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The DISPOSABLE CYTOLOGY BRUSH BC-202D/203D Series is intended to be used to collect tissue specimens in the tracheobronchial tree in combination with a bronchoscope.

The DISPOSABLE CYTOLOGY BRUSH BC-202D-1210/2010/3010/5010, BC-203D-2006 have been designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes. The Subject Device (SD) is inserted into the bronchoscope through a biopsy valve to reach the target area, where, by rubbing the brush on the target area, specimens or cells can be collected. The Subject Device is then withdrawn from the bronchoscope channel with the collected samples.

The Subject Device consists of:

• Handle
• Insertion portion

The handle consists of a ring and a grip. The insertion portion consists of a plastic tube, stainless steel wire, nylon brush (length 6mm or 10mm, diameters 1.2 – 5 mm) and stainless steel distal tip. The grip is attached to the tube and the ring is attached to the wire. The user can move the brush at the tip of the wire back and forth by holding the grip and moving the ring back and forth. The distal tip is designed to prevent damage to the inside of the tube and/or bronchial wall.

This document is a 510(k) clearance letter for a medical device, specifically a disposable cytology brush. It is not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies for AI/ML performance (e.g., sample size for test/training sets, expert consensus, MRMC studies, standalone algorithm performance, effect size of human reader improvement with AI) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device through:

• Biocompatibility testing: Ensuring the materials are safe for human contact.
• Performance testing (Bench/Non-Clinical): Evaluating the physical and mechanical performance of the brush.
• Sterilization and Shelf Life Testing: Confirming the device remains sterile and functional over its stated shelf life.

Here's how the provided information relates to the performance acceptance criteria and proof for this medical device:

Acceptance Criteria and Device Performance for Disposable Cytology Brush

For this medical device, substantial equivalence is proven by meeting established performance specifications through non-clinical (bench) testing, biocompatibility testing, and sterilization/shelf life validation. There are no AI-specific acceptance criteria or studies mentioned as this is a physical medical device, not an AI/ML software device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes for each bench test. For these types of physical device tests, sample sizes are typically determined by established standards (e.g., ISO, ASTM) and statistical validity for mechanical testing (e.g., n=30, or as per specific test method requirements).
• Data Provenance: The tests are explicitly described as "Non-Clinical (Bench) Performance Testing" and "Biocompatibility Testing." This means the data comes from laboratory experiments and material testing, not human or observational data. There is no mention of country of origin for the data; it would be generated in the manufacturer's or contracted test labs. All tests are inherently "prospective" in the sense that they are conducted specifically to validate the device's performance.

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

• Not applicable. This is a physical medical device. Ground truth for its performance is established by objective engineering measurements, material science principles, and biological safety standards (e.g., ensuring a certain tensile strength, confirming sterility, testing for cytotoxicity per ISO standards). It does not involve human expert interpretation of images or patient data in the way an AI/ML device would.

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Testing results are pass/fail based on predetermined numerical or qualitative specifications from recognized standards.

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

• Not applicable. This is not an AI/ML device used for diagnostic interpretation. Therefore, there is no human reader component to improve or compare against.

6. Standalone (Algorithm Only) Performance

• Not applicable. There is no algorithm or software for standalone performance evaluation. The device is a physical tool.

7. Type of Ground Truth Used

• Bench Test Specifications: The "ground truth" for this device's performance lies in its ability to meet predefined engineering specifications (e.g., force measurements, cyclical durability, material integrity) and biological safety standards (e.g., absence of toxicity, successful sterilization). This is determined through standardized laboratory testing methods rather than expert consensus on clinical cases or pathology.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/ML algorithm that learns from data.

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

• Not applicable. See point 8.

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The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes.

Intended patient population: Adults

The Disposable Cytology Brush is a sterile, single-use device as a kind of accessories for bronchial endoscopy. The Disposable Cytology Brush is intended to be used in conjunction with a bronchoscope to collect cells from the bronchi.

The Disposable Cytology Brush is designed to insert through suitable endoscope's accessory channel to collect cells from the bronchi.

The Disposable Cytology Brush mainly consists of brush head part and handle part. The brush head is composed of bullet, bristles, brush core, brush sheath, connecting tube and steel wire. The handle part is composed of hand grip and push/ pull rod.

