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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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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 Brush Biopsy Sets are intended to obtain pathology specimens from lesions in the ureter, renal pelvis, infundibula or calyces under direct vision.

The Deflectable Brush Biopsy Set is designed to be used through rigid or flexible endoscopes in order to obtain pathology specimens from lesions in the ureter, renal pelvis, infundibula, or calyces under direct vision. The Deflectable Brush Biopsy Set consists of a stainless steel shaft, radiopaque polytetrafluoroethylene catheter, and a nylon brush at the distal tip. The Deflectable Brush Biopsy Set is 3.2 French with a length of 115 centimeters. The Deflectable Brush Biopsy Set has a 3-ring handle at the proximal end that allows for deflection of the brush tip to within 15° from the shaft. The stainless steel shaft of the brush assembly is straight for the length of the catheter, and protrudes 6 centimeters from the distal tip of the catheter.

The sets will be supplied sterile and are intended for one-time use. The sets are packaged in a tray with lid in a peel-open pouch with a three-year shelf life.

The Deflectable Brush Biopsy Set subject of this submission have the same intended use, materials, dimensions, sterilization method, and shelf life as the Cook devices subject of reference submission Brush Biopsy Sets and Deflectable Brush Biopsy Set (K182231).

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Deflectable Brush Biopsy Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through extensive clinical trials or AI performance evaluations.

Therefore, the information requested in your prompt regarding acceptance criteria, study design for AI models, ground truth establishment, expert consensus, and human reader performance with AI assistance is not typically found or required in a 510(k) submission for a non-AI medical device like the Deflectable Brush Biopsy Set.

The document describes the device, its intended use, comparison to predicate devices, and "Performance Data" which, in this context, refers to engineering and biological testing to ensure the device meets its design specifications and is safe for use, not performance metrics of an AI algorithm.

Let's break down why this document doesn't contain the requested information about AI performance:

• Device Type: The "Deflectable Brush Biopsy Set" is a mechanical medical device used to obtain pathology specimens. It's a physical tool, not a software algorithm or an AI-powered system for diagnosis or analysis.
• Regulatory Pathway (510(k)): The 510(k) pathway is for devices that are "substantially equivalent" to predicate devices. This typically involves demonstrating similar technological characteristics, intended use, and safety/performance through bench testing, biocompatibility, and sometimes limited clinical data, but not usually large-scale performance studies like those required for novel AI/ML devices.

However, I can extract the "performance data" that is mentioned in the document, which pertains to the physical device's characteristics and safety:

Acceptance Criteria and Device Performance (as described for a physical medical device, not an AI model):

The document lists the types of testing performed to demonstrate that the Deflectable Brush Biopsy Set met applicable design and performance requirements. These are typically internal acceptance criteria based on engineering specifications and regulatory standards. The document states that the "results of these tests support a conclusion that the Deflectable Brush Biopsy Set will perform as intended."

While specific numeric acceptance criteria values are not provided in this public summary, the categories of testing performed imply the criteria that were met.

Since this is a filing for a mechanical device and not an AI/ML-driven diagnostic tool, the following points from your prompt are not applicable and therefore not found in the provided document:

1. Sample sizes used for the test set and the data provenance: Not applicable in the context of an AI test set. Performance testing likely involved a number of physical units, but not "data provenance."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic AI algorithm needing ground truth.
3. Adjudication method for the test set: Not applicable.
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: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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The Brush Biopsy Sets are intended to obtain pathology specimens from lesions in the ureter, renal pelvis, infundibula or calyces under direct vision.

The Brush Biopsy Set and Deflectable Brush Biopsy Set are designed to be used through rigid or flexible endoscopes in order to obtain pathology specimens from lesions in the ureter, renal pelvis, infundibula, or calyces under direct vision. The Brush Biopsy Set consists of a stainless steel shaft, a catheter, and a nylon brush at the distal tip. The Brush Biopsy Set is available in two sizes: 3.2 French with a length of 115 centimeters, or 5 French with a length of 67 centimeters. The 3.2 French version has a stainless steel wire shaft, a catheter constructed of radiopaque polytetrafluoroethylene, and a connector cap and pin vise located at the proximal end. The 5 French version has a stainless steel coil shaft, a catheter constructed of vinyl radiopaque tubing, and a side-arm adapter attached to the proximal end.

