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The ClearTip FNA and FNB Types are intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum).

The ClearTip is a manually operated endoscopic instrument intended to obtain tissue specimens of gastrointestinal tract (=digestive tract). The subject device mainly consists of a handle unit with an insertion part, a syringe, a stopcock, and a connector. ClearTip is offered in various needle gauges for insertion and aspiration. The available needle gauge sizes of 19, 22, and 25 gauge. The Needle which is dimpled for ultrasonic visualization is advanced into the target site for aspiration. The device allows for adjustment of the length of the coil sheath and the needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet to aid in inserting the Needle which is removed for injection and aspiration. This device passes through the working channel of endoscope, and the average contact time with mucosa of the human gastrointestinal tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

This FDA 510(k) clearance letter pertains to a medical device, and as such, it does not detail acceptance criteria or a study that would demonstrate the device meets those criteria in the way typically seen for AI/software-as-medical-device (SaMD) products. This document describes a traditional medical device (a biopsy instrument), not an AI system.

The "acceptance criteria" and "device performance" mentioned in your request are usually quantifiable metrics (e.g., sensitivity, specificity, AUC) for SaMD products, often against a ground truth for diagnostic accuracy. For a physical device like the ClearTip FNA and FNB Types, acceptance criteria typically relate to physical properties, functionality, safety, and compatibility, which are assessed through non-clinical (engineering, bench) tests rather than clinical performance studies against a diagnostic "ground truth."

Therefore, I will extract the information provided based on the context of a physical medical device submission, focusing on the nearest equivalents to your requested categories.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device, the "acceptance criteria" are implied by the performance standards for the non-clinical tests conducted. The reported "device performance" is typically that the device met these standards. The document does not provide specific numerical acceptance criteria or performance metrics for each test, but rather lists the types of tests performed.

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

This document does not describe a "test set" in the context of clinical data for diagnostic performance. The "tests" mentioned are non-clinical (bench/engineering) tests conducted on the physical device itself. Therefore, information on sample size for a "test set" or "data provenance" (country of origin, retrospective/prospective) is not applicable or provided given the nature of the device and the submission.

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

Not applicable. This is not an AI/SaMD product requiring expert-established ground truth for diagnostic accuracy. The "ground truth" for a physical device's performance often relates to engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication in a clinical context is described.

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

No. An MRMC study is typically for evaluating diagnostic performance of imaging or AI systems with human readers. This clearance is for a physical biopsy instrument.

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

No. This is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on engineering specifications, material standards, and regulatory requirements (e.g., for sterility, biocompatibility, mechanical strength). It is not pathology, outcomes data, or expert consensus in the diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning system.

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

Not applicable. There is no training set for this device.

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FORCYTE Autograft Harvest Kit is intended to harvest cancellous bone and bone marrow for combination with commercially available allograft or bone void fillers for filling bony voids or gaps that are not intrinsic to the stability of the bony structure.

The Subject device is a kit comprised of a bone and marrow harvesting needle, collection jar, suction tubing, drill-tip guide pin, and bone void filler hydration chamber. The FORCYTE system harvests autologous bone and marrow for use as a bone void filler.

Based on the provided FDA 510(k) clearance letter for the Forcyte Autograft Harvest Kit (K243407), the device is a Gastroenterology-Urology Biopsy Instrument. The letter explicitly states that "No clinical evaluations were conducted" for this device. This means that the 510(k) clearance relies solely on non-clinical (bench) testing, and therefore, it is not possible to provide acceptance criteria or a study description related to AI algorithm performance or diagnostic accuracy, human reader performance, or multi-reader multi-case (MRMC) comparative effectiveness studies from this document.

The information requested in the prompt (AI algorithm performance data, expert ground truth, MRMC studies, etc.) is typically associated with software as a medical device (SaMD) or AI/ML-enabled devices that perform diagnostic or prognostic functions based on image analysis, pattern recognition, etc. The Forcyte Autograft Harvest Kit, however, is a physical instrument for harvesting bone and bone marrow.

Therefore, many of the requested items are not applicable to the information provided in this 510(k) clearance letter. I will address the relevant points based on the document's content and explicitly state when information is not available.

Analysis of the Forcyte Autograft Harvest Kit (K243407) based on the Provided 510(k) Clearance Letter:

The Forcyte Autograft Harvest Kit (K243407) is a physical medical device, not an AI/ML-enabled device or software medical device. The 510(k) clearance for this device was based on non-clinical (bench) testing and substantial equivalence to a predicate device, not on clinical performance studies involving human readers or AI algorithms.

Therefore, most of the requested information regarding AI acceptance criteria, clinical study design (sample size, expert ground truth, MRMC), and training data is not applicable to this specific device and the provided document.