The Disposable Cytology Brush has two different models depending on different design of the brush head. The WB series is a cytology brush with straight type of brush head and the XA series is a cytology brush with oval type of brush head. Each model has different specifications depending on different working length.

The provided text is a 510(k) summary for a medical device (Disposable Cytology Brush) and primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based diagnostic product. The document describes a traditional medical device (a cytology brush), not an AI/software device.

Therefore, many of the requested categories for AI/algorithm performance (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract information related to non-clinical testing performed to demonstrate the device's performance and safety, which serves a similar purpose to meeting acceptance criteria for a physical device.

Here's the breakdown based on the provided text:

Device: Disposable Cytology Brush (AF series)

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

The document doesn't present a formal table of "acceptance criteria" with quantitative targets alongside "reported device performance" in the way one would for an AI diagnostic. Instead, it lists performance tests conducted to verify the device meets design specifications and is substantially equivalent to a predicate. The "acceptance criteria" are implied to be "met all design specifications" and "demonstrated safety and essential performance" based on applicable standards. The "reported device performance" is summarized as the tests being successfully performed and demonstrating substantial equivalence.

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

• Sample Size: The document does not specify the exact number of devices/samples used for each non-clinical test (e.g., how many brushes were tested for tensile strength).
• Data Provenance: The tests are described as "Non-clinical testing for Disposable Cytology Brush." The document's origin (Alton (Shanghai) Medical Instruments Co. Ltd in China) suggests the testing likely occurred there or was managed by them. The studies are bench (laboratory) tests and do not involve patient data in the typical sense of 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. This is a physical medical device. Ground truth, in the AI/diagnostic sense, is not established by human experts for these mechanical/biocompatibility tests. The "ground truth" here is compliance with engineering specifications and recognized international standards.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

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

• Not Applicable. This is not an AI/imaging device that would involve human readers.

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

• Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

• For biocompatibility: Adherence to ISO 10993 standards (e.g., no cytotoxicity, no irritation).
• For sterilization: Adherence to ISO 11135 standards (e.g., Sterility Assurance Level of 10-6).
• For shelf life/sterile barrier: Adherence to ASTM and ISO 11607 standards (e.g., package integrity, product performance after aging).
• For mechanical performance: Meeting internal design specifications and demonstrating performance comparable to the predicate device through side-by-side bench testing.

8. The sample size for the training set:

• Not Applicable. This is not an AI device that requires a training set.

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

• Not Applicable. See point 8.

In summary, this 510(k) pertains to a traditional medical device (a cytology brush) and not an AI or software-driven diagnostic tool. Therefore, the information provided in the document focuses on demonstrating substantial equivalence through non-clinical bench testing, biocompatibility, and sterilization validation, rather than the types of studies typically conducted for AI-powered diagnostic devices.

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This device is used to enter human gastrointestinal tract (stomach or duodenum) via endoscope to collect cells.

The main component of the proposed device is Brush Head, Outer Sheath, Sliding Handle, Thumb ring, Catheter and Steel Wire. The device is expected to use via endoscope to obtain cellular material from the human body. The main operation is move the Finger Ring back and forth to achieve the movement of Brush Head, and then the Brush Head can collect cells from the target site.

The proposed device has twenty-one (21) specifications, the main differences of these specifications are Diameter of Brush Head, Brush Length, Outer Sheath OD and Effective Length.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided document is a 510(k) premarket notification letter and summary for a medical device called "Single Use Cytology Brush." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and effectiveness through extensive clinical trials.

As such, the document does not describe a study proving the device meets acceptance criteria in the manner requested by your prompt (i.e., for an AI/ML-based medical device with performance metrics, ground truth, expert adjudication, etc.). Instead, it focuses on bench testing and an assessment of substantial equivalence.

Therefore, I cannot extract the information to fill your requested categories for acceptance criteria and a study that proves the device meets them in the context of an AI/ML device. However, I can explain what is presented in the document regarding the acceptance of this specific device.

