available in several needle gauge sizes and lengths. It is intended for use as a guiding needle with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. The outer cannula is one gauge-size less than the compatible biopsy instrument/needle. The Cutting cannula has numerical scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas.

This document describes the premarket notification (510(k)) for three medical devices: Automatic Core Biopsy Instrument, Semi-Automatic Core Biopsy Instrument, and Disposable Coaxial Biopsy Needle, manufactured by Zhejiang CuraWay Medical Technology Co., Ltd.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. This document primarily focuses on establishing substantial equivalence to predicate devices based on design, indications for use, and non-clinical performance testing.

Therefore, I cannot provide the requested information regarding:

• 1. A table of acceptance criteria and the reported device performance
• 2. Sample size used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method for the test set
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

The document explicitly states under section 5. Clinical data: "No clinical data was provided." This reinforces that the review was based on non-clinical (bench) testing and comparison to predicate devices, not on a study demonstrating clinical performance or AI/ML algorithm performance.

Summary of available information (Non-Clinical Testing):

The manufacturer performed the following bench testing to demonstrate the intended use of the products:

• Biological Testing (Biocompatibility):
  • In Vitro Cytotoxicity Test (ISO 10993-5: 2009)
  • Intracutaneous Reactivity Test (ISO 10993-23: 2021)
  • Skin Sensitization test (ISO 10993-10: 2021)
  • Irritation or Intracutaneous Reactivity (ISO 10993-10)
  • Acute Systemic Toxicity Test (ISO 10993-11: 2017)
  • Pyrogen Test (ISO 10993-11: 2017)
• Sterilization validation: Performed according to ISO 11135: 2014, with EO and ECH validated per ISO 10993-7: 2008. Sterility test per ISO 11737-2: 2019. SAL=10^-6.
• Packaging and shelf-life testing: Performed according to ASTM F1980: 2016.
• Performance comparison with predicate devices: Included appearance, dimensions, sampling performance, connection firmness, stiffness, toughness, resistance to corrosion, puncture force, and chemical properties.

Conclusion stated in the document:
"The indications for use, design and nonclinical performance testing indicate that the technological characteristics of subject device are equivalent to that of predicate devices. In conclusion, it can be determined that subject device is substantially equivalent to predicate devices."

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The product is indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone and/or bone marrow.

This product is a manual, sterile and disposable biopsy needle intended to aspirate bone marrow and obtain core biopsy samples of bone and/or bone marrow. The product is available in two models, BNMAB-1 and BNMA/CB-1. The main body of product consists of stylet part and cannula part, with a depth guard that can be adjusted for puncture depth. The model BNMA/CB-1 is equipped with an extraction cannula and extraction probe, they can be inserted into the cannula assembly to assist in cutting and removing the sample. The stylet part consists of the stylet and stylet socket, and the cannula part consists of the cannula and cannula socket. The cannula socket has a universal luer connector that can be used to connect the syringe and aspiration.

The stylet and cannula are combined to penetrate into the biopsy tissue, withdrawing the stylet and pushing the cannula forward into the tissue, at the mean time the bone tissue is extracted into the cannula lumen, swing the cannula to cut the root of the specimen, a full bone tissue is obtained.

The Bone Marrow Biopsy Needle is a single-use device, supplied in a sterile state sterilized by EO gas. Re-sterilization by users is forbidden. The shelf life is defined for 3 years.

This document is a 510(k) summary for a Bone Marrow Biopsy Needle. It includes a comparison to a predicate device and non-clinical testing. However, it does not include acceptance criteria for device performance, nor does it describe a study proving the device meets specified criteria. The document explicitly states "No clinical data was provided."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The information provided only demonstrates that bench tests (puncture test, torque test, stiffness test, toughness test, and corrosion resistance test) were conducted and "all test results meet the performance requirements." Furthermore, an "ex vivo sample quality comparison" was performed, and "all the result shows the subject are substantially equivalent to the predicate devices." No specific criteria or detailed results for these tests are presented.

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The Triopsy Biopsy System (instrument and needles) is intended for use in obtaining biopsies from the prostate.