The Deflectable Brush Biopsy Set consists of a stainless steel shaft, a radiopaque vinyl catheter, and a nylon brush at the distal tip. The Deflectable Brush Biopsy Set is 5 French with a length of 67 centimeters. The Deflectable Brush Biopsy Set has a 3-ring handle at the proximal end that allows for deflection of the brush tip to within 15° from the shaft.

The stainless steel shaft of the brush assembly is straight for the length of the catheter, and protrudes 7 centimeters from the distal tip of the catheter on the 5 French Deflectable Brush Biopsy Set to allow for deflection.

The sets will be supplied sterile and are intended for one-time use. The sets are packaged in a peel-open pouch with a three-year shelf life.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Brush Biopsy Set and Deflectable Brush Biopsy Set, as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes performance testing rather than specific, quantified acceptance criteria with corresponding numerical results. Instead, it lists the types of tests performed to demonstrate that the device "met applicable design and performance requirements." It concludes that the device "will perform as intended" based on these tests.

Therefore, I cannot create a table with specific numerical acceptance criteria and reported device performance. The document only lists the categories of tests conducted.

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

The document does not specify the sample sizes used for any of the tests (e.g., number of devices tested for tensile strength, number of porcine models used, etc.). It also does not explicitly state the provenance of the data (country of origin, whether retrospective or prospective). The testing appears to be conducted by the manufacturer, Cook Incorporated.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to the type of device and testing described. The Brush Biopsy Set and Deflectable Brush Biopsy Set are physical medical devices used for specimen collection. The "ground truth" in this context would relate to the physical properties and functionality of the device itself (e.g., did it break, did it corrode, did it successfully collect a specimen in a model). Expert interpretation of images or clinical data (which is where expert ground truth and adjudication are typically relevant) is not mentioned as part of the performance data.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3. Adjudication methods like 2+1 or 3+1 are used for establishing a consensus ground truth among multiple experts, particularly in image interpretation or clinical diagnosis studies. The performance data here pertains to engineering and material testing of a physical device.

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 assesses how AI assistance impacts human readers' performance in tasks like diagnostics. The device described is a physical tool for biopsy, not an AI-powered diagnostic system.

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

No, a standalone algorithm performance study was not done. The device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context would be based on:

• Engineering specifications and standards: For dimensional verification, tensile strength, and corrosion.
• Direct observation and measurement: For simulated use, bristle integrity, and acute performance in the porcine model (e.g., successful specimen collection, device integrity during use).
• Laboratory analysis: For biocompatibility and sterilization efficacy.
• Environmental testing: For packaging/distribution and shelf life/stability.

There is no mention of expert consensus, pathology (beyond the specimens collected by the device), or outcomes data used to establish the "ground truth" for the device's technical performance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument; it does not involve a training set as would be used for machine learning or AI models.

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

This information is not applicable for the reasons stated in point 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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The Infinity® ERCP sampling device is intended to retrieve cytological cell samples in the gastrointestinal tract.

Not Found

The provided text is an FDA 510(k) clearance letter for the Infinity ERCP Sampling Device. It states that the device is substantially equivalent to legally marketed predicate devices and is intended to retrieve cytological cell samples in the gastrointestinal tract.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details requested in the prompt.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the study that proves the device meets those criteria, as this information is not present in the provided text.

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The disposable Cytology Brush is intended to retrieve cytological cell samples in the gastrointestinal tract

Cytology Brush

The provided document is a 510(k) clearance letter from the FDA for a device called "US Endoscopy Cytology Brush." It does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth methodologies as requested in the prompt.

This document is a regulatory approval notice, not a study report. Therefore, I cannot extract the requested information from the given text.

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