Based on the provided text, here's what can be inferred about the acceptance process for the Single Use Cytology Brush:

The "acceptance criteria" here are fundamentally about demonstrating substantial equivalence to a predicate device (K172663). This is a regulatory pathway, not a performance study of an AI model.

No study proving device meets acceptance criteria in the AI/ML context was performed or described. Instead, the manufacturer performed bench tests to ensure the physical and operational characteristics of the device were comparable to the predicate.

Here's a breakdown of the information from the document related to "acceptance" of this device:

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

The document does not present a formal table of quantitative acceptance criteria for device performance with specific numerical targets like sensitivity/specificity for an AI model. Instead, it refers to regulatory and bench testing requirements.

• Appearance
• Dimension
• Operational performance |
  | Substantial Equivalence | Demonstrated to be "Substantially Equivalent (SE)" to the currently cleared predicate device (K172663) based on indications for use, technological characteristics (materials, design, configuration, packaging, fundamental technology, sterilization process), and safety and performance testing. |

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

The document does not specify sample sizes for the bench tests. It refers to general passing results without providing the number of units tested. This is not a data provenance in the sense of patient data; it's product testing.

• No mention of a "test set" in the context of patient data for an AI model.
• Sample size: Not specified for bench tests.
• Data provenance: Not applicable in the context of clinical data. The tests are performed on the device itself by the manufacturer.

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

Not applicable. This device is a physical medical instrument (cyto brush), not an AI algorithm. Ground truth (e.g., disease presence) is not established by experts for its performance in the way it would be for a diagnostic AI. Its "performance" refers to its physical capabilities and safety.

4. Adjudication method for the test set

Not applicable. There is no "adjudication" necessary for the physical properties and functional tests of a cytology brush.

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 not an AI-assisted device.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable. The "ground truth" for this device's acceptance is its ability to meet engineering specifications, adhere to ISO standards, and be substantially equivalent to a predicate physical device. There are no clinical "ground truth" labels like pathology for its clearance.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model, so there is no training set.

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

Not applicable. There is no training set or clinical ground truth in the context of this 510(k) submission for a physical device.

Summary relevant to the document:

The provided 510(k) submission for the "Single Use Cytology Brush" demonstrates that the device is substantially equivalent to a predicate device (K172663). This equivalence is based on:

• Similar intended use (collecting cells from the GI tract via endoscope).
• Similar technological characteristics (materials, design, configuration, packaging, sterilization).
• Successful completion of non-clinical bench testing for appearance, dimension, and operational performance, which all yielded "passing" results.
• Compliance with relevant ISO standards for biological evaluation and sterilization.
• Crucially, Section 9 states: "Clinical Test is not applicable for the proposed device. No clinical study is included in this submission." This confirms that no human clinical performance study was conducted or required for this 510(k) clearance, and therefore, no data related to AI/ML performance on patient data, expert ground truth, or MRMC studies would be present.

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The Pulmonary Cytology Brush is intended to allow brush sampling of tissue or cells from the upper or lower respiratory tract and/or to perform surveillance cultures

Not Found

This document is a 510(k) Premarket Notification decision letter from the FDA for a device named "Pulmonary Cytology Brush." It explains that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document is NOT a study report for an AI/ML medical device. It does not contain any information about acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes, expert qualifications, ground truth establishment, or any of the other details typically found in a clinical study report for an AI device.

The Pulmonary Cytology Brush is a physical medical instrument used for sampling tissue/cells, not an AI/ML algorithm that requires performance studies measuring its diagnostic or prognostic accuracy. Therefore, the requested information (acceptance criteria, study details, human reader performance, training set details) is not applicable to this document.

To answer your request, I would need a different type of document, specifically a clinical study report or a 510(k) submission summary for an AI/ML-based medical device.

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Used for collection of cells in the biliary system.

The subject devices, the Fusion Cytology Brush and CytoMax II Double Lumen Cytology Brush, consist of a nylon brush on a stainless-steel drive wire with a stainless-steel tip, a double lumen catheter with ink markings, radiopaque markers, wire guide access via a wire guide hub or and IDE port, a detachable extension line with a luer lock for optional flushing of the wire guide hub and a pin-vise handle.