Here's an attempt to address each point based on the provided text, clarifying what information is present and what is absent:

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

Based on the document, the acceptance criteria and performance data are related to the physical characteristics and functionality of the harvesting kit, not diagnostic accuracy.

Acceptance Criteria and Reported Device Performance (Non-Clinical)

Note: The document states "All testing had satisfactory results" but does not provide specific numerical acceptance criteria or detailed numerical results for each test. The acceptance criteria are implicitly that the device performs as intended and meets safety requirements.

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

• Sample Size for Test Set: Not specified in terms of number of units or test runs for the bench tests. The document only states "bench testing including simulated use testing, tensile, compression, torque, flexural, and vacuum testing were conducted."
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. As these are bench tests, the concept of "retrospective" or "prospective" data collection from patients is not applicable. The tests would have been performed in a laboratory setting. No geographical origin of the testing data is mentioned.

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)

• Not Applicable. This device is a biopsy instrument, not an imaging or diagnostic AI device requiring expert interpretation for ground truth establishment. Bench testing does not typically involve "experts" establishing a "ground truth" in the diagnostic sense; rather, it involves engineers and quality control personnel assessing physical performance against specifications.

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

• Not Applicable. As no expert interpretation or diagnostic "ground truth" was established, there was no need for an adjudication method. Bench testing results are typically assessed against pre-defined engineering and material specifications.

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. The document explicitly states: "No clinical evaluations were conducted." Therefore, no MRMC study, human reader improvement, or AI assistance was involved in the clearance. This type of study is irrelevant for a physical bone harvesting instrument.

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 or software. There is no "standalone" algorithm performance to evaluate.

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

• Not Applicable in the diagnostic sense. For a physical device, "ground truth" is established by manufacturing specifications, engineering design, and material properties. The device's performance is measured against these established physical and functional parameters (e.g., tensile strength, proper vacuum seal, successful harvesting of material, biocompatibility).

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a "training set" of data.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.

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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 Marquee™ Disposable Core Biopsy Instrument and Kit are 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.

The Marquee™ Disposable Core Biopsy Instrument and Instrument Kit is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The coaxial cannula release is color coded according to the various gauge sizes, e.g., yellow = 20 gauge, pink = 18 gauge, purple = 16 gauge, green = 14 gauge, and light blue = 12 gauge.

The Marquee™ Disposable Core Biopsy Instrument is available as a biopsy instrument only and as a kit, which includes the Marquee™ Disposable Core Biopsy Instrument and compatible Disposable Coaxial Biopsy Needle.

The provided FDA 510(k) clearance letter for the Marquee™ Disposable Core Biopsy Instruments and Kits does not contain the detailed acceptance criteria and specific study results traditionally associated with the performance of AI/ML-driven medical devices.

This document is for a physical medical device (biopsy instruments and kits) undergoing a "Special 510(k): Device Modification" clearance. As such, the performance data presented focuses on physical characteristics and material compatibility rather than AI/ML model performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will provide a summary based on the information that is available about the device's testing and a table of the acceptance criteria and reported "performance" based on the provided document's context, noting where information is not applicable or not provided.

A. Acceptance Criteria and Reported Device "Performance" (for a physical medical device)

Given that this is a physical biopsy instrument, the "performance" relates to its mechanical and material properties rather than diagnostic accuracy.

B. Study Details (as inferable from the document for a physical device)

1. Sample sizes used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for specific tests (e.g., how many instruments were tested for tensile strength or how many biopsies were taken in ex-vivo tests). The document states "ex-vivo testing was conducted on porcine tissue" using 12G, 14G, and 20G models.
   • Data Provenance: The biocompatibility testing followed ISO 10993-1:2018. The ex-vivo testing was done on "porcine tissue." The context suggests these are laboratory-controlled, prospective tests conducted by the manufacturer, Bard Peripheral Vascular, Inc. No country of origin for the data is specified, but typically, these studies are conducted in the country of the manufacturer or approved testing facilities.

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

   • Not Applicable / Not Provided for this device. For physical devices like biopsy instruments, the "ground truth" is measured against engineering specifications and material properties (e.g., tensile strength, successful sterile barrier). Expert consensus (like in image interpretation) is not directly relevant to these types of performance tests. The ex-vivo tissue quality assessment would likely involve pathologists or relevant subject matter experts, but their number and qualifications are not specified.

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

   • Not Applicable / Not Provided for this device. Adjudication methods like 2+1 are typically used in clinical studies or studies involving subjective human interpretation (e.g., reading medical images). For the mechanical and material tests described, results are objective measurements against predefined specifications.

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. This is not an AI/ML device. An MRMC study is completely irrelevant to this type of medical device (physical biopsy instrument).

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

   • No. This is not an AI/ML device. Standalone performance testing refers to the performance of an algorithm without human intervention, which does not apply here.

