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

The Precision GI Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device is a motorized, automated, rotational, cutting EUS-Biopsy needle with an echogenic tip inserted and operated through the instrument channel of an ultrasound imaging endoscope.

The Limaca Precision GI FNB needle is available in one size - 20G.

The Precision GI Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device is a battery-operated, motorized, automated rotational cutting biopsy device with an echogenic needle tip, advanced and operated by the physician through the accessory instrument channel of an ultrasound imaging endoscope.

This document describes the regulatory clearance of the Precision GI device, an Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device manufactured by Limaca Medical Ltd. It is intended for fine needle biopsy of submucosal lesions, mediastinal masses, lymph nodes, and intraperitoneal masses within or adjacent to the gastrointestinal tract.

The information provided in the document focuses on demonstrating substantial equivalence to a predicate device (EndoDrill® Model X biopsy instrument by Bibbinstruments AB, K212423) and, as such, does not contain a typical clinical study with specific acceptance criteria and detailed performance metrics as would be found in a study designed to prove the device meets pre-defined performance thresholds in a clinical setting.

Instead, the document details bench testing and a preclinical study to support the safety and effectiveness and demonstrate that the differences in technological characteristics do not raise new issues of safety or effectiveness.

Therefore, I cannot populate the table and answer all questions in the requested format as a conventional clinical study with explicit acceptance criteria and corresponding reported performance values is not presented.

However, I can extract the information available from the provided text regarding the performance data and study types:

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

The document does not explicitly state quantitative "acceptance criteria" for clinical performance. Instead, it lists various "Performance Data" obtained from bench tests and a preclinical study to support substantial equivalence to a predicate device. The implied acceptance criterion for these tests is that the Precision GI device is "as safe and effective" and does not raise new issues of safety or effectiveness compared to the predicate.

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

The document mentions "bench tests and preclinical study."

• Bench Tests: These typically involve testing of devices in a lab setting, not human subjects. Sample sizes would refer to the number of devices or components tested. This information is not provided.
• Preclinical Study: This likely refers to in vitro or in vivo animal studies. The specific sample size (number of animals or specimens) and data provenance are not provided in this summary. The country of origin of the data is not specified, but the submitter is Limaca Medical Ltd. from Ein Ha Emeq, Israel.

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)

This information is typically relevant for studies involving diagnostic accuracy where human interpretation informs the "ground truth." Since the document describes bench and preclinical studies for a biopsy instrument, and not a diagnostic AI device, this information is not applicable and therefore not provided. The performance data focuses on mechanical and functional aspects of the device and its ability to acquire samples, rather than the diagnostic interpretation of those samples.

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

Not applicable, as this information is specific to human-read diagnostic studies or studies involving agreement among multiple reviewers, which is not the focus of the provided performance data.

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. The Precision GI is a biopsy instrument, not an AI-assisted diagnostic tool.

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

Not applicable, as the Precision GI is a biopsy instrument and not an algorithm.

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

For the "Sample Acquisition" assessment in the preclinical study, the ground truth would likely be based on:

• Histopathology/Pathology: Evaluation of the acquired tissue samples to determine quality, diagnostic yield, and preservation, which would be interpreted by pathologists.
• Visual observation/measurement: For aspects like needle deformation, echogenicity, etc., the "ground truth" would be direct measurement or observation against predetermined specifications or comparisons to the predicate device's performance.

The document summary does not explicitly state how "good sample acquisition" was determined (e.g., specific metrics or expert pathology review process).

8. The sample size for the training set

Not applicable. "Training set" refers to data used to train AI/machine learning algorithms. This device is a biopsy instrument, not an AI device.

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

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

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The Clear Tip is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and 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) and tracheobronchial tree. The subject device mainly consists of a handle unit with an insertion part, a syringe, a stopcock, and a connector. This device passes through a working channel of an endoscope, and the average contact time with the submucosal or external lesions of a gastrointestinal tract or a tracheobronchial tree is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or resterilized.

The provided document does not contain information regarding the acceptance criteria of a study that proves the device meets specific performance metrics. It's a 510(k) summary for a medical device (ClearTip) seeking substantial equivalence to predicate devices, not a study report demonstrating specific performance against acceptance criteria.