The Fusion Cytology Brush and CytoMax II Double Lumen Cytology Brushes are used by passing the device through an endoscope over a prepositioned wire guide to a target location. The cytology brush is located at the distal end (patient contacting) of the device with the pin vise handle located at the proximal end (non-patient contacting). The handle is actuated by pushing the pin vise handle forward to extend the cytology brush and then pulling backward to retract the brush.

The provided text is a 510(k) summary for the Fusion Cytology Brush and CytoMax II Double Lumen Cytology Brush. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices after a design modification. It does not describe an AI medical device, nor does it contain information about acceptance criteria for an AI model, a study proving an AI device meets acceptance criteria, sample sizes for test or training sets for AI, expert involvement for AI ground truth, or MRMC studies.

Therefore, I cannot fulfill your request for information about acceptance criteria and studies related to an AI device based on this input.

The document discusses non-clinical bench testing to ensure the modified devices meet performance requirements and function as intended, specifically:

• Tensile Strength Testing: Assesses the strength of the device.
• Tensile Strength of Handle: Evaluates the handle's ability to withstand pulling forces.

These tests are to ensure the physical integrity and functionality of the cytology brushes themselves, not the performance of an AI algorithm.

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The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with Olympus bronchoscopes with channel φ1.7mm or larger.

The single use cytology brush BC-205D has been designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes. Identical to the predicate device, the subject device is inserted into bronchoscope channel to collect specimens with the brush which is equipped at the distal end of the subject device. Then users withdraw the subject device from bronchoscope channel and collect samples for cytology examination.

The provided document is a 510(k) summary for the Olympus Single Use Cytology Brush BC-205D, demonstrating its substantial equivalence to a predicate device. It focuses on the device's design, materials, and non-clinical performance, rather than a clinical study involving human patients or complex algorithms requiring extensive performance criteria.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone algorithm performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission because the demonstrated substantial equivalence is primarily based on bench testing and material characteristics, not clinical performance against a complex diagnostic ground truth.

Here's a breakdown of what can be extracted and why other parts are not applicable:

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

The document mentions several tests and standards applied, along with the statement "The technological differences between the predicate device and the subject device have been verified and validated by means of the following tests and standards to endorse the claims of substantial equivalence to the predicate device." However, it does not provide a specific table of quantitative acceptance criteria or detailed numerical results for each test. Instead, it lists the types of tests performed.

1. Brush operation with compatible endoscope
2. Dimension of each part of the brush
3. General durability
4. Joint/tensile strength
5. Package integrity. Implies successful meeting of performance criteria. |

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

• Sample Size: The document does not specify the exact sample sizes (number of units) used for each individual bench test (e.g., durability, tensile strength). It only states that tests were performed.
• Data Provenance: The tests are "non-clinical testing" conducted by or for Olympus Medical Systems Corp. and Aomori Olympus Co., Ltd. (Japan). The specific location where the testing was physically conducted (e.g., country of origin of the data/testing) is not explicitly stated beyond the manufacturing location. These are laboratory/bench tests, not patient data.
• Retrospective or Prospective: Not applicable, as these are bench tests, not involving patient data or clinical follow-up.

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

• Not applicable. Ground truth, in the context of diagnostic device performance based on expert consensus, is not relevant here. The "ground truth" for the engineering and material tests is defined by the physical or chemical properties being measured (e.g., tensile strength, biocompatibility standards, dimensions).

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

• Not applicable. Adjudication methods are used in clinical studies with human readers/interpreters to establish a consensus ground truth. Here, the "truth" is determined by engineering test methods and established standards.

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 medical device (cytology brush), not an AI/software algorithm.

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

• Not applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.

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

• The "ground truth" for this device's performance is established by engineering and material standards, physical measurements, and biological compatibility tests. For example:
  • Dimensions: Met specified dimensions.
  • Strength/Durability: Passed defined stress tests (e.g., joint/tensile strength, general durability).
  • Biocompatibility: Demonstrated non-toxicity, non-irritation, non-hemolysis, etc., as per ISO 10993 series and USP standards.
  • Sterilization: Demonstrated effective sterilization and maintenance of sterility over shelf-life per ISO 11135 and ASTM F1980.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. (See #8)

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Used for collection of cells in the biliary system.

