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The needle is designed to be used for soft tissue histological biopsy.

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I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "TRTM Guillotine Needle," indicating its substantial equivalence to previously marketed devices for soft tissue histological biopsy.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone algorithm-only performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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This device is to be used for taking cyto-histological biopsies of soft tissue.

Pan® Aspirating Needle (Chiba)

This is a 510(k) clearance letter for the Pan® Aspirating Needle (Chiba), dated May 2, 1997. It indicates that the device has been found substantially equivalent to devices marketed prior to May 28, 1976. This document does NOT contain information regarding acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.

The information provided confirms the following:

• Trade Name: Pan® Aspirating Needle (Chiba)
• Regulatory Class: II
• Product Code: KNW
• Indications for Use: To be used for taking cyto-histological biopsies of soft tissue.
• Submission Type: 510(k) premarket notification (K970872)

Since this document is a 510(k) clearance letter, it does not include the detailed information requested regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study results
6. Standalone algorithm performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

A 510(k) submission typically includes data demonstrating substantial equivalence, sometimes referencing existing predicate device performance or providing limited performance data for the new device. However, the clearance letter itself does not detail these studies. To obtain such information, one would need to review the full 510(k) submission (if publicly available or by freedom of information act request) or supporting documentation from the manufacturer.

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This device is intended to be used to take high quality histological core samples from soft tissue, including (but not limited to) liver, kidney, prostate.

The device is a spring loaded, disposable biopsy needle.

This document is a 510(k) summary for the "TZ®" Biopsy Needle, dated January 3, 1997. It describes a spring-loaded, disposable biopsy needle intended for taking histological core samples from soft tissues. The summary states that the device is identical in technological characteristics to its predicate device, the ProMedical Ltd. - PRO-B Biopsy Needle (K824598).

The document does not contain any information regarding acceptance criteria related to device performance in terms of diagnostic accuracy or clinical outcomes. The "tests" mentioned (Firing Test, Pyrogen Test, Biocompatibility) appear to be related to manufacturing quality, sterility, and material safety, not diagnostic performance. Therefore, I cannot construct a table of acceptance criteria and reported device performance as requested in point 1, nor can I answer points 2 through 9, as they pertain to a study proving diagnostic performance, which is not present in this document.

Here's a breakdown of what is and is not in the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not provided in the context of diagnostic accuracy. The tests listed are "Firing Test," "Pyrogen Test (LAL)," and "Biocompatibility," all of which "Passed." These relate to manufacturing and material safety, not how well the device performs its intended diagnostic function in terms of tissue quality or diagnostic yield.
• 2. Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic performance study described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical biopsy needle, not an algorithm.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and basic safety/manufacturing tests. It does not provide any clinical study data for diagnostic performance.

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The device is intended to be used for drawing osteomedullary substances and/or the explantation of bone marrow.

A manually operated biopsy needle used for aspiration or explantation of bony substance.

The provided document describes a medical device, the BIOMID® - Bone Marrow Biopsy Needle, and its safety and effectiveness based on a submission made in April 1996. The document details the physical characteristics and intended use of the device, comparing it to a predicate device (Promedical - Jamshidi style biopsy needle).

However, the provided text does not contain information related to acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), or any study details that would typically be associated with evaluating an AI/ML-based medical device.

The "tests" mentioned are standard biocompatibility and safety tests for a physical medical instrument:

• Intracutaneous Reactivity: Passed
• Acute Systemic Toxicity: Passed
• Pyrogen Test: Passed
• Cytotoxicity: Passed

These tests demonstrate that the materials used in the BIOMID® needle are safe for contact with human tissue and do not cause adverse reactions. They do not involve "device performance" in the sense of diagnostic accuracy or a comparison against a clinical ground truth, which is what your request implies.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance metrics (e.g., sensitivity, specificity) are mentioned beyond the "Passed" status of the biocompatibility tests.
2. Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted.
6. Standalone (algorithm only) performance: Not applicable; this is a physical biopsy needle, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document describes a traditional medical device submission focused on material safety and equivalence to a predicate device, not an AI/ML-driven diagnostic or assistive technology.

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The device is intended to be used for drawing osteomedullary substances from the sternum or from the iliac crest.

A manually operated biopsy needle used for aspiration or explantation of bony substance.

This document describes a medical device, the ISAN®-Sternal-Iliac Crest Aspiration-Biopsy Needle, and outlines its intended use, function, and a comparison to a predicate device. It also lists several tests performed to demonstrate safety, performance, and efficacy. However, it does not provide acceptance criteria or a study proving the device meets specific performance criteria related to its intended function (drawing osteomedullary substances).

The listed tests (Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Test, Cytotoxicity) are safety-related biological compatibility tests, not performance studies of the core biopsy function.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be answered based on the input:

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

   • Acceptance Criteria: Not explicitly stated for performance of the biopsy function. For the listed tests, the implicit acceptance criterion is "Passed."
   • Reported Device Performance:
     • Intracutaneous Reactivity: Passed
     • Acute Systemic Toxicity: Passed
     • Pyrogen Test: Passed
     • Cytotoxicity: Passed

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

   • Cannot be determined from the provided text. The document refers to "tests," but does not detail the methodology, sample sizes of these tests, 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):

   • Cannot be determined from the provided text. The listed tests are laboratory-based biological evaluations, not diagnostic performance studies that would typically involve expert ground truth establishment.