The Triopsy Medical Actuator and Biopsy Needle is comprehensive system that aids in the diagnosis and treatment planning of prostate cancer. The system utilizes an actuator instrument and biopsy needle (disposable) with the intention of gathering prostate tissue and properly identifying its pathology. The needle collects full-length, unbroken apex-to-base core samples with patented ridges that hold and protect the sample's integrity. The actuator allows for variable sample lengths for each area of the prostate to be biopsied increasing accuracy and patient safety by avoiding under or overshooting.

This FDA 510(k) summary describes the Triopsy Biopsy System, consisting of the Triopsy Actuator and Triopsy Biopsy Needles, intended for obtaining prostate biopsies. The submission leverages a comparison to a predicate device, the Bard Magnum Reusable Core Biopsy Instrument & Bard Magnum Disposable Biopsy Core Needle (K934370 & K934371), to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, quantitative manner. Instead, it lists performance requirements that were verified and states that the device "successfully passed all of the results."

Inferred Acceptance Criteria based on the provided text:

The document concludes that the device is "safe, effective, and performs as well or better than the predicate device," and that "technological differences do not introduce or raise new or different questions of safety and effectiveness."

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

The document does not specify the sample size used for the verification and validation (V&V) testing (e.g., how many biopsy procedures were simulated, how many actuations were performed for mechanical durability, or how many users participated in human factors studies).

The data provenance is also not explicitly stated in terms of country of origin or whether studies were retrospective or prospective. Given the nature of performance testing (mechanical, human factors), these are typically prospective studies performed in a controlled environment (e.g., a lab or simulated clinical setting).

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

The document does not mention the use of experts to establish a ground truth for the non-clinical and human factors studies described. These types of tests typically rely on objective measurements and established standards rather than expert consensus on diagnostic outcomes. For pathological evaluation of biopsy samples, there is no mention of experts, suggesting the focus was on the physical characteristics of the sample (e.g., full-length, unbroken) rather than the diagnostic accuracy of the device in a clinical context.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method as it pertains to expert reviews of images or data to establish ground truth. The testing mentioned (depth projection, mechanical durability, etc.) would be assessed against predefined engineering specifications and performance targets, not requiring an adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not conducted, or at least not described in this 510(k) summary. These studies typically assess human reader performance with and without AI assistance, which is not relevant to the mechanical and usability testing described for this biopsy system.

6. Standalone Performance Study

A standalone performance study was not conducted in the sense of an algorithm-only performance to derive diagnostic metrics like sensitivity or specificity. The device is a mechanical biopsy system, not an AI or imaging-based diagnostic algorithm. The "standalone" performance here refers to the device's ability to consistently perform its intended mechanical functions (e.g., penetration, sample extraction) and meet safety requirements. The document indicates that the device's performance requirements were verified through performance testing.

7. Type of Ground Truth Used

For the non-clinical tests:

• Engineering specifications and objective measurements were used as the "ground truth" to verify performance criteria such as depth projection, mechanical durability, penetration, activation force, and sample extraction.
• For human factors studies, the "ground truth" was likely the successful and safe completion of tasks by intended users in simulated clinical scenarios, as evaluated against predefined usability criteria.

There is no mention of pathology, outcomes data, or expert consensus serving as a ground truth for diagnostic accuracy, as this submission focuses on the safety and performance of the biopsy instrument itself, not its diagnostic outcome directly.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission, as the Triopsy Biopsy System is a mechanical device, not a machine learning or AI-driven system that requires training data.

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

As noted above, a training set is not applicable, so the establishment of ground truth for a training set is not relevant to this submission.

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The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).

The Semi-automatic Biopsy-Needle - BIM and Automatic Biopsy Needle - BAM are sterile, spring loaded, disposable percutaneous soft tissue biopsy systems. It consists of the following major components: handle, spring, cannula, stylet, trigger and spring guide. It is used to obtain multiple core biopsy samples from soft tissue such as breast, kidney, liver and prostate. The needle has to be inserted by a qualified physician under MR image guidance.

The FDA 510(k) summary for the Automatic Biopsy Needle BAM and Semi-Automatic Needle BIM provides details of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device (K222462). This report focuses on the performance of the device itself rather than a software AI or human-in-the-loop system. Therefore, some of the requested information regarding AI-specific criteria (like MRMC studies, training set details, or number of experts for AI ground truth) is not applicable to this submission.