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush (subject devices) represent modifications made to the Wilson-Cook Double Lumen Biliary Cytology Brush and Fusion® Cytology Brush (predicate devices) cleared to market via 510(k) K171573 by Wilson-Cook Medical, Inc.

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushes consist of a nylon brush on a stainless-steel drive wire with a stainless-steel tip, a double lumen catheter with ink markings, radiopaque markers, wire guide access via a wire guide hub or an IDE port, a detachable extension line with a leur lock for optional flushing of the wire guide hub and a pinvise handle.

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushes are used by passing the device through an endoscope over a prepositioned wire guide to a target location. The cytology brush is located at the distal end (patient contacting) of the device with the pin vise handle located at the proximal end (non-patient contacting). The handle is actuated by pushing the pin vise handle forward to extend the cytology brush and then pulling backward to retract the brush.

This document is a 510(k) summary for a medical device (Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush) and primarily focuses on demonstrating substantial equivalence to a predicate device based on modifications and non-clinical bench testing. It does not present a clinical study or performance data related to AI/algorithm performance, which is what your request is specifically asking for regarding acceptance criteria, training/test sets, ground truth establishment, or human reader improvement with AI assistance.

Therefore, I cannot provide the information requested in your prompt based on the provided text, as the document does not contain any details about:

1. Acceptance criteria and reported device performance (in the context of an AI/algorithm). The "performance data" mentioned here refers to mechanical and material properties, not clinical diagnostic accuracy or AI metrics.
2. Sample sizes used for a test set or data provenance for an AI/algorithm.
3. Number of experts and their qualifications for establishing ground truth for an AI/algorithm.
4. Adjudication method for a test set for an AI/algorithm.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used for an AI/algorithm.
8. Sample size for the training set for an AI/algorithm.
9. How ground truth for the training set was established for an AI/algorithm.

The document states: "Performance testing consisting of non-clinical bench testing that demonstrates the subject devices met the performance requirements to fulfill their intended use. This testing provides reasonable assurance that the subject devices will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate devices." This highlights that the evaluation was primarily focused on bench testing for mechanical and material properties, not clinical performance metrics typical for AI-powered diagnostics.

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The Cytology Brush is used to collect cells from the bronchi and upper and lower gastrointestinal tracts.

The main component of the proposed device is Brush Head, Outer Sheath and Handle. The main operation is move the Finger Ring back and forth to achieve the movement of Brush Head, then the Brush Head can collect cells from the target site. The proposed device has seven (7) specifications, the main differences of these specifications are Diameter of Brush Head, Diameter of Outer Sheath and Working Length, Color of Finger Ring. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10° and placed in a sterility maintenance package to ensure a shelf life of 2 years.

This document, K172663, is a 510(k) Premarket Notification for a Cytology Brush. It compares the proposed device to a predicate device and demonstrates substantial equivalence.

It does not describe an AI/ML-based medical device. Therefore, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

Specifically, it lacks the following information that would typically be present for an AI/ML device:

• A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets used for evaluating AI performance.
• The number and qualifications of experts for ground truth establishment.
• Adjudication methods for AI training/test sets.
• MRMC studies or effect sizes of AI assistance on human readers.
• Standalone algorithm performance.
• Types of ground truth (e.g., pathology, outcomes data).
• Sample size and ground truth establishment for training sets.

The document discusses performance in terms of:

• Biological safety: Meeting ISO standards for biocompatibility and sterilization.
• Mechanical performance: Dimension testing, tensile strength testing.

These are standard for physical medical devices but not AI/ML performance.

Therefore, based on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria as requested, because this document pertains to a physical medical device (cytology brush), not an AI/ML device.

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The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush are used for collection of cells in the biliary system.

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush (subject devices) represent modifications made to the Wilson-Cook Double Lumen Biliary Cytology Brush (predicate device) currently cleared to market via 510K K040324 by Wilson-Cook Medical, Inc.