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

   • For Biocompatibility: Compliance with ISO 10993-1:2018 standards and specific test results (cytotoxicity, sensitization, etc.).
   • For In Vitro Physical Performance: Engineering specifications, design tolerances, and established industry standards for mechanical properties.
   • For Ex-vivo Testing: The "sample quality" on porcine tissue would likely be assessed against histological standards (e.g., tissue integrity, architecture, presence of target cells). Whether this involved expert pathology consensus or objective criteria is not specified, but it would fall under a form of "pathology" ground truth for the sample quality.

7. The sample size for the training set:

   • Not applicable. This device is a physical instrument, not an AI/ML model that requires a training set.

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

   • Not applicable. This device is a physical instrument, not an AI/ML model that requires a training set.

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The ExpressCore Full Core Biopsy Device is intended for use in obtaining biopsies from soft tissues.

The ExpressCore Device is a sterile, single patient use, hand held full core biopsy device comprised of a plastic handle and three stainless steel needle components that work in sequence to capture a full core biopsy sample. The device is capable of infinitely variable throw distance between 10 and 30mm and is equipped with multiple firing modes to accommodate procedural requirements and physician preference. Multiple device gauge size and needle option combinations have been developed from 12ga x 10cm to 18ga x 25cm.

This FDA 510(k) clearance letter pertains to a device, the ExpressCore Biopsy Device, not an AI/ML software. The provided text details the device's characteristics, intended use, and comparison to predicate devices, but it does not include information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (for an AI/ML algorithm)
• Sample sized used for the test set and data provenance (for an AI/ML algorithm's test set)
• Number of experts used to establish ground truth and qualifications (for an AI/ML algorithm's ground truth)
• Adjudication method (for an AI/ML algorithm's test set)
• MRMC comparative effectiveness study (as this is a physical device, not an AI system assisting human readers)
• Standalone performance (as this is a physical device, not an AI algorithm)
• Type of ground truth used (for an AI/ML algorithm)
• Sample size for the training set (as this is a physical device, not an AI algorithm)
• How the ground truth for the training set was established (as this is a physical device, not an AI algorithm)

The document focuses on the physical and functional characteristics of the biopsy device and demonstrates substantial equivalence to existing predicate devices through bench performance testing, biocompatibility, sterilization, packaging, and shelf life data.

Key information from the provided text relevant to device testing (not AI/ML):

• Type of Study: Non-Clinical Bench Performance Testing, Biocompatibility, Sterilization, Packaging, Shelf Life.
• Purpose of Study: To confirm the device meets all system requirements and is substantially equivalent to the predicate device.
• Specific Tests Mentioned:
  • Usability of the Device
  • Biopsy Sample Collection
  • Finger Cannula Tensile Test
  • Spoon Cannula Tensile Test
  • Stylet Tensile Test
  • Representative Tissue Sampling

This document is a 510(k) clearance for a physical medical device, not a review of an AI/ML-based medical device.

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The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood.
The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.
The ALARA BMAC Needle is intended for use in harvesting core biopsy samples of cancellous bone and/or bone marrow.

The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / root location feedback during the approach to a pedicle to support a guidewire placement.

The ALARA BMAN and ALARA BMAC Kit includes various single-use needles designed for bone marrow aspiration and aspiration of autologous blood.

This document is an FDA 510(k) clearance letter for a medical device called the "ALARA BMA Neuro Access Kit." This type of document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than presenting detailed study results for a new AI/ML-driven diagnostic device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML diagnostic. The "Performance Testing" section lists various engineering and material tests (e.g., torque, pull, strength, sterilization, biocompatibility) relevant to the physical components of the device, not performance metrics for an AI algorithm.

Here's why the requested information cannot be extracted from this document:

• No AI/ML Component: The device description and performance testing sections indicate a physical medical instrument (needles for biopsy, aspiration, and a neuromonitoring platform for "proximity feedback" during pedicle preparation). There is no mention of an AI or machine learning algorithm. The "proximity feedback" is likely an electrical or mechanical system, not an AI interpreting images or data.
• Focus on Substantial Equivalence: A 510(k) clearance is primarily about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often relies on comparing design, materials, intended use, and non-clinical performance (like the engineering tests listed). It does not typically involve the rigorous clinical efficacy studies or AI performance validation described in your prompt.
• Lack of Diagnostic Claims: The device is for "aspiration of bone marrow or autologous blood," "pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback," and "harvesting core biopsy samples." These are procedural/interventional uses, not diagnostic uses that would involve interpreting data (image, signal, etc.) with an AI.

In summary, as the provided document pertains to a physical medical device and not an AI/ML-driven diagnostic, the questions about acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI are not applicable to the content provided.

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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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