Search Results

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 The Subject Device is then withdrawn from the bronchoscope channel with the collected samples.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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Fiber Optic Brushless Electric Micromotor Set (iM100) is a brushless DC electric micromotor controlled by a control unit. It is intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. It is indicated for use in the field of preventive applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.

The Fiber Optics Brushless Electric Micromotor Set, which model is iM100, is an electric device system comprised of brushless electric motor, control box, motor cord, and AC adapter. The Fiber Optics Brushless Electric Micromotor Set is designed to accommodate equal speed, gear-reduction speed, or gear-increasing speed handpiece attachment for the purpose of performing dental restoration procedures. Brushless electric motor utilize Permanent Magnet Synchronous Motor (PMSM) to offer stable torque, control box adjust the maximum speed and direction of brushless electric motor and show actual speed rate simultaneously, motor cord connect electric motor, control box and dental unit to offer handpiece water, air coolant and electricity. When equipped with the electric micromotor, the handpiece attachments provide the same effective drive force as would be provided by existing air motors. With motor control technology allows handpieces regardless of the front-end dental treatment operations or exposure to different functional groups or dental restorative material, and the speed of the drill can be kept within a certain extent but not easily change the load that make brushless electric motor operation is more easily and efficiently, unlike the operation of the air motor handpiece need to keep relied dentist technical experience. The Fiber Optics Brushless Electric Micromotor Set could control the speed range from 2,000 to 40,000 rpm.

The provided text is a 510(k) summary for a dental micromotor, not an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, expert involvement, or MRMC studies relevant to AI/ML device performance.

This document focuses on establishing substantial equivalence to a predicate device through non-clinical testing of safety and performance for a physical medical device. It does not involve AI algorithms, image analysis, or ground truth establishment in the context of diagnostic or prognostic tasks.

To answer your prompt, I would need a document related to an AI/ML medical device.

Ask a specific question about this device

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.

Ask a specific question about this device

The Oral-B® iO Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene.

The Oral-B® iO Test Drive Power Brush Trial Program Kit is indicated for use under the direct supervision of a dental professional, exclusively at conventions (e.g. professional, scientific, trade shows), as part of the Oral-B® iO Test Drive Power Brush Trial Program.

The Oral-B® iO Test Drive Power Brush Trial Program for conventions (e.g. professional, scientific, trade shows), is designed to introduce convention delegates to the newest, most advanced Oral-B electric rechargeable toothbrush as a means to promote good oral hygiene. The program kit contains a power toothbrush consisting of a rechargeable handle, a charger, replacement brush heads, and instructions for the proper use and care of the device. The program kit also contains plastic dental sheaths to prevent soiling and therefore allowing for easier cleaning of the multi-user handle. The sheath is manufactured by TIDI Products, LLC, is provided to Procter & Gamble as a finished, packaged non-sterile device (K132953) for inclusion in the program kit as an accessory. Detailed instructions for cleaning and disinfection of the reusable handle are also included. The program kit is indicated for use as an introductory trial, exclusively within the confines of a convention (e.g. professional, scientific, trade shows), under the direct supervision of a dental professional as part of the Oral-B® iO Test Drive Power Brush Trial Program.

The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding a powered toothbrush. It concerns the "Oral-B iO Test Drive Power Brush Trial Program Kit" (K200881). The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Oral-B Test Drive Power Brush Trial Program Kit, K141018) and a reference device (Oral-B iO Rechargeable Power Toothbrush, a Class I, 510(k) exempt device).

The information provided does not relate to an AI/ML medical device, a multi-reader multi-case (MRMC) comparative effectiveness study, or the use of AI assistance for human readers. It lists performance data for a physical device, including biocompatibility, electrical safety, software verification, and cleaning/disinfection validation. Therefore, many of the requested categories related to AI/ML device performance and study design (e.g., sample size for test/training sets for AI, expert adjudication, ground truth definition for AI, effect size of AI assistance) are not applicable to this document.

However, I can extract the relevant acceptance criteria and how the device meets them based on the provided "PERFORMANCE DATA" section.

Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a physical medical device (a powered toothbrush) and not an AI/ML algorithm, the "acceptance criteria" are typically defined by compliance with recognized standards and successful completion of specific non-clinical and performance tests to demonstrate safety and effectiveness for its intended use, and ultimately substantial equivalence to a predicate device. The performance data section describes how the device meets these requirements.

Here's a table summarizing the "acceptance criteria" (or performance areas tested for compliance) and the reported device performance:

Since this is not an AI/ML device, the following points are largely not applicable or cannot be definitively answered from the provided text:

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

   • For biocompatibility, electrical safety, EMC, and software, "samples" are devices or components. Specific numbers of units tested are not provided in this summary, but these are typically engineering and lab tests, not clinical studies with human subjects for efficacy.
   • For Cleaning and Disinfection Validation, the document mentions testing under "simulated normal use and worst-case scenario for wear" and establishing a "reuse life of 240 uses." This number (240 cycles) could be considered a "sample size" for this specific durability test.
   • For Human Factors Usability testing, "several formative and a summative" studies were performed. The number of participants in these studies (i.e., "sample size") is not specified.
   • Data Provenance: The manufacturer is Procter & Gamble Manufacturing GmbH (Marktheidenfeld, Germany) and distributed in the U.S.A. by Procter & Gamble, Co. (Cincinnati, Ohio). The studies are non-clinical, not patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., highly accurate disease labels) is not relevant for this type of device submission. The "ground truth" here is compliance with engineering standards and predefined performance specifications. Expert validation is implicitly part of these standardized testing processes (e.g., certified labs, qualified engineers).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is typically related to expert review of medical images or patient data for ground truth establishment in AI/ML studies.

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 powered toothbrush, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is a software component (Level of Concern - Moderate), but it's part of the device's function (e.g., user interface, power management, potentially guidance for cleaning), not a standalone diagnostic algorithm. The software verification confirms it "performs as intended."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from:

   • Compliance with recognized standards: ISO 10993 (biocompatibility), UL 1431, IEC 60335 series, ISO 20127 (electrical safety), 47 CFR Parts 15B, 15C, 18 (EMC).
   • Successful completion of pre-defined non-clinical tests: Cleaning/disinfection validation (e.g., microbial reduction, material integrity), Human Factors Usability (user ability to follow instructions).
   • Performance against specifications: e.g., reuse life, satisfactory cleaning/disinfection.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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)

Ask a specific question about this device

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.

Ask a specific question about this device

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