Search Results

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.

Ask a specific question about this device

BRUSH&BOND® PLUS is indicated for:

1. Direct Dental Restorations (e.g., resin-modified glass ionomer, resin core build-ups, compomers).
2. Indirect Dental Restorations (e.g., metal, resin-based composite, dental ceramics (e.g., porcelain, pressed ceramic, lithium disilicate, zirconia).
3. Desensitization of dentin.
4. Sealing of dentin, cementum or enamel.

BRUSH&BOND® PLUS is a self-etching. self-priming. light-cured bonding system which utilizes proven 4-META chemistry to enhance penetration into prepared enamel and dentin surfaces and to establish strong bonds to dental surfaces such as restorative composites, metals, dentin, enamel, cementum, and dental ceramics (e.g., porcelain, lithium, disilicate, zirconia, or hybrid ceramics). The Device is useful for all direct dental restorations, desensitizing teeth, and sealing tooth structures against microleakage. Moreover, the Device can be used without prior acid-etching of dentin or cutting of enamel surfaces.
The BRUSH&BOND® PLUS device is essentially a single-bottle, two-component system, comprising: a liquid resin which comprises monomers and 4-META chemistry, and an activator brush which comprises a bonding promoter to ensure complete activation and polymerization when contacted with the liquid resin. After activation, the activated resin can be applied directly onto restorative surfaces (except dental ceramic surfaces) using the activator brush or any appropriate dental instrument. For ceramic surfaces, the surface must first be coated with a ceramic primer (such as EaZy Primer'M,510K no. 142848) before the activated resin is applied.
BRUSH&BOND® PLUS is packaged as a single 3 mL bottle of liguid resin, an accompanying canister containing 100 activator brushes (either standard size or mini/endo size), and accompanying bottles of Parkell's ceramic rimer Ea Primer'M 5mL "A" and "B" bottles).

The provided text does not contain the acceptance criteria or a study proving that the "Brush & Bond® Plus" device meets such criteria.

This document is a 510(k) premarket notification for a dental bonding agent. It aims to demonstrate substantial equivalence to previously cleared devices, rather than presenting a study where specific acceptance criteria are defined and then met by the device's performance.

Here's a breakdown of why the requested information is largely absent given the input:

• Acceptance Criteria and Reported Device Performance: The document doesn't provide a table of acceptance criteria or specific performance metrics that "Brush & Bond® Plus" is required to meet as a standalone device against a pre-defined standard in real-world or simulated clinical scenarios. Instead, it compares its properties (like bond strength and biocompatibility) to predicate devices to establish substantial equivalence.

  • What is reported: The document states, "The Shear and Tensile Bond Strength tests were performed in accordance with ISO/TS 11405. The shear and tensile strength tests were compared to the Predicates and were determined to be equivalent." This indicates comparative testing, not testing against independent acceptance criteria.

• Sample size used for the test set and data provenance: Not explicitly mentioned for the bond strength tests. The document only states that "The shear and tensile strength tests were compared to the Predicates," without detailing the number of samples or whether the data was prospective or retrospective, or its country of origin.

• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The testing seems to be laboratory-based (shear and tensile bond strength tests), not dependent on expert interpretation of clinical data in the way a diagnostic AI device would be.

• Adjudication method: Not applicable for this type of test.

• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is relevant for diagnostic devices where human readers interpret images or data. This document is for a dental bonding agent, and the evaluation focuses on physical and chemical properties.

• Standalone performance: The document describes "non-clinical testing" including "Shear and Tensile Bond Strength tests" performed in accordance with ISO/TS 11405. This refers to laboratory testing of the material's properties, which could be considered a form of standalone performance evaluation for the material itself, but not in the context of an "algorithm only without human-in-the-loop performance" typical for AI devices.

• Type of ground truth used: For the bond strength tests, the "ground truth" would be the measured physical properties (e.g., force required to break the bond) obtained through standardized testing methods (ISO/TS 11405), rather than expert consensus, pathology, or outcomes data.

• Sample size for the training set: Not applicable, as this is not an AI/machine learning device.

• How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on demonstrating substantial equivalence of a dental bonding agent to existing predicate devices based on technological characteristics and non-clinical performance (like bond strength and biocompatibility), rather than presenting a study of a diagnostic AI device against pre-defined acceptance criteria.

Ask a specific question about this device