Here's a breakdown of the acceptance criteria and study results based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document mentions that for the penetration, shot, and sample quantity/quality tests, "different Semiautomatic Biopsy Needles - BIM and Automatic Biopsy Needles - BAM has been used. 18G and 16G biopsy needles were used. Two lengths were used: 150 mm and 200 mm." It also states, "The testing was conducted after the validated EO sterilization of all devices. Therefore the tests were conducted on final finished devices." However, specific numerical sample sizes for each test are not provided (e.g., how many needles of each size/length, or how many biopsy samples were collected).
• Data Provenance: The tests were conducted using various tissue types (muscle, liver, kidney) and optionally "animal tissue" for the shot test. Given the nature of these tests for a physical device, the data provenance is likely prospective wet lab/bench testing. The country of origin for the data is not specified, but the applicant, ITP Innovative Tomography Products GmbH, is based in Germany.

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

The ground truth for these performance tests (e.g., visual inspection for penetration, measurement with a ruler for sample length, video microscopy for sample quality) was established through direct observation and measurement during the non-clinical testing. There is no mention of external human experts (like radiologists or pathologists) being used to establish a "ground truth" as would be the case for image-based diagnostic AI. These are engineering and functional performance tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are direct measurements and observations of the device's physical performance, not subjective assessments requiring adjudication by multiple individuals.

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

No. An MRMC study is typically performed for AI-powered diagnostic devices to assess the impact of AI assistance on human reader performance. This submission is for a physical biopsy needle, not an AI or imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device operates without AI, the tests describe its physical function in relation to a "human-in-the-loop" application (a physician inserting and triggering the needle). The provided tests are "standalone" in the sense that they assess the device's functional characteristics independently of a diagnostic interpretation loop that characterizes AI.

7. The Type of Ground Truth Used

The ground truth used was empirical / physical measurement and observation. For example:

• Penetration: Visual confirmation of effortless penetration and lack of tears.
• Shot: Visual confirmation that the cannula completely covered the stylet tip.
• Sample Quantity: Direct measurement of sample length with a ruler.
• Sample Quality: Observation under video microscope for cylindrical shape, intactness, and abundance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/software device that requires a training set.

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

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

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Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. 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, lymph nodes, breast and muscle. 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, lymph nodes, breast and muscle. 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 guide 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. The ultrasound, X-ray, CT and other equipments are used to guide the puncture and sampling. These devices cannot be used under MRI.

The provided text is a 510(k) premarket notification for M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, and M Biopsy /SureAim Coaxial Biopsy Needle. It primarily focuses on demonstrating substantial equivalence to a predicate device (K222865) based on design modifications. These modifications include extending indications to breast and muscle tissues, adding a swab component, and introducing new models within existing specifications.

Crucially, this document does not contain the acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a software-based AI/ML medical device submission (e.g., performance metrics like sensitivity, specificity, AUC). The tests described are primarily related to the physical performance, biocompatibility, and sterility of the biopsy needles themselves, and their ability to obtain tissue samples. The "study" mentioned for the indication extension is an in vivo biopsy sampling from animal to compare the sampling performance.

Therefore, I cannot provide a detailed answer to your request in the format you've specified because the provided document does not contain the information about acceptance criteria and a study proving the device meets them in the context of an AI/ML device per your typical requirements.

Here's what can be extracted and inferred based on the provided document, addressing the points you requested, but with the caveat that it does not fit the typical AI/ML device study format:

Acceptance Criteria and Study for M Biopsy /SureCore and /SureAim Biopsy Needles

The provided document describes the safety and performance testing for a medical device (biopsy needles) which is not an AI/ML device. The "acceptance criteria" and "study" are therefore presented in terms of device functionality, material compatibility, and intended use as a physical instrument, rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML systems.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of a diagnostic test. For the in vivo animal study, the sample size is not specified. For the swab performance testing, "aged samples" are mentioned, but the quantity is not detailed.
• Data Provenance: The in vivo animal study data provenance is not specified (e.g., country of origin). The studies are "non-clinical testing" conducted by Canyon Medical Inc. (China). The data for physical/chemical tests (shelflife, EO/ECH residuals) would be from in-house lab testing.

