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

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 The Subject Device is then withdrawn from the bronchoscope channel with the collected samples.

The Subject Device consists of:

• Handle
• Insertion portion

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

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

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

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

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

Acceptance Criteria and Device Performance for Disposable Cytology Brush

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

6. Standalone (Algorithm Only) Performance

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

7. Type of Ground Truth Used

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

8. Sample Size for the Training Set

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

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

• Not applicable. See point 8.

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

Not Found

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Not applicable. This is a physical medical device (cytology brush), not an AI/software algorithm.

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

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

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

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

8. The sample size for the training set:

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

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

• Not applicable. (See #8)

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To be utilized through a flexible endoscope or the superDimension system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.

The superDimension® Triple Needle Cytology Brush is designed to obtain tissue samples for biopsy from endobronchial lesions, peripheral lung nodules, or lung masses. The superDimension® Triple Needle Cytology Brush is an endoscopic catheter comprised of an outer Ethylene Tetrafluoroethylene (ETFE) sheathing and an inner catheter assembly. The inner catheter assembly consists of a thumb ring at the proximal end and a twisted wire shaft to connect to the distal end. The distal end terminates in three connected brushes available in two lengths: 10 mm and 15mm. The brushes have sharpened ends, referred to as needle-tipped, that can be used to rough up tissue to obtain a sample of tissue or cells. When the catheter is inserted into a channel such as a bronchoscope or superDimension Extended Working Channel (EWC) with the distal brush in a retracted position inside the outer sheath. When the catheter is in position, the brushes can be extended into the tissue to obtain tissue samples by advancing the proximal thumb ring. When the physician believes that an adequate sample has been taken, the brushes are retracted back into the sheath and then the entire catheter is withdrawn from the channel The superDimension® Triple Needle Cytology Brush is for standard tissue analysis. similar to currently marketed cytology brushes except that it has three smaller brushes in place of one larger brush.

The provided text describes the 510(k) summary for the Covidien SuperDimension® Triple Needle Cytology Brush. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria with specific numerical thresholds for performance metrics. Instead, it states that the device "met the required specifications for the completed tests and performed similarly to the predicate devices." The performance evaluation is based on demonstrating substantial equivalence to predicate devices, rather than achieving pre-defined quantitative performance targets.

However, based on the described "Performance Data," we can infer the categories of performance evaluated:

• Catheter tensile strength
• Dimensional accuracy
• Ability to simulate use cases
• Trackability | Met required specifications; similar to predicate devices. |
  | Durability/Stability| - Shelf life (per ASTM F1980-07, ASTM F2096-11, and ASTM F88-09)
• Distribution integrity (per ASTM D4169-09) | Met required specifications; similar to predicate devices. |
  | Sterilization | - Sterility (per ISO 11135-1) | Met required specifications; similar to predicate devices. |
  | Biocompatibility | - Cytotoxicity, irritation, sensitization (per ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10) | Met required specifications; similar to predicate devices. |
  | Functional (In Vivo)| - Ability to collect tissue specimens
• Safety (no adverse events/complications in the animal model) | Demonstrated tissue collection and safety in a porcine model; similar to predicate devices. |

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

The document mentions "In-vitro and in-vivo testing" was performed, but does not specify the sample sizes used for these tests. For the in-vivo testing, it was conducted "in a porcine model," indicating an animal study, not human data. The data provenance is described as:

• In-vitro testing: Laboratory-based, likely conducted by the manufacturer.
• In-vivo testing: Porcine model (animal study).

There is no mention of human retrospective or prospective data for the performance evaluation.

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

This information is not provided in the document. Given that the testing involved in-vitro and in-vivo (animal model) studies, the "ground truth" would likely be established through objective measurements (for in-vitro tests) and pathological examination of collected animal tissue, possibly by veterinarians or animal pathologists. However, the specific number and qualifications of experts are not stated.

4. Adjudication Method for the Test Set:

This information is not provided. As the testing primarily involved objective measurements and animal studies, a formal adjudication method for human consensus on ground truth (like 2+1 or 3+1) would not be applicable in the absence of human clinical data or expert evaluation of test results.

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 MRMC comparative effectiveness study was done, nor is there any mention of AI assistance in this context. The device described is a physical medical instrument (cytology brush), not an AI-powered diagnostic or assistive tool.

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

This question is not applicable as the device is a physical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Based on the described testing:

• For in-vitro tests, the ground truth would be based on objective physical and material measurements against established engineering specifications and industry standards.
• For in-vivo testing in a porcine model, the ground truth for tissue collection would likely be pathological examination of collected animal tissue samples to confirm the presence and adequacy of collected cells/tissue. Safety would be assessed through observation and potentially post-mortem examination.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical instrument, and there is no mention of an algorithm or AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set mentioned for this physical device.

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