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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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