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushes consist of a double lumen catheter with ink markings, a cytology brush assembly with either a coil spring or bullet tip, a pin vise handle, wire guide hub, and a detachable connecting tube, which can be used for flushing of the wire guide hub. The endoscopic cytology brush is used by passing the device through an endoscope, over a prepositioned wire guide to the target location. The endoscopic cytology brush assembly is located at the distal (patient contacting) end with the pin vise handle located at the proximal (non-patient contacting) end. The handle is actuated by pushing the pin vise handle forward to extend the cytology brush and then pulling backward to retract the brush.

The provided text describes a 510(k) premarket notification for two cytology brushes, the Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than presenting a study to prove acceptance criteria for device performance in a clinical setting.

Therefore, many of the requested details regarding clinical study design, acceptance criteria, and performance metrics are not available in the provided text.

However, based on the information provided, here's what can be extracted:

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

The document mentions "performance requirements" were met through non-clinical bench testing. However, specific numerical acceptance criteria or reported performance values are not provided in the text. The non-clinical tests performed include:

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

• Sample Size: Not specified in the document. The testing mentioned is "non-clinical bench testing."
• Data Provenance: Not applicable as no clinical study or patient data is reported. The tests are benchtop tests.

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

• Not applicable. The document describes non-clinical bench testing, not a study involving human experts to establish ground truth.

4. Adjudication method for the test set:

• Not applicable. This pertains to clinical studies involving expert review and is not relevant to the described non-clinical bench testing.

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 describes a 510(k) submission for cytology brushes, not an AI-powered device, and no MRMC study is mentioned.

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

• No. This is not an AI device.

7. The type of ground truth used:

• Not applicable. For the non-clinical tests mentioned (shelf life, packaging validation, biocompatibility, and other performance bench tests), the "ground truth" would be established by the defined test methods and specifications for the device's physical and material properties, not from clinical outcomes or expert consensus on diagnostic interpretations.

8. The sample size for the training set:

• Not applicable. This is not an AI device and no "training set" is mentioned or implied.

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

• Not applicable. This is not an AI device.

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This device is used to collect cells from the bronchi or upper and lower gastrointestinal tracts.

The Bronchi and Gastrointestinal Cytology Brush (subject device) is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of stainless steel coil spring terminating in a nylon brush at the distal end. The coil spring and brush are secured inside an extruded polytetrafluoroethylene sheath. The brush is advanced from and retracted into the sheath.

The provided text describes a 510(k) premarket notification for a medical device and outlines its comparison to a predicate device and performance data. However, it does not contain the detailed acceptance criteria and the study that proves the device meets those criteria in the format requested.

Here's a breakdown of why the requested information cannot be fully extracted:

• Acceptance Criteria and Reported Device Performance Table: The document states that the device "meets the performance requirements to fulfill the intended use," but it does not list specific numerical acceptance criteria (e.g., minimum brush cell collection efficiency, maximum material degradation over time) or the quantitative results from testing against those criteria.
• Sample Size and Data Provenance (Test Set): No information regarding sample size for a test set, country of origin, or whether data was retrospective or prospective is present. The document mentions "performance testing," but no specifics on the test set are given.
• Number of Experts and Qualifications (Test Set Ground Truth): The document does not describe any study involving experts establishing ground truth for a test set. This type of information would typically be found in a clinical study report.
• Adjudication Method: Since there's no mention of a study involving experts and ground truth establishment, there is no information on an adjudication method.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The device is a physical cytology brush, not an AI or imaging diagnostic tool, so an MRMC study is not applicable to its evaluation.
• Standalone (Algorithm Only) Performance: Similar to the MRMC study, this is not relevant as the device is a physical tool and not an algorithm.
• Type of Ground Truth Used: No information on what type of ground truth was used for performance validation is provided, as specific study details are absent.
• Sample Size for Training Set: The document does not mention any training set, as it refers to a physical device rather than a machine learning model.
• How Ground Truth for Training Set was Established: Again, this is not applicable for the described device.

What the document does provide regarding performance:

The document states:

"Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrate that the Bronchi and Gastrointestinal Cytology Brush meets the performance requirements to fulfill the intended use of the device."

This indicates that a range of tests were performed, but the specific details requested are not disclosed in this summary. These details would typically be found in the full technical documentation submitted as part of the 510(k) application, which is not included here.

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