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

   • Cannot be determined from the provided text. (See reasoning for point 3).

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:

   • No MRMC study was done. This device is a manually operated biopsy needle, 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 medical device, not an algorithm.

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

   • For the biological tests, the "ground truth" would be the standard laboratory protocols and negative/positive controls as per relevant ISO or ASTM standards for biocompatibility testing. The document does not specify these. For the core function of the biopsy needle, no performance study data is provided, so no ground truth type can be identified.

8. The sample size for the training set:

   • Not applicable/Cannot be determined. This is a physical medical device, not an AI model requiring a training set.

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

   • Not applicable. (See reasoning for point 8).

In summary, the provided document focuses on the safety of the biopsy needle through biocompatibility testing, but lacks detailed information regarding performance efficacy related to its primary function (drawing osteomedullary substances) and the associated acceptance criteria and studies.

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The device is intended to be used for drawing osteomedullary substances from the iliac crest.

A manually operated biopsy needle used for aspiration or explantation of bony substance.

This document is a Summary of Safety and Effectiveness for a medical device, the ACRI®-Iliac Crest Aspiration-Biopsy Needle. It's a regulatory submission (K962568) from 1996.

This document describes basic safety tests for a physical medical device, not an AI/software-based "device" as implied by the questions regarding AI performance, ground truth, and training sets.

Therefore, most of the requested information cannot be provided from this document because it pertains to the evaluation of AI systems, not a physical biopsy needle.

However, I can extract the information relevant to the safety and performance of this physical medical device as presented in the document.

Acceptance Criteria and Device Performance (Based on provided document):

Explanation of Applicability to AI/Software Devices:

The questions provided are tailored for the evaluation of AI/Machine Learning-based medical devices, which typically involve assessing diagnostic accuracy, sensitivity, specificity, and other performance metrics against established ground truth. This document, being from 1996 for a physical "aspiration-biopsy needle," focuses on biocompatibility and basic safety tests.

Therefore, the following questions are not applicable to the provided document and cannot be answered:

• Sample sized used for the test set and the data provenance: Not applicable to biocompatibility testing of a physical device. There's no "data" in the AI sense.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set isn't relevant here.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 device does not involve human readers interpreting images with or without AI assistance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the AI sense isn't used for these tests. The "ground truth" for these tests is standardized biological assays.
• The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Summary of what CAN be inferred from the document regarding the physical device:

The document indicates that the ACRI®-Iliac Crest Aspiration-Biopsy Needle was subjected to basic biocompatibility and safety tests, and it "Passed" all of them. These tests are:

• Intracutaneous Reactivity: Measures the potential for the device's material to cause irritation or sensitization when in contact with skin. "Passed" means it did not cause undue irritation.
• Acute Systemic Toxicity: Assesses the rapid, general toxic effects of leachable substances from the device on a living system. "Passed" means it did not cause acute systemic toxicity.
• Pyrogen Test: Checks for the presence of pyrogens (fever-inducing substances). "Passed" means it is free of pyrogens.
• Cytotoxicity: Evaluates the potential of the device's materials to damage cells. "Passed" means it is not cytotoxic.

The study referenced is an internal safety and efficacy testing performed by the manufacturer, Gallini s.r.I., to demonstrate compliance with regulatory requirements for a Class II medical device (indicated by the K number submission). The specific details of how these tests were performed (e.g., specific animal models, cell lines, number of replicates, statistical methods) are not included in this summary.

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An automatic biopsy system designed to take core samples from a variety of soft tissues, including (but not limited to) liver, prostate, kidney.

The Speed-Cut® is an automatic spring loaded, depth programmable, disposable biopsy instrument.

The provided text describes a medical device, the Speed-Cut® Automatic Biopsy System, and its testing for safety and efficacy. However, it does not include information about acceptance criteria or a study that uses a test set, ground truth, or expert review in the way typically expected for evaluating AI/algorithm performance.

The "tests" mentioned are traditional medical device performance and biocompatibility tests, not studies evaluating diagnostic accuracy or clinical utility that would involve reader performance, ground truth, or specific statistical metrics like sensitivity/specificity.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated as "not available" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable / Not available. The listed tests are engineering and biocompatibility tests performed on the device itself or in animal models, not on a "test set" of patient data for diagnostic evaluation.

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

• Not applicable / Not available. There is no mention of a "test set" or "ground truth" in the diagnostic sense. The tests describe physical device performance and biological reactions.

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

• Not applicable / Not available.

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

• No. This study is not an MRMC study. It's for a physical biopsy device, not an AI or imaging diagnostic tool.

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

• No. This device is a physical biopsy system, not an algorithm.

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

• Not applicable / Not available. The "results" are based on laboratory testing protocols (e.g., "firing until failure" for the Firing Test, standard biological assays for the others).

8. The sample size for the training set

• Not applicable / Not available. There is no "training set" as this is not an AI/algorithm.

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

• Not applicable / Not available.

Summary of what the document does provide:

The document describes the Speed-Cut® Automatic Biopsy System, its intended use (to take core samples from soft tissues), its predicate device, and a list of performance and biocompatibility tests it underwent to verify safety and efficacy. The firing test, for instance, established a mean firing count of 50 before failure, with the manufacturer establishing a 10:1 safety margin. The other tests confirmed biocompatibility and lack of systemic toxicity or pyrogenic reactions.

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