The document discusses substantial equivalence based on:

• Indications for Use: The ClearTip is intended for Ultrasonically Guided Fine Needle Aspiration (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract.
• Comparison to Predicate Devices: The document provides a detailed comparison table between the subject device (ClearTip) and two predicate devices (SonoTip Pro and Pro Flex EBUS-TBNA Needle System, and Clear-Tip EUS-FNA) regarding various characteristics like device name, classification, product code, regulation number, indications for use, needle gauge, material, length, sheath material, accessory channel diameter, endoscope compatibility, use with syringe/stopcock, principle of operation, shelf life, sterility, and single use.
• Non-clinical Tests: The following tests were performed on the subject device to support substantial equivalence: Sterilization Validation Test, Shelf-Life Test, Appearance, Dimensions, Operability, Elasticity, Bending Strength, Pull-out, Tensile Force, and Biocompatibility Tests. The document states that the test results support the device's substantial equivalence but does not provide specific acceptance criteria or reported performance values for these tests.

Therefore, the requested information for a table of acceptance criteria and reported device performance, sample sizes, ground truth establishment, adjudication methods, or MRMC/standalone study results cannot be extracted from this document. The document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing primary performance metrics through a clinical or non-clinical study with defined acceptance criteria.

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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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The EndoDrill® Model X is intended to be used with an ultrasound endoscope for ultrasonically guided fine needle sampling of submucosal- and extramural lesions within gastrointestinal tract (i.e. esophagus, mediastinal masses, stomach, pancreas, liver, small- and large intestines, lymph nodes and perirectal masses). This device is for diagnostic purposes only.

The EndoDrill® Model X biopsy instrument consists of a single-use handle with a flexible sheath and a cylinder tip that can be rotated to collect tissue samples. An outer sheath covers the tip to facilitate smooth insertion, positioning of the instrument and extraction. The hollow cylinder allows for multiple samples being taken continuously without removing the instrument for harvesting between biopsies. Rotation is facilitated by an isolated reusable electrical motor controlled by the user. No current, heat, smoke or sparks are introduced into the patient. The device is designed to be used in flexible endoscopic instruments with ultrasound (EUS) used for examinations of the gastrointestinal tract. The single-use biopsy instrument consists of a needle and handle that are supplied sterile and is for single patient use only. The needle contains all patient contact pathways and is fully disposable. Cleaning, reprocessing and/or re- sterilization of the instrument is prohibited. The needle is inserted through the working channel of a flexible endoscope and fixed at the endoscope handle. The single-use and handle consists of the following pre-assembled, sterile components: 1. A biopsy needle consisting of stainless-steel with a coring cylinder tip collecting samples in a fluid- and airtight tubing when rotated. 2. An outer sheath that surrounds the rotating needle and may be used to place the inner needle at the biopsy site. 3. A handle that is mounted to the working channel of an endoscope, used to control sampling and attaches to a reusable drive cable that mechanically transfers rotation. The reusable electrical motor and drive cable facilitating the rotation of the tip are supplied non-sterile and reusable. The motor unit contains an on/off safety switch and rotation is activated with a pedal attached to the motor. The drive cable that mechanically transmits rotation to the needle is mounted on the handle prior to sampling. The motor unit accommodates a DC motor which includes a power indicator light and attachments for power cable, drive cable and pedal. The motor is isolated and provides mechanical rotation to the single-use handle via the drive cable. No current, heat, smoke or sparks are introduced into the patient.

The provided text describes a 510(k) premarket notification for a medical device called "EndoDrill® Model X." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety from scratch.

Therefore, the document does not contain the information typically associated with a study proving a device meets acceptance criteria derived from a full clinical trial or a deep learning AI model performance. Specifically, it lacks:

• A table of acceptance criteria and reported device performance (in terms of clinical outcomes or diagnostic accuracy). This document focuses on demonstrating comparable characteristics to predicate devices and performance in bench testing, not clinical performance metrics.
• Sample sizes for test sets where clinical performance is evaluated. The testing described is primarily engineering bench testing.
• Number of experts used to establish ground truth, their qualifications, and adjudication methods. Ground truth is not established in the clinical sense in this submission.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone (algorithm only) performance. This is a physical biopsy instrument, not an algorithm.
• Type of ground truth used (pathology, outcomes data, etc.) relevant to clinical efficacy.
• Sample size for training set or how ground truth for training set was established. This refers to machine learning models, not physical devices.