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

This is not applicable to this submission. The "ground truth" for these physical medical devices is established through engineering and biological testing (e.g., successful tissue sample retrieval, material integrity, sterility, biocompatibility), not through expert clinical consensus on diagnostic images.

4. Adjudication Method for the Test Set

This is not applicable as there is no diagnostic test performance being adjudicated by multiple experts for a test set.

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

No, an MRMC comparative effectiveness study was not conducted because this is a physical biopsy needle, not a software-based AI/ML device that assists human readers.

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

No, a standalone performance evaluation was not done. This is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Physical Performance Bench Testing: Verification that the device can successfully obtain tissue samples, the swab functions as intended (tissue removal, no residue), and the dimensions/mechanics are within specifications.
• Material Testing: Biocompatibility testing (per ISO 10993), sterility testing (per SAL 10-6 requirements), EO/ECH residual testing (per ISO 10993-7).
• Animal Studies: For the extended indications (breast and muscle), performing in vivo biopsy sampling in animals to compare performance with predicate devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable.

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This device is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal and extramural lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.

The EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) is an endoscopic ultrasound needle consisting of a needle assembly and syringe. The needle assembly is comprised of a handle, sheath, stylet and needle cannula. This device is available in one 22Ga needle size.

Here's a breakdown of the acceptance criteria and the study information for the EchoTip® AcuCore™ Ultrasound Biopsy Needle, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: It's important to note that the document extensively references "acceptance criteria" but rarely provides specific quantitative values for these criteria. It generally states that "All test articles met the acceptance criteria" or "meets the relevant acceptance criteria."

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

• Test Set Sample Size: The document does not specify the exact sample sizes for each non-clinical test. It refers to "All test articles" meeting the acceptance criteria, suggesting a finite number of devices were tested for each performance characteristic.
• Data Provenance: The studies were retrospective in the sense that they were conducted by the manufacturer (Cook Ireland Ltd.) for regulatory submission to demonstrate substantial equivalence. The data is from internal testing (Cook), rather than from external clinical trials on human subjects. The country of origin for the manufacturing and potentially the testing is Ireland, as indicated by "Cook Ireland Ltd."

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

• Not Applicable. The document describes non-clinical performance testing (e.g., puncture force, suction) and simulated use testing in a laboratory setting. There is no mention of a "test set" requiring expert ground truth establishment in the context of diagnostic accuracy, as this is a medical device for biopsy, not an AI or diagnostic imaging system. Therefore, no experts were used for this purpose in this context.

4. Adjudication Method for the Test Set:

• Not Applicable. As the performance testing is non-clinical and objective (e.g., measuring force, length), an adjudication method (like 2+1 or 3+1 used for expert discrepancies) is not relevant. The results are based on direct measurements and pre-defined acceptance thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or AI systems where human readers interpret medical images/data, and the AI's impact on their performance (with vs. without AI assistance) is evaluated. The EchoTip® AcuCore™ is a physical biopsy needle, and its performance is assessed through mechanical, functional, and simulated use testing, not through human reader interpretation of data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This question typically pertains to AI algorithms. The EchoTip® AcuCore™ is a physical medical device (biopsy needle), not an algorithm, so the concept of "standalone performance" in this context is not relevant. The device's performance is inherently tied to its use by a human clinician.

7. The Type of Ground Truth Used:

• The "ground truth" for the non-clinical tests was established by engineering specifications, material science standards, and established physical performance benchmarks. For example, the puncture test would have a "ground truth" derived from target tissue models (e.g., worst-case material representative of liver and pancreatic tissue) and measured force, while the extension length test would have a "ground truth" based on the design specifications and measurements. Biocompatibility relies on established regulatory standards and biological testing outcomes.
• For the "Indications for Use" change, the "ground truth" for the justification essentially relies on alignment with market standards (other cleared devices like Boston Scientific's Acquire) and the fact that procedural steps/risks were not identified as new by the internal quality system.

8. The Sample Size for the Training Set:

• Not Applicable. This question is relevant for machine learning algorithms. The EchoTip® AcuCore™ is a physical medical device and does not involve AI or machine learning, so there is no "training set."

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

• Not Applicable. As there is no training set for this device, the question of how its ground truth was established is not relevant.

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