Instead, the document details bench testing to demonstrate the safety and fundamental performance of the device and its substantial equivalence to predicate devices.

Here's an analysis of the provided information relevant to "acceptance criteria" and "study" in the context of this 510(k) submission:

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

The document doesn't provide a table of acceptance criteria with numerical performance targets and reported values in the typical sense of a clinical diagnostic study (e.g., sensitivity, specificity thresholds). Instead, "acceptance criteria" are implied by the comprehensive list of bench engineering tests performed to ensure the device performs as intended and meets safety standards applicable to a Class II device.

The study proves the device meets (implied) acceptance criteria through:

• Engineering comparative testing: Evaluating the effectiveness of needle advance/retreat, visibility, withdrawal from endoscope, repetition test, needle durability (including bending), proper functioning of motor/drive train/controls during penetration, and ultrasound compatibility.
• Endoscope compatibility.
• Locking mechanisms performance.
• Tissue penetration and collection.
• Tissue transport.
• Evaluation of tissue artifacts (absence of heat/burning/crushing).
• Determination of tissue penetration force.
• Sample acquisition and evaluation of sample quality.
• Performance testing of drive motor, drive cable, and controls.
• Sterilization/Shelf Life testing.
• Biocompatibility testing.
• IEC 60601 Electrical safety and EMC.

The overall acceptance criterion for a 510(k) is "substantial equivalence" to a legally marketed predicate device, ensuring the new device is as safe and effective as the predicate. The performance testing listed above serves to demonstrate this.

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

• Sample Size: Not specified for individual bench tests. Bench testing for medical devices often involves a sufficient number of units to demonstrate robust and reproducible performance, but exact sample sizes are typically detailed in the full test reports, not the public 510(k) summary. For example, "repetition test" implies multiple repetitions, and "needle durability" tests would involve multiple cycles or stress tests.
• Data Provenance: The testing was "non-clinical (bench) testing" performed by the manufacturer, Bibbinstruments AB (based in Sweden, as indicated by the address: S-223 81 Lund, SWEDEN). The data is retrospective in the sense that it was generated pre-submission for regulatory clearance. No external or patient data provenance is relevant here as it's not a clinical study.

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

• Not applicable in the context of bench testing for a physical device. Ground truth as understood in diagnostic AI or clinical trials (e.g., pathological diagnosis, clinical outcomes) is not established here. The "ground truth" for these tests are engineering specifications and performance metrics related to the device's physical functions.

4. Adjudication method for the test set:

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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 is a physical biopsy instrument, 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 biopsy instrument.

7. The type of ground truth used:

• The "ground truth" for this submission is based on engineering specifications, verified physical properties, and functional performance metrics established through bench testing, demonstrating that the device operates as intended and is comparable to predicate devices in terms of its mechanical function (e.g., ability to penetrate tissue, collect samples, durability, electrical safety). There is no "pathology" or "outcomes data" ground truth directly presented for the device's diagnostic accuracy in a clinical setting, as this type of clearance relies on equivalence for the instrument itself.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of a physical device's regulatory submission using bench testing. This term typically refers to data used to train machine learning models.

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

• Not applicable, as there is no training set for a machine learning model.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

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

8. The sample size for the training set

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

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

This is not applicable. There is no training set.

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

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

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

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

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

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

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

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

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

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

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The EchoTip® Ultra Endoscopic Ultrasound Needle is used with an ultrasound endoscope for fine needle aspiration (FNA) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

The EchoTip ProCore® HD Ultrasound Biopsy Needle is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

Echotip® Ultra Endobronchial High Definition Ultrasound Needle for Olympus scopes: This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA).

Echotip® Ultra Endobronchial High Definition Ultrasound Needle for Pentax scopes: This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA).

Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for Olympus scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract.

Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for Pentax scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree.

EchoTip Ultra Endoscopic Ultrasound Needle: This Needle is used in conjunction with an ultrasound endoscope and is available in needle gauge sizes of 19, 22 and 25 Ga. The device comprises of a needle assembly and a syringe. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The purpose of the needle cannula is for puncturing of the target site. The preloaded nitinol stylet is withdrawn from the needle when obtaining sample from the target site. The sheath covers the needle when it is not in use. The device handle allows for needle and sheath length adjustment. The syringe can aid in sample aspiration. The device is supplied sterile and is intended for single use. The device is for Rx use only.

EchoTip ProCore HD Ultrasound Biopsy Needle: This Needle is used in conjunction with an ultrasound endoscope and is available in needle gauge sizes of 19, 20, 22 and 25 ga. The device comprises of a needle assembly and a syringe. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The needle cannula has a bevelled tip design and a notch. The purpose of the needle cannula is for puncturing/biopsy of the target site. The preloaded nitinol stylet is withdrawn from the needle for biopsy. Some variants have a stylet that coils when not in the needle. The sheath covers the needle when it is not in use. The device handle allows for needle and sheath length adjustment. The syringe can aid in tissue aspiration. The device is supplied sterile and is intended for single use. The device is for Rx use only.

EchoTip Ultra / ProCore Endobronchial High Definition Ultrasound Needle: These Needles are used in conjunction with an endobronchial ultrasound endoscope and is available with needle gauge sizes of 22 and 25 Ga. The device is composed of a needle assembly and a syringe. An adapter can also be supplied for use with endobronchial ultrasound endoscopes with metal non-Luer hubs. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The needle cannula has a bevelled tip design and comes either with or without a notch. The purpose of the needle cannula is for puncturing/sampling of the target site. The needle is provided with a preloaded stylet which remains in place during advancement of the needle. The sheath covers the needle when the needle is retracted and not in use. The device handle allows for needle and sheath length adjustment. The stylet/syringe can aid in specimen retrieval. The device is supplied sterile and intended for single use only. The device is for Rx use only.

The provided text is a 510(k) Summary for medical devices, specifically various EchoTip ultrasound needles. It describes the devices, their indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence.

However, it does not contain acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a device based on clinical or diagnostic outcomes, nor does it describe a study that uses such acceptance criteria to demonstrate the device meets them. This document is a regulatory submission focused on proving equivalence to previously cleared devices through non-clinical performance testing and technological comparison.

Therefore, I cannot extract the requested information in the format provided. The document outlines performance testing as part of Cook Ireland's design control system, but these are engineering/material tests, not studies against clinical acceptance criteria.

To elaborate on what is present in relation to performance, albeit not in the requested format:

Performance Data (Non-Clinical):
The document states that performance testing was conducted as per Cook Ireland's design control system. These tests include:

• Tensile testing
• Crumple testing
• Joint strength testing
• Finite element analysis
• Simulated use and drop testing

Purpose of these tests:
To support the safety of the modified devices and demonstrate that they should perform as intended, thereby supporting substantial equivalence to the predicate devices. These are engineering and material science tests, not clinical performance studies for diagnostic accuracy.

Missing Information (as per your request):
The document does not provide:

1. A table of acceptance criteria and reported device performance related to diagnostic outcomes.
2. Sample size used for a clinical test set, nor data provenance (country, retrospective/prospective).
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a clinical test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, effect size regarding human readers improving with/without AI assistance.
6. Information about standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcome data) in a clinical context.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This is expected as the submission is for needle devices, which are instruments used by clinicians, not AI/diagnostic algorithms with specific diagnostic performance metrics. The criteria for these devices are typically related to mechanical integrity, biocompatibility, and functional equivalence to similar devices already on the market.

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The Biopsy Needle is intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone.

The Biopsy Needle is also indicated to provide breast tissue sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

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

The Biopsy Needle are used to remove, by cutting, a specimen of tissue for microscopic evaluation. The organs in which the device may be used include but are not limited to breast, kidney, liver, prostate, spleen and lymph nodes plus various soft tissue masses. As the device is single use device, which is individually packaged sterile devices. In the package, there is a whole device with the structure shown in the picture above without any accessories. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

This document describes the Ushare Medical Inc. Biopsy Needle (K191472) and its substantial equivalence to a predicate device. It primarily focuses on comparing technical characteristics and performance testing. However, it does not contain information about the device's diagnostic performance or any studies related to human-in-the-loop performance, as it is a medical instrument (biopsy needle) and not a diagnostic AI/ML device.

Here's a breakdown of the requested information based on the provided text, with clear indications where the information is not available for this type of device submission:

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

The document does not specify formal "acceptance criteria" for diagnostic performance, as the device is a biopsy needle and not a diagnostic tool. Instead, it outlines performance testing to demonstrate substantial equivalence to the predicate device in terms of mechanical, biological, and sterilization characteristics.

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